Not All Medical Device QMS Solutions Are Created Equal

For many early-stage medical device companies, a paper-based QMS is attractive. After all, there are thousands of software providers, hundreds of settings, and dozens of ways things can go wrong. Furthermore, software is expensive and paper is cheap, right? Wrong.
 
Paper-based systems (including digital documents and printouts in a filing cabinet) force medical device companies to run their quality system through SOPs and manuals. This leads to issues such as higher ongoing costs, a lack of teamwork, slow product development, and unnecessary corporate growth pains, just to name a few. For many device makers, entire teams need to be hired just to shuffle papers in a paper-based quality management system. Additionally, as medical device companies work toward regulatory milestones for their devices such as 510(k) clearance, paper-based systems impede the team’s ability to focus on product development, taking valuable time tackling administrative tasks necessary to demonstrate compliance.
 
So, how do you choose a QMS that can set your emerging company up for future success? As co-founder and CEO of my own startup medical device company and partner at a medical device incubator, I’ve been through the transition from a paper-based QMS to a quality management software platform, and there are a few tips I picked up along the way.
 
Find Efficiency in a Purpose-Built Platform
I can’t stress enough the importance of choosing a purpose-built QMS platform for medical device companies. If you’re taking quality and efficiency seriously at your company, then why would you choose a general-purpose system that services makers of anything from action figures to airplanes? I recommend focusing on the value that a QMS built with your unique use case in mind can have on your business, your development team, and your end-users. By choosing software built specifically for the medical device industry, your quality team can avoid the time-consuming process that comes with configuring general purpose quality management software to fit your needs. Not to mention the compliance risks that come along with potentially setting it up incorrectly.
 
For example, the solution my company chose had design controls, risk management, document control, and records management – capabilities we were legally mandated to have. With these built-in modules, we were able to quickly prove that our product met our user needs in a safe and effective way, allowing our team to focus on high-impact work that would lead to quicker 510(k) clearance and a quicker go to market strategy.
 
Identify a Provider that Is also a Partner
Just as important as the software itself is the team who built and services your QMS. They should be experts who understand the unique regulations of your industry and provide guidance and advice throughout the life of your product. We’ve found it extremely helpful to have a team of experts we can reach out to with questions: be it on the software itself or the regulatory landscape as a whole. Look not only for a partner invested in customer service, but also customer success.

These were just two of the many reasons we chose to work with Greenlight Guru for our medical device quality management system (MDQMS) needs. With a successful 510(k) clearance, we can now focus on the go to market launch of our intelligent surgical drainage system. The purpose-built MD QMS, developed by a team of industry experts, has been a key factor in our success and our team now has a high degree of confidence that, as changes to the regulations occur, we won’t have to worry about being out of compliance. Greenlight Guru’s software is always up-to-date, as is their industry knowledge and expertise. Every medical device manufacturer should weigh the pros and cons of a dedicated quality management software platform, that meets or exceeds the standards for our industry.
 

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Evan Luxon is co-founder and CEO of Centese (formerly Esculon), a Nebraska-based TheraNova spinout developing next-generation systems for surgical drainage. Luxon has experience in the design, test, and manufacture of medical devices, having worked at early-stage medical device companies in various roles spanning engineering and management.