INTRODUCTION: THE FUTURE OF HEALTHCARE
IS INTELLIGENT

In the last decade, pharma, biotech, and medtech companies have all been investing in and acquiring intelligent medical products, with many more in the pipeline.These solutions form an increasingly broad suite of software-based products that acquire patient data, analyze it, and use it to provide medical insights upon which diagnoses, or healthcare interventions, are made.These fall into two camps. One involves adding software and connectivity to physical medical products, such as heart-rate monitors. The other involves creating entirely software-based medical products (Software-as-a-Medical Device, or SaMD), such as AI tools, to gather insights from medical sensor data or apps that incentivize drug adherence.These new software activities promise to move medicine out of the hospitals and into daily life. They open the door to communication channels to patients and the collection of real-world data on people’s health. This can result in earlier diagnoses and personalized treatments, as well as provide remote services with less need for expensive hospital care. The data generated also provides a source of real-world evidence, which can show regulators and buyers that products are safe and effective and enable reimbursement by demonstrating improved outcomes.Perhaps most significantly, they offer the promise to transform business models – enabling companies to move from selling products to selling health insights or outcomes. Where once healthcare companies sold heart-rate monitors that would be used by a doctor to inform a diagnosis, they can now deploy software into patient-held devices and sell data-driven insights into heart health. That is a much more valuable offer.
This shift to value-based healthcare offers huge benefits to patients and efficiencies to healthcare systems. But it also transforms the way medical devices, and even drug regimens, are developed, sold, regulated, and managed over their lifetime.

In this paper, we explore the challenges and propose solutions for how to develop intelligent medical products in a way that is rigorous and secure, but that enables rapid innovation that is cost effective, minimizes time to market, ensures smooth compliance, and efficiently supports post-launch maintenance processes.