It’s rare for a small Medical Device business services provider to take on the commercialization of their own medical device. And that sort of challenge is not at all what Janet Kwiatkowski (CEO of MAE Group) intended when she founded the company in 2013. Her original intention was more focused on helping other companies provide life saving devices to the world through innovative solutions. However, when opportunity presents itself to an innovator, you see it for what it is. You take it. Here’s the story of MAE Group and how this small company with a large vision is commercializing their own oncology medical device.
Building a Company and a Team
From the earliest days, Janet Kwiatkowski knew she needed a team that reflected her core values: grit, a focus for finding solutions, and a desire for long-lasting customer relationships. And the team Janet assembled at MAE Group each have their own unique gifts and abilities that help those relationships thrive. For a decade now, the MAE Group team has excelled by providing trusted advice and solutions to a wide variety of medical device start-ups and a few more-established companies. MAE Group is often the capstone between the inventor and investor, offering a full bespoke suite of commercialization services to early-stage companies.
Taking on Commercialization
We’re honored that all our customers have selected MAE Group to help bring their innovative medical device and in vitro diagnostic device technologies to markets around the world. When Janet met Paul Stauffer in 2018, she knew MAE Group could do even more. Paul’s idea lacked what so many other innovations are missing: a commercial path to get new solutions to customers. Dr. Stauffer, lead researcher behind an innovative therapy for glioblastoma, was thrilled to learn about Janet’s success working with others, and suggested that MAE Group take up the commercialization of his device idea: a method for delivering thermobrachytherapy to patients suffering from one of the worst and most aggressive forms of cancer.
Janet Kwiatkowski coined the name for MAE Group’s first internal commercialization project: Project Hope. The promise of Dr. Stauffer’s idea is extending the life of patients with glioblastoma by delivering thermobrachytherapy (TBT), which combines hyperthermia with brachytherapy, radiation treatment in which the radioactive materials are sealed inside a seed, pellet, wire, or capsule, and are inserted into an implanted device for brief periods over several days. The radiation, delivered to the recessed tumor cavity post-surgery through a balloon catheter device, damages the DNA of nearby cancer cells. But more importantly with TBT, the combination of radiation and thermotherapy has been shown to increase the effectiveness of the treatments well beyond what either of them accomplish alone.
Phase I Funding
In 2021, MAE Group was awarded a NIH Phase I grant, rare for first- and even second-time applicants. The grant confirmed the value of the idea, increasing the determination of the team and empowering a complete investigation into the feasibility, technical merit, and commercial potential of the TBT System. As of late 2022, MAE Group is seeking Phase II funding from NIH, with other funding opportunities in sight, all allowing research and development efforts initiated in Phase I to move the device and TBT toward human clinical trials.
We close with the words of our CEO, Janet Kwiatkowski: “Every step we take and every decision we make must be towards the commercialization of the TBT system. Commercialization seem to be a cold, calculating word. There is another aspect though: bringing life-saving products to global markets means providing hope and courage for people diagnosed with devastating diseases. We are enabling them to fight and believe they can win or at least beat the odds, and that is crucial to standing up to the toughest fight they will ever have to face. To know there is a technology that is available to them that can play an important role in this fight is our obligation. We will succeed. Period.”
For more information in how you can support the MAE Group journey, visit our GoFundMe page.