Some medical device makers have caught on to how expensive paper is and have turned to so-called “digital paper”: spreadsheets, documents, and cloud file storage. In theory, this is a step forward; however, this “paper” is actually more expensive. Digital paper gives a false sense of quality and compliance.
If your organization is still relying on this outdated approach to quality management, let’s examine four key ways paper ends up being a significant expense for your company.
Software as a Medical Device, or SaMD, is one of the fastest-growing areas of the medical device industry. The ability for hardware and software to work together to identify, predict, and recommend treatments is groundbreaking. Apple and Google have both made significant bets with their wrist-based EKG devices.
These devices are both innovative and extremely complex from a design and regulatory perspective. Devices that incorporate hardware, firmware and SaMD elements require design controls for hundreds or thousands of components and subcomponents. Paper, be it physical sheets or digital, simply isn’t capable of managing this level of complexity.
As these types of devices become table stakes in the industry, manufacturers will be forced to make a decision: forgo these capabilities and lose market share to competitors, adopt a quality management system capable of supporting these devices years later when the transition will be even more difficult, or make the transition now before thousands of documents need to be uploaded, connected, revised, and tracked.
After more than 20 years in the medical device industry, I know which decision I would make.
A few years ago, I had a pretty staggering conversation with a medtech industry veteran. In an episode of Global Medical Device Podcast, I interviewed Ronny Bracken, executive and principal at Paladin Biomedical Consultants about the most common mistakes made by early-stage medical device companies. As a respected medical device research and development executive, and early-stage investor himself, Ronny has seen his fair share of mistakes.
Beyond sharing his insights on M&A activity in the industry, Ronny told the story of a manufacturer, seeking an investment, that was utilizing a general-purpose QMS for their design and development activities. Ronny and his team identified such poor design controls and risk management practices that it led his firm to cut the company’s overall valuation by $20 million. The lack of adequate controls reflected too much risk to investors.
A strong early valuation is vital for startups seeking follow-on funding, acquisition, or potentially an IPO. Saving money early makes sense initially; however, make sure you aren’t trading thousands of dollars of savings now for millions in value later.
Cease and Desist
Just as food, children’s toys, vehicles, and consumer electronics can be seized from production and recalled, 21 CFR Part 810 gives the FDA the power to, “Issue a cease distribution and notification order requiring the person named in the order to immediately: cease distribution of the device; notify health professionals and device user facilities of the order; and instruct these professionals and device user facilities to cease use of the device.”
This means that in a worst-case situation, the FDA can order a manufacturer to pull a medical device from the market and issue a recall until such a time that corrective actions have been implemented.
Medical devices often require years of work and millions of dollars to develop. For smaller organizations with only a single device, the cost of a recall and time spent off the market can be a death knell.
Last October, GE Healthcare issued a Class I recall — the highest hazard classification — for more than 20,000 devices. GE Healthcare, with its hundreds of devices and nearly $20 billion market cap, can survive such a recall; however, the same cannot be said about most small device companies. It’s not clear whether the GE recall was related to the organization’s quality management system or not, but I can surmise that risk management protocols and a quality-first mindset were lacking — traits that are reinforced by purpose-built, best-of-breed software. With millions of dollars in revenue, employees’ livelihoods and perhaps the future existence of the company at stake, why take the risk of using outdated methods and tools?
Paying for Paper
While I’ve addressed some executive-level concerns of relying on paper for an organization’s quality management system, I’d be remiss if I didn’t address the actual raw cost of using paper.
The application process for premarket approval (PMA) from the FDA entails a lengthy application consisting of dozens of elements, including an in-depth device description of the medical device, alternative practices and procedures, marketing history and clinical study data, just to name a few. A properly developed PMA application can easily run hundreds of pages. Add in the time and cost of printing, binding, and postage to deliver the application, as well as the ever-present last-minute revisions and subsequent manual removals and replacements of application pages, and you’ve produced an expensive document.
Did I mention the FDA requires six copies of your application?
You could reasonably estimate a cost of more than $2,000 to print, bind, and ship six copies of a 2,500-page PMA application. Bear in mind, 2,500 pages is a light to moderate-length application. I’ve seen applications fill multiple four-drawer filing cabinets.
Digital solutions compile all the necessary documents in one single location where applicants can file and submit a PMA or 510(k) application using digital media, saving your team the cost of materials and time that comes with a paper application.
Just as “iron sharpens iron,” high-quality systems and high-quality tools beget high-quality products.
While paper-based systems are technically compliant — for now — the purpose of a quality management system isn’t just to manage compliance, but also quality. It’s right there in the name.
Quality is a mindset with exacting standards. If you wish to set a high bar for your end product, shouldn’t you set a high bar for the tools you use to produce it?
Jon Speer is the founder and VP of QA/RA at Greenlight Guru a medical device quality management MDQMS software & a medical device guru with over 20 years of industry experience. Speer knows the best medical device companies in the world use quality as an accelerator. That's why he created Greenlight Guru to help companies move beyond compliance to achieve True Quality.