Insights into New Quality Benchmark for MedTech: Webinar

Randy Horton

Published on: November 26th, 2024

Insights into New Quality Benchmark for MedTech Products: An Independently Awarded Seal of Evidence, Usability, Privacy, Security & Equity

As medical device software, Software as a Medical Device (SaMD), and Digital Therapeutics (DTx) become more prevalent, patients, providers and payers need a reliable way to identify quality products that have been vetted for evidence, usability, privacy, security and equity. How can MedTech companies best communicate to stakeholders that their products are trustworthy in this increasingly complex and oft-confusing marketplace?

Orthogonal and the Digital Medicine Society (DiME), a non-profit organization dedicated to advancing digital medicine to optimize human health, hosted a webinar on December 12th, 2024 at 12 PM EST exploring the newly-launched DiMe Seal – a symbol of quality awarded by an independent governance committee to digital health software products.

In this conversation, DiMe CEO Jen Goldsack, CEO of Validic, Drew Schiller, and Sameer Sood, Longevity Physician at Rebel Health Alliance, Medical Department Head and Intellectual & Developmental Disability Primary Care Physician at Kramer Davis Health, and CEO at FwdSlash, shared insights into the rapidly evolving digital health tools landscape, highlighting the pressing need for a clear, unified definition of quality standards. The discussion explored how the DiMe Seal is designed to address these challenges by setting a benchmark for what ‘good’ looks like, empowering stakeholders across healthcare to identify and trust effective, reliable digital health solutions. By fostering transparency and consistency, the DiMe Seal intends to streamline processes for health systems and providers, ultimately enhancing the patient experience.

This webinar served as an opportunity for MedTech professionals to learn about this new initiative, its potential impact on our industry and emerging trends in quality assurance of digital health software products, which includes SaMD, DTx and medical device software.

Attendees left the webinar with:

A high-level understanding of DiMe Seal and its key evaluation domains.
An overview of how DiMe Seal is designed to aid medical device software, SaMD and DTx manufacturers in gaining consumer trust in an increasingly complex market.
Strategies for MedTech companies interested in further assessing the value of the Seal to their own devices and beginning the application process.

Webinar Recording

Watch Webinar Recording

Speakers

Jen Goldsack, CEO & Founder, Digital Medicine Society (DiMe)

Jennifer C. Goldsack founded and serves as the CEO of the Digital Medicine Society (DiMe), a global non-profit organization dedicated to advancing digital medicine to optimize human health. Jennifer’s research focuses on applied approaches to the safe, effective, and equitable use of digital technologies to improve health, healthcare, and health research. She is a member of the Roundtable on Genomics and Precision Health at the National Academies of Science, Engineering and Medicine and serves on the World Economic Forum Global Leadership Council on mental health.

Drew Schiller, CEO, Validic

Drew Schiller is the founder and CEO of Validic, the leading Health IOT platform for personal health data. He is the immediate past Chair of the Consumer Technology Association (CTA) Health Division Board and a member of the CTA Executive Board. He also contributes to advancing the industry through CTA policy efforts and involvement with the CTA Health Standards Subdivision. Drew is a member of the Highmark Health Technology Advisory Group. He has served as a Board Member at Executives for Health Innovation (eHI), the North Carolina Council for Entrepreneurial Development (CED), and as a Team Member for the Clinical Trials Transformation Institute (CTTI) project Advancing the Use of Mobile Technologies for Data Capture & Improved Clinical Trials. He previously served on the Federal Advisory Committee joint HITPC/HITSC API Task Force on Meaningful Use 3.

Sameer Sood, Longevity Physician at Rebel Health Alliance, Medical Department Head and Intellectual & Developmental Disability Primary Care Physician at Kramer Davis Health, and CEO at FwdSlash

Sameer Sood is an engineer and physician who has created several organizations at the nexus of healthcare and design. As a systems thinker, he’s sought to engage stakeholders in understanding how societal structures, individuals behaviors, psychology and socioeconomic status impact a person’s health and pursuit of meaning.

Bernhard Kappe, CEO and Founder, Orthogonal

Bernhard Kappe is the Founder and CEO of Orthogonal. For over a decade, Bernhard has provided thought leadership and innovation in the fields of Software as a Medical Device (SaMD), Digital Therapeutics (DTx) and connected medical device systems. As a leader in the MedTech industry, Bernhard has a passion for launching successful medical device software that makes a difference for providers and patients, as well as helping companies deliver more from their innovation pipelines. He’s the author of the eBook Agile in an FDA Regulated Environment and a co-author of the AAMI Consensus Report on cloud computing for medical devices. Bernhard was the founder of the Chicago Product Management Association (ChiPMA) and the Chicago Lean Startup Challenge. He earned a Bachelor’s and Masters in Mathematics from the University of Pennsylvania, and a Bachelor’s of Science and Economics from the Wharton School of Business.

Moderator

Randy Horton, Chief Solutions Officer, Orthogonal

Randy Horton is Chief Solutions Officer at Orthogonal, a software consulting firm that improves patient outcomes faster by helping MedTech firms accelerate their development pipelines for Software as a Medical Device (SaMD), digital therapeutics (DTx) and connected medical device systems. Orthogonal makes that acceleration happen by fusing modern software engineering and product management tools and techniques (e.g., Agile, Lean Startup, User-Centered Design and Systems Thinking) with the regulated focus on device safety and effectiveness that is at the heart of MedTech.

Horton serves as Co-Chair for AAMI’s Cloud Computing Working Group, as well as AAMI CR:510(2021) and the in-process Technical Information Report #115, all of which address how to safely move medical device computing functions into the cloud. He is a frequent speaker at conferences and webinars, including events hosted by AdvaMed, AAMI, HLTH, RAPS and the Human Factors and Ergonomics Society (HFES).