Commercializing an invention can be a herculean task. There are technical hurdles. Funding hurdles. Patent hurdles. Manufacturing hurdles. Regulatory hurdles. Eric and Sandy Wengreen, co-founders of a company working to commercialize a small container that uses phase change material to keep EpiPens close to room temperature, are familiar with all of it.
First, the invention:
After their son nearly died of a severe allergic reaction to macadamia nuts a few years ago, the Seattle couple realized the importance of having an EpiPen auto-injector handy at all times. Sandy invented the container, now known as MedShell, to ensure that people can take their EpiPen wherever they go, even if it’s hot or cold outside. It’s not just about being prepared for an unexpected allergic reaction. EpiPens are expensive. Leave one in a hot car or gym bag for a few hours and you’re out $300.
The Wengreens began developing their device, originally called EpiShell, a few years ago. They filed for patents and successfully tested prototypes.
Biobased phase change material is a key component of the MedShell, which is designed to keep EpiPens between 15º and 30º Celsius (59º and 86º Fahrenheit).
“I learned about PCM while I was researching how to change the melting temperatures of liquids,” says Eric, who has a master’s degree in engineering from Stanford University. “I was very happy to discover that Entropy Solutions had already engineered highly reliable PCM. At that point, I realized that I didn't need to re-invent the wheel. Instead, I simply ordered PureTemp samples for prototyping and testing. I also received samples from other PCM manufacturers, but I quickly found out that PureTemp PCM was superior.”
Last fall, after receiving written assurance from the U.S. Food and Drug Administration that the container would not be considered a medical device subject to FDA regulatory requirement, the Wengreens launched an Indiegogo campaign. The fundraising target: A modest $35,000.
“My goal was to raise awareness (rather than just raise money),” Eric says. “Most people don't know many medicines have strict storage-temperature requirements. I also wanted to test the market to see if other people cared about protecting their medicines from temperatures that are hotter and colder than the FDA-approved temperature limits.”
The response was strong. Within a few months, the campaign drew hundreds of backers and raised nearly $30,000. Two product videos were watched more than 15,000 times on YouTube. The Wengreens continued to refine the design of the vacuum flask and thermal management system. They began evaluating manufacturing options.
In November, they decided to change the name of the product to MedShell.
“Many people have talked with us about applications beyond epinephrine, the active ingredient in EpiPens,” Eric says. “As a result, we wanted the name to reflect our broader mission to protect many medicines from hot and cold temperatures. … Essentially, the storage-temperature requirements vary depending on the medicine, but the fundamental technology is the same, so MedShell can be adapted to just about any medicine.”
On Dec. 7, Eric alerted Indiegogo backers to an unexpected development:
“Recently, in an abundance of caution, we voluntarily asked the FDA to conduct a second review of our product. This time, we had detailed product information that was not available during the first review (because we had not finished the design details at the time of the first review). During this second review, the FDA decided that MedShell is a medical device subject to FDA regulatory requirements.”
The FDA’s decision, Eric told backers, “will dramatically delay our launch and increase our expenses.” The Wengreens suspended the Indiegogo campaign and offered refunds to all backers.
The Wengreens announced a new strategy in a January post on Indiegogo: “We now need to find a larger company that has the FDA expertise and resources to bring MedShell to market.” They continue to fund development with money earned from previous inventions.
The regulatory hurdle looms large, but the Wengreens remain committed to commercializing the product.
“Whether MedShell is a medical device is debatable,” Eric says. “Honestly, I don't know exactly what would be required to either convince the FDA that MedShell is not a medical device or meet the FDA's medical-device requirements. I reached out to the FDA for guidance, but I have not gotten specific answers regarding next steps.”
Although they have no plans to reopen the Indiegogo campaign, the Wengreens say they want to make sure supporters have the first opportunity to get the device when it launches. Consumer interest remains strong; MedShell's YouTube videos have now been viewed more than 76,000 times.
“My goal is to transfer my patents and designs to a company with the resources to remove the FDA uncertainty and bring the product to market,” Eric says. “A larger company is better suited to making the invention widely available.”