Medical devices – a rapidly evolving healthcare and technology landscape

In the early stages of medical device development and commercialization planning, one of the most important aspects to consider is which market to enter first.

Considerations regarding the size of the market, the demand for this particular device, the overall medical landscape it will enter, the procurement processes used by the major buyers, whether they are domestic or private customers, are crucial to ensuring its successful launch and generate revenue and reinvest in the business. One key element that too many businesses overlook is the impact that the regulatory pathways each country offers will have on bringing a product to market, both in terms of time and cost.

In today’s rapidly changing healthcare and technology landscape, navigating medical device compliance is becoming an increasingly complex endeavor. With advances in medical technology, the development and deployment of innovative devices, and unprecedented regulatory changes – with the introduction of new EU MDR and IVDR regulations and the future UK regulatory regime in major markets such as Europe and the UK – the scenario is difficult to navigate.

Manufacturers and stakeholders must navigate a web of complex country-specific standards, guidelines and regulations before deciding which markets will be most cost-effective to enter and which they should address first, laying the foundations for future success. While the global medical devices market size was valued at USD 512.29 billion in 2022 and is expected to grow from USD 536.12 billion in 2023 to USD 799.67 billion by 2030, at a CAGR of 5, 9% over this period, this article focuses specifically on three of the most popular markets – the EU, the UK and the US – highlighting some of the key issues involved in entering each of these geographies ‘first’.

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