cosmaa; Alex Oakenman/Shutterstock.com


Contract manufacturing


Tipping the scales


It’s one thing to come up with a theoretical design for a medical device, or even to prototype it and reach proof of concept, but quite another to assemble the manufacturing conditions necessary to produce it at a scale that make it a viable business. Of course, many companies offer manufacturing like this as a service, but for a start-up strapped for cash, bridging that gap between design and commercialisation can be a struggle. The Medical Device Manufacturing Centre of Heriot-Watt University in Scotland was founded to help solve this problem, and Duncan Hand, professor of applied photonics, who leads the initiative, tells Peter Littlejohns how it operates.


tarting a business is hard. It’s why we extol founders who take a commanding lead in their respective industries, and romanticise in TV and movies the grit and determination it takes to be successful. But all the determination in the world can’t change the fact that, statistically, going from start-up to scale-up and reaching profitability is an unlikely feat. In terms of raw numbers, nine out of 10 start-ups fail within 10 years of their inception – and this figure is industry agnostic. In the medical device industry, where regulation is stringent and the


S Medical Device Developments / www.nsmedicaldevices.com


burden of evidence to obtain commercial approval is high, the uphill climb can be even steeper. It’s for good reason of course; a flaw in medical equipment poses much too high a risk not to take the fine- toothed comb approach. But it also contributes to the reason it costs an average of $94m to bring a medical device to market through the FDA’s pre-market approval process in the US. This drops to $34m for its 510(k) process, which has a much lower evidence burden so long as makers can demonstrate its similarity to another device already on the market.


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