London In Vitro Diagnostics

Questions SMEs should ask about clinical trials and regulations

How do SMEs ensure that their innovations are safe and effective, and  how can they demonstrate this to payers, practitioners, regulators and patients?

DEC London attended a meeting organised by DigitalHealth.London to address these questions – and to help to connect innovative SMEs with key research and regulatory organisations, including the National Institute of Health Research (NIHR) and NICE.

The conclusion was that it is all about generating the right evidence whilst developing your innovation, and getting the right clinical and infrastructure support to carry out the research.

Here are five questions companies should consider about clinical trials and regulations:

  1. Is my innovation a medical device?
  2. Does my innovation require research or clinical trials?
  3. Does my research require approval?
  4. How can I found out where to get the clinical expertise and infrastructure to help generate evidence?
  5. How can NICE help me?

For more information on each of these points, read the full article by MedCity COO Neelam Patel, who chaired the meeting, here.