As an early-stage medical device company, it may seem simpler to implement a paper-based QMS than to choose from the thousands of QMS software providers out there. Better yet, you’re saving money by choosing the paper-based route, right? Wrong.
Ultimately, paper-based systems (Yes, that includes the use of digital document storage and spreadsheets) that force medical device companies to run their quality system through SOP’s and manuals lead to higher ongoing costs, hindered team collaboration, delayed product development, narrowed opportunities to scale, and other limiting factors. For many companies, this even leads to hiring additional personnel just for administrative oversight of a paper-based quality management system. Additionally, as medical device companies work toward compliance milestones for their device, such as 510(k) clearance, paper-based systems impede the team’s ability to focus on value-added activities; rather, valuable time is spent tackling non-value added or administrative tasks necessary to demonstrate compliance.
So, how do you choose a QMS that can help set your company up for success? As co-founder and CEO of my own early-stage 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.
Create Efficiency through a Purpose-Built Solution
I can’t stress enough the importance of choosing a purpose-built QMS software. If you’re truly seeking to streamline quality for your device, why would you choose a general-purpose system that could morphe to fit any industry? Rather, focus on the value that a QMS built with your unique use case in mind can have on your business and its end users. By choosing a software built specifically for the medical device industry, you can avoid the lengthy implementation process that comes with configuring general purpose quality management software and avoid the headaches of trying to identify the various capabilities truly needed to make your QMS worth it.
For example, the solution my company chose had specific capabilities around design controls, risk management, document control and records management. With these built-in capabilities, we were able to easily prove our product meets our user needs in a safe and effective way by:
- Identifying and evaluating risks, and developing, implementing and monitoring risk control
- Establishing a system for managing documents and records
Ultimately, this allowed our team to focus on high-impact work that would lead to quicker 510(k) clearance for our product and would help us scale.
Work with a Trusted Partner
Just as important as the software itself is the team of people who have built your QMS software. They, too, should be experts who understand the unique needs of your industry and can provide guidance throughout your quality journey. We’ve found it extremely helpful to have a team of experts we can reach out to at any time with questions on the software itself or the regulatory landscape as a whole—knowing they’ll help us navigate the evolving regulatory requirements as we work to provide high-quality devices to our customers.
These were just two of the reasons we chose to work with our medical device quality management system (MDQMS) partner. With a successful 510(k) clearance on an accelerated timeline, we can now focus on the commercial launch of our intelligent surgical drainage system to reach those who need it. The purpose-built software, conceived by a team of industry experts, has been a key factor in our success thus far. 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 because we are using MDQMS software and leveraging our partner’s industry expertise. I encourage every medical device manufacturer out there to not only make the move to a quality management software platform, but also to one that meets the highest standards for our industry.