SetPoint Medical, a pioneering medical device company, is on a mission to transform the treatment of autoimmune diseases and conditions like rheumatoid arthritis, Crohn's disease, multiple sclerosis, and psoriatic arthritis, among others.
The company’s groundbreaking approach, which leverages innovative, implantable devices, stimulates the vagus nerve to regulate inflammation and restore immunologic balance. By activating the body’s immunomodulatory pathways with targeted electrical stimulation, SetPoint's therapy offers a promising alternative to traditional immunosuppressant drugs, offering patients and providers a potentially safe and cost-effective treatment approach.
Early results have shown remarkable patient outcomes, with evidence pointing to significant improvements in disease activity as well as quality of life.
As part of the development of its pioneering implantable device, SetPoint needed to design and manufacture a durable, externally wearable charger that effectively communicates with the implant and an app used by physicians to program and charge the implant. The company also needed to establish and maintain manufacturing processes that would enable scalability and precise quality control, as well as the ability to navigate the stringent regulatory requirements typically associated with implantable medical devices.
“One of the biggest challenges in medical device manufacturing is the amount of regulatory and quality control across all aspects of development—every step of the manufacturing process has to be verified and validated based on stringent regulations and standards,” said John Long, SetPoint Medical’s VP of Operations.
“To manage that, you need to have really high engagement with your contract manufacturers, which, as you can imagine, can be difficult to do outside of the US when you are a small company like ours.”
Leveraging over 40 years of engineering, logistics, and manufacturing experience, as well as a network of world-class manufacturing partners in Asia, Kingstec has emerged as a trusted, strategic partner for SetPoint’s evolution.
Working directly with SetPoint’s manufacturing facilities in Asia, Kingstec has facilitated seamless project management and manufacturing for chargers and other external components, bridging any potential communication gaps and ensuring rigorous quality control.
"Without them, it would be impossible to have the same kind of support overseas. Kingstec has worked with some of its manufacturing partners for decades, which has allowed us to leverage a stable supply chain and expediently create a high-quality manufacturing process,” Long said, explaining that as the company moves closer to FDA approval and market launch, they are now prepared and well positioned for scalability and future growth.
“Our ability to pivot, to go in and say, 'Hey, we need to make this change, we need to implement this process, we need to validate this 'work'—this is where we're winning, and a lot of that is possible because of our relationship with Kingstec. They’re the gold standard, and if all of my manufacturing partners and program managers worked like Kingstec does, my life would be a whole lot easier.”
