By Ofek Levin, Co-founder and Chairman of the Board, Via Surgical
The challenge of bringing an idea from the concept stage to the marketplace is one every startup faces. In the MedTech space, there is the added layer of effort needed to ensure the safety and efficacy of a medical device. This involves going through an approval or clearance process with the U.S. Food and Drug Administration (FDA), which is responsible for protecting public health and ensures the safety and efficacy of not only food and pharmaceuticals, but also medical devices.
Devices that are considered high risk -- such as pacemakers -- are required to go through a very strict approval process. Other lower risk devices go through a 510(k) “clearance” process with the FDA before the manufacturer can legally start to market the device.
While the FDA’s website contains a lot of helpful information for companies that want to attain clearance for their medical devices, there are five tips that will help MedTech companies to more easily navigate the process.
Know the different pathways
The FDA categorizes medical devices as Class I, Class II, or Class III. Class III is for high-risk devices. If a medical device is not considered high risk but is truly novel, a company will likely file for a De Novo classification request.
The differences between the different classes are usually well-defined, and the FDA provides a searchable Product Classification Database that can help a company determine whether their product meets the definition of a medical device and whether a classification already exists for the type of device.
Because preparation for the FDA clearance process is long and costly, a MedTech startup will want to be certain from the start as to which pathway and classification their product belongs. Consideration of the classification must come in even before designs or prototypes are generated. FDA clearance must be kept in mind through every step of research and development, and when choosing materials and R&D processes.
Have a regulatory advisor from the start
Before starting the application process, it’s helpful for a MedTech company to meet with a regulatory advisor who can conduct a regulatory assessment of its idea and help determine which pathway is the right one to pursue. This can sometimes be a make or break point for a project. In addition, if a company chooses the wrong classification, the FDA may ask it to change the pathway, which necessitates starting again from square one. This is a big risk that any MedTech startup founder wants to avoid.
The regulatory advisor can offer an assessment as to which clearance path is the right one based on experience. An advisor can even help set up a preliminary discussion with the FDA so that the agency itself can assess which pathway is best for the startup to follow.
Prepare as much as possible, but there are many unknowns
While it’s important to prepare as much as possible before the clearance process begins, the truth is, there are a lot of unknowns. Sometimes, a company might think the FDA will ask about certain things, but then the agency takes a completely different approach and concentrates on something that the MedTech company had not thought about.
The unknowns in the clearance process are tough. Even with a preliminary assessment in hand, a company doesn’t know how the FDA will react to its actual application and what they will require for documentation. It’s like a chess game. A company can only try its best to anticipate questions from the FDA. The regulatory advisor can be of assistance in this respect, as well.
Another big unknown is how long it will take. Which leads to the next tip…
Secure excess funding in case the FDA clearance process goes longer than expected
The length of time it takes for a company to get clearance for its medical device can be as short as 40 days, or it can take up to a year or more. A startup should be sure to have enough time and budget allocated in case the process goes longer than expected.
Sometimes applicants will need to provide additional paperwork to respond to questions they hadn’t considered before the process started. If founders run into delays like this, they may need to focus on fundraising instead of R&D, or go back to angel investors.
Understand that the FDA treats everyone equally
In the middle of an application process for clearance, as the FDA sends requests for additional paperwork, a startup might feel like it’s being singled out for extra scrutiny. However, it’s important to know that the FDA is fair in its treatment of startups. The agency doesn’t discriminate between large and small companies, it just has to be thorough.
The FDA is very organized and communicates with applicant companies in a very clear manner. If the FDA assessors have a question and need more data, they know how to point out what is troublesome to them and to explain exactly why.
In the end, it’s about safety and efficacy
When a company wants to bring a medical device to the market, it’s important that the FDA has regulations and processes in place to ensure the safety of public health. Many countries around the world also accept FDA clearances and approvals for their own marketplaces, which is an additional incentive for MedTech startups to work the FDA clearance into the R&D timeline at the earliest point possible.
Gaining the ability to market a medical device is necessary and important, so companies should take the time to do it right. Keep in mind, though, that there are some big unknowns, and a startup should be sure to have enough funding and time to cover any delays. Be prepared. Be flexible. In the end, it’s a great relief when founders receive that final official notice that they can start selling their medical device on the market.
This article was originally published in Nasdaq.
Ofek Levin is Co-founder and Chairman of Via Surgical, a leading developer of novel surgical fixation solutions. Prior to Via Surgical, he served as Co-founder and CEO of PolyTouch Medical Ltd. where he led the company from inception to a successful M&A transaction with Covidien. He has over 13 years of experience managing medical device companies, having completed numerous capital raisings, and filed dozens of patents with 17 issued. Ofek received an MBA from Technion – Israel Institute of Technology and a B.Sc in Electrical and Electronics Engineering from Tel-Aviv University.
Leave a Comment