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Help Us Build an Authoritative List of SaMD Cleared by the FDA
This is Part 2 of Orthogonal’s SaMD Watering Holes series. To explore the full savannah of SaMD Watering Holes, visit the links below:
In our quest to improve patient outcomes faster by accelerating the development of Software as a Medical Device (SaMD), Digital Therapeutics (DTx) and connected medical device systems, Orthogonal has collaborated with people, companies and organizations all across MedTech. These collaborations, where we share findings, learn from others and develop best practices, have led us to exciting new insights, and sparked the creation of this comprehensive resource to help you to make a deeper connection to our industry and its people.
In nature, animals across an ecosystem come to the watering hole to drink. Regardless of size or strength, everyone benefits from coming together and sharing resources. Orthogonal’s SaMD Watering Holes series supports our natural tendencies to gather by highlighting how you can get involved in the entities and organizations that make up our industry. Forge new connections, gain diverse perspectives and help collaboratively solve the problems MedTech is facing today by tapping into these deep wells of knowledge.
The MedTech industry is nascent and in a constant state of change. A myriad of stakeholders, such as scientists, regulators and consumers, independently influence the kinds of products we make and avenues of distribution. By staying up-to-date with the latest news collected specifically for our industry, you’ll be able to steer your company towards continued growth and success. Publications, blogs and media that deliver findings from specific working groups and industry think tanks make it convenient to keep up with new developments in MedTech.
The sources in this list are avenues for publication, outreach and networking that can expand your professional opportunities and relationships, alphabetized by convening entities.
The Association for the Advancement of Medical Instrumentation® (AAMI) is a nonprofit organization founded in 1967. It is a diverse community of more than 10,000 professionals united by one important mission – the development, management, and use of safe and effective health technology. AAMI is the primary source of consensus standards, both national and international, for the medical device industry, as well as practical information, support, and guidance for healthcare technology and sterilization professionals.
AAMI Array is AAMI’s portal for organizational news, articles and features and standards and publications. Biomedical Instrumentation and Technology (BI&T) is AAMI’s award-winning peer-reviewed journal and is the premier source of practical guidance, research, and analysis for those working in the health technology, medical device standards, and sterilization fields. If you are interested in submitting an article for possible publication, BI&T accepts scholarly papers on a variety of subjects.
The Advanced Medical Technology Association (AdvaMed) is a trade association that leads the effort to advance medical technology in order to achieve healthier lives and healthier economies around the world. The Association acts as the common voice for companies producing medical devices, diagnostic products and digital health technologies.
AdvaMed’s research and policy papers contain new and valuable research. Their MedTech POV blog features all the latest developments, perspectives, and resources by and for the medical technology community.
AdvaMed’s podcast, MedTech POV with Scott Whitaker, covers the intersection of MedTech and policy from every perspective. Episodes feature interesting discussions with MedTech and healthcare policy leaders on issues that are driving the day – from business to policy and current events.
AFDO/RAPS HealthCare Products Collaborative (known as “The Collaborative”) is the successor organization to Xavier Health and is co-sponsored by the Regulatory Affairs Professional Society (RAPS) and the Association of Food and Drug Officials (AFDO).
The Collaborative sponsors an AI Working Group, whose mission is to challenge and advance current approaches to patient health, product quality, and process improvement by unleashing the power of AI through collaboration across pharmaceutical and medical device industry members, global regulators, and users at the point of care.
Their AI Blog features insights written by members of the AI Working Group. Past webinars and deliverables from the working group are easily accessible for anyone looking to learn more about the AI Initiative.
The Digital Medicine Association (DiMe) is the professional home for digital medicine. DiMe tackles the toughest digital medicine challenges, develops clinical-quality resources on a tech timeline, and delivers these actionable resources to the field via open-source channels and educational programs.
Scientific publications from DiMe project teams, DiMe Research Committee working groups, and DiMe staff are available on the DiMe site, as well as published in NPJ Digital Medicine, JMIR Publications and Telemedicine Reports.
DiMe’s blog contains articles and opinion pieces from industry experts. Podcasts, videos and more can be found on their Multimedia page.
DTA brings together leading organizations to advance the adoption and integration of digital therapeutic products into traditional medicine. Member companies are aligned in their collective mission to improve clinical and health economic outcomes through the use of high quality, evidence-based digital therapeutics for patients, clinicians, and payers. Get the latest news from DTA and member companies by visiting their newsroom.
Exits & Outcomes (E&O) is a subscription-only weekly newsletter for digital health strategists, creatives and operators, written by Brian Dolan. E&O is for later-stage startups and big company innovation teams, and focuses on incumbent strategy shifts, challenger companies with traction (and how they achieved it), long-form teardowns, market maps, emergent trends and other competitive intelligence data.
E&O’s weekly newsletter is free, with a paid subscription giving full access to exclusive research reports on digital health companies like Noom, UnitedHealth and Crossover Health, and databases on subjects such as digital health company executive compensation and prescription Digital Therapeutic pipelines.
For more than a decade, HealthXL has been bringing together leading minds working to solve healthcare’s biggest challenges – to share learnings, accelerate innovation and better serve patients across the world. Stay connected and up-to-date on the latest digital health news and reports with HealthXL’s blog.
HealthXL reports feature research and analysis on topics that matter most in digital health today. As technology continues to influence healthcare, these reports are designed to help the industry understand what comes next and make better decisions. Further HealthXL content is available to paid members of the community.
The Human Factors and Ergonomics Society is the world’s largest scientific association for human factors/ergonomics professionals. HFES provides education, builds connections, and advocates on behalf of the human factors/ergonomics field and fosters collaboration across the spectrum of professionals to drive forward advances in human factors and ergonomics.
The Society’s newest peer-reviewed journal is the open-source journal, Human Factors in Healthcare. The journal is a resource for human factors professionals who specialize in healthcare, as well as industry professionals such as healthcare providers and administrators, medical device and pharmaceutical industries, and regulators, who rely on human factors knowledge, methods, and theories.
The HFES International Symposium on Human Factors and Ergonomics in Healthcare is a focused, limited-attendance, interactive knowledge-sharing and networking event for professionals who address patient and provider safety research and practice. Proceedings of past events can be found here.
The HFES News Feed is updated regularly with articles, bulletins and announcements. HFES hosts periodic “Town Hall” forums to share information about Society activities with members and the broader community. Past Town Halls are available to watch on HFES’s YouTube page.
Medical Device and Diagnostic Industry (MD+DI), published by Informa Markets, is the primary resource for manufacturers of medical devices and in vitro diagnostic products. For over 40 years, its mission has been to help MedTech industry professionals develop, design, and manufacture products that comply with complex and demanding regulations and evolving market requirements.
MDIC’s mission is to leverage its unique position as the only public-private partnership of its kind to transform health care into human care. Collaborating with partners to advance science, MDIC enables transformational medical technology to shape the world for the better and make that world possible by shortening the path from innovation to safety and to access. Access the latest publications, news and initiatives at the MDIC newsroom.
Past MDICx series webinars, on topics including AI/ML for in vitro diagnostics, FDA Real-World Evidence guidance and medical device cybersecurity, are available to watch in their webinar archive.
The Medical Imaging & Technology Alliance (MITA), a division of the National Electrical Manufacturers Association (NEMA), is a full service trade association. Keep up with the many activities of MITA, including press reports, statements and news briefs by visiting their news page. MITA standards are also available for free download or purchase.
MedTech Intelligence is a digital media community for medical technology innovators, healthcare delivery professionals and industry regulators working to improve patient care and provide greater access to affordable, efficient healthcare. They inform, educate and connect medical device, diagnostic, digital health and regulatory organizations with features, reports, curated industry news and user-contributed content.
MedTech Intelligence’s past webinars are available to watch on-demand.
The Regulatory Affairs Professionals Society (RAPS) is the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Founded in 1976, RAPS helped establish the regulatory profession and continues to actively support professionals and lead the profession as a neutral, non-lobbying nonprofit organization.
Regulatory Focus is RAPS’s source for independent, quality regulatory news, information and analysis, fully dedicated to covering the issues associated with healthcare products and the regulatory profession. From guidance documents, regulations, rules and international guidelines to legislation, enforcement actions, legal decisions, business trends and more, Regulatory Focus covers everything needed to continue advancing public health. RAPS members also get access to the publication RF Quarterly.
The UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (UCSF-Stanford CERSI) is a joint undertaking among the University of California, San Francisco (UCSF) School of Pharmacy and School of Medicine, Stanford University School of Engineering and School of Medicine, and the U.S. Food and Drug Administration (FDA). These three partners work collaboratively on projects that promote the emerging field of regulatory science – including innovative research, education, outreach, and scientific exchange – together with foundations and commercial entities interested in the development of FDA-approved medical products.
UCSF-Stanford CERSI research publications are available from PubMed.gov. Organizational news and reports are listed on their news page. For those interested in their annual regulatory science conference, recordings of the 2023 Innovations in Regulatory Science Summit are available to watch. UCSF-Stanford CERSI is committed to developing an open-access library of video lectures and seminars in regulatory science.
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To explore the full savannah of SaMD Watering Holes, visit the links below:
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