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Stanford Ifarm Teamsа–Аthe Final Project Page 1 of 17 Stanford iFarm Teams – The Final Project STANFORD DOCKET NO. S13­015 A NOVEL APPROACH FOR DETECTING HEAD COLLISIONS IN SPORTS TEAM 5 Team: Charlie Ouyang, Alex Trzebucki Mentors: David Taylor, Amy Wilkinson 1. TECHNOLOGY DESCRIPTION, STATUS AND LANDSCAPE A. Idea Description The technology S13­015, “Novel approach for detecting head collisions in sports,” was invented by Bruce Cam, David B. Camarillo, and Lyndia Chun Wu. It consists of two main components: 1) an instrumented mouthguard containing a triaxial linear accelerometer and a triaxial gyrometer, along with other supporting electronics, and 2) an impact detection algorithm that distinguishes between non­impact events and true head impacts. B. Potential Commercial Applications of Technology The primary commercial application of this technology is detection of head impacts in contact sports, helmeted and non­helmeted, where head impact is of concern. Such sports include football, soccer, boxing, hockey, and lacrosse, and include all levels from amateur to professional. Additional commercial applications of the technology may include those in the following sectors: ● Military: Impact­related activities such as parachuting ● Automotive: Safety evaluation (pedestrian and vehicle) ● Elderly care: Head impact detection during falling events C. Features and Benefits The technology is able to provide high accuracy, raw kinematic data and can accurately classify recorded events as impact or non­impact (offline or in real time). The potential uses of this data are numerous. In the short term, the main value of instantaneous and cumulative head impact data lies in its potential use for prompting further clinical evaluation of players during or after sporting events. In the long term, this data will be broadly useful as a correlate to accepted clinical measures, ultimately better informing research on head impacts and leading to the development of devices and policies for improved detection, and more importantly prevention or minimization of head impacts and related sequelae. More broadly, this technology will lead to improved risk models for activities involving head impacts. D. Innovative Aspects The key innovative aspects of this technology revolve around the fully integrated, custom­fitted mouthguard form factor, which provides the following downstream competitive advantages: Page 1 of 17 1) Higher kinematic accuracy compared to alternative form factors/sensor placement (e.g. on the helmet, on the head, on the skin behind the ears. 2) Accuracy of impact event classification (noise vs. real impact) based on the quality of the kinematic data. 3) Usability in non­helmeted sports (compared to instrumented mouthguards with electronics external to the mouth). Other aspects of the technology, such as the sensor electronics and the classification algorithm itself support the overall novelty of the technology without being particularly novel independently. E. Regulatory Hurdles Without targeting this technology toward clinically significant applications, it can bypass typical regulatory hurdles applicable to medical devices. However, in the long term, future technologies evolving from this may need to clear such regulations, and the quality of the data provided by this device may largely determine the success of future regulatory approval. F. Development Status Currently, the technology is a functional prototype and has been fielded. However, several issues remain, including 1) the need to improve hermetic sealing of the electronics and robustness against chewing forces, 2) more data to validate the accuracy of the impact detection system. Page 2 of 17 2. INTELLECTUAL PROPERTY LANDSCAPE Status & Coverage of Patents – This docket has one associated patent application, US20140257051A1. Another related docket from some of the same inventors is associated with another related patent, US20140312834A1: Patent Number Title Status Priority Date Assignee Inventors US20140257051A1 Device for detecting Pending 3/8/13 Stanford Bruce Cam, David B. Camarillo, on­body impacts University Lyndia Chun Wu US20140312834A1 Wearable impact Pending 4/20/13 Stanford Yuji Tanabe, Ada Poon, David B. measurement device University Camarillo, Lyndia Chun Wu, Alex with wireless power and Yeh data communication Competing IP – A search using Innography Semantics Analysis with the search parameter “head injury ​ detection impact motion sensors”=2 resulted in 999 patents in 282 text clusters. Within the cluster “Mouth Guard”, there were 71 patents: Page 3 of 17 The following shows the top four organizations in this space by revenue, and the top five by patents: Organization Description Patents Bite Tech, Inc. Direct competitor with products for head impact detection in sports 14 and blast detection. More details in the market analysis section. Gard AS Shock Doctor brand of mouthguards. $84 million in revenue. 4 Opro International Ltd UK based custom fit mouthguard company that the Camarillo lab 3 collaborates with. MDM Oral Technologies ZONE brand of no­boil, self custom­fit mouthguards using a putty 3 COFRA Holding AG ? 3 As seen in the following chronological breakdown of the 71 patents, activity in the mouthguard space has grown in the past 5 years: Page 4 of 17 Alternatively, by searching the patent space beginning with known competitors, we arrive at the following data: i1 Biometrics According to the inventors, i1 has sued and acquired the rights to X2’s mouthguard­related patents. X2 Biosystems Patent Number Title Status Priority Date US8537017B2 Head impact display Grant 1/22/2010 US8466794B2 Head impact event reporting system Grant 1/22/2010 US8554495B2 Head impact analysis and comparison Grant 1/22/2010 system US20140088454A1 Adhesive shock patch Application 9/27/2012 All of the above patents are also published as WO, CA, EP. Reebok Patent Number Title Status Priority Date US20130110415A1 Body mounted monitoring system and Application 10/27/2011 (also EP filing) method Brain Sentry Llc Patent Number Title Status Priority Date US20140149067A1 Impact and acceleration detection Application 4/13/2012 (also WO filing) US20150109129A1 System and method for measuring bodily Application 10/18/2013 (also WO filing) impact events Blackbox Biometrics Patent Number Title Status Priority Date US20150040669A1 & Devices, systems and methods for detecting Application 8/8/2013 US20150040665A1 and evaluating impact events (also WO filing) Force Impact Technologies (none found) Others Page 5 of 17 There are many other similar patents or patent applications covering the head impact detection space. A small sampling of this space is listed as follows: Riddell Sports Group Inc., US20060074338A1 ­ 10/11/2000 Headcase LLC, US20150040685A1 ­ 8/8/2013 Raytheon, US8191421B2 ­ 5/7/2007 AT&T Intellectual Property I LP, US20120188083A1 ­ 1/20/2011 Safebrain Systems Inc., US20140333446A1 ­ 5/10/2013 While the above patents and patent applications may cover difference approaches to head impact detection, it is important to note that this is a crowded IP space and it would be prudent to further investigate how well the patents associated with R13­015 cover the unique and competitive aspects of the technology. Page 6 of 17 3. SWOT ANALYSIS A. Strengths Technology ­ The mouthguard form factor of the device is optimal for intended application of measuring ​ impact forces to the head. The kinematic accuracy due to this form factor is a major competitive advantage, as accurate data is critical for the future of the head impact detection field and the future development of devices with diagnostic value. Development ­ The product is at working prototype stage and is currently being fielded with the Stanford Football team for the 2015­2016 season. The research team is strong, with field­leading expertise in the head impact field, a vision for the direction of the technology and product, and collaborations or connections to the following: ● Stanford School of Medicine ● Stanford Athletics: men’s football, women’s lacrosse ● Duke University ● Industry: OPRO, i1, X2 Commercialization ­ The main strength on the commercialization side is the collaboration with OPRO, a ​ company that is the market leader in the sales and manufacturing of custom­fitted mouthguards (50,000/yr, with the capability to manufacture and additional 10,000/yr for the inventors). In addition, the inventors have several patent applications pending that cover the technology, and are active in technology disclosure and IP protection activities. Finally, initial commercialization of this product will likely not require regulatory approval. B. Weaknesses Technology ­ One weakness of the technology in its current state is that the issue of electronics robustness and hermetic sealing has not been completely solved. A related but separate issue is end user compliance ­ football players are known to chew on their mouthguards, an activity that has been observed in some instances to damage the relatively fragile electronics of the device. Development ­ The inventors require more data for development, and data collection is currently tied to the Stanford football team schedule. Quantity and quality of data appear to be of great importance in the development of both the physical device and the impact detection algorithm. In the long term, a large amount of high quality of data will be needed for regulatory approval, and quality data can only be collected with a well­developed instrument. Commercialization ­ At this time, there is no team in place to develop a commercialization plan or a ​
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