I’ve made my share of stupid mistakes. When I was younger, most of them stemmed from just not thinking things through. I still cringe to admit I had some really big hair in the 1980s, one of many reasons I’ll be forever grateful my younger years were not captured on a smartphone and shared on social media. I also wish I’d listened to that college advisor about which classes to take to finish my master’s degree. And there were more than a couple of lessons learned starting a test lab in a friend’s garage, which eventually laid the foundation for the Empirical family of companies I run today.

I thought I had prepared thoroughly. But because I didn’t know what I didn’t know, I was missing key information that could have spared me misery and money.
Even now, I armchair quarterback myself over the holes in my pre-game. If only I’d bothered to learn some rudimentary Chinese before my recent trip to Shanghai, I never would’ve ended up in that “massage parlor.”

This perfect hindsight we all have in the wake of a bad decision is what drives a good quality system. Whether you’re a major company or a one-man band, taking the time to lay out the checks and balances for device development is a small investment of time and money up front that will more than pay for itself in the long run.

Meredith May is vice president of Empirical Consulting, the branch of Empirical companies that focuses on guiding clients through the process of gaining and maintaining regulatory approval. She has helped to clean up a lot of mistakes that a quality system could have prevented.

“Spending money up front to ensure your system is complete will save you money down the road,” May said. “The majority of what I call ‘bleeding of money’ is paying for something but not making money because it’s when you rework, recall, and have to redo things. If you have a quality system in place, that will reduce those non-value-added expenditures.”

That may require a shift in thinking for smaller businesses and the solo entrepreneur. If your device is the make-or-break project for your company, it’s easy to get distracted by the almighty dollar. A good quality system will train your focus on the bigger picture, while still taking into account that you need to make a profit.

“It’s really easy to focus on sales and revenue because that’s going to be the lifeline of your business,” May said. “It may be easy to ignore the things that aren’t necessarily what you want to do because you don’t see a direct cost benefit. But a good quality system can prevent a major financial disaster. How much will it cost if you end up with a recall, warning letters, and shutdown?”

It also gives you a solid framework for dealing with employees and vendors.

“If you are a one-man band and you’ve got three people reporting to you, you don’t have the time to make sure they’re doing what they’re supposed to be doing,” May said. “By having a quality system, you provide them with the structure to tell them what to do. That protects you from the FDA coming in and alerting you to issues you could’ve addressed ahead of time.”

Once beyond your product’s feasibility stage, you need at least a partial system in place for design controls. As you add activities and stages, you need a quality system in place before progressing. If the plan is to sell your company or device, having a quality system is a mark of credibility and value.

“Let’s say I’m looking to acquire a small company. If that little company doesn’t have a quality system, I have little to no confidence that I’m protected from their decisions,” May said. “If they haven’t developed their product with a quality system, I don’t know if they’ve done everything that is required to be done.”

It can justifiably be a deal-breaker, she noted.

“Without a quality system, there may be liabilities there you don’t know you have because you haven’t been tracking it,” she said. “If I were doing due diligence on a small company, I’d either walk away or cut my price in half.”

That said, there’s no need to develop quality systems for aspects of your device your company doesn’t cover. If the goal is simply to create a device and sell your design, you don’t have to plan for issues such as how to handle complaints if you’re not selling directly to a hospital.

“Think of your quality system as a blueprint to prove your bases are covered,” May said. “The purchasing company will have more confidence in what they’re buying and will be willing to pay more for it. It’s a way of justifying your asking price.”

Regulations for your device are the starting point for devising your system. They don’t provide all the answers, however—they tell you what to do, but not how to do it.

“Regulations were put into place because industries learned lessons from failures,” May said. “Experts like us have learned how to put the systems in place because we’ve learned from our failures. We want you to benefit from our mistakes.”

That’s why we strongly recommend outside support to develop a quality system. This is really not something you should entrust solely to yourself. When you bring in someone who’s worked with numerous companies on an array of projects, you benefit from all the mistakes that expert has seen and had to clean up. It’s essentially compounding interest of “what-ifs”—your range of troubleshooting increases exponentially, as do your potential solutions.

“You want someone who has experience in your specific area, someone who has been audited by FDA or other regulatory bodies. Someone who has sat across from an inspector, looked them in the eye, and had to defend their choices,” May said. “That person will understand the deep implications of all the decisions they have to make in developing your quality systems.”

It’s an invaluable perspective often gained the hard way—one we’re happy to share with our clients. We’re here to prevent whatever slips we can, whether it’s flagging an incomplete design file or a heartfelt warning to not go through that door off a busy Chinese street. 

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Dawn Lissy is a biomedical engineer, entrepreneur, and innovator. Since 1998, the Empirical family of companies (Empirical Testing Corp., Empirical Consulting, LLC, and Empirical Machine, LLC) has operated under Lissy’s direction. Empirical offers the full range of regulatory and quality systems consulting, testing, small batch and prototype manufacturing, and validations services to bring a medical device to market. Empirical is very active within standards development organization ASTM International and has one of the widest scopes of test methods of any accredited independent lab in the United States. Because Lissy was a member of the U.S. Food and Drug Administration’s Entrepreneur-in-Residence program, she has first-hand, in-depth knowledge of the regulatory landscape. Lissy holds an inventor patent for the Stackable Cage System for corpectomy and vertebrectomy. Her M.S. in biomedical engineering is from The University of Akron, Ohio.