Top 10 SaMD Communities, Organizations & Working Groups

Randy Horton
Randy Horton

This is Part 1 of Orthogonal’s SaMD Watering Holes series. To explore the full savannah of SaMD Watering Holes, visit the links below:

 

Introduction

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 regularly collaborates with people, companies and organizations across the MedTech ecosystem. 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.

watering hole banner part 1200px

Part 1: Communities, Organizations & Working Groups

Professional communities and organizations are valuable places to network with peers, make concrete, one-on-one connections with like-minded people, and stay up to date with the latest in our industry. You’ll get to know people on a personal basis, which can lead to new opportunities to grow your career, your business and your professional network.

Communities aren’t the only way to enrich the MedTech community. Those interested in shaping industry regulations should consider joining a working group. In these specialized groups, members share their knowledge and expertise to help write new industry standards for hot-button issues, like cloud computing or AI. Help advance our industry by contributing your perspective, and get a voice in the future of MedTech.

This list contains our recommendations for communities, organizations and working groups to consider joining and/or tracking online for useful new sources of content, alphabetized by convening entities.

1. AAMI

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.

An AAMI membership can be a catalyst to your MedTech career. Access powerful professional development tools, stay up to date on news from the field, and develop relationships that will support your growth.

AAMI’s standards program is global. By actively participating in any of their more than 170 committees and working groups, you can have a direct role in shaping medical device and health technology standards. You’ll work side-by-side with industry colleagues, clinicians, academicians, and regulators like the Food and Drug Administration.

2. AdvaMed

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 Accel serves the MedTech industry’s small and emerging-growth companies – the drivers of disruptive innovation, job creation, and economic expansion. Governed by the AdvaMed Accel Board of Directors, this division of AdvaMed is committed to ensuring the voice of small, pioneering companies is always heard by policymakers. AdvaMed Accel advocates for regulatory and payment policies that support patient access to innovation and for an environment conducive to capital formation.

AdvaMedDx, a division of AdvaMed, represents over 70 manufacturers of innovative in vitro diagnostic (IVD) tests in the U.S. and abroad. AdvaMedDx seeks to advance policy to promote innovation and expand access to quality testing.

AdvaMed’s Center for Digital Health promotes the critical role of data and digital medical technologies in transforming health care. The Center advocates for public policies and best practices that advance digital health innovation and adoption and build trust among all stakeholders.

One of the best ways to become engaged in AdvaMed is through their committees and 100+ working groups. Each policy area has a number of working groups that focus on a variety of issues to address the increasing challenges facing medical device, diagnostic, and health IT companies today.

3. AFDO/RAPS Healthcare Products Collaborative

AFDO/RAPS HealthCare Products Collaborative (formerly known as Xavier Health) 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 annual MedCon conference is planned by a strategic committee of experts across the healthcare products industry. Take an opportunity to make a difference in lives around the world by joining them.

4. Consumer Technology Association (CTA)

The Consumer Technology Association convenes companies of every size and specialty in the technology industry to move us all forward.

Through one of CTA’s Standards Committees, you can influence the standards setting process and become an early player in market-shaping decisions. ANSI-accredited, CTA standards have shaped today’s industry. Their digital health activities have sparked innovative standards, research and video sessions.

5. Digital Medicine Society (DiMe)

The Digital Medicine Society (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.

DiMe’s dedicated Research Committee works on projects that are advancing digital medicine. Digital tools have the potential to make clinical research much more efficient than it has been in the past. There are also opportunities for digital tools to reduce the cost of healthcare and widen access to care by connecting patients with researchers and providers using innovative technology. All this has the exciting potential to improve overall health outcomes. DiMe publications are routinely cited in academic research.

DiMe initiatives include Core Measures of Digital Activity (for physical activity), Digital Health Measurement Collaborative Community (for digital measurement approaches), Digital Health Innovation at the VA’s (for veterans’ health), Digital Health Regulatory Pathways, Digital Measures in Alzheimer’s and Related Dementias, Diversity, Equity & Inclusion in Digitized Clinical Trials and IMPACT (which addresses virtual first care).

Join the ongoing conversation on digital medicine by becoming a part of DiME’s community Slack channel.

White Paper Advancing Agile Practices Across SaMD Life Cycle CTA

6. Digital Therapeutics Alliance (DTA)

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.

DTA’s efforts to transform global healthcare by advancing digital therapeutics are spearheaded through nine Task Groups, including the Clinical Evidence Task Group, Patient Engagement Task Group and US Commercialization & Reimbursement Task Group. DTA’s Task Group efforts will be instrumental in providing patients and caregivers, clinicians, policymakers and healthcare decision makers with reliable resources to meaningfully integrate DTx products into practice and transform global healthcare.

7. HealthXL

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. HealthXL members connect with industry leaders, attend member-led events and get a curated daily news feed from the world of digital health.

HealthXL Meetings are online, private group meetings limited to 8-12 people across different demographic and stakeholder groups. For 75 minutes, you take a deep dive into topics like digital therapeutics, patient support, telehealth, clinical trials, oncology and many more. Share learnings, successes and ideas with peers from payor, provider, pharmaceutical, health care and technology organizations.

HealthXL Digital Health Sprints allows you to deep dive into a topic over 2 focused sessions with the same group of 8-12 thought leaders, so you can walk away with deeper insights.

Get closer to industry experts and leaders with a HealthXL Masterclass. Each Masterclass is led by an expert anchor in their field as they dive into their specialty topic in front of a small intimate audience of 8-12 participants. Masterclasses also have an interactive element allowing you a space to share your thoughts and experiences as well as pose questions to the expert anchors.

8. HLTH

HLTH is the leading platform bringing together the entire health ecosystem, focused on health innovation and transformation. HLTH supports two non-profit entities focused on collaboration and inclusion in healthcare.

HLTH Foundation is a 501(c)3 non-profit that promotes equity, inclusion and opportunity in healthcare, focusing on underserved patients, healthcare professionals and innovators in digital health and health technology.

CSweetener matches rising women leaders in healthcare with luminaries that guide their careers during year-long virtual mentorships. CSweetener works with corporate sponsors to help them prepare, retain and advance effective women leaders and offers scholarships to individual program applicants through the HLTH Foundation.

9. Human Factors and Ergonomics Society (HFES)

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.

HFE members include psychologists, engineers, designers, scientists and user experience professionals. Members are invited to participate in working groups that establish ergonomics and human factors technical standards.

10. Medical Device Innovation Consortium (MDIC)

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. MDIC working groups include Health Economics & Patient Values (for patient perspectives research and real-world data), Digital Health and Technology (for data analysis), Clinical Science (for gathering clinical evidence and innovating on clinical trials) and NESTcc (for transforming the way medical device technologies are tested, approved and monitored).

Being a member of MDIC connects you to a network of MedTech industry leaders working together to advance the future of public health. Members have an active seat at the table to provide guidance and leadership through collaboration on regulatory, scientific, and health economic challenges within the medical device and diagnostic industry.

11. Medical Imaging & Technology Alliance (MITA)

The Medical Imaging & Technology Alliance (MITA), a division of the National Electrical Manufacturers Association (NEMA), is a full service trade association. As a member, you are eligible to take advantage of services from all of MITA’s core departments: technical services for coordination and guidance on standardization, business information services for expertise on statistical data about the medical device industry and its various products and the government relations department for information on federal and state legislation and regulations.

12. MedTech Color

MedTech Color offers an opportunity for leaders of color in MedTech to connect, engage, and thrive in the industry’s continuous need for diverse individuals to be involved in the design of medical innovations. MedTech Color focuses on coming together to explore ways of advancing representation and amplifying the experiences of people of color in MedTech.

MedTech Color membership provides access to an incredible group of diverse MedTech leaders and young professionals who work in the medical technology industry. As a MedTech Color member, you will have access to a membership portal and directory, receive discounts on MedTech Color’s and other industry partners’ event registrations, including early access to register for the 5th Annual Networking Breakfast, and curated member benefit opportunities to amplify your career.

MedTech Color’s Collaborative Community was convened to serve as a forum where MedTech professionals and other stakeholders can address minority health issues in medical device product development and clinical research.

13. Medtech Women

MedtechWomen is a 501(c)3 organization founded by MedTech executives to connect, educate and inspire fellow MedTech women by creating an ongoing content-driven, solutions-oriented dialogue on the future of the industry. Dedicated to highlighting and promoting underrepresented MedTech leaders inclusive of all races, ethnicities and gender identities, MedtechWomen envisions a time when the MedTech industry represents the diversity of its served populations, leading to improvements in diagnosis, treatment and outcomes.

MedtechWomen membership provides access to an incredible group of diverse MedTech leaders and people who work in healthcare, government, venture capital, technology and more. As a MedtechWomen member, you will have access to a membership portal and member directory, be eligible to apply for the MedtechWomen mentorship program, receive discounts on program and event registration and get early access to registration for MedtechVision.

14. Regulatory Affairs Professionals Society (RAPS)

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.

RAPS Membership offers education and training, professional standards, publications, research, knowledge sharing, networking, career development opportunities and other valuable resources, including Regulatory Affairs Certification (RAC) credentials, the only post-academic professional certifications to recognize regulatory excellence.

The RAPS Regulatory Exchange is a forum for RAPS members to collaborate and make connections that last a lifetime.

______________________________________________________________________

watering hole banner no part

To explore the full savannah of SaMD Watering Holes, visit the links below:

Related Posts

Talk

Gathering Medical Device Data & Evidence: Webinar

White Paper

Software as a Medical Device (SaMD): What It Is & Why It Matters

Talk

What Medical Device Software to Develop Under QMS: Webinar

Article

SaMD Cleared by the FDA: The Ultimate Running List