10. Cookie cutters work for Martha Stewart and Keebler Elves, but that’s about it.
There’s no single approach to the marketplace. Just because your last device sped through the process with ease and grace doesn’t mean your next project will follow suit. The same is true for the reverse; if you previously stumbled your way to approval or clearance shedding blood, sweat, and tears, you’re not doomed to repeat the mistakes of the past—particularly if you have the right team for your current project.
9. Speaking of cutting, watch those corners. This isn’t the 97th “The Fast and the Furious” sequel.
You need more than illegal engine modifications, obnoxious spoiler wings, and Vin Diesel to win. If you skip a critical step in the process in hopes of saving time and/or money, you may very well crash and burn. What may appear to be short-term financial savings could cost you dearly further along the development cycle.
For example, prototypes for testing or validation are costly per unit. But if one is destroyed and you didn’t produce any extras, you’ll spend additional time and money to go back and make more. Extra prototypes are a relatively inexpensive insurance policy to keep your project on track.
8. This ain’t your grandma’s FDA.
Yes, regulatory bodies are government agencies with protocols, processes, and procedures. But they’re also composed of people. That means these agencies evolve, change direction, offer feedback, and don’t necessarily do business the way they did 10 years or even six months ago. We’re on the cutting edge of a dynamic industry that’s all about breakthroughs and disruptive thinking. Regulatory bodies know that.
That’s why there’s a regulatory toolbox you can dig through. Make the most of pre-submission meetings, early feasibility trials, guidance documents, and other supports to improve interactions with the overseeing agencies that, like you, are here to ensure best patient outcomes.
7. You don’t know what you don’t know. Hint: IT’S A LOT.
If you’re the team lead, it’s not your job to know all the answers. It’s your job to know how to find them. I advise clients to perform a gross reality check. They need to take stock of the entire scope of the project from concept to reimbursement. Even if it’s a device you’ve built your career upon and you’re a subject matter expert, someone else knows something you don’t. I recently had a discussion with a client’s internal regulatory pro who didn’t know about the Early Feasibility Study program for Class III devices because they’d never worked with the particular device they were developing. It was a critical step for their project’s success. Regulatory consultants with relevant experience for the product indication are an essential resource.
6. So start with what you do know.
It may seem overly obvious, but having a clear understanding of what class of device you’re creating is the first step. It has direct bearing on every step that follows. Class II and Class III devices have radically different testing requirements, costs, and timelines. By extension, you’ll need a different pool of resources for regulatory, testing, validation, sterilization, and every other aspect of clearance or approval. Every device is different, but as a general rule you can plan for roughly nine to 12 months and about $250,000 for a Class III just for mechanical testing. For Class II, start with an estimate of $35,000 and eight to 10 weeks for your tests. You should also already know what your complete quality system will be from day one. This is not a detail to work out later.
5. One size does not fit all.
Size matters. So does shape. With that nod to my inner giggling 12-year-old boy, you have to determine the correct implant to represent the family of implants. The proper dimensions will ensure your mechanical testing represents the worst case for your product line. It’s no longer as simple as using the smallest and shortest version to represent the whole. I recommend looking to a validated finite element analysis (FEA) model of the corners of the size chart to determine worst case in each test mode. This is another point of the cycle where it’s tempting to cut corners. Be sure you get what you pay for with your FEA by double-checking FDA guidance.
4. Unless the flux capacitor in your DeLorean has passed its panel review, you’re gonna need a timeline.
Sharing the same deadlines with all stakeholders and team members keeps everyone on track, helps to manage expectations, and holds people accountable. You can better manage the crunch time by budgeting in down time or points of process review. Product development milestones will be clearly marked, as will points of heavy spends. Having the full scope of the project laid out is a snapshot of the big picture, and that’s what you’re all working toward. I also encourage all of my clients to have a full test plan in place in part because it lays out a reasonable timeline for the entire team. (See my column “So We’re All on the Same Page: You Need a Test Plan” in last month’s edition of MPO for more on test plans, because it’s a subcomponent of a strong timeline.)
3. Yes, this will be on the test.
With a development cycle timeline, you’ll know when and what to test. This can be expensive and time consuming if you don’t plan for it. You’ll need a solid protocol, acceptance criteria, feasibility testing (if it makes sense), and an accurate, realistic timeline from tip No. 4.
You also need to really do your homework on what tests are necessary for your device—a deeper dive than reading established guidelines. If there’s no established protocol, you have to create one. To do that, you need the right resources that understand not just your device, but also its application.
2. It’s time to call in the A Team.
You have to trust and ideally get along with the people joining you on the path to market. It’s not just a matter of technical expertise. It may sound petty, but I’ve seen personality conflicts derail devices. Choose your partners based on more than their CVs. Select people who understand and can work with your business philosophy as well as your market goals. Relevant stakeholders usually include surgeon champions who can share their perspective as end-users. You also need the right manufacturing voices. An increasing number of existing technologies are turning to new processes such as additive manufacturing. But many of these additive manufacturers outside of medical devices don’t have validated processes, because those aren’t required by other industries—yet another consideration. (More on this in my column in the October 2016 edition of MPO, “3D Printing: Third Industrial Revolution or Productivity Stalemate?”) You need regulatory experts as well as testing experts. You may also need team members who know clinical trials and reimbursement. What kind of legal support will you need to protect your intellectual property?
There’s a long list of experts you need to consider. Talk to colleagues you trust. Get their referrals, but also trust your gut. The process can be stressful and frustrating. But with the right team it can also be exciting, invigorating, and—dare I say—fun.
1. Take a deep breath. You’ve got this.
This is my top tip for a reason. If you’ve made it through the rest of the list, it’s true. When you start the process of improving patient health, you’re officially a part of the greater good. I am humbled by and grateful for the brilliant minds who’ve been part of my profession over the course of my career. Welcome to the club.
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.