Developing a new treatment device: How to get an idea to the marketplace

Abstract

A good idea does not inevitably lead to successful innovation; it needs additional "drivers" and coherent activity of a specialized team. The initial idea needs proof-of-concept and prototype testing. Alongside, market review must anticipate future need and competitors, and ensure that no current patents are infringed. The likelihood that reimbursement will be secured and that health systems will "adopt" the device has to be considered. Intellectual property (IP) protection is needed to maintain sole rights to exploit the core concept. Non-disclosure agreements (NDA) should be put in place, and commercial considerations should be remembered before any disclosure in the public domain, including publications. Prospective business partners will review the concept from many perspectives, including stage of device development, effective IP protection, any clinical trial evidence, and whether the device aligns with their business strategy. Royalties arising from sales of a marketed device are distributed to all parties contributing to its development; the party bearing the greater financial burden of developing the final product will gain the greater share of royalties. The innovator's employer will have a call on proceeds if the idea arose in the course of employment. All stages of development require fastidious documentation to meet requirements of the regulatory authorities responsible for permitting use in patients. Specific regulatory requirements depend on which region(s) of the world the device will be marketed in. This review explains all stages of the innovation pathway from concept to adoption, giving practical advice and signposting expertise relevant to each stage.