The MedTech Evolution
From bandages to pacemakers, and health apps to artificial hip implants, medical devices are important to our health and we expect them to reflect scientific progress. In 2017, 364 medical technology (medtech) patent applications were filed with the European Patent Office – more than in any other sector. What constitutes a medical device is changing as advances in sensor technology and artificial intelligence enable ever more data-driven products and services. Moreover, many medical device products have lifecycles of only one to two years before improved products enter the market. This constant flow of innovation makes the regulation and management of medical technology innovation particularly difficult.
Despite the difficulty, the need for governance has become all too apparent in recent years following catastrophic failings in some areas of medtech. According to a recent investigation (Implant Files) more than a million patients have been harmed by medical devices. In the past three years, 62,000 “adverse incident” reports have been submitted to UK regulators. About a thousand of these incidents resulted in the death of a patient. Previous scandals had revealed the use of unauthorised silicone filler in breast implants causing double the rupture rate. About 300,000 women in 65 countries are believed to have received these PIP implants. More recently, more than 800 UK women have begun legal proceedings against the NHS and the makers of vaginal mesh implants, used to treat pelvic organ complications, after suffering distressing side effects. These cases are driving regulatory change both in the EU and overseas.
The need for governance has become all too apparent in recent years following catastrophic failings in some areas of medtech
Adopted in 2017, European regulation on medical devices (MDR) sets out clearer obligations for technology providers and puts greater emphasis on traceability of devices. Post-market surveillance (PMS) systems, meaning the practice of monitoring pharmaceutical drugs or medical devices after their release onto the market, facilitate the identification of potential hazards. The usefulness of such databases by and large depends on an adequate identification and registration of medical device products. As technological change accelerates, determining what a device actually is and how it should be regulated has become more and more challenging. Regulators require a clear understanding of what products they are dealing with in order to determine how best to evaluate their safety and effectiveness.
Since the beginning of 2017, my research group in the Centre for Technology Innovation and Engagement (C-TIE) has been working on the development of research projects in the field of medical technology innovation and regulation. We want to understand innovation dynamics in the medtech industry. This industry is witnessing a digital revolution but also growing tensions induced by changing business models and increased cost pressures. Successful medtech innovation requires technology providers to become responsive to the needs of healthcare practitioners and their patients, as well as the strategic priorities of public health executives, policymakers
We are currently collaborating with the Global Medical Device Nomenclature (GMDN) Agency. The GMDN Agency is a not-for-profit organisation that provides a dynamic categorisation system used for data exchange among authorities and healthcare providers at a global scale, and its accuracy has important safety implications for patients all over the world. Given the speed of technology innovation, and the diversity and complexity of medical devices, the GMDN Agency faces an enormous task in developing the nomenclature in a timely and systematic manner whilst responding to competing demands from industry and regulators.
Regulators, manufacturers and healthcare providers all rely on the GMDN as a global language of medical devices. However these different stakeholders have different requirements regarding the level of detail in categorisation such as the importance of size, quantity or packaging or the intervals in which they update their systems. The creation of a new category or term can have technical, as well as political and economic implications.
We aim to co-produce a framework for the evaluation of the GMDN’s categorisation procedures, and corresponding tools for the assessment of device categorisation. This is the advent of ‘Big Data’ in medical device regulation. By researching how responsible innovation in medtech can be managed – both within firms as well as in partnerships and alliances – we hope to make useful contributions to better understand the management of innovation processes in complex innovation ecosystems. And in the context of medtech, this means going some way towards minimising risk to patient safety.