Striving for a clean bill of health
Red tape is one of the big issues facing start-ups in the healthcare sector
TRYING TO DO business in the medical world is possibly one of the the most complicated sector known to man. Getting a product to market takes a large amount of due diligence, research and trials. Then imagine trying to sell anything to an Irish public health service that is running at a deficit of €200 million. Your commitment to your product or service must be supreme.
Of course, the level of regulation is understandable. When dealing with something as important as human health, one must be sure that all facilities and resources being used by doctors, nurses and other care-givers have been stringently tested before entering the healthcare market.
The Irish Medical and Surgical Trade Association (IMSTA) is the representative body for all medical technology supply companies in Ireland, from plasters to MRI machines.
“The principal issue for any company, from a start-up to a major multinational, is access to market,” explains Justin Carty, president of the IMSTA.
“You can’t sell anything that’s not CE marked . This is controlled by the Irish Medicines Board. You can’t sell anything without their authorisation.”
Easier said than done. “Getting CE marking for a medical device is an extremely onerous task,” says Paul Maguire, CEO of Arann Healthcare.
“There are myriad rules and regulations you need to become au fait with very quickly. A number of consultants we’ve been working with have helped us with that. The best way to do it though, is to put in your own quality assurance system into the company from the get-go.
“CE marking is the norm in this business. If you have a great product, you just accept you must put in place these aspects. It’s just an added step in the process.”
Once this has been done, in an ideal situation a new company would develop its product further by working with clinicians.
“You would need to have the authenticity of your product trialled well before you go to the market,” stresses Carty. “In devices it’s called a clinical investigation, in drugs it’s called a clinical trial.”
The next logical step, according to Carty, is missing in the Irish system. “The product or service should then come before some sort of national body able to evaluate its clinical impact and the cost benefit of it,” he says.
“Before any new device goes to market the Government should be able to say, ‘Let’s trial that, see how it works, and decide whether it is needed and whether it will save money in the long term.”