When in the early stages of developing a medical device and planning for commercialisation, one of the most important aspects to consider is which market to enter first.
Considerations regarding market size, need for that specific device, the general medical landscape that it will be entering, the procurement processes used by major buyers whether these are national or private, are key to ensuring that it has a successful start and that it generates revenue to invest back into the business. One key element that too many businesses overlook is the impact that the regulatory pathways offered by each country will have on the launch, both in terms of timing and expenses.
In today’s rapidly evolving landscape of healthcare and technology, navigating the realm of regulatory compliance for medical devices has become an increasingly complex endeavour. With advancements in medical technology, the development and deployment of innovative devices, and the unprecedented regulatory shake-ups – in the form of the introduction of the new EU MDR and IVDR and the Future UK Regulatory System in major markets such as Europe and the UK – the scenario is difficult to navigate.
Manufacturers and stakeholders must navigate through a web of complex standards, guidelines and country-specific regulations before they decide which markets will be the most profitable to enter and which ones they should tackle first, laying the groundworks for future success. While the global medical devices market size was valued at $512.29bn in 2022 and is projected to grow from $536.12bn in 2023 to $799.67bn by 2030, with a CAGR of 5.9% over the period, this article focuses specifically on the three of the most popular markets – the EU, the UK and the USA – highlighting some key considerations relating to entering each of these geographies ‘first’.
Read the article in full here.
