Med tech companies were reminded that there are opportunities in emerging and growing markets as they look for ways to adapt to the uncertainties created by the U.S. administration threats of import tariffs. With large populations, and relatively untapped markets, these opportunities represent new destinations for the med tech products. However, the U.S. cannot easily be replaced and there will be challenges in these markets, delegates heard at the LSX World Congress, in London.
Despite a couple of med-tech deals transacted this year and more liquidity in the market, early-stage medical device companies in Europe continue to struggle to raise funds. To attract interest from Venture Capital (VC) funds, these companies must ensure they have a disruptive technology, be willing to change their story, and do the math to ensure that VC firms who back them can get an adequate return, investors advised at the recent LSX World Congress in London.
Precision medicine holds exciting promise for the medical device industry as it offers a range of solutions within diagnostics, digital devices and imaging, which could transform patient care, delegates heard at the LSX World Congress in London. However, there are a range of challenges ahead, including the population of clinical data, getting past the inertia of physicians and making it easier to run clinical studies.
Integra Lifesciences Holdings Corp. will not launch any new product in the EU before the U.S. because of the challenging requirements under the new Medical Device Regulation, Stuart Hart, chief medical officer at the Princeton, New Jersey-based company, told delegates at the LSX conference in London.
An increasing number of European med-tech companies are first seeking regulatory approval from the U.S. FDA because of the growing backlog and frustrations with requirements under the new regulatory framework of the EU Medical Device Regulation (MDR), which has been described as “not working.”
Med-tech companies often use robotics and artificial intelligence (AI) to transform healthcare systems and improve patient outcomes. However, the current hype around generative AI, such as ChatGPT, and the explosion in the use of data are raising questions around regulation, reimbursement, and whether AI and robotics are the right tools for certain jobs, participants heard at the LSX World Congress in London.
Companies such asMedtronic plc have become risk averse and are unlikely to takeover early stage medtech firms, Ori Hadomi, vice president strategic initiatives & partnerships, at Medtronic, told delegates at the LSX World Congress in London. Hadomi, who joined Dublin-based Medtronic after his firm Mazor Robotics Inc. was taken over by the company in a $1.64 billion deal in 2018, told early-stage startups “don’t waste their time” in approaching the company.
The industry is not over the post-COVID-19 funding crash, and as the dust settles there are mixed signs for future prospects, with some metrics in decline, others more or less back to pre-pandemic levels, and some showing signs of improvement. But on the key productivity metric, there is a downward trend, with fewer new molecular entities (NMEs) approved by both the U.S. FDA and EMA over the last year and a half.
The IPO market in Europe is firmly shut and not a single company went public in the first quarter of 2023. The impact of this is trickling down to limit access to venture capital for biotechs.
