UK SMEs operating in the medical diagnostics industry want to compete with the global companies yet often need a reminder about the importance of regulatory issues. A word of advice: appropriate risk management approval processes may protect you from future liability issues, so make sure your documentation is detailed and conforms to the European standards.

There are several issues I feel are hot right now: - Differing registration requirements in EU Member States affects the ability to gain reimbursement - Clinical trial reporting requirements for trials started prior to 21Mar10 - Unique Device Identification (UDI) is coming and companies should get involved now to understand it as it affects the whole supply chain - Software classification of all kinds (patient records/data handling, and more importantly when s/w is used in the diagnosis of the patient and involves some form of processing/interpretation)

Why is it so difficult to get funding for early stage life science technology businesses? Does the classic model of VC funding and exit by floatation or trade sale still work?

(Principal Analyst - Healthcare Editor at Clinica-Scrip) The IVDs sector in the UK needs a long-term commitment to the early health model. A simply structured, well worded commitment to promoting, using and monitoring use of these technologies will result in benefits all round - to patients, to the healthcare system, and thus to the government. Too little is invested in this vital segment from the UK healthcare budget.
Click here for more