Monitored Therapeutics, Inc: Building an Audit-ready QMS in 3 Months

In-home diagnostics and patient monitoring are changing the game for patients and the broader healthcare industry. 

Monitored Therapeutics, Inc. (MTI) is a remote patient monitoring company with a focus on respiratory diseases. For MTI, choosing an affordable MedTech-specific QMS that would help them successfully navigate audits and manage post-market surveillance was critical.

Monitored Therapeutics: Bluetooth Diagnostic Devices for Home and for Clinic

MTI is an Ohio-based MedTech company that currently sells proprietary diagnostic products globally. The company has built a powerful cloud-based system that enables their devices to share accurate patient data back to clinicians in real-time. Their flagship product, GoSpiro, is a Bluetooth spirometer that allows patients to get lab-quality diagnostics from the comfort of their homes at a significantly lower cost. GoSpiro is just one of several other at-home diagnostic products Monitored Therapeutics sells today. 

The company's mission is to extend access to care to patients through a standardized technology platform, while decreasing cost of healthcare by allowing patients access to healthcare from the comfort of their homes.

Challenges

Navigating the regulatory landscape poses a challenge to the entire industry, and MTI is no exception. Keeping up with the quality and regulatory field gets more complex when distributing products globally, and ensuring compliance is just one piece of the puzzle.

For MTI, success is defined by maximizing patient safety while producing and communicating accurate patient data. When FDA, ISO 13485, MDSAP, and several customer audits were on the horizon, MTI needed to switch to a QMS that was more than just a tool. They required a solution that would be their guide and support them along the way. 

Like many medical device companies, cost was also a challenge for MTI as they started to scale. Choosing a QMS for them meant choosing a solution that was the right fit for all of their key teams: Executive, Quality, and Product Development.

The Solution: Greenlight Guru

The primary factors in their decision to partner with Greenlight Guru were the affordable cost, the robustness of the solution, and the services that came alongside the solution. Greenlight Guru’s proven track record of helping 1000+ MedTech companies across all stages of scaling a MedTech business was another contributing factor to their thoughtful selection of a vendor.

The Results: Benefits of using Greenlight Guru

Within 14 months of implementing Greenlight Guru, MTI is confident in its ability to manage its commercialized products globally and manage the company’s quality as it grows and matures. 

Successfully navigated 6 audits over the course of a year

Selling products around the world comes with the need to consider different sets of regulations and regular audits. Greenlight Guru’s eQMS and Strategic Guru Services helped MTI’s team navigate three customer audits, an FDA audit, an MDSAP audit, and an ISO 13485 audit. 

          “Greenlight Guru completely streamlines the Change Order and Document Control process for us. The Nonconformance, CAPA,             and Audit workspaces are organized so you never miss a step with what needs to be documented. The platform Greenlight                   Guru has is built for medical device companies and has everything we need,” -Arianne Hatfield, QA Specialist


Scaled office by 7x 

MTI was able to migrate office space at the same time getting started with Greenlight Guru. They also doubled the company’s headcount during this time. 

          “The easy-to-follow onboarding and implementation process at Greenlight Guru allowed us to scale our business while.                           implementing the eQMS.”  - Amanda Feddersen, QA Manager


The Guru Strategic Services and SOP Templates are essential to the team as they continue to expand the company’s services


          “The Boost Templates and the SOP Templates were exactly what we needed to navigate the audits that we had. In fact, the FDA             auditor also told us they loved Greenlight Guru’s Implementation Plan.” - Amanda Feddersen, QA Manager

Adding on Guru Strategic Services has been valuable for MTI. Their dedicated consultant was one call or click away for their team to ask any questions about the industry or their specific needs. 

Greenlight Guru Academy courses and certification tracks serves as training and education for their new hires

What’s Next for Monitored Therapeutics?

MTI is in the process of developing new diagnostic and treatment solutions to add to their product line to allow clinicians to better manage their respiratory patients. The company will use Greenlight Guru’s Design Control and Risk Management to document their work as they continue to achieve their product goals.