The medical device product lifecycle is filled with intricacies, complexities, and detailed regulatory requirements, but the process itself is quite simple. As manufacturers move through the lifecycle, they'll focus their efforts on three main areas at different points:
Medical Efficacy: In this area, manufacturers are primarily concerned with identifying the medical need for the device and working with healthcare providers to understand all of the biological parameters at play.
Manufacturing Feasibility: A device could meet a legitimate medical need and pass all milestones for regulatory compliance, only to find out that the design itself is not suitable for mass manufacture. New Process Development (NPD) principles are a crucial consideration to ensure that each component can be produced, assembled, packaged, and delivered appropriately and cost-effectively.
Regulatory Compliance: Ideally, the goal of regulatory compliance is to ensure that medical efficacy is achieved safely. It costs between $31 million and $94 million to bring a medical device to market, depending on its class. Higher class levels require obtaining Pre-Market Approval (PMA) from the FDA, a stringent process that takes an average of 276 days to complete.
It’s important to note that we’re generally focusing on noninvasive medical devices. Invasive, or Class III, medical devices (such as pacemakers, stents, and artificial joints) face a much more stringent process in each of the three areas outlined above.
What are the Stages of the Medical Device Product Lifecycle?
The first stage is Concept Development, which begins with the initial idea. Due diligence is required in each of the three main areas listed above to identify a legitimate medical need, whether the market is large enough to bear the cost of development, and if such a device can be mass-produced. Although each area is involved, Medical Efficacy is the overarching priority here.
Next comes Prototype Design, where napkin drawings are transformed into CAD designs and finally prototypes. Tools such as 3D printing, powder bed fusion, and CNC machining play critical roles in confirming that the device will work and that the model can be built. It is vital for designers to study each component and how it’s manufactured, tested, assembled, and packaged. A critical failure at any junction could wreck the entire design at a much later (and far more expensive) point. A simple example would be using the wrong packaging for sensitive electronic equipment—if the device is damaged in transit and delivers faulty data resulting in patient injury or death, nothing else matters. Manufacturing Feasibility takes center stage at this point.
Third is Concept Validation, and this is where the spotlight is on Regulatory Compliance. This stage begins with device class assignment, which is briefly summarized in the table below.
The class a device is assigned determines what subsequent testing, validation, and controls are required by the FDA. It will also drive any clinical trials which must be completed before the manufacturer can apply for Pre-Market Approval (PMA). Only 5 percent of medical devices are invasive and fall into Class III, but these are far more expensive, requiring three times the investment to bring to market.
Once all of the necessary FDA approvals have been obtained, the fourth stage—Product Launch—can begin. If you’ve frontloaded your NPD efforts during the Prototype Design stage, this is where you reap the benefits. If you’ve neglected to keep the manufacturing process front and center during design, you’ll face untold headaches that could end up destroying the entire process.
This is also where marketing becomes a priority. Medical devices come with a host of advertising restrictions, requirements, and mandatory disclosures, so working with an experienced legal team specializing in this area is absolutely critical.
The product lifecycle doesn't end when the device hits shelves. The fifth and final stage is the Post-Market Review, where reports of side effects, product failures, and any other issues must be tracked and closely documented. If any recalls are necessary, they’ll stem from the careful observation that occurs in this stage. If problems are severe enough, it could drive additional clinical follow-up studies. If everything goes smoothly and the device is successful, it can be introduced to secondary markets.
What is Most Important about the Medical Device Product Lifecycle?
The single most critical aspect of a successful medical device product lifecycle is planning. Mapping out the process, following strict project management best practices, and pulling in medical/manufacturing/legal experts as they’re needed is crucial. Ad-hoc processes are detrimental to the lifecycle, and poor management can ruin a good product design even if everything else has been successful. This requires mapping out the product lifecycle, getting your entire team on board, and carefully tracking each stage as you move through it.
Tami Schultz is the Vice President of Business Development at Dynamic Computer Corporation, where she leads the sales and account management functions with her expertise in developing and executing strategy. As a service outsourcing veteran, Tami has a proven track record in leading complex national and global service programs that leverage technology to enable business objectives while growing market share. She is also a member of Michigan Women in Technology and the Supply Chain Leaders in Action – Women in Action Committee.