Taking a medical device from initial idea to finalized product isn’t easy to do, but it can be easy to understand — if you have the right help.
This guide makes one assumption: that you’ve already developed a prototype. That means going through the effort to determine relevant market and user needs, develop concepts and complete device and packaging design.
At this point, it’s time to start thinking about what the FDA requires in order to approve medical device commercialization. Below, we’ll walk through the associated requirements and processes needed to complete a successful submission — getting your device in front of consumers faster.
What Should I Know Before Pursuing Medical Device Product Approval?
The first step of approval is making sure you understand where your device will fit into the market and how to communicate that effectively. It’s important to consider:
- Your competitors. Competitive analysis involves studying similar devices already on the market, analyzing their features, performance and market share. You want to use this information to help identify unique selling points and potential differentiators for your device.
- The size of the market. You want to have a deep understanding of your target patient population, healthcare system demands and the potential market share for the device. This analysis helps determine the device’s commercial viability, pricing strategy and market entry plans
How Do I Classify My Device?
Getting your medical device classified and making sure you understand the appropriate regulatory controls is the first step toward commercialization. These classes range between Class I, II and III. The higher the class number, the more regulatory control the device will face.
The FDA provides a number of resources that can help you in determining your device’s classification:
The easiest way to easily and accurately classify your device is by working with a regulatory partner that understands the intricacies of the process. The APEX Program from NAMSA connects you with top MedTech industry experts to accelerate regulatory approval and commercialization.
What Testing Is Needed During The Medical Device Commercialization Process?
Before selecting and preparing the correct premarket submission, testing is required. The results you gain from this testing will help improve the odds of commercialization and approval of your medical device by the FDA.
- Preclinical testing. The objective of preclinical testing is to assess a device’s safety, functionality and performance characteristics.The FDA requires it to ensure potential risks associated with the device are identified and mitigated before proceeding to human trials.
- Biocompatibility testing. This is a specific aspect of preclinical testing that focuses on assessing how a medical device interacts with biological systems. The goal is to evaluate a device’s potential for adverse biological responses when in contact with living tissue.
Depending on the unique characteristics of your device, different tests will be required. If you’re curious about digging deeper on what’s included in a successful get-to-market strategy, take a look at our product development process.
How Important Is Having A Reimbursement Pathway During This Process?
Very important. If you don’t have a reimbursement pathway from the start, you might as well not develop a product.
Reimbursement is the process by which healthcare providers, such as hospitals or clinics, receive payment from insurance companies or government programs for the use of medical devices in patient care. Reimbursement is a critical consideration for medical device manufacturers, as it impacts the device’s commercial success and adoption.
To obtain reimbursement, you’ll need the information gathered during your initial trials and testing to help support claims of care and cost-effectiveness compared to existing treatment options.
The FDA medical device commercialization approval process provides foundational evidence for reimbursement, as regulatory approval is often a prerequisite for reimbursement applications.
How Do Premarket Submissions Work?
The correct premarket submissions will be identified during the product classification process. Some devices don’t need premarket submissions, but most do — the four most common types of premarket submissions include:
- 510(k). Many Class I and II devices require what is called a 510(k). This submission requires the sponsor to demonstrate that their new device is “substantially equivalent” to an existing one in relation to its intended use, characteristics and performance testing results.
- PMA. PMA, otherwise known as Premarket Approval, is required for Class III devices. It’s the most stringent variety of premarket submission, which means it requires scientific evidence that demonstrates reasonable assurance of both safety and effectiveness in regards to intended use.
- De Novo Classification Request. This submission is for novel medical devices that have general and/or special controls that provide reasonable assurance of safety and effectiveness. This is for commercialization of medical devices that don’t have an existing predicate device.
- HDE. HDE stands for Humanitarian Device Exemption. This is a unique regulatory pathway for class III devices developed with the intention of supporting the treatment of rare conditions. Special applications are involved when pursuing this exemption.
After you’ve gathered the relevant information for your premarket submission, then it’s sent to the FDA for review. The process can take between 90 and 180 days on average depending on the type of premarket submission you’re using. The FDA will be in touch with you during this process as they review all your documentation.
The medical device commercialization process is complex — it involves a lot of moving parts and unique pathways depending on the type of device you’re creating and its intended use.
The easiest way to make it through as quickly and effectively as possible is by partnering with experts who have helped hundreds of others through the same process.
Monica Tantalean, BS, AAS, CVT currently serves as one of NAMSA's Global Marketing Specialists and joined the organization with the acquisition of American Preclinical Services (APS) in 2021. She has been with APS since 2017. Monica has 7 years' experience within the medical device and veterinary healthcare industries and has worked in a variety of roles from Surgical Technician to Business Development. In her role at NAMSA, she is responsible for assisting with the development and execution of marketing communications that contribute to organizational growth and sales.