POLICY & REGULATION COMMERCIAL R&D An update on NEST real-world Mark Hitchman of Canon Medical Two firms nab US breakthrough evidence efforts, p. 6 Systems discusses market growth status, p. 22 strategies, p. 15 Medtech Issue 80 Pharma Intelligence Informa February 5, 2018 medtech.pharmaintelligence.informa.comInsight 'WE SURVIVED MDSAP': The final visit from the US agency that year was the last straw, she said. "That FDA inspection really made me Cynosure Aces Single-Audit Program want to get Cynosure involved in MDSAP because I cancelled a vacation to Indonesia Twice; Tells How Your Firm Can, Too to stay behind for that inspection," Hoy said. "That's when I learned that travel insurance SHAWN M. SCHMITT [email protected] doesn't consider an FDA inspection to be an emergency that's reimbursable." MDSAP , created by the International Medical Device Regulators Forum (IMDRF), allows firms to undergo only one audit by an accredited third party to satisfy quality regulations for five countries: the US, Can- ada, Brazil, Japan and Australia. The program runs on a three-year cycle, albeit with differing scopes for each audit. Firms are certified to MDSAP in the first year; in the second and third years, they submit to surveillance audits, which are typically quicker than a certification audit. The cycle then repeats, with recertification to MDSAP Shutterstock: alphaspirit Shutterstock: occurring in the fourth year, and so on. MDSAP ran as a pilot program for three or longtime quality and regulatory "It was particularly difficult that year to full years from January 2014 through expert Connie Hoy, the decision to be in the quality department at Cynosure December 2016, but is now a bona-fide F ditch the prying eyes of multiple because all we did was get audited. It did way for device-makers to be inspected. regulator-inspectors for the relative ease not stop," said Hoy, executive VP of clini- In fact, manufacturers must be audited of the one-and-you're-done approach of cal development and regulatory affairs to MDSAP by Jan. 1, 2019, if they want to the Medical Device Single Audit Program for the device-maker. sell product in Canada. (MDSAP) was a no-brainer. "We had regulators in from Japan and (Also see "'Perfect Storm' The year was 2014, and she was fed Korea. We had three Brazilian audits – one Arrives: Clock Ticking For up with the sheer number of intrusive, for our site and at our two OEMs [original Device Firms To Conform costly and disruptive audits her compa- equipment manufacturers]. We also had CLICK To ISO 13485, MDSAP, EU ny had to undergo to prove compliance two FDA audits related to IDE [investiga- Check out these 8 things you need to & ASEAN Regs" - Medtech with a variety of regulatory schemes tional device exemption] devices. And we know about MDSAP: Insight, 11 May, 2017.) http://bit.ly/2nvPXVg. from around the world. had an FDA quality systems inspection." CONTINUED ON PAGE 10 FROM THE EDITORS OF: THE GRAY SHEET, CLINICA, START-UP AND MEDTECH INSIGHT NEWSLETTER Pharma intelligence Intelligence with a Global Perspective The Premier Resource In The Life Sciences Industry Biomedtracker Pink Sheet Datamonitor Healthcare Pharmaprojects In Vivo RxScorecard Meddevicetracker Scrip Medtrack Sitetrove Medtech Insight Trialtrove Pharmaintelligence.informa.com 17 20 21 inside: explore more: Cover / "We Survived MDSAP": Cynosure Aces Single-Audit exclusive online content Program Twice; Tells How Your Firm Can, Too – Connie Hoy, executive VP of clinical development and regulatory More on MDSAP affairs for the Westford, Mass.-based device-maker, explains http://bit.ly/2nvPXVg how the firm handled audits at two separate facilities under http://bit.ly/2BGaY4N the Medical Device Single Audit Program. "There’s not one Check out insights from US FDA's Kimberly Lewandowski- company that cannot pass the MDSAP audit," Hoy insists. Walker – the agency's point person for the Medical Device Check out her valuable tips and advice – and colorful Single Audit Program – and NSF International's Kim anecdotes – in this feature article. Trautman, in companion articles to this week's cover story. EDITORS' PICKS EU deadlines 5 Boston Scientific Hooks In Millipede, But Still Trailing http://bit.ly/2Fvb958 Behind In Mitral Valve Race – Boston Scientific is pumping http://bit.ly/2E2Ohg6 money into the high-potential mitral valve repair space by EU competent authorities issued clarifications on making a strategic investment in Millipede, as well as signing implementation timelines for the new EU regulations for an acquisition option agreement that could be worth nearly devices and diagnostics. The documents are helpful, but half a billion dollars. However, its cardiovascular rivals are questions remain. already some distance ahead in this space. Diagnostics duo 6 NEST Coordinating Center At Year One: Device Data- http://bit.ly/2DO05Q8 Sharing Network In Its Sights – A year after the NEST US IVD firm Access Bio has teamed up with Australia's Coordinating Center was launched, the group has expanded Atomo Diagnostics to bring the latter's all-in-one HIV its staff and now it wants to get a data network in place rapid diagnostic test to new international markets. by year's end with real-world evidence information that device manufacturers can use to impress US FDA reviewers. Bezos, Buffett and Dimon Medtech Insight spoke to NESTcc's executive director. http://bit.ly/2BF2niN Amazon has partnered with Berkshire Hathway and POLICY & REGULATION JPMorgan Chase to set up a joint health-care venture 8 Medicare Will Look To Informal Pathways For Faster initially aimed at leveraging technology to make Medtech Reimbursement – The US Centers for Medicare affordable health care accessible to the three companies' and Medicaid Services has withdrawn efforts on a proposed US employees. CEOs Jeff Bezos, Warren Buffett and Jamie rule to offer faster Medicare reimbursement to novel Dimon have put their heft behind the effort, which is devices, but the agency still plans to work on different music to the ears of digital-health firms. approaches to provide "timely patient access" to device innovations, a spokeswoman said. AdvaMed says it is Device Week disappointed with the decision. http://bit.ly/2y4lpgk Check out the latest episodes of our weekly podcast, 9 Talking To Payers: Advancing Bill Would Broaden What including an upcoming discussion on legal issues and Firms Can Say About Investigational Products – The important lawsuits impacting the medtech industry. US House Energy and Commerce Health Subcommittee advanced a Republican-sponsored bill that would permit communications between manufacturers and private and medtech.pharmaintelligence.informa.com public insurers about the benefits of unapproved devices and drugs. Democrats on the panel expressed strong medtech.pharmaintelligence.informa.com February 5, 2018 | Medtech Insight | 3 Medtech insight reservations that FDA may feel unduly pressured by insurers DAVID FILMORE @MEDTECHDAVID to rush through product approvals. [email protected] COMMERCIAL TINA TAN @MEDTECHTINATAN [email protected] 15 Hindsight 20/20: Mark Hitchman – In this installment of SHAWN M. SCHMITT @MEDTECHSHAWN our Q&A feature where medtech industry veterans share [email protected] their experience taking diverse businesses, Mark Hitchman, REED MILLER @MEDTECHREED UK managing director of Canon Medical Systems, shares [email protected] insights on how to grow your business' market share and AMANDA MAXWELL @MEDTECHAMANDA get that one-up over your competitors, as well as how to [email protected] remain a market leader once you reach the top. MARION WEBB @MEDTECHMARION [email protected] 16 Illumina Awarded $26.7m In Patent Row – The verdict SUE DARCEY @MEDTECH_INSIGHT resolves an intellectual property dispute in which Illumina [email protected] alleged Ariosa was violating Illumina's patents on prenatal FERDOUS AL-FARUQUE @MEDTECH_DANNY genetic testing technology. [email protected] ELIZABETH ORR @ELIZABETHJORR 17 GSK Consumer Tries On Wearable Pain Relief With [email protected] NeuroMetrix Deal – GSK Consumer purchases outside- CATHERINE LONGWORTH @MEDTECHCATE of-US rights to pain-relief device Quell from NeuroMetrix [email protected] in a deal that includes co-development of transcutaneous ASHLEY YEO @ASHLEYPYEO electrical nerve stimulation products. [email protected] MAUREEN KENNY @SCRIPREGMAUREEN START-UP SPOTLIGHT [email protected] 18 CorInnova, Taking Robotics To Heart To Reduce LVAD- NEENA BRIZMOHUN @SCRIPREGNEENA Linked Stroke – EpicHeart by CorInnova is an advanced [email protected] cardiac compression device that combines the advantages VIBHA SHARMA @SCRIPREGVIBHA of a flexible endoskeleton and soft robotics to provide [email protected] biventricular cardiac support for heart-failure patients. Because JANET HANIAK SENIOR DESIGNER the device does not touch the blood, many adverse events GAYLE REMBOLD FURBERT DESIGN SUPERVISOR such as stroke and gastrointestinal bleeding associated with RICHARD FAINT HEAD OF MEDTECH existing cardiac-assist technologies are eliminated. [email protected] PHIL JARVIS MANAGING DIRECTOR R&D Editorial office: 20 SOPHiA Genetics Combines In Vivo And In Vitro Cancer 52 Vanderbilt Avenue, 11th Floor, New York, NY 10017 Analyses With Enhanced AI Platform – Clinical genomics phone 240-221-4500, fax 240-221-2561 company SOPHiA Genetics is integrating new radiomics CUSTOMER CARE: capabilities to enhance