On the face of it, South Africa might not be the first country that leaps to mind as a leading innovator in medical devices. And that doesn’t just apply to foreign perceptions; far too many local South Africans still believe that products made overseas, particularly those in the high-tech biomedical field, are inherently higher in quality and sophistication than anything we could hope to produce at home.
Upholding a cardiovascular tradition
And yet to Greg Starke’s mind, the fact that his company, DISA Vascular, is a leading developer of innovative vascular medical devices that are distributed internationally, is not a surprise. “What I find more surprising is that there aren’t more of us around,” he says. “South Africa is, after all, the home of the world’s first successful human heart transplant. For a time, the world looked to our country as a leading light in the cardiovascular field.”
It’s a tradition in the footsteps of which DISA has been following for more than ten years, researching, developing and manufacturing leading vascular devices for the treatment of coronary artery disease. “It can get quite technical but, simply put, we develop devices that allow doctors to open up blocked arteries, and keep them open,” says Starke. These devices are known as stents and comprise a ‘scaffold’ that holds the wall of the vessel open to allow the free-flow of blood to the heart.
It might sound simple, but, like anything in the medical devices sector, the field is highly competitive and the most successful players are those that continually innovate. DISA currently has what’s known as a combination device undergoing human trials. Starke explains:
“About five years ago the market saw the introduction of the first combination stent devices – these are both mechanical and drug-delivery devices. In addition to keeping the wall of the artery open, they deliver drugs locally to stop the proliferation of scar tissue cells around the device, which often causes a new blockage.” The problem with these new combination devices is that, in a small number of patients, they can lead to something known as late stent thrombosis – the formation of clots at the site of the stent, which can be fatal. “Our new product is designed to overcome this issue,” says Starke.
Keeping up with expenses
Human trials take time and research and innovation necessarily require significant amounts of capital. “Finding funding is a huge part of what DISA has had to do – almost too much of our time is required to do it,” Starke says, adding that it’s more difficult to raise really large sums in South Africa. “In the United States, for example, a company like ours would raise between US$10 million and US$20 million at a time, whereas we might raise between R10 million and R20 million. This makes the gaps between funding much smaller for us, so it’s a constant challenge.”
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Fortunately, it’s one that DISA’s proven itself particularly adept at solving. Impressively, Starke and his founding partner financed their first device to the point of human implant stage through their consulting work. “We leveraged contacts, called in favours, convinced and cajoled people into giving us their time free of charge,” he said. Having that first implant gave the company enough credibility to raise funding to get European regulatory approval for the product. Since then DISA has raised funds from the IDC, Cape Biotech and BioVentures.
Turning challenges to opportunities
Another challenge in the early days was knowing how to get the products to market. Today DISA distributes its own products to over ten countries across the globe, but the first product went to market via a partner. “When we started, and still today, there was no regulatory body in South Africa for medical devices, so we got approval from the relevant European authorities and I think this proved to be a differentiator in the end.
“It showed our credentials and opened up other markets for us,” says Starke. He maintains, however, that the South African market was ironically the most difficult to break into initially. “I think it would have been easier to sell to South Africa if we were a Swiss company, because of local perceptions about local products,” he explains. But the challenges have also brought opportunities. “Our counterparts in the US and Europe can take a much longer time developing products, because they don’t face the same financial pressures that we do. We have had to do everything cost-effectively, which makes for a good business model, and we’ve also had to focus on getting a product commercially ready much sooner than they might have to. I think it’s made us more competitive in the long run,” he says.
Plans for the future
Looking ahead, Starke aims to take DISA up to what he terms a “tier two company – just below the ‘big four’” in five year’s time. That will mean broadening the product range, growing the company’s global footprint from ten to 25 countries and establishing a physical presence in Europe, DISA’s biggest growth market.
The company is already investigating minimally invasive revascularisation products for diabetic patients who risk losing limbs as a result of poor circulation. Starke keeps his eyes firmly on the next new development. “If you ask me what I’m most proud of, I’d have to say our innovation,” he concludes.
Player: Greg Starke
Contact :+27 21 448 0923, www.disavascular.com