SaMD

How to Create a SaMD Venture: A Step by Step Guide

Software as a medical device (SaMD) is software that performs a medical function without being part of a hardware device. SaMD can monitor, diagnose, or treat various health conditions, such as apps that measure blood pressure, detect skin cancer, or recommend medications. SaMD is an exciting and innovative field that offers many opportunities for entrepreneurs […]

Developing and Launching Successful Digital Health Products: Five Considerations

Digital Health, Entrepreneurship, Technology / 2023-11-20 / Digital, DTx, Healthcare, Novartis, SaMD

Digital health products (such as digital therapeutics, mobile health, telehealth, and personalized medicine) development has been on the rise in recent years, promising to transform healthcare delivery. However, the challenges faced in developing, commercializing, and marketing successful digital health products are significant, including market access and reimbursement; regulatory challenges due to lengthy and costly regulatory

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