Partnering with Greenlight Guru streamlined Puzzle Medical's communications with manufacturing and allowed them to focus more time and resources on prototyping and V&V testing.
Puzzle has seen incredible success with prototyping their Class III medical device and has made great advances towards their clinical work.
Puzzle Medical Devices is striving to maximize the quality of life with their device, ModulHeart, which provides a minimally invasive option for heart failure treatment. Puzzle Medical has streamlined their development processes and are on track to conduct their first human clinical trials in 2022.
HQ: Montréal, QC, Canada
Device Classification: Class III
Greenlight Guru Champions:
Co-founder & Chief Executive Officer
Manager of Quality Assurance and Design Control
With their novel medical device, Puzzle is on a mission to increase survival rates, reduce hospital readmission rates, and improve the quality of life. Their device avoids blood damage and stroke risk, while providing stability so these patients can partake in proper outpatient therapy.
Developing prototypes is no easy feat in the medical device industry. The challenges include the need to have appropriate regulatory and development documentation, selecting manufacturers, and ensuring quality control over supply chain processes.
As Puzzle is developing a Class III device, it is especially critical that the prototypes produced are exact and that they meet all the quality checks and testing requirements. And let’s not forget, developing a unique device also entails developing and documenting new test methods that support it.
Every minute, at least 1 person in North America alone passes away due to heart failure. Treatment for those with the condition is expensive, sitting at close to $180 billion in healthcare spending globally.
Puzzle Medical Devices made it their mission to find a way to improve the quality and longevity of life for those patients. With their proprietary device, ModulHeart, Puzzle Medical aims to help patients who are not well managed on medical therapy to retrieve their quality of life with a minimally invasive option.
Along with this, their device avoids blood damage, avoids stroke risk, and provides stability so these patients can partake in proper outpatient therapy. Complications are avoided because their device triples blood flow support at low speeds, ensuring that blood components are not damaged and shear stress is minimized.