Driving a Successful Medical Device Product Development Cycle

Historically, the automobile industry has been the American industry of record. But given the explosion of technology and focus on patient care, the medical device industry is positioned to emerge as American Auto version 2.0. U.S. Food and Drug Administration (FDA) acceptance and clearance are the gold standard worldwide when it comes to marketing medical devices. Even if the device is not released in the United States, FDA clearance provides “street cred” and marketing mojo for products from foreign countries because of the high value manufacturers and patients place on the blessing of our primary regulatory agency.

So what does it take to earn that internationally sought clearance or approval? It’s rarely a smooth, straight road to market, particularly for first timers or innovators who don’t have the backing of a major international corporation. When I worked with the FDA as part of their Entrepreneurs in Residence program, one of my primary jobs was to develop a road map so anyone—individual surgeon, inventor or international medical device conglomerate—would have a guide to help them get their devices to market.

Here’s some of what I learned about what it takes to make it through the long haul.

Parts is Parts
Because every medical device is somehow unique, there really is no standard assembly line or single starting point to get a device on the road toward market approval. But there are common features and parameters that apply to just about any device to help you minimize road hazards and other obstacles to give you reproducible, successful results.

You have an extraordinary idea that will revolutionize patient care. That’s why we’re in this industry; we work to make people’s lives better. To make your journey easier, faster and better, you need to figure out how to make it a reality. You ask yourself a seemingly endless stream of questions. How long will it take to get to market? How big is the market? How long will it take to make a return on my investment? Do I have the resources to make it all the way to market? The answers to those questions will depend on your specific device and circumstances.

Be honest. If you don’t know, find someone who can help you. A reliable, knowledgeable navigator will make all the difference in how well and quickly you travel the road to market.

Know Your Make and Model
In the United States, there are three classes of medical devices: Class I, Class II and Class III.¹ There are significant differences in requirements and time to clearance or approval.

Class I medical devices have the least amount of regulatory control because they present minimal harm to the user. Such devices include wheelchairs, crutches and other external products. It is required that the manufacturing facility for a Class I device is registered and the device be listed in the FDA database.

For Class II devices, general controls aren’t a high enough standard; they require more scrutiny, typically a premarket clearance through the 510(k) process before they make it to market. They’re typically an improvement to an existing device, usually one that goes into the body such as a new pedicle screw or hip joint.

Class III devices require the most stringent standards because these are considered completely new technology for the body. As far as the FDA is concerned, they present significant risk to the patient and/or require significant scientific review of the safety and effectiveness of the medical device prior to commercial introduction. Most Class III medical devices require a premarket approval application (PMA).

Once you know which class your product falls into, you’ll have a much clearer idea of how to proceed.

Know the Lay of the Land
Before you hit the road, check out the forecast and the terrain you’re traveling through. Does the market currently exist for this product? Is it a $300,000 market or a $300 million market? If this is a disruptive technology (for example, intervertebral body fusion devices), what is the potential market value of this device? Based on the regulatory path, what is the timeline to get to market? A Class II device may be a year or less, but a Class III device could be two to five years or longer for PMA alone. What are the costs for development? Factor in engineering, prototypes, testing, building inventory, etc.

And the most critical concern from a long-term standpoint, is if the device can receive reimbursement. You may design and garner clearance for the most revolutionary technology since Capt. Steve Austin from “The Six Million Dollar Man,” but if no sponsor can get paid for rebuilding him within our current health insurance and medical reimbursement system, Capt. Austin is terminal.
If your brainchild is a disruptive technology, make sure you have a plan for reimbursement at the time you receive your approval. Shareholders can be fickle folks; they don’t want to have a game-changing device with no way to get paid.

Know the Rules of the Road
Because the FDA is an evolving organization much like the evolving technologies it evaluates, the landscape will change with each submission. New clinical data, medical device reporting and new ASTM standards lay the path for future submissions.² Just because you included something in a previous submission, that doesn’t mean the same rules still apply. Per the 2015 Strategic Priorities Document, the FDA Innovation Pathway 2.0 is a streamlined route to regulatory approval.³

The goals of this new approach are to strengthen the clinical trials enterprise, strike the right balance between premarket and postmarket data collection and provide excellent customer service. The FDA also is actively updating tools to facilitate collaboration with their clients. You can now even request a presubmission meeting to help mitigate any regulatory pathway risks and make sure you and reviewers are headed in the right direction.⁴

What Drives Your Plot?
I tell clients that the road to regulatory approval is really the chance to write your own story for your medical device. Although there is no standard form for submissions, there is a right and wrong way to submit your information. So be sure you lay out the plot with precise detail. If your submission is well-written and easy to follow, it’s the foundation for productive, positive dialog with your reviewer.

As the author, you’ve been working on your project for months, maybe even years. You know all aspects of the design history and every painstaking decision of the process. But your reviewer is a new reader who can only go off what you provide. The FDA reviewers are responsible for making sure our parents, friends and family all have safe and effective products for better health. The more in-depth, clear and vetted information you can provide, the quicker you can travel the road to market.

Picking the right lead for the regulatory submission is critical. Will you be better off with internal or external regulatory support? The answer depends on the project. If the regulatory department has many submissions hitting at the same time, prioritize the projects and outsource to meet your deadlines. If this is wholly new technology, bringing in external consultants with fresh perspectives and experience on a wide range of devices may be more beneficial than the internal team who’s focused solely on the company’s products. Of course, startups are usually relying on consultants, and well-established companies have internal support. Be open to making the most of your resources.

Beware Tunnel Vision
We all have personal biases about what is important and how to improve on existing processes. Bear in mind, however, that FDA standards and requirements are set to ensure we’re all working together to safeguard public health. 

To receive clearance for a Class II device, there’s an existing measure of safety and efficacy and the requirement that your device is substantially equivalent (SE) to another cleared device. The mechanical testing and characterization of the device answers one aspect of SE—others include material, size, shape, indications, etc. You also need a solid mechanical test plan (what testing is required vs. what testing is outlined in a particular standard), the correct size of implant to test (worse-case size for the family of implants), the types and modes of testing (static/dynamic and axial, shear, torsion, etc.), and number of test samples (plus extras) all are critical components. The protocol should follow a recognized ASTM (the international technical standards organization) or ISO standard with acceptance criteria. There is a significant investment in the mechanical testing portion of the product development cycle—the cost of the implants, the cost of the testing activities with feasibility or multiple rounds of testing, and the time for the actual testing (typically at the end of the product development cycle and the last activity prior to compiling the submission).

Who’s Driving This Thing Anyway?
You know what kind of device you have, what kind of market you’re tackling, what you need to do to get it approved, how it’s getting reimbursed, and when your shareholders (or you) can expect to make money. Now you need to know who’s behind the wheel. You need and deserve the very best partners to make this road trip as easy and successful as possible. Critical team members include: product manager, engineering (design, FMEA, controls, design history file, quality systems), product champions (user group or surgeon team for an orthopedic device), regulatory, mechanical testing and manufacturing. Class III devices also will include extra team members such as animal testing, biocompatibility testing, clinical trials, etc.

Once you have your team in place, you can map out the product development timeline, milestones, possible obstacles and expectations. A small sampling of things to keep in mind: design controls, usability studies, design validation, creation and maintenance of the design history file, and postmarket surveillance are critical components for the engineering and quality team to manage and execute. Understanding the quality activities to maintain excellence after you receive clearance is important for patient safety and market success; this is a very real and often overlooked aspect of having a cleared medical device. Then there are considerations about manufacturability and process validation. Depending on your device as well as market and long-term plans, there are still more factors and issues that can and do pop up.

Buckle Up and Enjoy the Ride
Perhaps the most important thing to keep in mind is there’s more than one way to get where you’re going. If you can keep an open mind and approach your product development cycle with a positive expectation, flexibility and the right team, you’ll steer your project to success and the marketplace with minimal bumps in the road. 

References

1. www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/default.htm
2. www.fda.gov/medicaldevices/safety/reportaproblem/default.htm
3. www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHVisionandMission/UCM384576.pdf
4. www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=514.5

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Dawn A. Lissy is president of the Empirical family of companies (Empirical Testing, Empirical Machine and Empirical Consulting). Lissy is a biomedical engineer, an entrepreneur and an innovator. For more than 20 years, she’s worked with clients to bring groundbreaking medical devices to market. She was recently selected for the U.S. Food and Drug Administration’s (FDA) Entrepreneurs in Residence program, which invited top professionals from the medical device industry to work with the FDA to streamline and improve the approval process for devices. Her close contact with regulatory officials enables her to keep Empirical clients and peers abreast of all ASTM, FDA and CE regulations that may affect product testing and development. She’s frequently invited to share her expertise at biomedical events and conferences around the world. She also volunteers for the Perry Initiative, a nonprofit dedicated to bringing more women into engineering and orthopedic surgery. Since 1998, the Empirical family of companies has operated under Lissy’s direction. She has been responsible for all Empirical operations, including designing test fixtures and protocols, running test protocols, and writing complete reports. She holds an inventor patent for the Stackable Cage System for corpectomy and vertebrectomy. She is a member of the Biomedical Engineering Society, Society of Women Engineers, the American Society of Biomechanics and the American Society for Testing and Materials. She holds an M.S. in biomedical engineering from The University of Akron, Ohio.