The rapidly evolving fields of data analytics, AI/ML, and managing compliance risk are of special importance to the medtech / med device industry. In a September 2023 interview with Alison Sathe, the Senior Vice President of Medtech at Redica Systems, we discussed the greatest challenges and opportunities as well as what the future might hold.

The video chapters and accompanying timestamps are here for your easy reference:

  • 0:00 – Introductio
  • 0:21 – Alison’s Background and Role at Redica Systems
  • 1:39 – Utilization of Data Analytics in the Medtech Industry
  • 3:49 – Differences Between Medtech and Pharma
  • 5:31 – Importance of Unique Identifiers in Medtech
  • 6:34 – Linking Data for Novel Insights
  • 7:52 – The Power of Structured and Enriched Data
  • 8:16 – Data as a Tool for Risk Management
  • 10:00 – Forecasting the Future of Medtech
  • 12:01 – Harmonizing Internal and External Data
  • 13:00 – Conclusion

If you’d like to discuss Quality and Regulatory Intelligence with a medtech expert from Redica Systems, you can get in touch here.

About the Speaker

Alison Circle 3

Alison Sathe is Redica Systems’ SVP of Medtech, where she leads the company’s product strategy for the medical device industry. With a background in biomedical engineering, Alison began her career working in medical device startups and has specialized in regulatory and quality affairs for over 15 years. Previously an executive team member overseeing Regulatory and Quality Affairs for 100+ employee company with domestic and international sales, Alison has managed teams and been regulatory lead for multiple product lines from concept and strategy through product release including early FDA interactions, regulatory submissions, and FDA clearance/approval. She is also an entrepreneur, having founded ClearMark, an electronic QMS software platform specifically developed for Medical Device designers, developers, manufacturers and entrepreneurs.

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