Ami Anderson is the director of operations and quality management at NeuFit. [Photo courtesy of NeuFit]
The right quality management system can be instrumental for success, but how can medical device companies adopt a comprehensive process and platform that meets their current and future needs?
Ami Anderson, NeuFit
Quality isn’t optional in the world of medical devices. Every item that makes its way into the hands — or the body — of a patient needs to be manufactured to the absolute highest standards with no deviation in uniformity or function.
Not only do devices have to work exactly as advertised, but companies must continually prove that they are completely on top of every part of their design, manufacturing and testing processes in a clear, complete and accessible way.
That’s why a proactive, fit-for-purpose quality management strategy isn’t optional, either. Working with the wrong electronic quality management system (eQMS) can make it exponentially more difficult for a device company to pass muster with the FDA, bring products to market with speed, and continue to innovate on behalf of patients and their loved ones.
Unfortunately, many device companies just don’t know what they don’t know about picking the right eQMS. At the start of our journey, NeuFit was one of them.
We are the Austin, Texas-based manufacturer of Neubie, a neuromuscular electrical stimulation medical device that helps patients recover from neuromuscular damage and can treat conditions from plantar fasciitis to strokes and spinal cord injuries.
We’ve found that it can be very challenging for companies like ours to define the scope of their need and choose a partner to fully support their mission. Here are some of the lessons we learned while transitioning away from piecemeal quality management to a digitally enabled, platform-based approach.
Assess and identify your quality management needs early
Like many early-stage medical device companies, NeuFit did not launch with a fully fledged quality management framework in place. We used a combination of paper-based processes and a patchwork of digital tools, such as DocuSign and Adobe Acrobat, to keep track of our documentation. We weren’t entirely happy with this system, but we didn’t know just how inadequate it was until NeuFit underwent an FDA inspection.
Our consultants and the FDA told us we needed a more robust and accessible system ASAP. By that point in the process, however, we were at risk of making a suboptimal decision due to the urgency of getting something acceptable in place so we could satisfy the FDA requirements.
Fortunately, we were able to properly complete our due diligence, select a high-value partner and avoid any significant issues without delays. But had we been more informed about the critical role an eQMS would play in our approvals process, we may have investigated our options sooner.
Consultants and external subject matter experts are valuable resources for navigating FDA approvals, and medical device company leaders should leverage these assets fully when appropriate. Ask them to review your current quality management procedures and identify any weaknesses in established processes that might catch the eye of the FDA. And complete a thorough review of documentation management workflows well in advance of submitting an application to ensure there is enough time to make changes and optimize eQMS methodology.
Go as paperless as possible
If an FDA auditor arrives with a thumb drive expecting to be able to load electronic quality documents, they don’t want a stack of three-ring binders instead.
They know that paper-based processes are prone to errors. Downloading, redlining, scanning, uploading and sending documents can be extremely time consuming. Key document updates can also easily be forgotten, and searching for information in multiple logs and filing cabinets can be overwhelming, especially for a startup team.
Medical device companies need full, up-to-date visibility into everything that is happening within the enterprise. Their eQMS should be the single source of truth for that information. Fully integrated, all-digital systems offer customizable reporting and one-click access to important documents so nothing gets missed and leaders can stay on top of every nuance of the production process.
When assessing potential eQMS partners, get clarity around how their tools ingest, store, share and export mission-critical data. Carefully review workflows for unnecessary complexity and flag any tasks that take information out of the digital stream and into the physical environment. While paper may be unavoidable in some rare cases, check that the vendor has a workable, intuitive plan for reintegrating the data into the digital system with appropriate assurances and best practices.
Don’t underestimate the value of a good customer experience
Executives may feel inundated by pitches from companies offering an array of services, not all of which are well-matched for their unique needs. I know we did.
When taking meetings with solutions providers, don’t ignore your gut. Some companies rely on questionable sales tactics such as putting down competitors or overpromising on future features, instead of clearly and honestly promoting the real value of their own product.
Discomfort during the sales process isn’t going to go away once the contract is signed. Instead, it signals that the relationship is starting off on rocky footing and may only get worse over time.
Make sure potential partners fully understand the real-world challenges of the medical device environment and have concrete solutions for common issues, such as coordinating with outsourcing partners and providing necessary data to FDA for approvals and audits.
Consider how many internal staff members it will take to manage the quality documentation process on an ongoing basis. And ask for demonstrations of how specific features can be used to reduce the costs of external consultants and shorten the timeframes for resolving quality events, completing audit requirements and bringing new devices to market.
Above all, be certain you have accessibility to the right level of training, implementation support and continued customer care. Peace of mind is priceless, and it only comes from an open, collaborative, responsive relationship with a true partner.
Define metrics for success and get ready to exceed them
Quality management is all about monitoring successes and trouble spots in device production, but executives need to carry that same scrutiny into all of the processes that make their business work.
Establishing clear and concise metrics for a new eQMS platform can help companies evaluate their ROI and build on positive outcomes. At NeuFit, we can concretely measure what we’ve achieved by moving to a fully digital eQMS, which allows us to celebrate our goal achievements and continue pursuing opportunities for greater efficiency and clearer communication across our enterprise.
For example, we’ve dramatically accelerated our quality event close-out rate. With our hybrid system, it used to take about six months to address issues. Now, with our eQMS, we can resolve events in 30 to 60 days. Audits that used to take six days now take four or five hours.
Our eQMS isn’t the only thing that’s positioning us for success. We clearly believe our cutting-edge product has strong value for patients. But getting on track with our internal quality processes and staying one step ahead of regulatory requirements is absolutely crucial for allowing our device to speak for itself in a highly competitive marketplace.
By freeing our staff to collaborate easily and demonstrate compliance to auditors and regulators, our digital eQMS platform has unlocked our potential as a leading player in our space so we can continue to grow our product line and help patients live their lives to the fullest.
Ami Anderson is the director of operations and quality management at NeuFit. She joined the Neufit team in 2019, and has more than 20 years of program and project management expertise across several industries.
The opinions expressed in this post are the author’s only and do not necessarily reflect those of MedicalDesignandOutsourcing.com or its employees.
