Whitepaper release: Digital health solutions and SaMD - pharma’s five steps for success

June 15, 2021 Jim O'Donoghue

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Whitepaper release: Digital health solutions and SaMD - pharma’s five steps for success

Low-level, low-impact digital solutions, like those that focus solely on patient education, onboarding, or initial engagement, no longer drive the value pharma really needs. The solutions needed to address challenges that range from providing value beyond drug discovery to creating new commercial models, fall increasingly into the classification of SaMD.


Not all digital health solutions are classified as SaMD, so it’s important to be clear on the influencing factors and the implications of going down this path. While digital health solutions classified as SaMD are often more complex to develop, embracing these solutions offers a series of significant benefits, including: 

  • Improving treatment outcomes, since SaMD solutions are more likely to play a direct role in the care of an individual
  • Supporting holistic management of conditions by helping to manage symptoms and comorbidities
  • Furthering research and insights on disease trajectory by capturing standardized, real-world data across regions
  • Differentiating pharmaceutical treatments by combining them with digital solutions that influence outcomes
  • Increasing confidence among clinicians, thus increasing adoption as a result
  • Providing greater reassurance to patients that these solutions are regulated, safe, and appropriate to use, building trust in digitally-delivered treatment elements
  • Supporting reimbursement with real-world data, and improving engagement with payors and healthcare providers


To fully realize these benefits, in our latest whitepaper we’ve outlined our top five steps to help pharma succeed with more in-depth, SaMD digital health solutions:


  • Step 1: Define intended use early
  • Step 2: Choose where you’ll launch first carefully
  • Step 3: Plan your regulatory roadmap
  • Step 4: Consider the potential of platforms to reduce risk and accelerate your time to market
  • Step 5: Don’t try to do everything in-house


whitepaper release june 2021


Download the full whitepaper, ‘Digital health solutions and SaMD: Pharma’s five steps for success':



Includes insights and advice from:

  • Jim O’Donoghue, President of S3 Connected Health
  • Andrew Wright, Owner of H1 Consulting and former Vice President of Digital Medicine at Otsuka Pharmaceutical Companies
  • Caroline Beaufour, Project Director at WeHealthTM Digital Medicine, the e-health division of the Servier Group
  • Hans-Peter Frank, Founder and CEO of T-S-P Health GmbH, CBO of Artha AG
  • Marzena Tabaka, Quality Manager at S3 Connected Health
  • Vitaliy Myskov, Mobile and Embedded Solutions Manager at S3 Connected Health