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ABHI at 30 Guest Blogs. The Three Major Transformations Over The Past Three Decades

Over the last 30 years our medical engineering work in iMBE has focused on implants and biomaterials for musculoskeletal, cardiovascular and wound care applications. We have worked closely with industry and clinicians from across the globe, to advance and translate new engineering knowledge and technology into improved products and services. We currently host the national UKRI EPSRC Centres for Medical Technology Innovation MTIKC and for Innovative Manufacturing in Medical Devices MeDe. We also host the Leeds City Region Grow-Medtech programme supported by UKRI Research England.

Our work on implants and biomaterials, have seen significant changes over the last 30 years, driven by the needs and expectations of an active ageing population, 50 active years after 50®. If we go back to the 1980s, orthopaedic joint replacements were most commonly implanted in patients over sixty years of age, often over seventy, with life expectancies of ten years or less. Indeed, a patient in their fifties requiring a hip implant due to osteoarthritis and pain in the 1980s, would frequently be told they would have to wait until they were over 60 before a replacement would be offered. Today more than 20% of joint replacements are implanted in patients under sixty, there is a substantial increase in demand, in patient activities. Expectations of prosthesis lifetimes are now extending beyond 30 years. Successful surgical interventions and implants are driving increased use. Expectations of increased lifetimes and reliability are coupled with the need for improved cost effectiveness in the system.

The last three decades have seen substantial innovation and growth in the use of medical devices, with three major transformations in medical technology and medical engineering, which have substantially altered the products and services being offered to patients across the world. Up to 1980s, many implants and biomaterials, were designed around “an inert philosophy”, reducing adverse reactions and improving biocompatibility.

The first transformation came in the 1990s with the introduction of bio-active biomaterials, examples include hydroxyapatite coatings to improve bone in-growth into and onto orthopaedic and dental implants and anti-calcification treatments of bioprosthetic heart valves. This transformation was supported by the concept of functional biocompatibility of the whole implant system, whereby it was possible to improve physical functions to improve biocompatibility and extend lifetimes. New concepts and approaches for less invasive surgery were also starting to be introduced at this time, with new forms of endoscopies, arthroscopy and trans-catheter heart valves. Together these technologies form the basis of many of the implant systems used successfully today.

The turn of the century saw new discoveries in regenerative medicine and advancement in understanding of stem cell technology. The conversion of these scientific advancements into new technologies and products has taken time. Increased costs, uncertainties and new regulations have led to longer translation pathways. We are now beginning to see successful products reaching the market, with some cell therapies receiving approval and new regenerative devices and scaffolds leading to improved tissue regeneration in wound care, cardiovascular and musculoskeletal applications.

The third and potentially the biggest transformation of medical devices sector is now upon us, driven by the needs of the ageing population, more cost-effective treatments, increased reliability and extended lifetimes, which require increased levels of precision and stratification, improvements in predictions during design and development and customisation of products which is supported by increased levels of evidence to support adoption. This is beginning to be delivered in the sector by embracing the opportunities associated with the convergence and integration of different types of technologies, (physical /materials, biological and digital) to enable successful development and delivery of third generation, multifunctional, 21st century devices, products and services.

The future global medical technology market is predicted to grow 50% by 2025. There is an opportunity for UK healthcare industries to grow with the market to address global healthcare needs, as well as improving health and care of the population in UK in a cost-effective way. This will need new collaborative approaches to integrate innovation across the whole industry system and value chain, extending from product concepts to service delivery, in order to create successful 21st century products.

John Fisher, Institute of Medical and Biological Engineering, iMBE, University of Leeds