Breaking The Regulatory Burden
At first glance, the development of breakthrough innovations in the medical devices sector can seem enticing for a tech-savvy startup. A dynamic market place, the sector is set to grow at a CAGR of 6.1% from 2021 and reach $603.5 billion in 2023.
Often commanding high unit prices, medical devices enjoy an economically stable market (and bouncing back as we look to a world learning lessons from COVID-19). Add to that the prize of patents, Intellectual Property, and the potential to sell to a larger business. What’s not to like?
But dive down a little deeper. Look beyond the bare mechanics of production and assembly and you uncover a virtual hornet’s nest of regulation and the need to gather evidence at every stage from concept to development. Of course, given the importance of medical devices, no sensible person would reject the requirement for stringent regulatory and compliance protocols. [Read more…] about Breaking The Regulatory Burden