5 months

accelerated go-to-market time

360 Hours

saved on QMS activities per employee per year

100%

training compliance

THE CHALLENGE

Having all the documentation ready and clear for regulatory, R&D, and supply chain processes for a fast-paced, high-growth company.

THE SOLUTION

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.

THE RESULTS

Puzzle has seen incredible success with prototyping their Class III medical device and has made great advances towards their clinical work.

Puzzle Medical

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:

Jade Doucet-Martineau,

Co-founder & Chief Executive Officer

Maxime Rochon,

Manager of Quality Assurance and Design Control

“The key for us is to develop products that are safe for patients. Every doctor is told, 'primum non nocere,' which means to 'first, do no harm.' This is why offering a treatment option that poses very little risk to the patient was important for us."

Dr. Gabriel Georges, Co-Founder & Chief Scientific Officer, Puzzle Medical

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.

Challenge

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.

Goals

Manufacture precise and high-quality prototypes in a fast-paced environment while maintaining compliance
Connected R&D, quality, manufacturing, and supply chain documentation and processes
Obtain their ISO 13485 certification in the coming year
Continue to capture testing data, protocols, risk, and processes in the Greenlight Guru eQMS
Collaborate with their partner teams to develop components of the ModulHeart device

Results

Accelerated their go-to-market timeline by 5 months out of the past year since their partnership with Greenlight Guru
Saved an average of 5-10 hours of work per employee per week when taking into consideration all the activities performed using Greenlight (Change Orders, Training, Design & Development, Risk Management, Audit, etc)
U.S. FDA Breakthrough Device designation granted confirming novelty of the device and for providing a more effective treatment option based on preclinical data
Utilized the Training Management workspace to maintain up-to-date training records for 100% of their employees
2 patents granted and 5 additional underway

ABOUT

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.

Customer story

Putting Together the Pieces For Success with Greenlight Guru