The hard truth: compliance can make or break your medical device start-up
Article by: David Ashworth PhD, Flintloque Management Systems
Designing a new medical device is HARD.
Demonstrating that your new medical device works as intended is HARDER.
Proving that your new device meets the regulatory framework for your markets is HARDEST.
So, are you and your team up to the task?
A major cause of business failure is ineffective management. The statistics around these failures, specifically in the UK, can be found easily on the Internet, but can be summarised as:
- c. 20% of startups fail within the first year,
- c. 33% of startups fail within two years, and
- c. 60% of startups fail within five years.
The exact figures are not what is important; the fact that UK startups fail is the problem.
Surviving the regulatory battlefield – proving your medical device is safe, effective and compliant
Imagine that getting to your markets is analogous to fighting your way onto the battlefield. Obviously, you would want to go in “armed and armoured”…wouldn’t you?
And, in this case, that means having an effective management system that meets all the appropriate statutory and regulatory requirements for your markets. This allows you to PROVE that your device is safe and effective, that it has been developed under the aegis of a compliant management system, and this will stop you falling at the first hurdle!
So, why is it that I encounter so many medical device startups whose wannabe soldiers enter the battlefield with, in effect, their trousers down and holding the equivalent of a pointy stick?
We are told in business that “Failure is Good”, that we should “Fail Fast”, etc. But, when we are looking at the obstacles on the road from idea to market, this path is well-trodden, and we know where the potholes are likely to be located, allowing us to avoid the failures that OTHERS have made.
Now, I am fortunate to have worked with many marvellous management teams, growing businesses to get their new, novel and non-obvious ideas to the markets in the UK, EU, US, etc. These teams recognise that “strapping on their arms and armour” before even thinking about entering the battlefield, is likely to increase the chances that their business will still be alive in the immediate future.
Your medical device is effective – make sure your management system is too
My advice is always, “Start thinking about implementing an effective management system sooner rather than later”. If you wait, then it might be too late, and you are in real danger of having to repeat the work you have already completed. Remember, you must prove that your device was developed under the aegis of a compliant management system, not retrofitted after the fact.
So, don’t repeat the failures of others (it’s daft), ask for assistance “today”, not “next year” (it’s wise), strap on your “arms and armour” before you march off to war (it’s sensible), and do not become another medical device startup failure statistic.
David Ashworth PhD, Principal Consultant, Flintloque Management Systems
E: [email protected] | M: 07528 472 222
