Learn about the pre/post approval process for medical technology product development.
Medical technology products often take a long time to get to market. There are two separate processes before getting your product to market: pre-approval and post-approval. In the US (and around the globe) there are various stages to product development that a company must go through, each requiring approval from the government. This is one of the reasons that products take such a long time to come to market. This article will highlight the different stages of a product’s life cycle, and how a company should go about this process.
Companies must hit various markers before their product is approved. These can include:
Invention and planning is the first part of creating a product. An early question to ask yourself is who would want to pay for your device, why, and how much? You might have a phenomenal idea, but if it is not needed in the market, it might not be necessary to move the idea forward.
The next question to ask yourself is whether or not you can obtain a patent for your idea. If your idea has been covered by an existing patent it might be hard to engage in next steps. Many companies' products are killed during the first few years, because they are not able to obtain patents on their ideas. You might also want to ask yourself where you would like your patent to originate from. Is your market in the US, China, Europe, or somewhere else? The answer may even be all of these places. These questions may best be answered with the advice of a patent attorney.
After you have considered the first steps in planning, you will need to think about how your idea could affect the market. One question that is asked by many insurance companies and other purchasers is "what medical need is met through your device?" You may want to ask yourself these questions in order to respond:
These questions should help guide you in ensuring your product will have the demand after you go through the technical processes. The last question is especially important, as it indicates whether or not your product is needed vs wanted by the market.
If your product is an improvement on an existing method, you might need to prove that your product is particularly better than what exists today. Is it worth it for your potential customers to change their practices to your product as opposed to staying with the status quo? This question is especially important if your product will be more expensive than the current standard.
After you have a patent, your next steps are finalizing your design and product development. The design may become stagnated if a company becomes too obsessed with small details. There will always be things that can be improved upon. Keeping a close eye on designers and engineers to make sure that they are not “tinkering” with the original product design is important to staying on track with your schedule.
A great outlook to take is separating your research from your development. This could mean working on developing Model 1 as you continue to research a possible Model 2. This creates a tangential process that ensures your first Model will go to market as you continue to search for how to improve upon your original idea.
Documenting the process of changing your original idea is also important. Creating changes in design is okay as long as the thought process is well documented.
Almost all new medical products regardless of their benefit will come with some type of risk. This risk can come in all shapes and forms, but it is important for designers to understand how this risk can affect the future of the product.
Most countries have some type of approval system that involves you documenting risk. You will need to classify the type of risk and how it might affect patients or your potential customers. This is a great time to involve external, and independent medical experts. You will also need to consider adding on new risks as data becomes more available for your product. These new risks should be documented as they become apparent, whether in clinical trials or other ways.
Clinical studies are the single most expensive and time gating component of the pre-market pathway. Yet, clinical studies are one of the most important parts. Risk management and regulatory factors are the main drivers in your clinical studies and what the results may mean.
Clinical studies also often go over budget. A great way to mitigate this type of risk is by assuming that your company will go over 150% of your planned budget. This will allow you a little bit of leeway room when completing your study.
Because clinical studies are so important, this is also a great time to get independent medical expert advice and obtain counsel for regulatory suitability. Extra council and extra advice might cost your company money in the short run, but it will be better than running into potential problems down the road.
The main things to consider while manufacturing is guarding your supplier selection and control as you do with the core of your business. Revealing your suppliers to 3rd parties can reveal company secrets, so only reveal this type of information if necessary. With that being said, you will need to ensure that your suppliers have experience and are certified for the type of work you need.
Throughout the manufacturing process, you will want to make limited changes to your design. Changing your design at the last minute can be very costly, and may lead to bankruptcy or money issues in the long run. If you need to change something, that may be ok, but make sure that you create an impact analysis beforehand.
Regulatory approvals are necessary for many types of medical devices. Companies need to keep regulatory approval in the back of their mind throughout this entire process. Waiting for the end or only for specific deadlines can eventually hurt your product.
In the US new products will often require a pre-submission meeting with an FDA representative. Around 90% of products will benefit from a pre submission meeting with the FDA, but it will cost money and may take some extra time. If you are unable to commit to a pre submission meeting you may want to contact the FDA’s Division of Industry and Consumer Education which can provide some insight on the approval process. This service is also free of charge.
If you are looking to become approved in the EU you will need to evaluate the different needs of that regulatory body. European standards are quite different from American standards, each will need to be researched depending on the product.
Now that you have been approved, the race is not over yet! Here are some additional factors you’ll need to consider after you get approved:
A few of these factors are explained in more detail below.
The good news is: if you are a distributor, you will have less responsibilities than a US importer with the FDA. In Europe, these rules will vary and each entity will have their own responsibilities. You should understand these economic operators before you start manufacturing the product. This will make the transition from design to actual sales much easier. Your research in this field may benefit from an expert in the country you plan to distribute to. It is always nice to have someone that knows the country’s laws inside and out.
Post market compliance is all about ensuring your product stays safe and necessary for the market. This can mean a range of things including updating risk management, incident reporting, etc. Making sure that you comply with each country’s regulatory agencies is very important to ensuring that your product remains safe and legal.
There are a few main types of exit strategies for emerging life science startups:
Many of these exit strategies have positives and negatives. The positives to getting bought are the ease and monetary gain, but the parent company might become overbearing or change the direction of the company too much. Merging is another viable option but it introduces complicated legal processes between the two companies, including issues with personnel, assets, and liabilities.
This article attempts to highlight the main pre/post approval processes for a new life science company and their products. Failure factors like poor management and too much trust at the wrong time should be avoided in order to grow the company. New life science companies will also need to think about regulatory affairs, protecting their IP, and manufacturing along the way (not just once they are needed).
Dr. Jaap Laufer has over 30 years of medical device regulatory experience and specializes in implant and high-risk device submissions, FDA QSR compliance, and clinical study approvals and compliance. As Medical Director, Jaap is an expert reviewer of clinical data and evidence for novel and high-risk devices. In his additional capacity as senior clinical consultant, he also peer reviews EU Technical File submissions, and assists with Notified Body selection and classification. Jaap holds an MD from the Medical School of the University of Nijmegen and a Doctor of Pharmacy from the University of Groningen, both in The Netherlands.
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