In an effort to address limitations facing smaller medical device companies wanting to launch into the United States, European diabetes brand, Timesulin, today launched a crowdfunding campaign on Indiegogo. The smart replacement cap for insulin pens that shows time since last injection to help avoid accidental double or missed doses was first launched in the United Kingdom in 2012 and is today sold in over 40 countries around the world. A majority of visitors to the company’s website originate from the United States and the demand for distribution there has been large from day one. This campaign aims to find a new way to reach the diabetes community in America by crowdfunding the $35,000 required for necessary FDA approvals, and will run until April 20, 2014.
A number of factors prevent innovative medical device startups from launching into the United States, where typical launch times are three to four years behind their European counterparts. In fact, many American companies are launching their technological advances in Europe before introducing it to patients in the United States. Among these challenges are:
Requirements for U.S. regulatory registration on medical devices are lengthy and more expensive than elsewhere.
The sheer size of the U.S., which makes distribution and logistics a challenge.
The costs of marketing a new brand in a market cluttered with medical advertising from big pharmaceutical brands with enormous budgets.
Patients in the United States are not given the same choices about which devices will help them live their best possible life with diabetes.
“The Timesulin team and I have been frustrated at our inability to crack the barriers to entry into the United States. Crowdfunding allows us to empower people with diabetes, just like us, to decide for themselves which tools they need to manage their diabetes in the best possible way” says Timesulin CEO and co-founder, John Sjölund.
Unlike other crowdfunding campaigns, funds from the Indiegogo campaign won’t go towards research and development, but towards overcoming the barriers that exist in the U.S. market and giving an established market base access to the simple diabetes management tools that Timesulin creates. “Crowdfunding provides a powerful way for small companies, like ours, to innovate and compete with huge pharmaceutical companies on a level playing field”, Sjölund continues.
The crowdfunding campaign has a few key goals:
Raise the funds necessary to create and submit an application for FDA approval, which needs to be adapted from the international applications used elsewhere.
Obtain the necessary market approvals and prepare for unknown demand and long application times.
Highlight the enormous hurdles small companies face when bringing their product to the United States.
Create an awareness of Timesulin amongst the U.S. diabetes community and make Timesulin available to the thousands of nurses, doctors and patients who want to use it.
Leading U.S. diabetes advocate, Riva Greenberg, a journalist for the Huffington Post and author of multiple books on the topic of living with diabetes, agrees, “My life is focused on helping people with diabetes flourish – and Timesulin is a tool that helps me flourish! I can’t tell you how many mornings I sit down to work, completely lose track of time and forget whether or not I took my habitual insulin shot. This little cap has saved me from missing many doses.”
(See full video testimonial here: http://bit.ly/timesulin_testimonial)
The campaign has also garnered the support of international diabetes patient organizations and key opinion leaders, including former Chair of the Education and Research Foundation of the American Association of Diabetes Educators, Paul Madden. “Every person living with diabetes should have access to simple tools that can make their lives a little easier, less worrisome and safer. Timesulin is such a product and the fact that these barriers are preventing my friends with diabetes from having access to a device that increases safety and diabetes balance is wrong. I support this campaign to help everyone with diabetes be able to make their own decisions about the products they want to manage their condition with.”
Visit the Timesulin campaign on Indiegogo here: http://igg.me/at/timesulin