Feature article by Timothy Bubb, Medtech regulatory specialist and TechnicalDirector at IMed consultancy.
Technology is taking an increasingly central place in healthcare. Drivers include advances in AI and robotics and the continuous development and deployment of innovative devices. There exist undoubted and immense opportunities for enhancing patient care. All of this is reshaping the healthcare industry. Indeed this also means regulators have adapted their outlook and demands to uphold patient safety, device effectiveness, and ethical standards. In fact medtech regulatory compliance considerations have in some cases led to a temporarily more complicated regulatory compliance system.
Medtech Regulatory Considerations
Businesses wanting to place innovative devices in new markets need to have a deep understanding of this changing regulatory landscape. In particular they need to have meticulous planning, robust quality management systems and effective risk assessment strategies in place. In other words the stakes are high, with the global medical devices market size at $512.29 billion in 2022. Furthermore this figure is projected to grow to $799.67 billion by 2030, a CAGR of 5.9% over the period,
Market entry or expansion into new territories can be complex. This means choosing the right “starter” market is the first step to ensure a successful and seamless commercialisation journey. This article summarises key considerations when choosing where to head first. The US, UK or EU markets all present their own challenges, which I summarise here.
The United States
The US medical device market, valued at USD 176.7 billion in 2020, offers a tempting entry point. This is somewhat offset by the FDA’s reputation for being a particularly strict regulator.
Introducing a novel device that does not have a so-called “predicate” can be challenging. A predicate is an equivalent, already legally marketed device. For most medium-risk devices the FDA requires 510(k) registration. This means the manufacturer needs to demonstrate that the device is as safe and effective as an equivalent with the same intended use. That said, the process can still be complicated. Indeed gaining access to all the information about the predicate can be challenging. This is especially so if it is manufactured by another company. In this case information will be restricted to what is in the public domain. As such, critical technical information will be hard to come by.
On a positive note, overall regulatory approval fees in the US are generally lower than in the EU. Furthermore the FDA follows specific response timelines that can help with planning and commercialisation objectives. In addition demonstrating substantial equivalence via the 510(k) submission can sometimes obviate the need for a clinical investigation. This can significantly reduce time-to-market and overall costs.
European Union
The US holds the title for the biggest market with 43,5% share of medical device sales. Next up is the European Union trade bloc, with 24.5% of global sales. The European Union medical device market is mature, with over 500 000 types of medical devices and IVDs available.
Contrastingly the regulatory approval journey for a medical device in the EU can prove complicated and take considerably more time. Compliance requires a comprehensive technical file dossier and engagement with a Notified Body (NB).
In addition there have been significant changes from the old rules to the new Medical Device Regulation (MDR) scheme. Capacity issues alone have slowed the process as notified body requirements have increased pressure on this piece of the jigsaw. Consequently time-to-market has stretched, in some cases very significantly. That said, the EU Commission is actively taking steps to strengthen the appeal of the EU market. Importantly it is striving to avoid potential risks associated with a shortage of new, innovative, and even existing medical devices. To this end the EU commission is working towards simplifying the transition to the EU MDR/IVDR. It has also extended deadlines for the implementation of new regulations. This will hopefully ease the burden on products already certified under older regulations.
United Kingdom
The UK medical device market remains attractive on a few counts. This is despite it being smaller when compared to the US and EU. Not least is the absence of a language barrier for US manufacturers and many other global producers. Then there’s selling to the National Health Service (NHS), which accounts for approximately 86% of the country’s healthcare provision. Acute hospital trusts carry out most NHS procurement, accounting for $13 billion spent each year on medical technology.
The publication of the 2019 NHS Long Term Plan outlines priorities and objectives for the next ten years. Digital innovation is a key element of the Medical Technology Strategy. As a result the Government hopes to establish the UK as an attractive market for innovative and specialised products.
On the regulatory front, the shift to the new UK Medical Device Regulation (MDR) is in full motion. In fact the pace at which new requirements are emerging may catch many medical device manufacturers off guard. Notably the UK is also exploring the recognition of approvals from other countries to expedite market access. This can help to accommodate the diverse requirements of advancing cutting-edge technologies.
Using a Medtech Regulatory Specialist
In conclusion, navigating the intricate landscape of market entry strategies can be a challenge for medical device manufacturers. Approaching this journey without the guidance of experienced professionals can expose manufacturers to unwarranted risks and pitfalls.
By engaging with international medtech regulatory specialists, medical device manufacturers enhance their capability to navigate complex regulatory landscapes. In addition they can also gain a competitive advantage. For example, specialist advisors can play a pivotal role in helping manufacturers structure a well-informed and strategic market entry plan.
References
1 Fortune Business Insights, The global medical devices market size was valued at $512.29 billion in 2022. It’s projected to grow from $536.12 billion in 2023 to $799.67 billion by 2030, https://www.fortunebusinessinsights.com/industry-reports/medical-devices-market-100085
2 Grandview Research, U.S. Medical Device Manufacturers Market Size, Share & Trends Analysis Report By Type. (Diagnostic Imaging, Consumables, Patient Aids, Orthopedics), and Segment Forecasts, 2021 – 2028.
https://www.grandviewresearch.com/industry-analysis/us-medical-device-manufacturers-marke
3 MedTech Europe, The European Medical Technology in Figures, Market (Last update 19.09.2022) https://www.medtecheurope.org/datahub/market/
4 Euro Dev https://www.eurodev.com/medical-devices (Last accessed 12.12.2023)
5 US International Trade administration website https://www.trade.gov/country-commercial-guides/united-kingdom-medical-technology (Last accessed 12.12.2023)
6 US International Trade administration website https://www.trade.gov/country-commercial-guides/united-kingdom-medical-technology (Last accessed 12.12.2023)
7 Medical Technology Strategy Plan, February 2023, https://www.gov.uk/government/publications/medical-technology-strategy/medical-technology-strategy
8 US International Trade administration website https://www.trade.gov/country-commercial-guides/united-kingdom-medical-technology (Last accessed 12.12.2023)
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published: December 15, 2023 in: Articles of interest, Regulatory