Stanford iFarm Teams – The Final Project · Stanford iFarm Teams – The Final Project ......

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 ChunWu. 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:

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.

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 onbody impacts

Pending 3/8/13 Stanford University

Bruce Cam, David B. Camarillo, Lyndia Chun Wu

US20140312834A1 Wearable impact measurement device with wireless power and data communication

Pending 4/20/13 Stanford University

Yuji Tanabe, Ada Poon, David B. Camarillo, Lyndia Chun Wu, Alex Yeh

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:

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 and blast detection. More details in the market analysis section.

14

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 collaborates with.

3

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:

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 system

Grant 1/22/2010

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 (also EP filing)

Body mounted monitoring system and method

Application 10/27/2011

Brain Sentry Llc Patent Number Title Status Priority Date

US20140149067A1 (also WO filing)

Impact and acceleration detection Application 4/13/2012

US20150109129A1 (also WO filing)

System and method for measuring bodily impact events


Blackbox Biometrics Patent Number Title Status Priority Date

US20150040669A1 & US20150040665A1 (also WO filing)

Devices, systems and methods for detecting and evaluating impact events


Force Impact Technologies (none found) Others

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.

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 broader business plan. Though collaborations exist with OPRO, there currently no ability to scale up manufacturing. Further detailed analysis will be required to determine the market size of this product. In addition, the associated patents have not yet been granted.

C. Opportunities There are numerous opportunities that could be taken advantage of moving forward. In terms of product development, the proximity to sports teams could facilitate the gathering of data for a number of sports at different levels of play. In addition, the proximity to venture capital and the entrepreneurial culture of the SF Bay Area is a competitive advantage in terms of financing. In terms of the market, there has been an increasing public awareness of sportsrelated head impact injuries and their acute and long term effects

of 17

(e.g. as seen in the 2009 GQ article “Game Brain” by Jeanne Marie Laskas and the upcoming, highprofile movie “Concussion”). The recent years have also seen other related trends: a growth in the personal, wearable sensors market, greater emphasis on health analytics and big data, and brain and cognitive research (e.g. BRAIN initiative). Together, these trends appear to indicate a growing need for head impact sensing in sports that provides reliable, and eventually actionable, data.

D. Threats Threats to this technology include the possibility of opposition, at all levels from players to governing bodies, to changes in current practices that would both be necessary for and result from the use of this technology.

Benefit Burden

Players In the short term, this is little to no medical benefit since subclinical head impacts are thought to be cumulative, and thus negative health effects are longterm. The technology may provide benefit if mandated or used with mandated procedures, though this amounts to negative reinforcement.

May exist mouthguard may require more care to use, or may feel uncomfortable compared to standard mouthguards due to the form factor

Coaches/Trainers Mandated use of mouthguards may alter game plans revolving around personnel availability.

Governing bodies Governing bodies would benefit from reduced liability and positive public perception.

The technology represents an operating cost, and there is a risk that the data may negatively affect public perception of the sport.

In addition, the burden on governing bodies has the potential to filter down from professional to collegiate and high school/youth levels. The NFL in April 2015 settled with thousands of current and former players with no cap in the monetary awards. If this trend continues down to the collegiate level for example, the involved schools, insurers, and governing bodies may find football or other headinjury prone sports unprofitable thus leading to a shrinking market. Another threat is competition in the head impact detection and mouthguard space, as described in the following section.

of 17

4. MARKET ANALYSIS Expert Opinions Inventors (Camarillo Lab) The inventors have a vision for this technology that may be different from that of a mass market perspective. In general, they prefer to take a longterm approach of building the foundation for the market by disseminate the technology as widely as possible to researchers and sports teams. The inventors place greater value on the quality of the technology than on the speed of launching the product into the head impact detection market, citing other companies that have tried but failed to gain traction due to subpar technology. The longterm view is that widespread dissemination of the technology will form a foundation the next stage of mouthguards that can provide clinical readouts. Data are not equivalent across form factors or products so early dissemination may help raise the barrier to entry in the future. The inventors are investigating avenues for further research (and possibly startup) funding, including SBIR grants. Manufacturer (OPRO) Because of their close collaborations with the Camarillo Lab, we spoke to OPRO about their perspective of the instrumented mouthguard market. OPRO believes that current client base, which is comprised largely of youth athletes, likely wouldn’t be interested in impact detecting mouthguards and are more concerned with dental protection. OPRO opines that their professional clients or professional teams in general would be more interested (especially rugby). We asked OPRO if they believed that the future of mouthguards is in sensor integration, and they expressed that they do not see that as the case (for the UK market), but that impact detection capabilities would likely become a premium feature for mouthguards. OTL OTL has provided several thoughts on this technology. First, it seems reasonable to expect that the patent application for this technology will be issued at some point. The main issue will be how well it covers the potential product. On the other hand, a patent may not be necessary to form a successful startup based on the technology. OTL has received some initial interest from various small companies, but there have been not further developments beyond this. OTL believes this hesitation from potential licensees may be in part due to patent status, and that upon being granted licensing may be sufficiently derisked to attract firmer committments.

of 17

Competitive Landscape The following is a summary of the main competitors to R13015’s technology with qualitative ratings of the competitor’s claimed technology, the deployment of their technology, and the quality of their owned patents.

BiteTech Details on Bitetech’s BTX2 technology could not be found, but based on available media it appears to be an instrumented mouthguard with similar capabilities. BiteTech has licensed its noninstrumented mouthguard technology to Under Armour. It has deployed prototypes to the Stanford University, University of Notre Dame, and University of Washington football teams. While BiteTech owns a large number of patents in the mouthguard space, only one appears to cover instrumented mouthguards and it is currently an application.

of 17

i1 Biometrics i1 has deployed its Vector mouthguard to high schools and a few NCAA teams (Texas A&M and University of South Carolina). Its technology is suited only for helmeted sports due to the location of the electronics external to the mouth. i1 is a spinoff from X2 Biosystems, and was successful in suing X2 for its instrumented mouthguard related patents. i1 likely has the strongest IP in this group due to the fact that its instrumented mouthguard patents have been granted. X2 Biosystems X2 has a data management platform in addition to its xPatch instrument. The former has been deployed widely (e.g. NFL and NHL), while the latter has been deployed to high school football and professional rugby. X2 also has collaborations with the US military for impact detection applications. However, the patch as a form factor appears to be inferior to the mouthguard in terms of accuracy, thus reducing X2’s competitive advantage against R13015. Blackbox Biometrics The company spun out of an RIT incubator and has had collaborations with the US military in the past. The LinxIAX is a sensor and management software attached to a wearable (e.g. skullcap), limiting its accuracy. The product has been deployed primarily to high school boxing. Blackbox has also developed blast detection technology. Reebok Reebok’s Checklight (originally developed by MC10) is similar to Blackbox Biometrics’ LinxIAX and enjoys wider exposure in addition to being commercially available. Sponsorship reasons currently prevent the NFL from using the device but it’s generated interest from the NFL and high profile players. Brain Sentry This helmetmounted device is the least accurate device in this group. It is commercially available and has been deployed to high schools. Force Impact Technologies The claimed technology appears to have similar capabilities as R13015, but there is little or no evidence that this product has been developed beyond concept. The main innovation claimed by FIT is an integrated LED in the mouthguard that displays impact level, but not patents assigned to FIT have been found. Overall, this company is likely not a serious competitor, but is an example of the ability of good marketing to generate press coverage. Others: Simbex

of 17

5. INDUSTRY ANALYSIS – PORTER’S FIVE FORCES

A. Competitive Rivalry ● Moderate degree of rivalry as there are several different companies using a variety of form

factors, with deployment across various sports and level of play. However, none of these technologies are yet firmly entrenched.

B. Bargaining Power of Suppliers

● The materials used to manufacture the mouthguards is cheap and widely available. ● The electronics components are not cheap and are custom made, but are not unique and could be

supplied by different sources. C. Bargaining Power of Customers

● Currently, customers have leverage to switch products or not use them at all. Customers also have the leverage to demand features and product quality (especially impact detection accuracy).

D. Threat of New Entrants

● Low barriers to Entry ○ Technology: Low cost to play as it is relatively easy to cobble together an instrumented

device, higher cost to play competitively in terms of impact detection technology ○ Logistics: In the US, low barrier to implement as there are plenty of football programs

from youth to HS level ○ Intellectual property:

● By disseminating the technology early, the inventors may be able to effectively raise the barrier to entry in the future, when the technology provides (and the market demands) readouts with clinical significance.

E. Threat of Substitutes

● Changes to rules or practices may reduce the demand for this product. ● Advances in medicine may reduce the need to monitor collisions closely. ● Advances in impact detection technology may replace the mouthguard as the preferred form

factor.

of 17

6. REGULATORY ANALYSIS Not applicable initially, but the device will likely fall under Class I but require a PMA, as the device itself is lowrisk, but there are likely no similar predicate approved technologies (an instrumented mouthguard from which head impact data is measured and clinical significance can be derived):

(from http://libguides.clemson.edu/meddevice) It will be worthwhile to investigate the regulation of personal dosimetry devices, as this is a reasonable analog in both cases, what is measured is subclinical and thought to be cumulatively harmful, though in a nondeterministic manner.

of 17

http://libguides.clemson.edu/med-device

7. OPPORTUNITY ASSESSMENT A. Industry Assessment for Primary Application According to a BCC Research market report on sports protective equipment, the U.S. market for protective sports equipment was $1.916B in 2014, and $1.973B in 2015. It is projected to be $2.273 B by 2020, which represents a 2.9% compounded annual growth rate (CAGR). Within this category, the market size for football equipment in 2014 and 2015 was $338M and $355M, respectively. The projected market in 2020 is $521M, which represents an 8% CAGR. Face and head protection comprises 67% of the total football protective equipment market. It follows that in 2020, the total market for face and head protection will be approximately $350M. In the U.S., football participation rates were as follows for the 2013/2014 season:

High school and NCAA participation comprise nearly 100% of the participants. As seen in the following figures, growth in high school and college participation is expected to be less than 2% CAGR.

of 17

Because the total market growth outpaces growth in participation, one can expect a growth in the average spend per customer. B. Nonmarket forces In April of 2015, the NFL was involved in litigation over player concussions which ultimately resulted in a settlement with thousands of players with no cap on funds for monetary awards. The NFL is expected to dedicate a portion of the fine towards concussion research. In addition, concussions in football are beginning to take hold in the public consciousness, as seen in increasing trends in news articles mentioning football concussions, as well as a recent highprofile Hollywood film shedding light on the issue:

In the short term, these developments would appear to improve market attractiveness for our technology.

of 17

8. POTENTIAL PARTNERS We recommend first seeking a manufacturing partner rather than licensee. This may be advantageous for the inventors as this would keep the option open to form a startup after manufacturing is in place. By partnering with OPRO for manufacturing, the inventors (or whoever is driving the commercialization of the technology) would benefit from existing collaborations as well as OPRO’s marketleading capabilities in the manufacture and distribution of high volume custom fitted mouthguards. Pros:

● Existing collaboration with Camarillo Lab ● Leader in manufacture of customfit mouthguards ● Able to scale up manufacturing (current: 50K/year, possible: +10K/year instrumented) ● Existing patents on manufacturing techniques

Cons:

● Majority of customer base likely not interested in instrumented mouthguards ● Does not see sensor integration as the future of mouthguards, just premium segment

The following table provides an assessment of potential partnerships based on the company type:

of 17

9. IFARM TEAMS TECHNOLOGY SUMMARY AND RECOMMENDATION A. Where did you mainly focus your efforts for this technology? We focused our efforts mainly on 1) understanding the competitive advantage of the technology and 2) researching competitors and differentiating factors between their technology and this one. B. How have you contributed to the licenseability of this invention? We’ve helped bring awareness to the licensing/startup pathway for the inventors by providing a snapshot of the market and licensing potential of this technology. C. Did you address the associate’s comments from the iTP? Yes, we looked into the concerns listed on the iTP and more. D. If you had more time to work on this project, what areas would you plan to further investigate? Given more time, we would investigate start up and licensing opportunities, and build a business plan. E. How do you recommend OTL should proceed with this technology? Our recommendation is to work closely with the inventors as they have a better grasp on the technology’s marketability and a vision for it’s use, and could use help in identifying opportunities and in recruitment of personnel to work on commercialization. This technology is more nuanced than it might seem. It would help to build a better understanding of the future market for impact detection devices in football.

of 17

Stanford iFarm Teams – The Final Project · Stanford iFarm Teams – The Final Project ......

Documents

Transcript of Stanford iFarm Teams – The Final Project · Stanford iFarm Teams – The Final Project ......