Medical Devices: Panel Discussion

Abstract

Most technology is developed along commercial lines and the development process is well understood in terms of capturing requirements, specifications, product or system engineering and marketing, logistics and sales. Medical technology, on the other hand, has the added burden of proving itself fit for purpose in the more highly regulated world of care delivery, where safety and performance are measured by those paying for the technology, often in quite different ways from the way in which standard business decisions are evaluated. In most parts of the world, the patient is not the only person paying – indeed, the patient may not pay at all – and so governments or insurers make purchasing decisions using their own concepts of value that may reflect the users’ needs as a cohort, rather than a user’s needs as an individual.