Innovating in the medical device industry - challenges & opportunities ESB 2015 translational research symposium

The European Society for Biomaterials 2015 Translational Research Symposium focused on 'Innovating in the Medical Device Industry - Challenges & Opportunities' from different perspectives, i.e., from a non-profit research organisation to a syndicate of small and medium-sized companies and large companies. Lecturers from regulatory consultants, industry and research institutions described the innovation process and regulatory processes (e.g., 510K, PMA, combination product) towards market approval. The aim of the present article is to summarise and explain the main statements made during the symposium, in terms of challenges and opportunities for medical device industries, in a constantly changing customer and regulatory environment. Innovation and new product development in the medical device industry have largely been technology driven in the last decades but always to solve clinical needs. Advancements have been often rapid and significant. Today's biomaterial implants have reached high standards; consequently, the state of art treatment generally supports acceptable return to daily activities and quality of life. Nonetheless, today's product development occurs in a complex healthcare environment, with multiple stakeholders involved. Each of these stakeholders can have different and sometimes conflicting requirements and expectations. While technological innovation to solve current clinical needs may still be the driving force behind new product development, in many cases it is not sufficient to reach the clinic. Innovation in the medical device industry can take many forms. From an entrepreneurship perspective, it does not require inventing something completely new; it can simply involve applying an existing idea in a new way or to a new situation. Innovation includes (i) rapid cadence of market release of new devices or services; (ii) scientific communication on a company's latest products with key opinion leaders support; (iii) clinical education of care providers; (iv) skilled communication channels; and (v) brand equity or the value of the brand name. Those are the five pillars of success in medical devices business. Innovation is greatly influenced by the patients, the care providers, the physicians, the payers, the policymakers and the producers who can all influence real-world healthcare decision-making. Putting on the market innovative products also depends on the fulfillment of regulatory requirements (which vary from continent to continent and even between countries), which are difficult but are in place to attempt to guarantee the safety and efficacy of any market approved products. This is a crucial bottleneck in time and cost for a biomaterial-based device and therapy. This topic was specifically addressed at the European Society for Biomaterials 2015 in Krakow, where the Translational Research Symposium focused on 'Innovating in the Medical Device Industry - Challenges & Opportunities' from different perspectives. This was from a non-profit translational research organisation to a syndicate of small and medium-sized companies (SMEs) and large companies. Lecturers from regulatory consultants, industry and research institutions described the innovation process and regulatory processes (e.g., 510K, Pre-market approval [PMA], combination product) towards market approval. The customer and the constantly changing regulatory environment represented both innovation challenges and opportunities for medical device industries.