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Sweden's Medical Innovators Heading For U.S. Via The Crowd
April 21, 2014 (Forbes) It is something of a Holy Grail for many European entrepreneurs with plans to export. The U.S. market is vast, potentially lucrative, but tough
And when their products require U.S. Food and Drug Administration (FDA) approval, it gets even tougher.
It is a familiar situation for Swedish medical device company, Timesulin whose product ? a smart replacement cap for insulin pens displaying the time since the last insulin injection was administered ? helps diabetes patients manage their condition more effectively. They know that consumer demand in the U.S. is there, but FDA approval, requiring a process that is complex and costly beyond their means, is not. So their hopes are now resting on a crowdfunding campaign on the Indiegogo platform to raise the cash they need for FDA registration.
The idea for Timesulin came from its Stockholm-based CEO and co-founder John Sj?lund, who has lived with Type 1 diabetes for 28 years.
"It offers a simple solution to answer what is arguably the most important question we have to deal with everyday, ?did I take my insulin shot, or not?'" he explains.
Not hitting blood glucose targets is a problem that affects an estimated three quarters of the 380 million people around the world currently living with Type 1 and Type 2 diabetes, several times every month.
Keeping track of your diabetes and managing it well requires hundreds of decisions per day; testing your blood sugar up to ten times a day, counting carbs, remembering to take all your supplies with you ? insulin pen, needles, blood sugar meter, strips, lancets, carbs ? and figuring out how to get those supplies ? it is very easy to lose track, says Sj?lund.
Determined to find a solution he quit his high profile, well paid, international job in marketing to develop Timesulin, along with his brother, a usability expert who was involved in creating Skype, and a third partner with a product development background from MIT.
Friends and family provided the modest first investment round that enabled them to get a first version of their product to market in 2012. Since then Timesulin has expanded to over 40 countries, including Japan, the Middle East and Canada.
Frustratingly, 50% of the firm's global website traffic comes from the U.S., but without FDA approval the market remains out of their reach. And it is an essential.
Unlike other markets where commercial partners have been willing to enter into a distributors' agreement and launch or purchase conditional on getting approval, in the U.S. we cannot even have the discussion without the FDA approval being in place," says Sj?lund.
The team is optimistic of crowdfunding the $35,000 they need to cover the costs of the FDA application and pay an agent who will submit the application and manage the process on their behalf.
As well as raising funds, the crowdfunding campaign is also creating awareness of the plight of small medical device companies and the tremendous challenges they face when trying to enter the U.S. market.
It isn't just the FDA, who Sj?lund admits have actually been extremely helpful to them, but also the large pharmaceutical companies that he says are stopping simple innovation from reaching the people who need it most. "Most US medical device companies end up launching in Europe years before launching in the U.S., because of this. For example, an insulin pump developed by American firm Medtronic which cuts off insulin delivery when it detected hypoglycaemia was launched in Europe four years before the United States," he said.
Companies in this field, he says, are exceptionally risk adverse, with the effect that patients with diabetes in the U.S. are not getting the same opportunities to decide what products can work best for them.
Since the launch of the crowdfunding campaign Timesulin has been contacted by a number of distributors who have expressed an interest in working with them ? once they are FDA approved that the awareness raising efforts, at least among smaller distributors that are embracing innovation, is working. But the real game changers could be the patients themselves, and Sj?lund is hoping that through crowdfunding, the diabetes community will step up and take control of their own destiny and health to a much greater extent.