17. Reducing device connectivity to adapt to market demands - Mike Acosta, CoaguSense & Wade Schroeder, Greenlight Guru

MedTech Speed to Data

There’s nothing like finding a partner with a map when you're exploring new territory.

CoaguSense developed the first point-of-care prothrombin time/Internationalized Normalized Ratio (PT/INR) monitoring system for cardiac patients who have been prescribed warfarin. Their Coag-Sense® device monitors blood clotting rates and helps patients maintain rates within a therapeutic range. It’s designed for both professionals and patient self-testers. As with any MedTech device, there were plenty of regulatory hoops to jump through. So they looked for outside help and found it with Greenlight Guru, a company that provides an out-of-the-box electronic quality management system specifically designed for MedTech companies.

Listen in as Andy Rogers talks with Mike Acosta, EVP/Head of Compliance, CoaguSense, and Wade Schroeder, Medical Device Guru at Greenlight Guru, to learn how outsourcing can facilitate speed to data and get you to market more efficiently.

NEED TO KNOW:

• Understand the market by getting users' feedback—what they want/need versus “if you build it, they will come.” Go out there and get that information.
• An outside partner can provide a built-in knowledge base.
• In the med tech industry, quality for the sake of compliance is no longer enough.
• COVID pandemic challenges have delayed FDA review time.

THE NITTY-GRITTY:

According to the FDA, about two million people in the United States take warfarin to prevent blood clots and to prevent stroke in people with atrial fibrillation, heart disease, or artificial heart valves.

So CoaguSense was poised to capitalize on a large market. But as a small company with a new technology, the path to regulatory approval could have been long, tortuous, and costly.

Greenlight Guru came to the table with a purpose-built platform that could manage all the quality, regulatory, clinical, and product development activities across the entire device lifecycle. And having the design control aspect upfront helps all the way.

Coag-Sense is now a market leader, and they’re working on a 3rd Gen simpler version to meet the needs of their older patients. Every step of the way, data drove the decisions.

Fast data. The Coag-Sense® meter directly measures clot formation in seconds.

Procedures and templates from Greenlight Guru were audit-ready to align with regulations, including ISO 13485 and FDA CFR Part 820, and provide a traceable source of truth.

Independent diagnostic testing facilities (IDTFs) can be used to manage call-in results from self-testers, even if a device lacks connectivity.

Developing a “downgraded” next-gen version without connectivity for elderly patients

The Gen 3 version of Coag-Sense actually has fewer bells and whistles in response to the needs of older in-home self-testers who are less tech-savvy. Here are the hows and whys:

Consider elderly patients' desire for simple devices - Many older people don’t have computers at home or are not savvy with smartphones; they don’t want or need connectivity. These patients are more commonly managed by IDTF’s who can manage self-testers.

Build in time for FDA reviews - First, a Gen 3 FDA review is more challenging than a Gen 2 review. You’ll need to show more performance data: FDA wants to see data comparing operator to operator. In addition, the classic 30-day review for 510k is now taking almost a year, with older reviewers retiring and new reviewers coming on board.

Be ready with a plan for post-market surveillance - IVDR - Capturing post-market surveillance data is required now and will feed back for potential improvements.

Find partners who continually evolve – CoaguSense partnered with Greenlight for an out-of-the-box solution for QMS & documents, but just as important for keeping up with what needs to be reviewed in international markets and traceability mapping too.

It all adds up to one interesting discussion. Listen in.

USEFUL LINKS:

https://coag-sense.com/about-us/

https://www.greenlight.guru/