How could a first-time medical device inventor—whose efforts to independently advance his project had stalled—get the funding and support to develop, produce and launch a new medical device innovation?
In 1998, SurgiLance® Safety Lancet inventor John Teo had reached a project-stopping obstacle faced by many early stage medical device inventors. Although he had a prototype of an innovative medical device and had presented his medical device idea to venture capitalists (VC) and angel investors in Singapore, a lack of medical device funding was threatening to kill his project.
Through a focused, determined and collaborative effort of scoping, planning, financing and testing the medical device invention with Patrick Yi, the SurgiLance® Safety Lancet was successfully launched in 2000—and continues to be one of the best-selling safety lancets in the world.
In critical need of support, Teo turned to his brother-in-law, Patrick Yi, a successful marketing and business development manager and consultant. Yi conducted some brief research to ascertain the medical device’s viability.
Yi gave the prototype to three qualified resources—his wife (a medical doctor), his sister (a staff nurse) and his sister-in-law (a midwife)—to test and compare with similar, available products. Their unanimous voice-of-consumer (VOC) feedback validated a compelling value in Teo’s innovation: ease of use.
Yi’s research also identified a potentially lucrative U.S. market estimated at $50-100 million in which Teo’s medical device could thrive. Bolstered by the possible (and eventual) enactment of the 2000 U.S. Needlestick Safety and Prevention Act, Yi agreed to be Teo’s business partner.
Unable to attract Asian investors that were unfamiliar with the U.S. medical product market (in addition to not having a proven track record), Teo and Yi opted to bootstrap their startup with their own money and sweat capital.
To conserve cash, Teo and Yi:
- Filed a provisional patent in Singapore, giving them an additional year before a conventional application need be filed—thus deferring expensive patent costs till later.
- Focused on the U.S. market, deferring the expense and time required to obtain CE certification and European regulatory approval till the medical device was accepted in the U.S. market.
- Employed contract manufacturers rather than set up their own manufacturing facilities.
Mindful of the urgency to get customers before their cash ran out, Yi pitched the product to distributors in the United States as soon as prototype samples were available. All of the initial marketing was done from Singapore—via phone calls, faxes, e-mail and the Internet.
His efforts were soon rewarded with two sizable U.S. medical product distribution contracts by late 1999. After skillfully leveraging a pre-delivery deposit from one distributor to fund production, Yi parlayed the cash to push the SurgiLance® Safety Lancet into full production.
Under pressure to deliver final product to the distributor, Yi and Teo accelerated the testing phase. Unfortunately, the first batch of products had an unacceptable failure rate and was recalled. It took another six months to fix the quality problems, and the product was finally launched in late 2000.
Ultimately, the solutions for Teo’s challenges were found in a partnership with Patrick Yi that not only helped him overcome the obstacles, but resulted in MediPurpose’s launch—a company that continues to recognize the unique sets of challenges faced by many new medical device inventors and innovators.
If you are a medical device inventor that is interested in getting your invention developed and launched, please tell us about your new medical device invention.