Medical technologies discovery and optimisation for clinical development
Workshop facilitator(s): Dr Anthony Metcalfe & Dr Richard Williams
Developing a new device from an original concept at the laboratory bench through to the launch of a finished clinical product is a complicated process which can take many years and be very costly. The idea for a device application for the treatment of a medical issue can come from a variety of sources including academic and clinical research, and from industry. It can take many years to build up a body of supporting mechanistic, physical and pre-clinical evidence before selecting the finalised device technology for use in the clinic. Industrial companies, and more recently, some academic groups are identifying ways of streamlining a number of early processes to identify and test devices which possess suitable characteristics for use as medical treatments.
This workshop will give a holistic overview of key aspects of developing drug products and medical devices, including: building a network to triage and nurture ideas; the regulatory pathway; establishing safety; manufacturing at scale to clinical grade; and defining relevant measures of clinical success in trials. Critically, the talk will highlight how considering the abovementioned aspects early on through relatively simple lab experiments and engagement with relevant regulatory bodies can help companies and academics innovate and get to market faster, at reduced cost and with less risk. Finally, an overview of some of the commercial considerations of medical device development will be considered.