Studying Compliance Burden to Improve SaMD Development

Randy Horton
Randy Horton

Are your digital health innovations being slowed or even derailed by regulatory, security, privacy or legal compliance issues? Orthogonal and AnavoDX launched the Digital Health Compliance Investment and Operations Study to understand the burden of digital health compliance and its effects on development cost, release frequency and software design. By drawing on our industry’s collective knowledge and experience, this study strives to chart a new and better approach for developing digital health solutions.

Kicked off at the beginning of 2023, the study is co-led by:

  • David Feygin, Founder of Anavo DX. David previously served as VP and Chief Digital Health & Data Officer at Boston Scientific and as VP for Health IT Integration and Strategic Innovation at BD.
  • Randy Horton, Chief Solutions Officer at Orthogonal. Among his past work experiences, Randy has helped conduct public policy research related to the use of technology and software in healthcare.

David and Randy are actively seeking MedTech and digital health leaders to interview for their insights into the costs and challenges of achieving compliance for Software as a Medical Device (SaMD), connected medical device systems and other digital health products. Perspectives are being solicited from experts involved in product, service and device development as well as in compliance-oriented functions, including regulatory, quality, privacy, security and legal professionals.

All participants will receive pre-publication access to the report. Additionally, David and Randy will provide personalized business insights to the participants that can help them assess their organizations’ performance, lobby internally for greater investment and drive change by identifying areas for potential improvement.

Interviews will take place during Q1 of this year. Information shared in these interviews will be published in aggregate form, and the identities of the people and companies will remain strictly confidential.

If you are interested in participating, please reach out to David Feygin ([email protected]) and Randy Horton ([email protected]).

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