From FDA to the EU: the five stages of the medical device development process

The exact stages of medical device development vary in each region, with different regulations and standards needed to be met in the US, EU, UK, Canadian and Asian markets. They’re overseen by relevant regulatory and notified bodies such as the FDA in the US, Medicines and Healthcare Regulatory Agency in the UK, different EU authorities and National Medical Products Association in China.

At every stage of medical software development, you must meet the requirements of the area your healthcare product will be used. For instance, the FDA requires all Class II and Class III medical devices to undergo clinical trials. In contrast, the EU has self-certification processes that can be achieved through just clinical evaluation.

With that said, there are overall steps in the product development lifecycle that are shared in common worldwide. These five steps are initiation, formulation, design and development, validation and launch and post-market surveillance.

We’ll briefly walk you through these steps loosely following the FDA’s Device Development Process and outline the key action items you need to address along the way.

Stage 1: Initiation

Initiation, also referred to as Discovery and Opportunity Analysis, is where you begin the medical device development journey. Start by answering these questions:

• Is there an unmet need a new product could satisfy?
• Are there predicate (existing) devices already on the market that can help streamline the approval process?
• What risks would a new device pose to patients and users?
• What classification will this product be, and how will risks impact classification?
• What funding strategies do you have? Remember, the development path can be complex, lengthy and costly.

Just peeling apart one of these questions can be quite the undertaking. Let’s take product classification and risk management, for example. A Class I device typically requires fewer controls and less stringent documentation. On the other hand, Class II and Class III devices require more documentation and post-market approval as risk management is more complex for them—and so too are associated costs.

This is where you’ll want to start getting a quality management system into place to help you manage regulatory requirements along the way.

Stage 2: Formulation, preclinical research and prototyping

Now comes the fun part! Once you have a solid idea and are convinced that your device could have a market position and is financially feasible, you’re ready to start moving.

This is when you need to start interrogating the end user’s needs and thinking about risks and requirements. You’ll conduct surveys and focus groups, competitor analysis, market research and use this information in your design and product iterations.

Even with a strong initial concept, you’ll need to be prepared to revise the design as feedback comes in. You also need to document all changes until you reach the “design freeze.” Then you’ll finally be able to take your concept and start building.

Stage 3: Design & development, validation & verification

At this point, you have a prototype and have even done a few trials, but you haven’t really tested it. To achieve regulatory approval, devices must be safe, effective and reliable. This is the process of validation and verification, and it’s where you show your product can stand up to real-world challenges.

You’ll want to create a design trace matrix that will help track your customer needs and help you translate them into engineering requirements. These are the specific product engineering components that you build into the product.

Be sure to answer these questions:

• What test equipment do you need?
• What is your risk management strategy? What failures can occur because of product failure or poor design?
• What’s your manufacturing process and quality assurance plan?
• Will you do this internally or work with a specialist HealthTech development partner?
• Does your product meet local regulatory requirements and those of any other markets you plan to launch in?

Some of these considerations should have already popped up in earlier stages. For example, you should already have identified the market you plan to launch in during stage one. However, you might discover additional opportunities elsewhere. So be realistic about how much you can tackle at one time but always keep your long-term endgame in mind.

Finally, if clinical trials are necessary for your product, you’ll need to begin your clinical plan and use the prototype from your design freeze in a real clinical environment.

Stage 4: Regulatory review

Once you have sufficient data on how well your device performs and its risk, you’ll be ready to apply for regulatory review. Before submission, you’ll need to have completed your final documentation—this is the full file of evidence the relevant authority will audit for completeness against their requirements.

While the exact process changes by device classification and market, you should be prepared for deep scrutiny of your product. For example, FDA PMA (Pre-market approval) for Class III devices necessitates a thorough review of all production facilities and an evaluation of all clinical and nonclinical study results. However, this is the highest level of review. Products deemed at lower classes generally are easier to get approved provided they follow industry best practices and guidelines.

At the same time, you should be getting ready to scale up your production process. If you’ve done everything correctly so far, it is only a matter of time before you’ll be permitted to launch your product and begin marketing it.

Stage 5: Launch and post-market surveillance

Once the authorities sign off your device, you might be ready to kick back and relax. But that isn’t the case. Nowadays, the average medical device has a 10+ year lifespan. And since you’ll definitely be launching a connected MedTech or digital healthcare product, you’ll need to have a team monitoring security, providing updates and patches and generally monitoring for safety and performance issues.

Regulatory bodies may choose to inspect your facilities at any point, especially if your product has been flagged as unsafe by concerned consumers. This is also when you can begin understanding how well your device operates at scale. You’ll be able to collect usage data and identify how to evolve the next version of your medical device or branch out on similar paths. Either way, the fun is just getting started!

The stages of the medical device development process

We provided a quick, high-level overview of the stages. Of course, each one comes with its considerations, challenges and opportunities along the way.

The most important thing to remember is that while medical device development can be complex and time-consuming, the reward is creating products that improve health outcomes, reduce provider burden and drive commercial success.

Accelerate your product journey with Star. Our HealthTech Practice helps startups and enterprises like One Concern, Constant Therapy and ZEISS ideate, design, build, launch and scale breakthrough HealthTech products that have helped them grow, prosper and transform lives worldwide. See what our team of regulatory and product strategists, designers and engineers will do for you.