Engaging Early-Career Physicians in Medical Device Innovation and Entrepreneurship.

Abstract

HomeStrokeVol. 53, No. 5Engaging Early-Career Physicians in Medical Device Innovation and Entrepreneurship Free AccessResearch ArticlePDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissionsDownload Articles + Supplements ShareShare onFacebookTwitterLinked InMendeleyRedditDiggEmail Jump toSupplementary MaterialsFree AccessResearch ArticlePDF/EPUBEngaging Early-Career Physicians in Medical Device Innovation and Entrepreneurship Vallabh Janardhan, MD and Vikram Janardhan, PhD Vallabh JanardhanVallabh Janardhan Correspondence to: Vallabh Janardhan, MD, FAAN, FSVIN, FAHA, Insera Therapeutics, Inc, 5546 Serrano Ave, Dallas, TX 75248. Email E-mail Address: [email protected] https://orcid.org/0000-0003-3137-9626 Insera Therapeutics, Inc, Dallas, TX. Search for more papers by this author and Vikram JanardhanVikram Janardhan https://orcid.org/0000-0002-1417-3258 Insera Therapeutics, Inc, Dallas, TX. Search for more papers by this author Originally published28 Mar 2022https://doi.org/10.1161/STROKEAHA.121.036866Stroke. 2022;53:e197–e199Other version(s) of this articleYou are viewing the most recent version of this article. Previous versions: March 28, 2022: Ahead of Print AbstractDownload figureDownload PowerPointEarly-career physicians have several career paths to pursue given the large number of health systems that are looking to build or substantially expand their interventional program.1 In addition to providing clinical care inside or outside the interventional laboratory, many are called to take on administrative responsibilities.1 Additionally, physicians pursuing a career in academic medicine seek to explore opportunities for cutting-edge research and mentoring the next generation of trainees by taking on pedagogical responsibilities. A frequently overlooked career path involves medical device innovation, which can be mutually beneficial to both physicians and industry. From a physician standpoint, the broad spectrum of entrepreneurial activities can provide intellectual stimulation and a sense of purpose. This has benefits to the community by helping usher in next-generation technologies for the diagnosis and treatment of stroke and venous thromboembolism. In addition, this can positively impact the physician’s lifestyle, free from emergency call, potentially mitigating burnout. From an industry standpoint, physicians can contribute to all aspects of device entrepreneurship from the idea stage all the way to the clinical commercialization stage. This article examines such an entirely new career path for early-career physicians in medical device innovation and entrepreneurship.The US Food and Drug Administration (FDA) defines a medical device as an instrument, apparatus, machine, implant, or in vitro reagent that is intended for use in the diagnosis, mitigation, treatment, or prevention of disease.2 Leading market research firms expect the global medical devices market to reach $671.49 billion by 2027.3 Medical technology aimed at the diagnosis and treatment of stroke and venous thromboembolism has evolved rapidly over the past decade paving the way for new ways in which physicians can participate in and influence the innovation process.In 2015, the results of several clinical trials (SWIFT-PRIME [Solitaire With the Intention for Thrombectomy as Primary Endovascular Treatment], EXTEND-IA [Extending the Time for Thrombolysis in Emergency Neurological Deficits–Intra-Arterial], and ESCAPE [Endovascular Treatment for Small Core and Proximal Occlusion Ischemic Stroke]) of retrievable stents for acute ischemic strokes were simultaneously presented in close heels to the results of MR-CLEAN (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands),4 ushering in a new era for mechanical thrombectomy.1 Since then, several clinical studies (COMPASS [Comparison of Direct Aspiration Versus Stent Retriever Thrombectomy as a First-Line Approach], ASTER [The Contact Aspiration Versus Stent Retriever for Successful Revascularization], ETIS [Endovascular Treatment in Ischemic Stroke], and CLEAR [Cyclical Luminal Evacuation Aspiration and Retrieval]) have validated the use of vacuum aspiration systems for the treatment of acute ischemic stroke.5,6 Novel intrasaccular aneurysm treatment devices have recently received FDA postmarket approval, paving the way for an alternative to aneurysm coiling. Industry players now offer a wide ranging portfolio of devices for use in the endovascular treatment of stroke and venous thromboembolism.So what are the various ways in which interventional and noninterventional physicians can engage in the innovation and entrepreneurial process (Table S1)? The time commitment can vary widely, ranging from a part-time advisory capacity to a full-time employee or perhaps a fully committed founder of your own medical device start-up. For purposes of this discussion, we classify the innovation life cycle into 3 broad stages and identify specific ways in which early-career physicians can engage meaningfully (Figure). The authors declare that all supporting data are available within the article (and its Supplemental Material).Download figureDownload PowerPointFigure. Opportunities to engage in medical device innovation from napkin to bedside. Engaging physicians in medical device innovation and entrepreneurship can be broadly classified into 3 stages: (A) idea stage (napkin), (B) preclinical stage (bench), and (C) clinical stage (bedside). CE indicates Conformité Européenne; FDA, Food and Drug Administration; IDE, investigational device exemption; IP, intellectual property; SBIR, small business innovation research; and STTR, small business technology transfer.Idea StagePhysician employment contracts cover a wide range of topics and are too often difficult to understand. Very few of them explicitly encourage, support, or reward device innovation. It is important for physicians to enter into employment contracts that clearly define ownership of new innovation (with and without the use of hospital material resources). This includes intellectual property ownership, licensing opportunities, revenue/profit sharing, corporate spinoffs, and other legal consequences of innovation that may emerge during the course of the physician’s employment at the health system. This is a critical first step that paves the way for physicians to participate in device innovation.Many medical device companies have a scientific advisory board that seeks input from physicians on the unmet need for a device, current and addressable market size, device preferences, and shortcomings. Joining a start-up’s scientific advisory board is an excellent way for early-career physicians to begin participating in the device innovation process.The ability to poll colleagues in other hospital systems or leverage social media platforms to successfully conduct surveys of physician end users is a tangible asset to device companies. What starts as an invitation to join the scientific advisory board (part-time) could evolve over time into a more permanent engagement with the medical device company, whether it is a fledgling start-up or an established corporation. A good example of a long-term engagement is the role of the Chief Medical Officer (full-time) who provides sustained guidance to the engineers in the company in the application of technology to solve problems related to stroke or venous thromboembolism care whether it is improving patient outcomes or increasing access to care.Physicians, especially the ones working in an academic setting, are also well suited to partnering with medical device companies in the joint pursuit of funding opportunities, for example, small business innovation research or small business technology transfer grants from the federal government.Preclinical StagePreclinical tests play a very critical role in the design and development of medical devices. Regulatory agencies such as the FDA, or competent authorities in the European Union via the Conformité Européenne mark approval of medical devices, have guidelines on a specific checklist of preclinical tests that need to be performed. Physicians can help design and perform such tests, also called design verification and validation tests, as part of independent third-party laboratories.An example of such design verification tests would be usability tests to assess whether the medical device is equivalent, superior, or inferior in ease of use compared with a benchmark or predicate device. Physicians can also play an integral role in design validation tests to assess whether the medical device conforms to the end user needs and intended use. An example of such design validation tests would be in vitro (eg, simulated flow model tests for efficacy) or in vivo tests (eg, animal model tests for safety) of medical devices compared with benchmark or predicate devices. The results of such preclinical tests can be presented at national or international conferences and published in medical literature.7,8Part of the technical file documentation to be submitted to regulatory agencies (eg, for the Conformité Européenne Mark approval in the European Union) includes an annual clinical evaluation report, which can include a meta-analysis or systematic review of benchmark or similar technologies, that physicians can assist with. In addition, physicians can provide the necessary cognitive and technical skills needed for training and in-servicing physicians before their first clinical use of device.Clinical StageNoninterventional physicians and interventionalists can play an invaluable role in keeping the engineering team laser focused on how the innovation can improve the lives of patients rather than getting lost in technological nuances that may or may not translate into measurable patient benefit.Physicians can play a key role in the study design and the operations of a clinical study, for example, an FDA investigational device exemption study. Based on the training and skill level, they can serve on advisory committees (eg, data safety monitoring boards or clinical event committees), can assist with independent imaging review (imaging core laboratory) or independent technical review of procedural metrics (technical core laboratory), or serve as independent advisors to interact with the FDA. Physicians can also present and publish their first-in-human use of medical devices6 or be involved in the early commercial launch of medical devices after regulatory approval.6There are several ways for physicians to avail themselves of this new career path. Reach out to established physician innovators and have them make an introduction to an executive at a device manufacturer. Engage with industry players on social media. Learn the device development process by investing in a device start-up or network with industry executives over a cup of coffee or a meal at major medical conferences.Anyone going into this career path or considering it should be aware of the following drawbacks: (1) patience is needed as it takes several years for product development, (2) perseverance is invaluable as several failing prototypes before the final product is not uncommon, (3) and a willingness to learn new skills as medical device development is a melting pot of several disciplines such as medicine, engineering, software, intellectual property law, quality, regulatory affairs, and business.ConclusionsEngaging physicians in patient-centered innovation is crucial in developing next-generation medical devices. Physicians can contribute to all aspects of medical device innovation from the idea stage all the way to the clinical commercialization stage, which can be very rewarding and fulfilling.Article InformationSources of FundingNone.Supplemental MaterialTable S1Disclosures Dr Vallabh Janardhan reports grants from the National Science Foundation, other from Insera Therapeutics, Inc, and other from the Society of Vascular and Interventional Neurology, outside the submitted work; Dr Vikram Janardhan reports grants from the National Science Foundation and other from Insera Therapeutics, Inc, outside the submitted work. In addition, both have over 12+ patents pending and 70+ US Patent and Trademark Office and worldwide patents issued or allowed.FootnotesThe opinions expressed in this article are not necessarily those of the editors or of the American Heart Association.Supplemental Material is available at https://www.ahajournals.org/doi/suppl/10.1161/STROKEAHA.121.036866.For Sources of Funding and Disclosures, see page e199.Correspondence to: Vallabh Janardhan, MD, FAAN, FSVIN, FAHA, Insera Therapeutics, Inc, 5546 Serrano Ave, Dallas, TX 75248. Email [email protected]com