Avenda Health, a company focused on improving the quality of life and outcomes for men diagnosed with prostate cancer, faced significant challenges in bringing their novel device to market. The company's team is dispersed across the country, making collaboration across product development and quality teams difficult without a unified source of truth. Additionally, navigating the complex regulatory climate to bring their Software as a Medical Device (SaMD) product to market was a daunting task. Keeping up with requirements and documentation, while ensuring alignment across teams from coast to coast, was a top priority for Avenda. However, the remote collaboration and staying up to date with the necessary documentation proved to be a significant challenge.

Tenacore, a leading ISO 13485:2016-certified medical device repair and service company in the United States, faced significant challenges with its paper-based Quality Management System (QMS). As the company continued to scale and manage over 100 medical devices, the paper-based QMS became increasingly difficult to manage. Crucial tasks such as obtaining Original Equipment Manufacturer (OEM) documentation, updating technical manuals, and managing and qualifying suppliers to meet Tenacore’s high-quality standards became exceptionally difficult. The paper-based system also hindered cross-team collaboration and created inefficiencies in their processes.

Medical device companies often struggle with managing their Quality Management Systems (QMS), Design Controls, and Risk Management. The challenges are often at two extremes: either the QMS is deficient and does not address regulations, or it meets regulations but is overly complicated. Both scenarios pose potential problems. A deficient QMS is a compliance risk that must be avoided, while an overly complicated QMS may not be followed as prescribed, leading to non-compliance. Additionally, companies often struggle with documenting Design Controls during product development, making the process unnecessarily complicated. The medical device regulatory world is also shifting its focus towards risk management, requiring QMS to implement risk-based approaches. This shift has left many companies struggling to keep up with the new regulatory focus.

MediBeacon, a medical technology company, was facing challenges in managing documentation and preparing for audits with a paper-based Quality Management System (QMS) while bringing a Class III device to market. The company's Transdermal GFR Measurement System (TGFR) is a class III combination device, which means it must go through the FDA Premarket Approval (PMA) pathway. Additionally, MediBeacon had contracted with multiple device development and manufacturing organizations, and the drug component of their device had to comply with 21 CFR Part 4 - Regulation of Combination Products. The company quickly realized that a paper-based QMS or a generic software solution was not sufficient to navigate the required regulatory and management hurdles.

Monitored Therapeutics, Inc. (MTI), a remote patient monitoring company specializing in respiratory diseases, faced significant challenges in navigating the global regulatory landscape. The complexity of maintaining compliance while distributing products globally was a daunting task. The company was also preparing for several audits, including FDA, ISO 13485, MDSAP, and customer audits. The challenge was to find a Quality Management System (QMS) that was not just a tool, but a comprehensive solution that could guide and support them through these audits. Additionally, as MTI began to scale, cost became a significant factor. The company needed a QMS that was affordable and suitable for all their key teams: Executive, Quality, and Product Development.