Scott Gottlieb Calls It Quits After an Active Tenure at US
Medtech Issue 134 Pharma Intelligence Informa
March 11, 2019 medtech.pharmaintelligence.informa.comInsight Scott Gottlieb Calls It Quits After An Active Tenure At US FDA DAVID FILMORE [email protected] FERDOUS AL-FARUQUE [email protected] SUE DARCEY [email protected]
cott Gottlieb abruptly resigned his Drugs in the next month," Gottlieb wrote. post as FDA Commissioner March 5, "There’s perhaps nothing that could pull S effective in one month. me away from this role other than the The news came as a surprise to agency challenge of being apart from my family watchers. In his 22 months on the job, Got- for these past two years and missing my tlieb has instituted some significant reor- wife and three young children." ganizations, and he is generally viewed as Gottlieb stated, however, he still has Scott Gottlieb has led FDA for one of the more popular agency officials in work to do in the month ahead, including the past 22 months. the Trump administration. He is praised by securing next year’s budget and helping industry as a supporter of innovation, but the agency transition to a new leadership. health challenges, including greater use he has also gained respect of many in the “I’ll be working closely with the Secre- of medtech to combat the opioid crises.” public health community for his work, for tary of Health and Human Services, Alex Mark Leahey, CEO of the Medical Device instance, in countering youth smoking. Azar, who is a friend to me and a staunch Manufacturers Association, also voiced And he has attracted a substantial fol- advocate for the agency,” he added. his admiration for Gottlieb’s work at the lowing on social media, where he regu- Azar isn’t Gottlieb’s only friend who will be helm calling him a “tremendous leader” larly tweets substantive updates on FDA sad to see him leave. The commissioner was who supported patient care and medical policies and support for his staff.(Also see seen positively by the medical device in- innovation. "Gottlieb Takes To Twitter To Raise FDA Mo- dustry and, especially, AdvaMed CEO Scott “He has initiated regulatory reforms rale Amid Shutdown" - Medtech Insight, 3 Whitaker, who says he is a personal and pro- that will impact our ecosystem for years Jan, 2019.) fessional friend of the commissioner. to come,” he added. In a memo sent by Gottlieb to FDA staff “We want to thank Dr. Gottlieb for his Robert Califf, Gottlieb's predecessor at on March 5 he suggested the decision service to the American public and his FDA, who serve as commissioner under was made so he can spend more time commitment to ensuring patients have the Obama administration, said the resig- with his family, who live in Connecticut access to the latest treatments, diagnos- nation is a "big loss for the country." while he commutes to FDA headquarters tics and cures,” Whitaker said. “During in Maryland. his tenure as FDA commissioner, Dr. Got- ACTIVIST COMMISSIONER "It is hard for me to write this note to tlieb has been a tireless advocate for im- The resignation could put the brakes on share with you the news that I’ll be leaving proved patient care and for promoting what has been an extremely active period my job as the Commissioner of Food and innovative solutions to our most pressing CONTINUED ON PAGE 5
FROM THE EDITORS OF: THE GRAY SHEET, CLINICA, START-UP AND MEDTECH INSIGHT NEWSLETTER
POLICY & REGULATION COMMERCIAL R&D VA device purchasing reforms, p. 5 2018 earnings spotlights, p. 7-10 Clinical trials results recaps, p. 13 FDA FORUM PMA/510(k) Workshop and FDA Forum
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explore more: inside: Cover / Scott Gottlieb Calls It Quits After An Active Tenure At US exclusive online content FDA – The commissioner says he will step down next month, leaving a legacy of active policy development, but also a lot of What's next in Congress for medtech? initiatives and pilot projects that are still in the works. https://bit.ly/2TCz8tC https://bit.ly/2Tk86YF EDITORS' PICKS https://bit.ly/2CNFhYy 5 VA Medical Supply Purchasing Reform Could Open Overviews of medtech-related legislation that will be New Doors – The US Department of Veterans Affairs is under consideration in the US House and Senate, and our giving the VA’s four prime vendors for medical and surgical Congress Tracker. supplies more latitude to directly choose suppliers as part of ongoing updates to the Medical/Surgical Prime Vendor.
EU highlights https://bit.ly/2XGK2Ow COMMERCIAL 7 2018 Earnings Spotlight: Stryker And Nuvasive Lead A roundup of the top stories on EU regulatory and The Ortho Pack In 2018 –NuVasive and Stryker reported policy issues in February, including a major focus on the high single-digit growth while Smith & Nephew grew in the potential implications of Brexit. low single-digits, fueling reports that Smith & Nephew may try to buy NuVasive. Corin buy https://bit.ly/2H4ukHN 8 2018 Earnings Spotlight: Transcatheter Valve Repair Hip and knee replacement firm Corin Group is taking its Remains Big Driver For Medtronic, Edwards, Abbott – digitally-connected ecosystem concept a stage further Reported sales and earnings from the publicly traded after agreeing to acquire US-based Omni Orthopaedics. cardiovascular device companies in 2018 were generally strong, led by transcatheter aortic valve devices. iRhythm momentum https://bit.ly/2EDphdS 11 ECR 2019: Philips Launches New CT System With Lifetime Results from a study of more than 91,000 records Guarantee – Philips is offering a lifetime warranty for its collected with iRhythm’s Zio ambulatory continuous Incisive CT, unveiled at the European Congress of Radiology cardiac monitoring device gives the 12-year-old (ECR) in Vienna. Phillips hailed the warranty an “industry first” company confidence that it will be profitable very soon. putting them ahead of the curve with competitors.
Device Week 11 ECR 2019: Siemens Healthineers Unveils 'One Stop Shop' https://bit.ly/2y4lpgk Stroke System – Siemens Healthineers has unveiled its new Check out the latest episode of Medtech Insight's weekly 'one stop shop' stroke system, the Artis icono angiography podcast for a discussion the surprise resignation of US system, at the recent European Congress of Radiology. FDA Commissioner Scott Gottlieb.
12 Inogen's Stock Collapses After Earnings Call Addressing medtech.pharmaintelligence.informa.com Short-Seller Concerns – Inogen acknowledged data from its previous research firm were inaccurate on its latest investor call. medtech.pharmaintelligence.informa.com March 11, 2019 | Medtech Insight | 3 13 Survey Suggests 'New Normal' In Securities Suits Against Life Sciences Firms – A recent survey by law firm Dechert LLP found that 86 class action suits were filed Medtech insight against life sciences companies in 2018 - a slight drop from DAVID FILMORE @MEDTECHDAVID 2017, but still 350% higher than just a few years before. [email protected] SHAWN M. SCHMITT @MEDTECHSHAWN [email protected] R&D REED MILLER @MEDTECHREED 14 Results Recap: Support For Medtonic's 'Suspend [email protected] Before Low' Insulin Pump Feature; Neuroelectrics' AMANDA MAXWELL @MEDTECHAMANDA Starstim Treats Epilepsy Seizures – Medtech Insight's [email protected] Results Recap covers major device trial results appearing MARION WEBB @MEDTECHMARION on MedDeviceTracker. The latest edition, covering Feb. 22 [email protected] through Feb. 28, includes Myriad’s companion diagnostic SUE DARCEY @MEDTECH_INSIGHT for pancreatic cancer. [email protected] FERDOUS AL-FARUQUE @MEDTECH_DANNY 15 Starts & Stops: First-In-Human Trial Of RaniPill Drug- [email protected] Delivery Device Begins – Starts & Stops compiles all the ELIZABETH ORR @ELIZABETHJORR clinical trial announcements, initiations, completions and [email protected] suspensions tracked by MedDeviceTracker. CATHERINE LONGWORTH @MEDTECHCATE [email protected] ASHLEY YEO @ASHLEYPYEO POLICY & REGULATION [email protected] 16 EU MDR Transparency Not Enough: Time For A Big MAUREEN KENNY @SCRIPREGMAUREEN Debate? – Increased transparency is often highlighted [email protected] as one of the major steps forward in the new EU Medical NEENA BRIZMOHUN @SCRIPREGNEENA Device and IVD Regulations. Some participants at a Feb. [email protected] 27 European Parliament committee meeting believe the VIBHA SHARMA @SCRIPREGVIBHA changes do not go far enough. [email protected] ANDREA CHARLES CUSTOM CONTENT 18 EMA Issues Guidance On Medical Devices That Are [email protected] Integral To Pharma Products – The Medical Devices JANET HANIAK SENIOR DESIGNER Regulation is the vehicle to clarify the role of EU notified GAYLE REMBOLD FURBERT DESIGN SUPERVISOR bodies in medicinal products with integral medical devices, RICHARD FAINT HEAD OF MEDTECH such as pre-filled syringes. New guidance from the EMA [email protected] on the MDR shows how the pharma and device sectors are PHIL JARVIS MANAGING DIRECTOR working increasingly collaboratively. TO SUBSCRIBE, VISIT medtech.pharmaintelligence.informa.com 19 UK Regulator Reveals Post-Brexit Fees Under New TO ADVERTISE, CONTACT Registration Scheme – Will your company be impacted [email protected] by the UK MHRA’s new registration scheme in the event of EDITORIAL OFFICE: a no-deal Brexit? What will it cost you, and how frequently 601 Third Avenue, New York, NY 10158 US will you have to pay? phone 212-520-2700 CUSTOMER CARE: 20 Medical Device Registration In UK Under A No-Deal [email protected] Brexit: Questions Answered – The UK government is US Toll-Free...... +1 888 670 8900 introducing new registration requirements for medical US Toll...... +1 908 547 2200 devices in the event of a no-deal Brexit. UK & Europe...... +44 (20) 337 73737 Australia...... +61 2 8705 6907 Japan...... +81 3 6273 4260 21 US FDA Inspection Goals Reduced After Shutdown; All stock images in this publication courtesy of www.shutterstock.com Review Dates Look Safe – Commissioner Scott Gottlieb tells unless otherwise stated Congress FDA won’t meet all its planned inspection goals © 2019 Informa Business Intelligence, Inc., an Informa company. All rights reserved. after a month-long partial government shutdown, but he No part of this publication may be reproduced in any form or does not expect a noticeable impact on product reviews. incorporated into any information retrieval system without the written permission of the copyright owner.
4 | Medtech Insight | March 11, 2019 © Informa UK Ltd 2019 � COVER STORY � of policy development at FDA under Got- back from some in the medtech sector can serve as alternatives to opioids or that tlieb. Since Gottlieb took over in 2017, the suggesting that FDA gave Apple special can help treat addiction. agency launched initiatives, published treatment. (Also see "FDA's Speedy Apple guidance documents and advanced pilot Watch De Novos Raise Questions For Indus- DEVICE SAFETY GETS ATTENTION, programs at a rapid rate. (Also see "How try" - Medtech Insight, 24 Sep, 2018.) BUT ADVOCATES UNIMPRESSED A Rapid, Well-Messaged US FDA Offense Is In general, during Gottlieb's tenure, Aside from Gottlieb's reputation as a sup- Driving Spectators To Their Feet And Twitter FDA advanced a more "firm-based" porter of innovation, he has been also Accounts" - Medtech Insight, 22 Aug, 2018.) rather than "product-based" oversight been very active and vocal about pushing One area this was felt in the medtech approach, where a company can let the policies to improve oversight of medical realm was in his major push to establish agency look under its hood, so to speak, product safety, in some cases making in- a new regulatory framework for digital and if FDA likes what it sees, it will allow dustry nervous. health. Gottlieb prioritized a light-touch the firm to move forward with less regu- The device center issued a "Medical De- approach for FDA oversight of software latory scrutiny. (Also see "US Regulatory vice Safety Action Plan" last year that in- tools and championed the promise of digi- Roundup, 2018: 5 Core Issues That Help Ex- cludes some initiatives that have industry tal health technologies to transform health plain The Year In Medtech Policy" - Medtech buy-in, such as work on the National Evalu- care. He lent his support, for instance, to Insight, 4 Jan, 2019.) In addition to the ation System for health Technology (NEST), a nascent "pre-certification" paradigm, digital health pre-certification program, and others that worry device companies. where companies might undergo a special Gottlieb has also championed a similar For instance, Gottlieb has advanced re- appraisal to prove operational excellence approach in the realm of diagnostics, forms to the 510(k) program that would put in exchange for reduced, or even elimi- establishing a streamlined path for 23an- more restrictions on use of predicate de- nated, pre-market requirements. (Also dme genetic screening services. (Also see vices and give FDA more leeway to upclas- see "2019 Will Be Testing Period For US FDA's "US FDA Implements 'Firm-Based' Regula- sify products outside of the 510(k) realm. Novel Pre-Cert Paradigm For Digital Health tory Approach To DTC Genetic Health Risk (Also see "An FDA Age-Based Predicate Policy " - Medtech Insight, 8 Jan, 2019.) Tests" - Medtech Insight, 6 Nov, 2017.) Would Be Arbitrary, Reg Experts Complain" - The agency's push to work with tech And, somewhat similarly, FDA has rap- Medtech Insight, 12 Dec, 2018.) companies entering the health sector, idly advanced work on a program that In the wake of growing public scru- though, has also led to pushback. In Sep- allows companies' manufacturing facili- tiny on device safety, with the release of tember, Gottlieb joined device-center ties to undergo "maturity" appraisals and the Netflix documentary "The Bleeding director Jeff Shuren in issuing a press re- gain regulatory benefits as a result. (Also Edge" in July and the public launch of lease touting the de novo classification/ see "Assessing A Device-Maker's Manufac- the "Implant Files" investigation by the clearance of electrocardiogram software turing Capability Is Serious Business For International Consortium of Investigative on the latest version of the Apple Watch. These 2 Longtime CMMI Appraisers. Here’s Journalists in November, Gottlieb has in- (Also see "FDA: Apple De Novo Approvals Their Story" - Medtech Insight, 20 Sep, 2018.) creasingly made efforts to tout the agen- Signal Innovation To Digital Health Firms" Gottlieb also put significant emphasis cy's efforts to promote patient safety. - Medtech Insight, 12 Sep, 2018.) Several during his tenure on fighting the opioid Of note, in November, Gottlieb pledged weeks later, Gottlieb felt the need to epidemic, including championing incen- that FDA would be "consistently first defend the approval following push- tives for the development of devices that CONTINUED ON PAGE 22
� EDITORS’ PICK� VA Medical Supply Purchasing Reform Could Open New Doors ELIZABETH ORR [email protected]
hanges to the US Department of Veterans Affairs’ medi- cal and surgical supply purchasing program could open C new opportunities for device manufacturers – but may also present drawbacks. The VA plans to update the department’s purchasing model, known as Medical/Surgical Prime Vendor program (MPSV 2.0), by medtech.pharmaintelligence.informa.com March 11, 2019 | Medtech Insight | 5 � EDITORS’ PICKS�
April 2020. The revised system will give the agency a hand in the Additionally, she feels that giving the prime vendors power selection and pricing of many more types of medical supplies. over suppliers violates procurement law by transferring a govern- The agency’s key goals for MSPV 2.0 include giving Veterans mental function to the private vendors without proper process. Health Administration (VHA) clinicians more choice by offering a Waldron notes that it’s unlikely that the VA will ask for bids on wider range of similar but distinct items, as opposed to a smaller specific products, such as a single type of bandage. Instead, the standardized formulary; maximizing the use of existing Federal bids are likely to ask for prices on a range of supplies, and prime Supply Schedule contacts; and maximizing the participation of vendors will probably contract with multiple suppliers. “I think small businesses owned by veterans, especially veterans dis- by that very nature, it's going to expand potential access for abled during service, said Roger Waldron, president of the Coali- manufacturers to sell their product,” he said. tion for Government Procurement. Right now, VA lists only about 7,800 products on its formulary CONCERNS OVER COMPLEXITIES of medical and surgical supplies. Companies hoping to supply But the boons won’t come without a cost. Nagowski speculates that medical or surgical equipment to the VA submit bids and are se- the increased competition could pose challenges to companies al- lected based on price. The procurement and distribution of that ready selling to VA. “I think a lot of people have invested a lot of re- relatively limited set of supplies is then handled by four private sources into being efficient and advantaged in this market, and they companies, which are known as prime vendors and split the no longer will be,” she said. “It'll be a commercial entity, and actually country geographically. The prime vendors are Cardinal Health, for many, it'll probably be easier to have play in this market because Kreisers, Medline and American Purchasing Services. they'll be dealing with commercial-rewarding officials.” Under the new MPSV 2.0 model, the formulary will massively Companies that make treatments for conditions common in the expand and could include as many as 80,000 products. In April VA patient population may see the largest gains, Nagowski said. 2018, the VA issued official notice that it would allow the four These could include treatments for Parkinson’s disease, mental prime vendors to begin choosing potential suppliers for the ex- health conditions, central nervous system conditions and cancer. panded shopping list. The procurement community also has “questions and con- The prime vendors will identify potential sources for clinical cerns” about the VA National Acquisition Center’s (NAC’s) ability products and submit them to the VA Strategic Acquisition Center to effectively manage FSS awards and modifications to ensure and the MSPV Program Office for approval. Approved products product availability in support of MSPV 2.0, Waldron said. Specifi- will go on the master product list for distribution to VA facilities. cally, both VHA and the VA’s Strategic Acquisition Center will rely “While the exact extent of small business participation in the on the NAC’s ability to maintain product availability. VHA will be program has yet to be determined, it appears that SD/VOSBs using FSS contracts to establish direct purchase agreements for (service-disabled and veteran-owned small businesses) will be supplies that will be distributed via MSPV 2.0 contracts managed part of the MSPV supply chain,” Waldron said. “In many cases, by the SAC, Waldron explained. manufacturers will sell through SD/VOSBs to the prime vendors “Manufacturers, small businesses and prime vendors will need rather than selling directly to the prime vendors. Manufacturers to be keenly aware of the structures, roles and respective respon- will need to strategically partner with small business to success- sibilities of the NAC, VHA, and the SAC in supporting MSPV 2.0.,” fully compete in the program. At the same time, we can expect he said. “A flow chart might help.” that the VA will be monitoring the price, performance, and risk of The VA Office of Small and Disadvantaged Business Utiliza- adding layers to the supply chain.” tion has been hosting events to educate businesses and other The expanded supply list is greatly needed, said Cheryl Na- stakeholders about MPSV 2.0. The next event, which will bring gowski, senior director of federal markets, D2 Consulting. together original equipment manufacturers and veteran-owned “Not only has the scope of the current list been inappropriate, small businesses to discuss possible opportunities, is set for but the tools that they're actually procuring are inappropriate March 14. And a formal RFP for suppliers who plan to sell to the because they haven't been clinically led,” she said. “They've been prime vendors is expected in April. essentially selected by procurement officials rather than clini- cians that actually need the tools.” Published online 3/4/19 This leads to VA hospitals ignoring the formulary and buying needed supplies on the open market, paying more than they would under contract, she said. The changes are an attempt to get that situation under control, while also providing a wider ’ range of items to clinicians. LET S GET But letting prime vendors select suppliers also poses pitfalls, she said. SOCIAL “It’s a huge conflict of interest,” Nagowski said. “At a very basic level, you've got someone benefiting from distribution choosing @Medtech_Insight the sources of supply that they're going to be distributing.”
6 | Medtech Insight | March 11, 2019 © Informa UK Ltd 2019 � COMMERCIAL �
2018 EARNINGS SPOTLIGHT: Stryker And Nuvasive Lead The Ortho Pack In 2018 REED MILLER [email protected]
SPINE & NEUROTECH LEAD STRYKER TO “STELLAR” YEAR by 2.2% from lower prices. The MedSurg business recorded or- Stryker Corp. posted the best growth numbers among the big ganic net sales growth of 8.6% in 2018 including 9.3% from in- ortho players in 2018 with a 7.9% year-over-year organic increase creased unit volume partially offset by 0.7% from lower prices. in net sales, reported Jan. 29. For 2019, Stryker expects 2019 organic net sales growth to be in “2018 was a stellar year for Stryker,” CEO Kevin Lobo said during the range of 6.5% to 7.5%. the company’s Jan. 29 fourth-quarter/full-year 2018 earnings call. “Following tough comparisons from a successful 2017, we deliv- SMITH & NEPHEW SEES EVIDENCE OF A TURNAROUND ered impressive organic sales growth and leveraged adjusted Smith & Nephew PLC named Namal Nawana as its new CEO in earnings gains. Our talented team has launched new products, May to drive more growth across all its businesses. Over the last drove sales and marketing execution and benefited from prior decade, the company’s compound annual growth rate was just acquisitions that are broadened our portfolios.” (Also see "Q3 2.5% while the markets it competes in – orthopedics, sports Earnings Spotlight: Ortho Firms Show Mixed Results Against US Pric- medicine, and wound management – have grown 4% annually. ing Pressure" - Medtech Insight, 12 Nov, 2018.) Nawana has made a lot of changes to the company’s structure The company’s Neurotechnology & Spine business reported – moving to a franchise approach with five commercial leaders full-year 2018 sales of $2.6bn, representing 18.0% constant cur- reporting to him – and its executive team. (Also see "Exec Chat: rency growth and 10.6% organic growth, including 8.4% organic New Smith & Nephew CEO Namal Nawana Outlines Growth Strat- growth in the fourth quarter. The company said unit volume egy At JP Morgan" - Medtech Insight, 11 Jan, 2019.) grew 12.2% in 2018, but was offset 1.6% by lower prices. The company’s underlying revenue growth rate was just 2%, The $1.4bn acquisition of K2M Group Holdings Inc., announced in but during its Feb. 7 earnings call, Nawana stressed that the com- August, represents Stryker’s commitment to continuing the growth pany is moving in the right direction with 3% underlying growth of this business in 2019 and beyond. “We’re excited about the acqui- in the second half of the year and a 7% improvement in trading sition of K2mm, which meaningfully enhances our competitive po- profit. “H2 2018 was a solid start toward our goal to accelerate sition in the spine market,” Lobo said. “While 2019 will largely be an our top line growth and deliver that growth sustainably with integration year as it relates to K2M, the team is off to an impressive consistent margin expansion,” he said. start with notable excitement across our combined selling organi- Smith & Nephew’s top-performing businesses in 2018 were the zations.” (Also see "Stryker Makes Big Investment In Spine Surgery With Sports Medicine Joint Repair, which grew 9% in 2018, and the $1.4Bn K2M Acquisition" - Medtech Insight, 30 Aug, 2018.) Other Surgical Businesses category, which grew 11%, driven by On Feb. 27 at the SVB Leerink Partners Global Health Care Con- the rapid adoption of the Navio surgical robot. (Also see "AAOS ference, Stryker’s VP-Strategy & Investor Relations Katherine Owen Roundup: Robotic Ortho Surgery Continues To Gain Traction, Led By explained the role of K2M acquisition in Stryker’s overall strategy. Stryker's MAKO " - Medtech Insight, 9 Mar, 2018.) “We're less about breadth across offerings, more about category Nawana pointed out that sales of the Regeneten rotator-cuff leadership. And, spine was one where we had struggled. We were repair device more than doubled in 2018, exceeding the compa- not a category leader. And so, we spent an enormous amount of ny’s expectations. The US sales force is fully trained now on the time as a team, understanding why spine deals that don't have a device now and the company is beginning to launch Regeneten great track record hadn't worked and what would be unique for us. outside of the U.S. during the course of 2019. (Also see "Market “And, what we found with K2M was, it was going to give us an im- Intel: Innovation Drives Growth, Draws Younger Patients In Joint Re- mediate product refresh. Our core portfolio had gotten a little bit placement Implants Market" - Medtech Insight, 21 Sep, 2018.) long in the tooth. We had done some really innovative things with In December, Smith & Nephew agreed to pay up to $105m for 3D printed technology in spine. But the core portfolio was starting to Ceterix Orthopedics, maker of the NovoStitch Pro knee-repair get dated. It also gave us a strong foothold in the deformity segment device. NovoStitch Pro is “a unique technology that enables that really drives a lot of the key opinion leaders,” she explained. surgeons to repair a broader range of meniscal tears,” Nawana K2M was one of five acquisitions Stryker announced in 2018, said. “As a market leader in meniscal repair, we’re really well-po- including photonics firm Invuity for $190m and $220m for Hyper- sitioned to sell it through our existing sales force.” Branch, which makes the Adherus hydrogel for dural repair. (Also “We’re moving in the right direction, but there’s still more see "Stryker Strikes Again, Buys HyperBranch Medical Technology" - work needed to get business areas growing at or above their Medtech Insight, 2 Oct, 2018.) markets and to get our overall growth rate, firstly, to the 4% Stryker’s orthopedics businesses collectively grew 5.9% in aggregate market growth that we’ve called out, and then, of 2018, including 8.1% from increased unit volume partially offset course, beyond that,” Nawana said. medtech.pharmaintelligence.informa.com March 11, 2019 | Medtech Insight | 7 � COMMERCIAL �
NUVASIVE BLAMES SPINE MARKET FOR did hit the target set in October. “[This] reflects the challenges we RELATIVELY SLOW GROWTH faced during the year related to in-source manufacturing efforts On Feb. 20, NuVasive Inc. reported that its global revenue grew along with targeted investments to sustain revenue growth objec- 5.1% on an organic basis to $1,101.7m, which is below the $1,105m tives in 2019 and beyond.” to $1,110m projection the company gave at the end of October. On Feb. 8, Financial Times reported that Smith & Nephew is in “I continue to be encouraged by these growth rates against the talks to buy NuVasive for over $3bn. (Also see "Device Week, Feb. backdrop of an overall U.S. spine market that has trended rela- 13, 2019 – Femtech Draws Investment; Smith & Nephew/Nuvasive tively flat, but remains stable,” NuVasive CEO J. Christopher Barry Merger Rumors Emerge" - Medtech Insight, 13 Feb, 2019.) said Feb. 20. “These results were primarily driven by continued Commenting on that report in a note the same day, Wells strength in the U.S. hardware business, solid U.S. commercial Fargo analyst Larry Biegelsen pointed out that a 2017 Financial execution, and strong performance in key international regions” Times report suggested that Smith & Nephew might be trying like Southern Europe and Japan. “Looking holistically at the busi- to buy Wright Medical Group NV, so a deal for NuVasive would ness, I would characterize more than 5% organic growth or 7% make a deal for Wright unlikely. NuVasive is currently the fourth reported growth as a solid year-end result for the organization.” biggest spine-device company in the world, by revenue, behind Barry, who took over as NuVasive CEO in October, highlighted Medtronic PLC, , and Stryker. NuVasive might be attractive for the 4.4% growth in US spine hardware sales, driven by some new Smith & Nephew because its spine business is growing faster product introductions throughout 2018 as well as strong adop- – about 5% in 2018 versus low-single digits for Smith & tion of NuVasive’s expandable titanium and Porous PEEK Nephew’s spine products, according to Biegelsen. implants. (Also see "Medtronic Vet Christopher Barry Takes The table below includes a summary of that latest sales Helm At Nuvasive" - Medtech Insight, 19 Oct, 2018.) and earnings reported by noteworthy public orthope- NuVasive launched more than 20 new products across CLICK dics device companies' for the year or nine-months, de- its core spinal hardware business in 2018 as well as the For a table detailing pending on the company’s fiscal year, that ended Dec. key earnings figures in Pulse surgical automation platform. the orthopedics sector 31, 2018. Barry also pointed out that, unlike the overall revenue go online: https://bit. ly/2ES5kRK. number, the company’s operating margin of 15.1% in 2018 Published online 2/27/19
2018 Earnings Spotlight: Transcatheter Valve Repair Remains Big Drivers For Medtronic, Edwards, Abbott REED MILLER [email protected]
MEDTRONIC SEES CONTINUED SUCCESS FOR COREVALVE Medtronic’s cardiac rhythm and heart failure business reported a WHILE REST OF CARDIO BUSINESS STRUGGLES 2.3% decline in revenue, year-over-year, during the quarter. Sales of Medtronic PLC continues to rely heavily on the success of its the Micra transcatheter pacing system and the Azure wireless pace- CoreValve transcatheter aortic valve (TAVR) to drive revenue maker grew around 5% while sales of the Tyrx absorbable antibacte- growth. For the third quarter of fiscal 2019, ended Jan. 25, 2019, rial envelope grew about 25% year-over-year, but sales of Medtron- Medtronic’s Coronary & Structural Heart business recorded rev- ic’s HeartWare left-ventricular assist device were down about 45%. enue of $913m, representing a 5.9% year-over-year increase on During the company’s Feb. 19 earnings call, VP-Cardiac and a constant currency basis, led by about 15% constant currency Vascular Group Michael Coyle identified competition with Ab- growth in revenues from CoreValve transcatheter aortic valves. bott Laboratories Inc. HeartMate 3, which FDA approved as a Revenue from Medtronic’s coronary devices was flat on a con- destination therapy in October, as a major contributor to this de- stant currency basis – sales of guide catheters grew around 15% cline. He estimated that Medtronic’s share of the LVAD market and coronary balloon sales were up around 10% but drug-elut- dipped from 35% to 20% in the last quarter due to a surge of ing stents sales slid around 5%. interest in HeartMate 3. "Our competitor brought out a meaning- The company’s drug-eluting stent did get some good news in ful improvement over their older technology. There was a lot of February. On Feb. 26 that FDA approved an expanded indication for interest in the market to try it and see how it was performing. We Medtronic’s Resolute zotarolimus-eluting coronary stent platform to have seen some of those accounts coming back, but there is a big treat patients with coronary artery disease who have chronic total correction that now has taken place," he said. occlusion. CTO patients are among the most difficult coronary in- The overall market for LVADs also took a hit from new guide- terventions due to the risk of complications and have traditionally lines on allocation of heart transplants issued by the United Net- been treated with coronary artery bypass graft surgery. work for Organ Sharing in October 2018. "We think the U.S. mar-
8 | Medtech Insight | March 11, 2019 © Informa UK Ltd 2019 � COMPANIES � ket was down 20% to 25%, as ... patients with LVADs were kind driven by new devices and expanded indications for existing pe- of put to the bottom of the list for heart transplants," Coyle said. ripheral drug-eluting devices. Companies in this space include The market for LVADs may also have taken a hit from separate Medtronic, Spectranetics Corp., Becton Dickinson & Co., Cook, safety recalls for Medtronic’s HeartWare and Abbott’s HeartMate and Boston Scientific Corp. 3 announced last June. (Also see "Class I VAD Units Recalls Continue From Abbott, Medtronic" - Medtech Insight, 5 Jun, 2018.) EDWARDS ANTICIPATES CONFIRMATION OF Overall, for the first nine-months of the fiscal year, Medtronic TAVR’S BENEFIT IN LOW-RISK PATIENTS reported revenue of $8.219bn, representing 4% year-over-year Edwards Lifesciences Corp. transcatheter aortic valve contin- growth. On Feb. 19, the company updated its organic revenue ues to drive the company’s growth, led by Sapien 3 Ultra which growth guidance from a range of 5.0 to 5.5 percent to a range of earned FDA-approval in December. (Also see "Global Device Ap- 5.25 to 5.5 percent. provals, Weekly Snapshot: FoundationOne CDx In Japan" - Medtech Insight, 31 Dec, 2018.) META-ANALYSIS CREATES DOUBTS ABOUT Edwards total revenues in 2018 overall were $3.81bn, includ- DRUG-COATED BALLOONS ing $982.7m in the fourth-quarter, representing year-over-year Medtronic’s aortic, peripheral, and venous revenue improved growth of 10% and 9.8%, respectively, the company reported 6.1% year-over-year to $476m, led by demand for the VenaSeal Jan. 31. Sales of transcatheter heart valves, which represented closure system and the Valiant Navion thoracic stent graft, which about 60% of Edwards’ revenues in 2018, grew 12.2% in 2018 to FDA approved in October. (Also see "Results Recap: Medtronic's Val- $2.3bn, including $592.4 in the fourth quarter. iant Navion Earns FDA Approval Based On 30-Day Results" - Medtech Edwards said that TAVR sales growth has been the fastest in Insight, 27 Oct, 2018.) the newer and smaller centers, which are providing access to a Sales of Medtronic’s drug-coated balloons grew about 15%, but broader population of aortic stenosis patients. peripheral drug-coated balloons like Medtronic’s IN.PACT devices Results of the low-risk cohort in the PARTNER 3 trial of Sapien are now facing an uphill battle in the marketplace following the re- 3 will be presented as a late-breaking trial at the American Col- cent much-publicized release of a meta-analysis calling into ques- lege of Cardiology Scientific Sessions in New Orleans in March by tion the safety of paclitaxel-coated balloons and paclitaxel-eluting Martin Leon from Columbia University. (Also see "EuroPCR 2018: stents. (Also see "SCAI, Manufacturers Defend Peripheral Paclitaxel Real-World TAVR Data Show Consistent Performance With Edwards, Devices Against Doubts" - Medtech Insight, 30 Jan, 2019.) Abbott, And Medtronic's Systems" - Medtech Insight, 23 May, 2018.) In a Feb. 20 note, Wells Fargo analyst Larry Biegelsen wrote, Edwards said the company's guidance continues to assume that "There is now a mortality signal with the leading paclitaxel- it will receive FDA-approval to expand Sapiens indication to in- coated drug-coated balloons and leading paclitaxel coated clude low-risk patients by the end of 2019. Medtronic is spon- drug-eluting stents. We think there will be uncertainty around soring a 1,200-patient randomized trialv of its CoreValve Evolut R paclitaxel-coated drug-coated balloons and drug-eluting stents TAVR system in low-risk patients. (Also see "TAVR Update: Edwards until the FDA and [vascular interventionalist society] VIVA com- Delays European Launch Of Sapien 3 Ultra; New Medtronic CoreV- plete their own analyses later this year." alve Data" - Medtech Insight, 23 Mar, 2018.) Data from Medtronic's Bieglesen also points out that Medtronic disclosed on Feb. 15 trial will also be presented at ACC by Michael Reardon of Meth- that the summary report from its IN.PACT Global post-market odist DeBakey Heart and Vascular Center in Houston. study contained an error causing mortality data at two and three The low-risk patient population is larger than the existing pool of years to be inadvertently omitted from the summary tables. (Also patients eligible for TAVR – inoperable, high-risk, and intermediate see "Results Recap: Medtronic Highlights Data To Contrast With Recent risk. Wells Fargo’s market models project the worldwide TAVR mar- Meta-Analysis That Sparked Drug-Coated Balloon Scrutiny " - Medtech ket will grow from $3.8bn in 2018 to $4.3bn in 2019, but Wells Far- Insight, 25 Jan, 2019.) Also, the authors of the pivotal study of Cook go analyst Larry Biegelsen projects that if PARTNER 3 or Medtron- Group Inc.Zilver PTX stent recently issued a correction in Circulation ic's trial show TAVR is superior to surgery in low-risk patients, "our stating that the five-year mortality rate was inadvertently reversed 2019+ TAVR market estimates will likely prove conservative." by the authors in the original manuscript – instead of the five-year Edwards is also sponsoring EARLY TAVR, an 1109-patient mortality rate favoring the Zilver stent, the five-year mortality rate randomized trial comparing Sapien 3 to no intervention in in the study actually favors the percutaneous transluminal angio- patients with severe-but-asymptomatic aortic stenosis. Dur- plasty group, 16.9% versus 10.2%. The IN.PACT SFA trial of ing its Dec. 5 Investors Day presentation, Larry Wood, the IN.PACT Admiral drug-coated balloon showed signifi- Edwards’ VP-Transcatheter Heart Valves, said that trial cantly higher mortality rate at three years with the IN.PACT is about 30% enrolled. than percutaneous transluminal angioplasty (10.7% versus CLICK During the Jan. 31 earnings call, CEO Michael Mussal- 1.9%), Biegelsen notes. For a table detailing lem said, "We’re very excited about EARLY TAVR, but it’s key earnings figures in Wells Fargo analysts estimate that the worldwide mar- the cardiovascular going to take us a while until we see that. It’s continu- ket for peripheral drug-coated balloons and stents is sector go online: ing to enroll nicely. I’d like to think that TAVR continues to https://bit.ly/2VIoQ8V. worth $367m and will be worth $686m in 2020, especially stay popular; that the spotlights provided by additional medtech.pharmaintelligence.informa.com March 11, 2019 | Medtech Insight | 9 � COMMERCIAL � evidence will maybe stimulate that enrollment some, but it’s ear- estimate the global TMTT opportunity to reach $3 billion by 2024. ly to tell. But we’re making steady progress, and we’re really look- Edwards says it encouraged by the US early feasibility study for ing forward to getting results from that trial because we believe Evoque transcatheter mitral valve replacement and continues to that’s an underserved population." enroll patients in a US early feasibility study for Sapien M3 and The company is also sponsoring a US pivotal trial of self-ex- plan to initiate the US pivotal trial in late 2019. (Also see "CRT 2018: panding Centera valve in intermediate-risk patients. Edwards ex- Late-Breakers Feature Sapien MR, Selution DCB, Low-Risk TAVR, and pects enrollment of this trial to be completed next year. (Also see Radial Access PCI " - Medtech Insight, 11 Mar, 2018.) "Latest Sapien Valve Gets EU Go-Ahead, But Germany Will Have To The company also announced that it is on track to introduce Wait" - Medtech Insight, 16 Nov, 2018.) the Harpoon minimally-invasive mitral valve surgery system in The results from the low-risk patients in PARTNER 3 and EARLY Europe in mid-2019. (Also see "Harpoon Finds Its Whale: Edwards TAVR could also allay some of the fears among patients and some Spends Up To $250m For Beating-Heart Mitral Repair Option" - physicians – described last year in one of the "Implant File" reports Medtech Insight, 12 Dec, 2017.) from the International Consortium of Investigative Journalists – that TAVR was embraced too enthusiastically and used in non-high-risk MITRAL REPAIR CONTINUES TO DRIVE ABBOTT’S patients who may have been better served with a surgical valve. MEDICAL DEVICE BUSINESS (Also see "Market Intel: Martin Leon's TAVR Technology Tour Of The Fu- Abbott is the most established player in mitral valve repair with ture" - Medtech Insight, 5 Oct, 2018.) That concern was voiced by many its MitraClip mitral repair device, which continues to help drive physicians, especially surgeons, in the early days of TAVR, especially the success of its structural heart business. in Europe. But in the last decade, the TAVR technologies have im- During its Jan. 23 fourth-quarter 2018 earnings call, Abbott proved and a growing body of evidence shows that TAVR can be at CEO Miles White cited MitraClip and the Amplatzer patent fora- least as safe and effective as surgical valves out to fiveyears.(Also see men ovale occluder as products that drove Abbott’s structural "TAVR Update: Edwards Delays European Launch Of Sapien 3 Ultra; New heart revenues up 13% to $1.24bn. Medtronic CoreValve Data" - Medtech Insight, 23 Mar, 2018.) Abbott expects the results of the COAPT trial, announced at The downside of all this TAVR success for Edwards is that it is tak- the TCT meeting in September, to support US FDA-approval of ing business away from Edwards’ long-standing surgical valve re- an expanded indication for MitraClip to include secondary mitral pair business. Despite the challenges, the underlying growth rate regurgitation. FDA approved MitraClip in 2013 to treat primary or for Edwards surgical structural heart in 2018 was 3.4%, including degenerative mitral regurgitation. COAPT is the first randomized 5.5% year-over-year growth in the fourth-quarter, driven by "solid trial to show that mitral-valve repair could improve outcomes in aortic unit volume and continued adoption of our newer premium patients with secondary mitral regurgitation. (Also see "TCT 2018: aortic valves," Mussallem said. The company continues to roll-out Abbott Expects COAPT Results To Support Expanding MitraClip's In- its Inspiris Resilia tissue aortic valve across all major territories. "This dication" - Medtech Insight, 23 Sep, 2018.) valve was designed to be an attractive option for active patients, Specifically, the COAPT results showed MitraClip repair reduces and we’ve observed a trend of physicians treating younger pa- the two-year heart-failure hospitalization and all-cause mortality tients with Inspiris versus traditional heart valves," he said. rate in heart failure patients with moderate-to-severe secondary The company is also sponsoring the RESILIENCE trial evaluat- mitral regurgitation who remain symptomatic despite optimal ing the durability of Resilia in patients under 65. medical therapy. Abbott submitted the data to FDA during the "Even as TAVR adoption expands, we are excited about our fourth quarter. "If approved, this advancement would further ability to provide innovative surgical treatment options for more enhance our leadership position in this large and highly under- patients and extend our global leadership in surgical structural penetrated disease area and offer the potential to create a new heart technologies," Mussallem said. multibillion-dollar cardiac device market over time," White said. Echocardiographic outcomes and quality-of-life data from CO- EDWARDS, ABBOTT AMONG THOSE SEIZING THE APT will be featured in the late-breaking trials at the ACC meet- MITRAL VALVE REPAIR OPPORTUNITY ing in New Orleans. Edwards’ investment in a variety of mitral valve repair devices is Overall, Abbott’s medical device business 9.1% in 2018, includ- bearing fruit. (Also see "Edwards Adds To Wide Range Of Approach- ing 19.6% year-over-year revenue growth in electrophysiology es To Mitral Repair" - Medtech Insight, 12 Dec, 2017.) led by cardiac mapping and ablation catheters such as the Advi- In the fourth-quarter, sales of the Cardioband transcatheter mi- sor HD Catheter approved in 2018. In January, Abbott announced tral annulus repair system, which Edwards acquired in 2016 were FDA-approval of its TactiCath Contact ForceSensor Enabled atrial just $1m due to ongoing supply constraints, but Mussallem said fibrillation ablation catheter, "which will further strengthen our the process of moving Cardioband to new manufacturing facilities competitiveness in this highly under-penetrated market," White is "on track, and we continue to expect supply to progressively im- said. (Also see "US FDA Approves Abbott’s Sensor-Enabled TactiCath prove throughout 2019. As this therapy advances, we believe that AF Catheter" - Medtech Insight, 25 Jan, 2019.) the annular reduction provided by Cardioband can be an important first-line treatment for many mitral patients." Edwards continues to Published online 2/28/19
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ECR 2019 – Philips Launches New CT System With Lifetime Guarantee
CATHERINE LONGWORTH [email protected]
hilips Healthcare has launched its new CT platform with a unique ‘Tube for Life’ guarantee, aimed at reducing health- Pcare organization's operational costs. Under the guarantee, Philips says it will replace the Incisive CT'sX-ray tube – at no addi- tional cost throughout the entire life of the system. Philips claims the guarantee could potentially lower operating expenses for providers by an estimated $400k. The platform is the newest addition to Philips’ diagnostic imaging portfolio and will be available in Europe and Asia in the first half of 2019 and rolled out to the US later in the year. The company unveiled the Incisive CT at the European Congress of Radiology in Vienna Feb. 28 through March 2. Speaking to Medtech Insight at the conference, Philips Global "The possibility to have a lifetime guarantee is a big deal. Some CT Marketing Leader, Mark Olszewski said X-ray tubes were a of the systems by our competitors can last only 18 to 24 months dominant factor in driving operational expenditures. "We’ve with the best ones being about three years. If the average use is done a lot of innovation over the last few years to bring the three years, then in a 10 year lifetime span, we’re talking about cus- reliability of our tube up, so we believe strongly that this is a tomers changing a tube up to three times," Boussebaa said. "In- proposition that will put our customers ahead of the curve in cisive CT combines a unique range of innovations that empower managing their operational costs," he said. "The Incisive CT is hospitals to deliver on the promise of value-based health care." focused on managing total cost of ownership for our custom- Boussebaa added that Philips' competitors had some time to go ers.We believe that our offer to replace it free of charge if it before they would be able to catch up with the design of Incisive. fails is unique in the industry and something our customers "We have a couple of decades in tube- development and this is the have been really asking for." latest generation," added Philips Global CT Product Manager, Adam Replacing X-ray tubes can be a costly component for hospitals, Vanderwall. "We have a tube here that is a monster design from the with the average use of a CT system being around three years. ground up. We’re so confident in the design of the tube that this is With CT increasingly becoming a cornerstone of radiology prac- why we’re willing to put the guarantee behind it. We’re here and tice, Karim Boussebaa, the CEO of Philips CT and Advanced Mo- we're putting our money where our mouth is." lecular Imaging, told Medtech Insight that customer expectations for systems had changed. Published online 2/28/19
ECR 2019 - Siemens Healthineers Unveils 'One Stop Shop' Stroke System
CATHERINE LONGWORTH [email protected]
iemens Healthineers AG revealed its new 'one-stop shop' Siemens Global Product Manager, Peter Hildebrandt told Medtech system for strokes at the annual European Congress of Ra- Insight at ECR. "Interventional radiologists normally have scheduled S diology (ECR) held recently in Vienna. patients while a stroke patient is an emergency patient. The current The Artis icono biplane will be launched in Europe in June 2019 workflow in place for patients is that they undergo a CT scanning, and is the first of a new family of interventional angiography sys- then if you want to do a thrombectomy you would then need to tems from Siemens Healthineers. The company said the system transfer the patient to the interventional suite." would transform stroke intervention in hospitals, enabling faster Siemens' new system allows patients with stroke symptoms to treatments with greater accuracy. be imaged immediately to see if the stroke is ischemic or bleed- "The big challenge for our customers is that they have to rear- ing, without separate computed tomography or lengthy transfer range workflows in their hospitals when it comes to stroke patients," to the interventional suite. "With the Artis icono, you can put the
medtech.pharmaintelligence.informa.com March 11, 2019 | Medtech Insight | 11 � COMMERCIAL �
patient directly on the table and do the diagnostic part of this invasive interventions are growing at about 11% per year. As the angiography and then proceed to treatment directly without complexity of these procedures increases as well, angiography delay. Studies have proven that you can save up to one hour by systems are becoming the key to efficient and effective patient doing this one-stop shop approach," he said. care. The multidisciplinary use of Artis icono enables angio labs Siemens bi-plane system can switch between 2D and 3D im- to be optimally utilized, and the medical institution can offer a aging during an intervention which adapts to the needs of in- broader range of interventions." terventional radiology, neuroradiology, cardiology, and vascular The system is currently undergoing US-FDA review, which Sie- surgery, according to the company. mens said was a "work in progress." Michael Scheuering, Head of Siemens Interventional Radiol- ogy said "The procedure numbers for image-guided minimally Published online 3/1/19
Inogen's Stock Collapses After Earnings Call Addressing Short-Seller Concerns FERDOUS AL-FARUQUE [email protected]
nogen Inc.’s stock value plummeted after its most recent earn- ings call where the company’s CEO seemed to acknowledge it I did not trust its own research firm that gave it a glowing mar- ket report and prospective analysis. However, the company is still sticking by some of the projections it predicted last year, despite concerns it will not be able to meet its long-term profit goals. The maker of portable oxygen concentrators (POC) has come under scrutiny from the short-seller Muddy Waters for inflat- ing its future projections. While Inogen has stated its market potential is about 3 million patients and it expected an annual growth of 7% to 10%, the short seller argues its total address- able market (TAM) size is closer to 1.3 million patients and the market is actually shrinking at a rate of 2.6% annually. (Also see "Muddy Waters Short-Sells Inogen, Citing Inflated Market Projec- tions" - Medtech Insight, 8 Feb, 2019.) On Feb. 26, Inogen presented a fourth quarter and year-end financial report to investors stating its total revenue was almost it did not trust its previous research firm’s analysis. The company is $360m in 2018; up almost $44% from 2017. The company also now using a different set of data to make its projections, he said. said its net GAAP income was $51.8 million which was almost “As many of you know, recently, there have been some questions 150% increase compared to 2017 and a 14.5% return on reve- from certain members of the investment community on the size nue. It did, however, acknowledge that it was downshifting its and growth of the US long-term oxygen therapy market and the projections from a seven-to-10 year forecast to five year fore- business practices of some of our Internet resellers,” he said. “I'd like cast because it says it’s been using the same numbers for the to comment on the 2015 Wintergreen Report, which we had previ- past few years without accounting for the time change. ously cited and felt was a reasonable source for long-term oxygen Inogen's share price dropped precipitously after its earnings call on therapy market data and growth rates.” the afternoon of Feb. 26. Wilkinson said since the report came out last year, there have Prior to Inogen’s call, Muddy Waters published a letter to the com- been changes in the US long-term oxygen therapy market that pany specifically stating the device-maker has inflated its market he attributed to the Medicare durable medical equipment com- and profit potentials, and asked it why there were discrepancies be- petitive bidding program. tween Inogen’s data and Muddy Water’s analysis. The short seller “Given the age of the report, the market changes that have oc- specifically outlined six questions for Inogen to answer. For the most curred following its publication and the recently released Medi- part, the company did not address Muddy Waters directly nor the care data from October, we have updated our view of the market specific issues it raised during its investor call. based on more recent sources,” he added. “While there is no up- Inogen CEO Scott Wilkinson however did acknowledge during dated single source of long-term oxygen therapy market data, the call that there were critics of the company and admitted that we are now basing our current market estimates on data from
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CMS, the Kaiser Family Foundation, the US Census, the Center for Carson Block, chief investment officer for Muddy Waters, says Disease Control and our own internal data.” he found Wilkinson's statements about not using the Winter- Wilkinson said the new data provided a more up-to-date view Green report odd. of the long-term oxygen therapy market in the US but maintained “They claimed to have stopped using WinterGreen because the company’s market size is still between 2.5 and 3 million people. it’s a 2015 report, but that doesn’t seem correct,” he said. “We re- “While Medicare beneficiary data showed a decline in 2017, viewed a 2017 version of the WinterGreen research, which be- when taking into account the shift to Medicare Advantage, lies that statement. Management’s statement might have been a private insurance, retail sales and the expanding cap base, we misrepresentation.” believe that overall patient growth was in the low-single digits Block also argues that Inogen was not clear on why they con- in 2017 and we expect that trend to continue for the next few tinue to claim a market size of 3 million patients when Muddy years,” added Wilkinson. Water’s estimate is closer to 1.3 million. However, he argues other factors, such as reduced reimburse- After the call, Inogen’s share price took a nose-dive, losing ment rates resulting from competitive bidding and enhanced around 25% of its value. Block says the company’s statements Medicare coverage and billing requirements, will create more op- during the call that its recent growth was in the low single digits portunities for Inogen to keep its customers and add new patients. was likely a surprise to the investors listening. “Additionally, the industry is going through a major conversion “I think the drop was due to the evasiveness of TAM size, their as- from tank deliveries to POCs,” said Wilkinson. “We believe that sessment of recent low single digit growth, and downshifting the the combination of these factors should lead the growth rates long-term growth language to five years from 7-10,” he added. for POCs above the overall long-term oxygen therapy market growth rate over the next five-plus years.” Published online 2/28/19
Survey Suggests 'New Normal' In Securities Suits Against Life Sciences Firms
ELIZABETH ORR [email protected]
hareholders filed 86 class action suits alleging securities fraud ticompetitive conduct or faulty internal bookkeeping practices. against life sciences companies in 2018, a recent survey by law Most of the remaining claims involved charges that the plaintiff S firm Dechert LLP shows. had given faulty information related to mergers, sales and other That’s a slight decline from the 88 suits filed in 2017 but still transactions. (See Figure 2.) represents a significant hike from five years ago in 2013, when The process of device development itself presents a risk for the only 19 suits were filed. Attorney David Kistenbroker, who dis- kind of stock drops that may trigger lawsuits, Kistenbroker said. cussed the survey with Medtech Insight, said the sustained high Specifically, device companies may let investors know about prod- rate may represent “the new normal.” (See Figure 1.) ucts that are in development. But if the new technology is delayed The trend is driven by a few factors, he said. “Most importantly, life at the FDA or fails to get approved altogether, stock prices may sciences companies, when bad news arises, tend to have big move- drop significantly when expected income from the new product ments downward in their stock, which is not surprising. That attracts fails to materialize. plaintiffs' firms. The second thing is, there are three plaintiffs' firms “A large drop in market capital, in plaintiff's terms, could very that are clearly focused on the sector and attracted by the stock well mean that there's a reason for the stock drop that they drop,” Kistenbroker explained. might be able to convince a court is something other than The plaintiffs' firms in question -- Glancy Prongay & Murray LLP, just happenstance because of the FDA rule,” he said. “In other Pomerantz LLP and The Rosen Law Firm – were responsible for words, that the company might have done something wrong.” 50 of the 86 lawsuits filed, Dechert’s research shows. Additionally, ongoing coverage of the fraud at shuttered diag- The specific causes behind the suits varied, Dechert says. nostics company Theranos may highlight the realm as low-hang- About 20% of the suits claimed that the manufacturers had ing fruit for lawsuits, he said. misrepresented the efficacy and safety of the products in ques- An emerging trend in 2018 was a greater number of suits in- tion. Another 14% said that the manufacturer had misled inves- volving large companies. About 60% of the life sciences compa- tors about steps in the regulatory approval process, such as the nies named in class action securities fraud complaints are worth timing of FDA submissions or the likelihood a product would be at least $500m, and almost 50% are worth $1bn or more. And approved, while 30% alleged that the defendant had partici- more than 20% of suits were filed against companies with market pated in illegal conduct such as the payment of kickbacks, an- caps of $5bn and up.
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FIGURE 1 RESULTS RECAP: Life Sciences Class Action Securities Suits The number of class action securities suits filed against life sciences companies rose Support For sharply in recent years, more than quadrupling since 2013. 90 Medtronic Insulin 80
70 Pump Feature; 60 Neuroelectrics' 50 Starstim Treats 40
30 Seizures REED MILLER [email protected] 20
10 02/25/2019 MINIMED 670G/640G 2013 2014 2015 2016 2017 2018 MEDTRONIC PLC Medtronic shared data from several tri- Information courtesy Dechert LLP. als of its MiniMed 640G and 670G insulin pumps with SmartGuard software at the FIGURE 2 But these lawsuits against life sciences International Conference on Advanced companies often meet some resistance Technologies & Treatments for Diabetes Causes of Action In Class Action from the courts. There were 65 significant (ATTD) in Berlin, in February. Suits, 2018 decisions in life sciences securities cases SMILE (Study of MiniMed 640G Insulin issued in 2018. Plaintiffs got the charges Pump with SmartGuard in prevention of Common allegations backing class action securities cases against life sciences fully dismissed in 40 of those cases and Low Glucose Events in adults with Type 1 companies included inaccurate SEC filings partially dismissed in another 15, Dechert diabetes) is the largest randomized trial and misrepresentations of a product's says, while motions to dismiss failed in of MiniMed 640G’s “Suspend Before Low” efficacy or safety. only 10 cases. technology compared to insulin pump But securities suits can be expensive therapy without continuous glucose and time-consuming even if they eventu- monitoring (GCM) in decreasing hypo- ally vindicate a company. To protect them- glycemia in adults with type 1 diabetes 20.21% selves from the risk, Kistenbroker recom- prone to hypoglycemia. mends company officials should make sure Six-month results from SMILE pre- 39.33% their public statements are transparent, in- sented at the ATTD meeting showed the clude known risks, and give a full picture of Suspend Before Low feature effectively what’s happening with any technologies reduced hypoglycemia, including severe 13.83% in development. Additionally, companies hypoglycemia, over six months in hypo- should review procedures for disclosing glycemia-prone adults with type 1 dia- information about products. The policies betes, compared pump therapy without should cover verbal statements by ex- CGM, with no increase in HbA1c and no ecutives as well as written statements, he episodes of diabetic ketoacidosis. 26.60% said. Additionally, statements of opinion Suspend Before Low reduced sensor- shouldn’t include misleading language. based hypoglycemic events from 4.13 Product misrepresentations Companies may also benefit from an events per week to 1.12 events per week Regulatory misrepresentations internal trading policy to help avoid al- and reduced the rate of severe hypogly- legations that executives were aware of cemia from 52.1 to 8.5 events per 100 Unlawful conduct a problem in advance and sold stocks in patient-years. “The results suggest that Inaccurate SEC filings time to avoid the loss. the therapy would be clinically beneficial for patients impacted by hypoglycemia Information courtesy Dechert LLC. Published online 2/27/19 exposure,” Medtronic says.
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The ATTD meeting also featured a pre- medium-sized meal of 40g of carbohy- non-invasive and non-pharmacologic op- sentation of three-month data from a drate was minimized to have the same ap- tion for those whose seizures have not been study of MiniMed 670G in children two proximate impact as a large-sized meal of controlled by drugs or by surgery. Our pa- to six years-old with type 1 diabetes. The 80g that had been reported to the system tients and families have seen clear improve- data showed that in-home use of MiniMed ahead of consumption. ments in well-being and quality of life.” 670G in the younger population is safe and Starstim is designed to be a non-invasive associated with improved glycemic met- 02/25/2019 STARSTIM alternative for seizure patients who are not rics, including reduction in HbA1c – 8.0% NEUROELECTRICS BARCELONA SLU candidates for epilepsy surgery as well as to 7.5% – and increased the percentage Neuroelectrics Corporation presented patients who have undergone epilepsy of time the patient spent in the preferred results from 17 patients in a clinical trial surgery but continue to have seizures. I de- glycemic range from 55.4% to 63.6%, com- of its Starstim neurostimulator in patients livers transcranial current stimulation with pared to baseline. The percentage of time with drug-resistant epilepsy at the recent the proprietary Precision-tCS to target the spent above 180 mg/dL was also reduced. American Epilepsy Society Annual Meet- specific areas of the patient’s brain where “These data mirror the results in older ing in New Orleans. seizures originate. youth and adults with type 1 diabetes us- Eight-week results from the trial show The Massachusetts Life Sciences Center ing the MiniMed 670G system,” according that treatment with Starstim reduced in (MLSC), public–private investment agency to Medtronic. The MiniMed 670G system seizure frequency of at least 40% from that promotes life sciences research and has not been approved by the FDA for baseline in 75% of the patients. There development in Massachusetts, provided this population yet. In June, FDA expand- were no device-related adverse events some of the funding for the trial. ed the indication to included patients as reported during the study. young as seven. MiniMed 670G was ap- The patients enrolled in the US FDA-sanc- 02/26/2019 BRACANALYSIS CDX proved for users with type 1 diabetes 14 tioned study had not responded to at least MYRIAD GENETICS INC. or older in 2017. (Also see "Good News For two anti-epileptic medications. For many, Results of the Phase III POLO study shows Senseonics, Medtronic Diabetes Devices" - the only other option would be brain sur- Myriad’s BRACAnalysis CDx can identify pa- Medtech Insight, 25 Jun, 2018.) gery to resect the region of the brain where tients with metastatic pancreatic cancer with Medtronic also presented preliminary the seizures originated. The treatment pro- BRCA mutations and benefit from olaparib, a data from a study of a new prototype en- tocol called for 20 minutes of daily stimula- novel PARP-inhibitor drug. hanced hybrid closed-loop system which tion applied for 10 days over two weeks, fol- These data will support a PMA supple- demonstrates the device’s ability to mini- lowed by an eight-week monitoring period ment application to US FDA for BRAC- mize the exposure to hyperglycemia follow- to measure seizure frequency. Analysis CDx as a companion diagnostic ing a pre-meal bolus or unannounced meal. Co-Principal Investigator Alexander Ro- for olaparib in this population. The preliminary data show that hypergly- tenberg, Harvard Medical School said “We cemia exposure due to an unannounced, and our patients are delighted to have a Published online 3/1/19
STARTS & STOPS: First-In-Human Trial Of RaniPill Drug-Delivery Device Begins
REED MILLER [email protected]
02/28/2018 RANIPILL eat or fast prior to swallowing a drug-free RANI THERAPEUTICS LLC version of the RaniPill capsule. The sub- The first human study of Rani Therapeu- jects reported no sensation of the capsule tics’ RaniPill, an ingestible, robotic cap- inflating or deploying, and the remnants sule for delivering biologics to the wall of passed successfully. Intestinal deploy- the small intestine, was run by a contract ment times were similar for both fasted research organization in Texas, the com- and fed subjects, suggesting that food pany announced Feb. 28. does not impact RaniPill's performance. In this study of RaniPill’s safety and tol- The next human study, scheduled to RaniPill™ capsule outlined in red, moving erability, subjects were assigned to either start later this year, will test RaniPill’s ability from the stomach to the intestines. medtech.pharmaintelligence.informa.com March 11, 2019 | Medtech Insight | 15 � R&D�
to deliver octreotide, a drug for the treat- tibodies, peptides, and proteins. The ani- impressive bioavailability data in preclinical ment of acromegaly. The version of RaniP- mal studies showed RaniPill can deliver the testing, while methodically and significantly ill in that study will also have a drug-filled equivalent of 3 mg of drug – the equivalent de-risking its platform. With strong pre-clin- resorbable needle. (Also see "Market Intel: of 80 units of insulin – with bioavailability ical results and an extensive patent portfo- Robotic Pills And The Future Of Painless Drug equivalent to or better than subcutaneous lio, Rani is poised to benefit patients across a Delivery" - Medtech Insight, 13 Sep, 2018.) injections, according to the company. range of therapeutic areas, including diabe- RaniPill has been evaluated in more than Rani board member Dennis Ausiello of tes, psoriasis, Crohn's disease, rheumatoid 100 animal studies during the he past five Harvard Medical School said, "The oral de- arthritis, hemophilia, among others." years showing it can work just as well as livery of biologics is considered the holy injections for the intestinal delivery of an- grail of drug delivery. Rani has generated Published online 3/4/19
� POLICY & REGULATION � EU MDR Transparency Not Enough: Time For A Big Debate? AMANDA MAXWELL [email protected]
uring the hour-long debate on February 27 at the European D Parliament in response to the global "Implant Files" investigation into medical device safety and oversight, the one topic that stood out most as being unresolved was transparency. It emerged that there is a mismatch be- tween the International Consortium of In- vestigative Journalists’ view of how much information should be made available in the best interests of patients, based on The Parliament's ENVI Committee met in Brussels its research, and how much the European Feb. 27 to address debates over EU device oversight. Commission believes is best. The ICIJ co- ordinated the Implant Files investigation, a collaboration of about 250 journalists in COMMISSION RELUCTANCE mission had argued that publishing in- 36 countries that added a heavy dose of WON’T CUT IT cidents reports could scare the public. scrutiny to the medtech sector with ar- WITH MEDICAL COMMUNITY “Transparency could scare the public?” he ticles beginning last November. (Also see The European Commission suggests does repeated incredulously. “We were quite "10 EU-Based Key Medtech Opinion Leaders not want to make full information on shocked when we heard that.” React To The 'Implant Files'" - Medtech In- medical device incidents public, Bowers The Commission, Bowers said, had also sight, 28 Nov, 2018.) said. He added that this is of great con- expressed concern that industry would Speaking at the European Parliament, cern to many of the doctors and patient be more reluctant to report concerns Simon Bowers, ICIJ reporter and Europe groups the ICIJ interviewed. about their devices if they knew the infor- partnership coordinator, was critical of the Similarly, Bowers said, the Commission mation was to be transparent. lack of clarity from the European Commis- does not want to make public full data “We felt that was a shocking answer,” sion over how much information will be from pre-approval clinical studies. There Bowers challenged. The medical commu- made transparent in the context of the will be a summary, he noted, but the full nity is outraged and demands transparen- EU Medical Device Regulation, which is data will not be made available. cy, he told the meeting. “It is very hard to scheduled to take full effect in May 2020. “This is a sop,” he said. “The idea of only find an independent doctor who does not Bowers was addressed a meeting of a summary being made available won’t believe in transparency on these issues.” the European Parliament's Committee cut it with medical community.” He argued that the MDR simply does not on Environment, Public Health and Food go far enough, citing some member states Safety (ENVI), the committee that was in- 'SHOCKED' AT COMMISSION as “having to supplement MDR by intro- volved in the drafting of the MDR and IVD RESPONSE ducing compulsory implant registries in Regulation (IVDR). Bowers told the committee that the Com- response to the implant files."
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This seems to be very much welcomed He explained that decisions around Otherwise, there may be more calls for by the medical community, he said, “but disclosing information must be based on modifying the regulation. The position of it is curious it is detached from the EU good reasoning. “Incidents require careful Nicola Caputo from the Italian Democrat- process of regulation”. analysis of their nature and cause to deter- ic Party offered a stark warning for indus- mine whether they result from a malfunc- try to ensure it answers its critics. INDUSTRY CALLS FOR MORE tion of the device itself of whether they are In light of the ICIJ investigation, Parlia- TRANSPARENCY due to any other factors that can be better ment “has to support an immediate modi- Bowers was one of three main speakers controlled such as incorrect use or clinical fication of the regulation and perhaps a re- at the ENVI debate. MedTech Europe CEO environmental aspects?” he said. structuring inside the European Medicines Serge Bernasconi also took center stage, “It is in the public’s interest,” Peltomäki Agency” to create a new department re- as did Antti Peltomäki, deputy director said, “that we provide verified, accurate sponsible for assessing implants and other general at DG Grow (the Internal Market, information when incidents occur, not po- devices, Caputo said. “This would allow Industry, Entrepreneurship and SMEs tentially misleading automatic reporting." these products to be put to a more rigor- division of the European Commission). Peltomäki said many of the issues raised by ous testing before they are approved.” There was also time for four members of the ICIJ reporters were in line with concerns Parliament (MEP) to give their views – to that drove the Commission and co-legisla- IMPLEMENTATION ABOVE ALL an otherwise nearly empty European Par- tors to reform the current EU directives into Bernasconi warned that now is not the liament auditorium. the new regulations in the first place. The time to start changing the regulation as There is increased understanding from MDR and IVDR, he said, “are an appropri- this would cause delays in improving the industry that we need to improve and ate and balanced response to the identified safety of medical devices. be more transparent, Bernasconi told weaknesses of the current system." “If things are not fixed enough, or mov- the meeting, emphasizing how positive ing sufficiently in the right direction, then industry is about the MDR changes it MEP VIEWS DIVERGE we shouldn’t be afraid to say that we need is implementing. At least one MEP, Christian Democrat Fran- to continue to improve what is being pro- “We have to be transparent,” he said. çoise Grossetête, a member of the MEP posed,” the MedTech Europe chief said. “We shouldn’t be afraid to be transpar- Heart Group and the European Society of But, in his view, the worst thing that ent. … Anyway that is what is happening Cardiology, agreed that the problems high- could happen is to try and change every- in other places around the world.” lighted in the Implant Files reports have thing now. The new regulations have “not already been dealt with by the new regula- even been put into motion," he noted. “Do COMMISSION RESPONSE tions that are soon to be fully implemented. we want to go back to years of discussion Peltomäki, the Commission representa- The ICIJ’s revelations, she suggested, before we go forward?” he challenged. tive, spoke of how the MDR is raising “showed up some real structural problems; Bernasconi stressed the need to imple- medtech standards and considerably these are the very problems that the Parlia- ment the new MDR and IVDR now for the tightening the rules. And he cited trans- ment has sought to resolve with the MDR." sake of patients and urged that all players parency as one of the three most impor- But the efforts taken by the European do everything possible to make the new tant improvements being introduced Parliament – in tightening up pre- and post- rules implementable as soon as possible. through the MDR. market monitoring rules, for example, has In relation to transparency, he men- not been sufficiently stressed, she said. Published online 2/27/19 tioned the revised Eudamed medical de- “Certain broadcasts and newspapers vice database and the detailed informa- have very much exaggerated the prob- tion that it will contain. lems,” she argued. She added: "You can “Important parts of the information in mention the problem without trying to LET’S GET Eudamed will be publicly available,” he alarm patients unnecessary or trying to sul- told the Parliament. This includes, for ex- ly the reputation of the whole sector. We SOCIAL ample, information about corrective ac- need to ask journalists to take more care." We are tweeting, liking and tions taken by manufacturers. Grossetête was the only MEP of the four In responding to Bower’s comments to speak at the European Parliament on sharing the latest industry that Eudamed is not as open and trans- February 27 who squarely defended the news and insights from our parency as it should be, Peltomäki said: new regulations. The other three MEPs global team of editors and “It is true we are still in discussing with EU said they have ongoing concerns and also analysts, join us! member states the full extent of informa- highlighted issues with transparency. tion that will be disclosed. It might well This is clearly a topic that the medtech be that not all Eudamed information will community needs to pay more attention @Medtech_Insight be made public.” to as the implementation forges ahead. medtech.pharmaintelligence.informa.com March 11, 2019 | Medtech Insight | 17 � POLICY & REGULATION �
EMA Issues Guidance On Medical Devices That Are Integral To Pharma Products
AMANDA MAXWELL [email protected]
he European Medicines Agency has and when the number of notified bodies is issued the first in a series of guidanc- One In Four decreasing. T es related to the EU Medical Devices Regulation (MDR). The initial document fo- The EMA notes that approximately WHAT THE Q&A ON INTEGRAL cuses on the implementation of Article 117 one in four centrally- authorized DRUG/DEVICES SAYS of the MDR and notified body involvement medicines includes a medical de- If the device component of a drug/device on medicinal products that have an integral vice component, and the majority combination regulated as a drug and featur- medical device element. of these involve an integral device. ing an integral device already has a CE mark- Under Article 117, the device component This includes, for example, pre- ing, then the applicant is expected to provide of combination products (such as pre-filled filled syringes and pens, patches a declaration of conformity and/or EU noti- syringes), which are regulated as drugs, for transdermal drug delivery and fied body certificate allowing the manufac- will need to have a notified body opinion pre-filled inhalers. turer to affix CE marking to the device. Pro- and certificate. Indeed, it has been clarified viding this documentation will facilitate the that, as of May 26, 2020, marketing authori assessment of the device component with respect to meeting the requirements of An- EMA COMMITTED TO CLARIFYING nex I of the MDR, the EMA says. DRUG/DEVICE BORDERLINES If, on the other hand, the dossier does The EMA describes its guidance, which has The EMA Move Out not include a declaration of conformity and been written in a Q&A format, as a “living Of London EU notified body certificate and the device document.” It says that the questions and component falls into one of the following answers are being updated continuously, The EMA officially left its London risk classes - sterile class I, measuring class I, and will be marked by “NEW” or “Rev.”, with offices after 24 years on March 1, class IIa, class IIb or class III medical device the relevant date, upon publication. 2018, in a Brexit-related move, and - then the applicant must provide an opin- It is not just medicinal products with inte- will be officially working out of ion from a notified body on the conformity gral medical device that will demand more Amsterdam from March 11, 2019. of the device part with the relevant general attention from the pharma authorities. During the week of March 4-8, it safety and performance requirements set The new regulations introduce new roles is operating a teleworking service out in the MDR’s Annex I. and responsibilities for EMA and national with a small staff on site in Amster- Among further clarifications in the EMA competent authorities (NCAs) in relation to dam to deal with emergencies. Q&A document are the following: other types of medical devices and IVDs. • The EMA/NCAs strongly recom- “With the ever-increasing pace of innova- mend submitting the EU certificate/ tion and the blurring of traditional boundaries between medicines declaration of conformity/notified body opinion as part of and devices, it is inevitable for the agency to assume new respon- the dossier of the initial MAA for the medicinal product to sibilities in regulating complex medicines with a medical device facilitate smooth running of the procedure; component. The big challenge we face is to ensure we have the • If it cannot provide the required documentation at the time appropriate expertise and resources to adequately carry out these of MAA submission, the applicant should discuss at the EMA/ new tasks,” said Guido Rasi, executive director of the agency. za- NCA pre-submission meeting its plans to provide the required tion applications (MAAs) for medicines with an integral medical documentation. The absence of this may result in additional device must include the results of the device’s assessment of con- clock stops during the procedure, as the documentation is formity by a notified body and demonstrate that the device part necessary for the adoption of a favourable CHMP opinion. meets the relevant requirements of Annex I of the MDR. Annex I • It is not intended that the requirements of the MDR apply- lists the General Safety and Performance Requirements. ing to medicinal products with an integral medical device It is the first time that this requirement has been clarified – will apply retrospectively to already-authorized products, or through the MDR, and now the EMA guidance. The the rules will to those MAAs submitted prior to May 26, 2020, unless there create a significant amount of additional work for the notified bod- is a “substantial change” to the design or intended purpose ies at a time when their workload is massively increasing anyway of the device component, or a new device is introduced. In to cope with the more conventional medical technology products such cases, any required certificate/declaration of conformity/
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NB opinion should be submitted as part of the variation/ specific medical treatment. extension application, as appropriate to EMA/NCA. This first guidance was developed jointly by EMA and the Co- The Q&A explains where a new or updated EU certificate, dec- ordination Group for Mutual Recognition and Decentralised Pro- laration of conformity or notified body opinion is needed. cedures – Human (CMDh), in close collaboration with the Euro- pean Commission. WHAT GUIDANCE NEXT? The agency says that it will publish further updates to the Q&A Published online 3/5/19 document addressing other requirements for various categories of devices, including those made of substances that are systemi- * Medtech Insight notes that the European Biopharmaceutical Enter- cally absorbed, products which are not clearly defined as me- prises (EBE), together with EFPIA (the European Federation of Pharma- dicinal products, known as "borderline products," and in vitro ceutical Industry Associations), issued a reflection paper in July 2018 on diagnostic (IVD) tests used to determine patients’ eligibility for a Articles 117 of the MDR and the impact on how medicines are assessed.
UK Regulator Reveals Post-Brexit Fees Under New Registration Scheme AMANDA MAXWELL [email protected]
he UK government has revealed the details of the fees required for all products being placed on the UK market - although that it is going to charge medical device and IVD com- there is a staggered roll-out of requirements. T panies under new registration requirements that will be Devices will have to be registered within the following time introduced in the event of a no-deal Brexit on March 29 - an out- frames after Mar 29: come that still remains a distinct possibility. Class III medical devices; There will be a statutory fee of £100 per registration appli- Class IIb implantable medical devices; By July 29, 2019 cation. Although, “depending on the number of devices you Active implantable medical devices; and have, you may be able to register all of these in one applica- IVDs in List A. tion,” the UK Medicines and Healthcare Products Regulatory Class IIb non-implantable medical devices; Agency said. Class IIa medical devices; By Nov. 29, 2019 A fee of £100 will also apply for adding new and/or subsequent IVDs List B; and changes to medical device(s) and/or IVD(s) registrations. Self-test IVDs. What is more, companies will need to renew their registration Class I medical devices; one year after their registration application or confirmation was By Mar 29, 2020 self-certified IVDs; and made, and every two years after this date. They will be charged class A IVDs (if already complying with the EU IVDR) the £100 statutory fee for each renewal. Failure to renew registration will result in the removal of device Registration for custom-made devices will be in line with the records from the UK database, after which companies will need risk class of the device. to complete a new registration application or else they would no longer be able to place their device on the UK market. ALREADY REGISTERED WITH THE MHRA? Companies already registered with the MHRA will need to confirm WHO HAS TO REGISTER AND BY WHEN? the accuracy of the information registered with the MHRA according Details about the new registration scheme are featured in the to the risk class of the product by the relevant dates set out above. MHRA's guidance on Regulating medical devices in the event of There will be no charge for this, unless they need to make any a no deal scenario. changes. Registration will only be necessary for companies who newly However, they must notify the MHRA, and pay the statutory place their products on the UK market after March 29, 2019. fee of £100 where there is a change of: The scope of products needing to be registered is being ex- • registered place of business; panded in the event of a no-deal Brexit as the UK will not have • company name; access in the future, or at least until new agreements are made, • company type e.g. if it becomes a limited company; to the EU databases containing such information. • adding device(s) to their registration record; and Until now, registration has not been needed for products that • status of an IVD, for example a change from "performance require notified body involvement, but after March 29, it will be evaluation" to "new." medtech.pharmaintelligence.informa.com March 11, 2019 | Medtech Insight | 19 � POLICY & REGULATION �
Where the manufacturer is currently registered on the MHRA’s • Where a manufacturer is not established in the UK, it must system through an EU Authorised Representative, it must up- designate a UK Responsible Person that has a registered date the information to include a UK Responsible Person – and place of business in the UK to register and act on its behalf; this will also entail a fee of £100. • If the manufacturer or its UK Responsible Person is a UK There are circumstances where the fee is not chargeable. These are: company, then the “registered place of business” should • change of email address or telephone numbers; be the same as its “registered office” under the Compa- • adding or removing product information for registered nies Act 2006. That would be the address held by the devices; and Registrar of Companies, which would have been included • removing devices from registration record. in the original application for company registration (and any change of address would have been notified to the HOW TO DESCRIBE A DEVICE Registrar); and To register any class of device with the MHRA, manufactur- • In certain cases, the UK Responsible Person may not be a ers will need to use the Global Medical Devices Nomencla- company. If this is the case, the person’s contact address, or ture (GMDN) to describe their device. (They do not have to be any address where official documents can be sent, will need a member of the GMDN Agency to find and select the appropri- to be provided. This address will be made publicly available ate GMDN terms within the MHRA’s online registration system.) on the MHRA’s Public Access Registrations Database (PARD). Initially, the MHRA will require all devices to be registered at the level of GMDN code. If companies do not know which GMDN code MORE GUIDANCE TO COME applies to their device, they will need to select the relevant de- Although these registration requirements are already quite de- scription term from the MHRA’s system. tailed, the MHRA says that it “will provide further guidance on For Class III devices, companies will also have to provide: the how to register with us in due course." medical device name; model; and catalogue or reference number. Changes to registration requirements will come into force in Some basic registration reminders and additional details: May 2020 for medical devices and in May 2022 for IVDs. The ad- • Manufacturers wishing to place a device on the UK market ditional registration requirements can be found in the UK MDR must first register with the MHRA; 2002 (as amended by the UK MDR 2019). • Once registered, These cover unique device identification (UDI) requirements; company names and ad- the need for the Secretary of State to set up an electronic system The registration requirements are dresses are added to the for registration (in the absence of access to Eudamed); and the set out in Regulation 7a (for medi- Public Access Database for registration of economic operators. cal devices), Regulation 21a (for Medical Device Registra- Registering your devices with the MHRA “does not mean that active implantable medical devic- tion. Records are listed we give you any form of accreditation, certification or approval es) and Regulation 33a (for IVDs) by manufacturer name, for the device and you should not claim this in any marketing in the UK MDR 2002 (as amended address, MHRA reference materials, on the packaging or in the instructions for use.” by the UK MDR 2019). number, and list the de- vice types registered; Published online 2/27/19
Medical Device Registration In UK Under A No-Deal Brexit: Questions Answered AMANDA MAXWELL [email protected]
nder a no-deal Brexit, new products that have been CE- The UK’s MHRA confirmed toMedtech Insight that to place marked following conformity assessment by an EU27 a device on the UK market, manufacturers without a place of U notified body will still be allowed to be placed on the business in the UK will first have to appoint a UK responsible market in the UK for a “time-limited” period, the UK government person (UK RP). says. (Also see "UK Publishes Medical Device No-Deal Brexit Contin- This UK RP needs to be physically located in the UK and act- gency Legislation" - Medtech Insight, 25 Jan, 2019.) ing on behalf of a manufacturer established outside the UK (i.e. But questions are being asked about who is responsible for including manufacturers in the EU27 post-Brexit). (Also see "UK To registering those products, especially for those companies not Demand 'Responsible Person' Be Physically Located In Country Un- based in the UK, and whether products already on the market der No-Deal Brexit " - Medtech Insight, 9 Jan, 2019.) before March 29 need to be registered too. They carry out specified tasks on behalf of the manufacturer,
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including registering products with the MHRA before the device is placed on the UK market. After March 29, 2019, all medical devices, active implantable UK RPs – The Requirements medical devices, IVDs and custom-made devices will need to be The full requirements of the UK Responsible Person are registered with the MHRA prior to being placed on the UK mar- outline in Regulation 7A (Amendment of Part II of the ket. This is an extension of existing registration requirements. 2002 Regulations) in the draft of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019. "PLACED ON THE MARKET" – TERM EXPLAINED Critically, products that have already been “placed on the mar- They include keeping certain information at the dis- ket” – an EU term that has just been explained in some detail posal of the MHRA such as declarations of conformity by the European Commission – before March 30 will not need and technical documentation. to be registered, the UK MHRA told Medtech Insight (Also see "Eu- ropean Commission Answers Vital Questions In Second Major Brexit Response " - Medtech Insight, 22 Feb, 2019.) • Four months, for class III medical devices, class IIb implant- The recent explanation by the European Commission of what able medical devices, active implantable medical devices, “placed on the market” means, suggests, among other things, and IVDs in List A; that goods held in the EU27 by a wholesaler, or on the shelf of • Eight months, for class IIb non-implantable medical a store, by the UK’s withdrawal date from the EU are considered devices, class IIa medical devices, IVDs List B, and self-test placed on the market. The Commission also stresses that the con- IVDs; and cept of placing on the market addresses: • 12 months, for class I medical devices, self-certified IVDs, • Each individual product, not a type of product; and and class A IVDs. • The first instance making a product available on the EU27 New guidance has just been published by the MHRA on market, i.e., the first supply of a good for distribution, con- regulating medical devices in the event of a no deal scenario . sumption or use, after the manufacturing stage. Medtech Insight will be posting a piece providing information on For all new devices, there will be grace periods to allow time the latest detailed requirements for registration within the next for compliance with the new registration process, with high-risk 24 hours, including details about registration fees. devices being prioritized under staggered deadlines after March 29, and specifically within: Published online 2/26/19
US FDA Inspection Goals Reduced After Shutdown; Review Dates Look Safe MICHAEL MCCAUGHAN [email protected]
S FDA is reducing its target for the number of medical “Even though the lapse in appropriations has ended, we are product inspections it will conduct during fiscal 2019 as a still responding to its effects,” Gottlieb told the committee. “We U result of the 35-day partial government shutdown at the won’t be able to conduct as many inspections of food and medi- start of the year. cal product facilities, and reviews of imports, as we had originally “We’re lowering our inspectional and import and field sampling planned,” Gottlieb said. “This is because we focused on the high- goals for the year,” Commissioner Scott Gottlieb told the House Ap- est risk establishments during the lapse, and many other types of propriations/Agriculture Subcommittee in testimonysubmitted for a inspections didn’t take place. hearing on Feb. 27. “The effected programs include human and ani- “In setting new targets for the year, we’ll use our risk-based ap- mal food, biologics, and devices,” he said. “We believe we’ll still hit our proach, focusing on high-risk products, facilities that were never original goals for pharmaceutical and compounding inspections.” inspected, and firms with troubling compliance records, so that Gottlieb was invited to testify about the impact of the funding we can continue to protect consumers and carry out our public lapse on the agency from the 35-day shutdown that consumed health mission,” he added. most of January. After the shutdown ended, Congress finally en- acted a fiscal year 2019 appropriations bill for the agency that in- BILL TO ADDRESS FUTURE SHUTDOWNS cluded a healthy budget increase. (Also see "Trump Signs 2019 US Medtech companies were concerned about the status of, and slow- Federal Funding Bill, Stopping Another FDA Shutdown; CDRH Sees downs in, agency work on their PMA, de novo and 510(k) submis- $69M Boost" - Medtech Insight, 15 Feb, 2019.) sions during the late December and January government shutdown.
medtech.pharmaintelligence.informa.com March 11, 2019 | Medtech Insight | 21 � POLICY & REGULATION �
(Also see "As US FDA Shutdown Continues, What Will Be The Cost Of Not vering from our gold standard for safety and effectiveness.” Spending?" - Medtech Insight, 2 Jan, 2019.) So they are now applauding Medical product policy development is also moving along introduction of a bill in the House of Representatives on Wednesday largely unaffected, he indicated. “Certain policy work will also be to prevent similar future FDA regulatory application delays. delayed, especially in our food and animal health programs,” he The “Medical Innovation Never Stops Act,” introduced by Rep. said, noting that “animal health” activities in particular were af- Tom Emmer, R-Minn., would ensure that FDA can continue to accept fected by the shutdown because “protection of ‘animal health’ device user fees, access those funds and conduct device reviews does not often meet the Anti-Deficiency Act standard of ‘im- during any future scenario when agency appropriations lapse. minently threaten the safety of human life or the protection of “The provisions in this legislation, if adopted, would help en- property,’” work that impacts animal life and health generally sure the pipeline of innovative new diagnostics, treatments and was not permissible during the lapse. cures will not be delayed when agency appropriations lapse” commented AdvaMed president and CEO Scott Whitaker Feb. 27. FOCUS ON RETENTION Gottlieb also implicitly noted the greatest potential impact of the WORKING THROUGH THE APPLICATION BOLUS shutdown: the effect on employee morale – and the likelihood But, on a reassuring note, FDA does not expect to see much rip- that will ripple through into recruitment and retention. ple effect from the shutdown on product review deadlines, Got- “Ultimately, FDA’s greatest strength is its people,” Gottlieb tlieb said. (Also see "Bumps In The Road As US FDA Tries To Catch Up said. “I’ve spent much of my time talking to our staff about the From Shutdown" - Medtech Insight, 31 Jan, 2019.) impact of the lapse in appropriations on their work and their “During the 35-day lapse, we could not accept new medical personal lives. I know they’re relieved to be back at work and product applications that required a user fee. As a result, we dedicated to FDA’s mission. But I also know that Federal service could not initiate the review of medical product applications is hard. The FDA can be hard. There’s a lot at stake in the work from sponsors that we received during the lapse,” Gottlieb noted. that we do. That’s what gives our work its purpose. But it also “With continued hard work and careful planning by our medi- adds to the challenges that we face every day in performing our cal product centers, we will work to review this bolus of drug and serious obligations.” medical device applications in timeframes that are consistent Highlighting the agency’s retention challenges was a same-day with our user fee goals,” he said. announcement by Parexel International Corp. that Amy McKee, “Despite the impacts of the lapse, we will endeavor to mitigate deputy director of FDA’s Oncology Center of Excellence, would any observable impacts on our review performance goals in the be joining the firm as VP-regulatory consulting services. coming year. We’re committed to making sure that patients con- tinue to have access to the treatments they need, and never wa- Published online 2/28/19
� COVER STORY �
CONTINUED FROM PAGE 5 In a statement titled, "Good Riddance “However, while he was a very effective among the world’s regulatory agencies to FDA Commissioner Scott Gottlieb," advocate for issues he cared about at FDA, to identify and act upon safety signals re- Public Citizen's Michael Carome said that for devices, he was moving in a particular lated to medical devices." (Also see "FDA "his tenure as commissioner was marked direction the agency has taken for several Looks To Lead World In Post-Market Device by regulatory decision-making regarding years now, in the direction of lowering Surveillance With Safety Plan, Investments" - medications and medical devices that tilt- pre-market safety reviews at FDA,” she Medtech Insight, 20 Nov, 2018.) That was in ed further in favor of industry's financial added. “Although he talked a lot about some ways a safety-focused addendum to interests rather than the interests of pub- post-market surveillance, for devices and one of the primary strategic goals the de- lic health." He continued, "It's imperative, putting more emphasis on post-market vice center announced at the start of 2018 but sadly unrealistic, that the next nomi- safety, he never accomplished that." – to streamline the pre-market process suf- nee for FDA commissioner be someone ficiently so manufacturers of novel tech- who is independent from industry ties PRAISE FROM THE HILL nologies plan to bring their devices to the and will make protection of public health Both Democratic and Republican lead- US first or, at least, in parallel with other the agency's top priority." ers of the House Energy and Commerce major global markets. (Also see "FDA's US- Another frequent critic of FDA's over- Committee said March 5 they have First Strategy: Device Center Sets Three-Year sight of devices, Diana Zuckerman, presi- been impressed by Gottlieb’s leader- Goals" - Medtech Insight, 17 Jan, 2018.) dent of the National Center for Health ship at FDA. Gottlieb's efforts, however, did not win Research, said he was "very surprised he’s “Commissioner Gottlieb has always over some staunch consumer advocates, resigning, noting that "he was one of two been a powerful partner and advocate who continue to view him as overly tied of the most politically astute commission- for consumer and product safety during to the drug and device industries. ers at FDA, in my 30-year memory. his tenure. He has been a good steward of
22 | Medtech Insight | March 11, 2019 © Informa UK Ltd 2019 � COVER STORY �
FDA,” committee chairman Frank Pallone lower drug prices, get a record number little experience inside the agency but has Jr., D-N.J, commented. of generic drugs approved and onto the worked with FDA in other roles. She is an “In all my years of public service, I’ve market, and so many other things. He and oncologist and has worked at Duke Uni- never worked with a more talented, his talents will be greatly missed!" versity, which employs former commis- forthright, and effective agency leader The commissioner is stepping down sioners Mark McClellan and Robert Califf. than Dr. Scott Gottlieb,” stated GOP less than a year after announcing a sig- (Also see "Commissioner Succession Plan? Ranking Member Greg Walden of Or- nificant organizational change at FDA, Abernethy As Gottlieb’s Number Two Offers egon. “He worked effectively with Con- elevating the agency’s medical product One Option" - Pink Sheet, 17 Dec, 2018.) gress to find solutions and to improve centers, including Shuren, to report di- Former Commissioner Margaret Ham- the quality of life for us all.” rectly to the commissioner in an effort to burg employed a similar strategy in hir- "flatten" the org chart. (Also see "US FDA ing Califf as deputy commissioner for IS ABERNETHY NEXT? Centers Will Report Directly To Gottlieb: medical products and tobacco. Hamburg Gottlieb will remain at the helm of FDA 'Flattened' Structure Will Make Future Politi- announced her departure a few weeks until the start of April. The White House cal Transitions Easier" - Medtech Insight, 19 later and Califf soon was nominated for gave no indication that it asked for Got- Jul, 2018.) Who will run the agency after the permanent position. (Also see "FDA tlieb to leave or that it has another imme- that remains to be seen. Lands Califf As Top Deputy, Potential Next diate candidate for the post in mind. Until President Trump nominates a re- Commissioner" - Pink Sheet, 2 Feb, 2015.) "Scott Gottlieb, who has done an abso- placement, Principal Deputy Commission- lutely terrific job as Commissioner of the er Amy Abernethy* may be in line to head Published online 36/19 FDA, plans to leave government service the agency on an acting basis. Abernethy, sometime next month," President Trump who joined FDA about a month ago from Derrick Gingery contributed reporting to tweeted March 5. "Scott has helped us to Roche subsidiary Flatiron Health Inc., has this article.
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