The hows and whats of the medical devices biz

If you are thinking of getting into medical devices and equipment manufacture, make sure you have first tied up a whole lot of things.

From the initial idea to product commercialisation, the roadmap has to be clear, with set timeframes.

The puzzle needs to be constructed, said John Begg, Managing Director of Australia-based Medical Product Design Pty Ltd.

He should know. Begg has been involved in developing medical devices and equipment for over two decades, and was part of a company that developed a heart implant. Medical Product Design, a company launched by Begg, is into designing gastroenterological devices.

“The early steps in medical devices development are very important because you will be forced to endure them for a long time,” said Begg.

And, given that the regulatory process is extremely stringent, he said, you should make sure you do not set yourself additional hurdles.

For this, it makes sense to have on board a person knowledgeable not just with the development process but also with regulatory procedures.

“There is an awful lot to be lost if you don’t take careful decisions,” he said.

Export market

Right from the beginning, development parameters must encompass the export market.

The Australian market is too small and hence medical equipment makers always take into account the regulatory issues in Europe and the US while working on the device.

High-end medical devices need vision and a lot of funding.

Begg lists funding, political/commercial will, regulatory issues, academia-industry tie-ups and speed as some of the critical issues in the development and rollout of medical devices.

These devices, according to him, require a minimum of five years to even see the beginnings of results and probably 10 years to see commercial results and return on investment.

Giving an example of the funding requirement, Begg says the company that developed the left ventricular assist device first raised A$6 million, which gave it two years’ worth of capital.

Then, it did an initial capital raising of about A$20 million and raised a further A$70 million from the market. “That is the sort of money you are talking about,” said Begg.

Speed matters

Another issue that medical devices makers must keep in mind is speed — from the time the idea is conceived to getting a proof-of-concept ready.

“If it took you any more than five years to have a proof-of-concept, the rate at which things change, you might find that you have missed the boat,” said Begg.

For example, the ventricular assist project had the first prototype for an animal implant in 18 months, and took another three-and-a-half years to get to the point where they could put it into a person.

This period was taken up in developing the product for a mass production environment.

Toughest part

According to Begg, commercialisation is the toughest part of product development, while development is relatively easy.

Commercialisation — putting in place the whole design dossier, verification and validation plans, regulatory plans and raising funds — takes a lot of time and effort, he said.