John Sjölund and the international team of Timesulin want you to cast your vote to expand the choices of tools and treatment available to you as a patient. OK, and they want you to do it by crowdfunding their efforts.
That is, the clever insulin pen-cap timer (did I take my shot or not?) that lifelong type 1 John and his team have created is now available in 40 countries around the world, but not yet in the United States because "the barriers to entry are so high for smaller, independent companies." John and his team of five (located in Sweden and the UK, and manufacturing in Germany) have received some funding to enable manufacturing and distribution internationally, but have been scrambling to pull together the $35,000 required to apply for product approval with the FDA. It's a huge risk for them, because they have no real assurance of the outcome of FDA's evaluation.
"We've been struggling to find the right commercial strategy to enter the U.S. market. We know there's a need because of the success of the product in other countries -- and I created this thing as a patient myself because I felt the need to help simplify diabetes management," John says.
In short, Timesulin is launching an Indiegogo crowdfunding campaign, asking the diabetes community to donate $5 or more to help them bring this unique injection-reminder to the States as an option for those who use insulin pens (see today's press release). "It's a rather low-tech innovation, but one that could make a big difference in some peoples' lives, and why shouldn't patients in the U.S. have access to it?" John says.
He really views their Indiegogo campaign as an initiative for freedom of patient choice.
How does Timesulin actually work again? It's a plastic cap with a little digital readout window that works with various insulin pens already on the market: Novo Nordisk FlexPen (Levemir, Novolog, Novolog Mix 70/30, NovoRapid and also Victoza), Lilly KwikPen (Humalog, Humalog Mix 75/25, Humalog 50/50), Sanofi Solostar (Apidra), and a few others.
(It could possibly make the need for Novo's new EchoPen with memory obsolete...?)
All you do is replace the cap that came with your pen with the Timesulin cap. Then each time you take your insulin and place the cap back on, a timer is started which tells you how long it's been since your last injection — unless you only take a very short peek at how much insulin is left. A quick peek won't reset the timer. The cap can be used for 12 months before it needs to be recycled and replaced.
The product uses common watch batteries that last up to a year, and the retail price in the U.S. is expected to be about $39.
John told us in a previous interview about where the inspiration came from for this product:
"For the longest time, I was asking my doctors when a solution to forgotten injections would be coming along, and I never got a conclusive answer. After years of having this problem and often speaking with my family about it, it was actually my brother Andreas who had the 'Eureka!' moment for how to solve this back in June 2008. If you figure that the average person with diabetes takes four injections per day, that equates to nearly 1,500 shots per year. Of course we are going to forget every once in a while, right? It happens to the best of us: young, smart, active people just like me."
In 40 other countries, the Timesulin cap is available through traditional medical device distributors and pharma partners like Roche Diabetes, and also through the online stores of three national patient organizations including Diabetes UK, plus the company does some direct sales on its own website -- but you cannot order from the U.S.
Check out this video testimonial for Timesulin created by D-advocate and author Riva Greenberg:
Breaking into the U.S. Market
"We are unhappy about the fact that our product isn't available in the United States and get many emails from customers in this regard; more than half the traffic to our site comes from the U.S. The reason for this is a balance between regulatory and commercial hurdles," John tells us.
What he means is that Timesulin has apparently met with "all the big pharma players" in the U.S. diabetes market, but none are willing to partner with his tiny company to back a product with such a niche market and low cost margins. It's simply not worth their while -- at least not until Timesulin has passed FDA evaluation, the expensive and risky part.
So how are they able to be so successful elsewhere in the world? "The methods of selling are different in Europe. In the U.S., the blood glucose monitoring and other device companies have the pressures of reimbursement policies and competitive pricing. Compared to selling in other parts of world the risk is higher," John says.
"We are looking to try to start a movement to garner support from the community to allow patients to take a greater role in influencing how they get their own treatment -- let them vote to get the tools the need to manage their own diabetes best, through crowdfunding," he says, adding that this innovative open-community funding model "gives the smaller companies have a chance to move the needle in the U.S., where they've essential been blocked out in the past."
John notes that at the recent ATTD (Advanced Technologies and Treatments for Diabetes) conference in Vienna, he first heard the expression in medical devices known as "going HIV on the FDA." This refers to the strong AIDS lobby that emerged in the 1980s and early 90s, when the disease began effecting young, successful, affluent men in their 30s and 40s. These patients were socially and economically strong, and not getting the drugs they needed. So for the first time ever, a powerful lobby made up of patient voices was able to stand up to the FDA and affect change.
Some think that PWDs (people with diabetes) will continue this tradition now, with the artificial / bionic pancreas. I'd say it's happening already in the patient outcry for open diabetes data systems, hashtag #wearenotwaiting !
"We're a product company and need to sell product, yes. But we're also hoping to start a bigger discussion about why people in the U.S. aren't getting access to the same tools to manage their diabetes and how crowdfunding can be a way to support innovation and access," John says.
Good point, and we noticed that Timesulin is not the only fledgling diabetes device group turning to crowdfunding to move its product forward. The team behind the QuickIt Saliva Analyzer blood glucose monitor, for one, also ran an Indiegogo campaign recently, but raised only a little over $4,000 of its ambitious $100,000 goal. There are a number of emerging diabetes smartphone apps attempting to raise money this way too.
Why does Timesulin expect better results? "Many of these are just in the development stages... and (QuickIt) has no working prototype, only a 3D model of a product that doesn't exist. But we have a product that hundreds of thousands of people across the world are already using," John points out. "Funds from our 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."
Simplicity (!) and Rewards
On this note, John says he and his team members are on a genuine mission to help make life with diabetes easier, by simplifying D-tools; see the passionate guest post he wrote on that topic here at the 'Mine in December.
"A new diabetes tool doesn't have to be all bells and whistles, Bluetooth, wifi, NFC, memory of the last 15,000 blood tests and enough USB cables to be able to re-wire my house. All I need are simple tools that help make decisions related to my diabetes easier, fewer in number and less complicated," he says.
Their Indiegogo compaign -- which launches today, March 11, and will run until April 20, 2014 -- aims to raise the necessary $35K to complete the FDA regulatory work for Timesulin. "We are not expecting to make money on this... and we want to give back to those who contribute so we're using the rewards feature of the platform to offer incentives," John says.
The rewards run roughly along these lines:
- for $30, you can sign up to be one of the first people to receive the product (at a slight discount) when it comes out, "basically the day after we get FDA approval," John says
- for $35, you'll receive a complementary copy of Riva Greenberg's latest book "Diabetes Do's and How-To's"
- at $349, you can opt to donate 10 Timesulin products to the clinic of your choice
- for business contributors, starting at about $5,000, special access accommodations will be made -- for example for a diabetes supplies web supplier, they could be the first in the U.S. to offer to Timesulin to their customers
- for a very large donation, around $10,000, the Timesulin team is considering organizing a trip to Stockholm to visit with them and learn about diabetes care and innovation in Sweden
- finally, they're dreaming really big: if some supporter should come forward with $250,000 or more, Timesulin could organize a trip on the space shuttle -- "so the first Timesulin unit can go up in space," John chuckles
On timing, John says: "As soon as we see that we are nearing the $35,000 goal we will start the application process, even if the campaign isn't over. According to the FDA when they looked at our project, they estimated 150 days. Actually 90 days is quickest response you can get from FDA, and they need to finalize within 180 days."
If Timesulin doesn't reach its full fundraising goal, the project will be cut off and they will receive no funds, he says, adding: "It's unlikely that we would get Timesulin into the U.S. anytime soon on our own in this case."
And there's one other concern: with the time gap from the European launch, products are often on version 2.0 abroad before version 1.0 is even available in the U.S. So we asked if Timesulin was working on any upgrades or redesigns? John's response: "Absolutely -- this is an experiment to test if we can launch new product ideas in this way. We are quite far ahead in some cool new concepts, all along the lines of making it easier to manage the day-to-day of your diabetes. Not ready to share details yet though..."
Overall, John admits that a special cap for an insulin pen is a pretty niche item; "it's not for everyone, not everyone needs this." But in the same breath he insists that crowdfunding for diabetes products can pave the way for other entrepreneurs -- and help allow all patients to have more choices about their treatment options.
"The message is: this is a new way for people to choose what they need to flourish with their diabetes."
— type 1 entrepreneur John Sjölund, on using crowdsourcing to support new medical innovations
btw, John and his wife are expecting twin boys any day now -- congrats to them! And there must be something in the air because fellow type 1 entrepreneur Chris Angell of GlucoLift and his wife just recently had twin girls -- congrats x2!