The challenges in bringing new products to market successfully have never been greater. In the past product approval meant demonstrating safety and efficacy to regulatory bodies in discrete countries. Clinical evidence came from trials that focused on device functionality and patient outcomes. Patients included in randomized clinical trials were subjected to inclusion and exclusion criteria based on condition parameters but typically didn’t reflect population diversity in age, race, gender or other factors.

While R&D was complex and associated with significant risk, research scientists, and study clinicians didn’t need to worry about reimbursement and product adoption — that was literally someone else’s job. R&D was incented on the number of approvals or CE marks achieved. Once the product met its approval milestones, they handed off the asset to other colleagues. Today, all of this has changed.