Regulating Digital Health - Demystifying SaMD and its impact on MedTech

Unlocking the full potential of MedTech: The crucial role of regulated Digital Health



  • 3PM London / 10AM New York
  • Free

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Alex Gilbert
VP - Commercial Companion, MedTech, Huma London

Alex has worked within the Digital Health industry alongside healthcare, pharmaceutical, medical device
and tech organisations. He joined Huma as one of their first employees and leads their global MedTech
practice. Huma is Europe's fastest-growing health organisation, having raised over 250 Million in funding
to date whilst partnering with the likes of Smith & Nephew, Boston Scientific, Bayer, Stanford,
AstraZeneca and many more. His passion is the use of technology to empower and engage the patient to
take control of their care."

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Mani Shanmugham
Senior Director Quality & Regulatory, US & South America

Dr. Mani Shanmugham's qualifications include Ph.D in Human Factors Engineering from Mississippi State Univ, USA, Masters in Mechanical/Biomedical and Bachelors' in Mechanical/Materials Science Engineering. He was part of the original committee at AAMI and FDA HF and co-authored the following standards: IEC 62366-1 and 2 (Human Factors Engg Std) and AAMI TIR-50 (Contextual inquiry). His accomplishments include multiple medical device patents in infusion therapy, apheresis, and pediatric vascular devices, publications in peer-reviewed journals regarding Medical Device Alarms and Metacognition, Metamemory, and review board memberships at JMIR Journal.  Currently working as Director of QA/RA at Huma Therapeutics. Been in the medical device and pharmaceutical industries for the past 20+ years in R&D, Manufacturing, and QA/RA. Prior to Huma, worked at Boston Scientific, C.R.Bard, and Becton Dickinson at various capacities.

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