This year marks the 25th anniversary of Medilink. Since the launch of Medilink in 1997, there has been a colossal amount of change to the innovation landscape. In this short review, Patrick Trotter, the Head of Innovation, Commercialisation and Regulatory at Medilink North of England, reviews four ways in which the landscape has evolved and highlights how Medilink has adopted its service provision to accommodate the changing needs of businesses.
Technical and scientific advancements
Technology and scientific advancement have been an enabler of new innovation, often coupled with the convergence of technologies. For example, electronics and microsensors have contributed to the introduction of disruptive new devices such as bionic limbs, and diagnostics. These also include wearables which allow real time monitoring such as the Abbot Freestyle Libre device that monitors blood glucose, or the Apple Watch that detects that irregular heart rhythms. Big data, artificial intelligence and the increasing trend for connected devices mean that we are at the start of a technical transformation that is changing how we live and the way healthcare is delivered.
Enhanced innovation and product development processes
Although innovation was recognised as an important means to drive growth in the 1990s, product launches often failed in the market at that time, often because they didn’t meet the needs of market and users. This was mainly the result of the “technology push”, and resulted in the development of a range of innovation tools and methodologies to identify unmet needs and robust early-stage gate systems that could equate and build evidence regarding the market, the competitors, product positioning, indication and claims, and importantly, define clinical evidence needed for adoption. These best practice methodologies transformed how product development is conducted, while increasing efficiency and speed to market, reducing risk and maximising profitability.
Changes in procurement and market trends
Coupled with technological advancements, market trends have emerged, often driven by patient safety, the need to improve outcomes, and changes to reimbursement and procurement that favours technologies working to keep patient out of hospital, facilitating a trend towards self-management. In addition, there is a trend for procurement system based on value and not cost, both in the UK and international markets. These changes are driving innovation, but also the need to generate more compelling clinical and health economic evidence to support adoption.
Enhanced more robust regulatory systems
The biggest challenge to innovators is changes to the regulatory system. These changes have been driven by patient safety with high-profile cases such as PIP breast implants in which implants were found to be fraudulently manufactured with an unapproved silicone gel. In Europe, such high profile cases have seen the implementation of the Medical Device Regulations (MDR 2017/745) in May 2021 and the In Vitro Diagnostic Regulations (IVDR 2017/746) that just came into effect from May 2022. These regulations result in higher regulatory burden with more emphasis on traceability, clinical evidence and more robust post-market surveillance systems. The forthcoming UK Medical Device Regulations are also likely to further increase the regulatory weight on companies. Although the government has indicated that there might some alignment with the EU MDR, the new regulations will undoubtedly mean that UK companies will have to overcome additional hurdles in the near future.
Medilink is currently looking at market needs. Our Innovation team have adapted to these needs over the last decade to ensure we have the skills to help. The services that we offer include innovation strategy and planning, developing business models, market and competitor analysis, development of value propositions and regulatory support (including gap analysis and authoring clinical evaluation reports).
If you need help and support with any of the above elements, please contact [email protected].