Solugenix Marketing Manager Crystal Kolosick recently sat down with Dr. Donna G. Hartzfeld, Ph.D. who is an FDA consultant with more than 20 years of experience. Dr. Hartzfeld Joined Crystal to discuss some of the top compliance matters that medical device companies should know when starting their journey to bring a product to market.
Crystal Kolosick: Donna tell us how you got started as an FDA consultant?
Dr. Hartzfeld: Early in my career I worked in a startup pharmaceutical drug company that relied heavily on FDA consultants to help reach our goals of FDA product approval. I was so intrigued by the knowledge and what the consultants brought to the table, I decided to pursue a consulting path. I team up with several former FDA compliance officers and PhDs, and we began working with other startup companies.
Compliance Process Preparedness
Crystal: I wanted to ask you a few questions about compliance which is an area that many medical device manufacturers struggle with navigating successfully. I’d like to start by asking you what medical device manufactures can do differently to better understand the FDA regulations that they must meet in the pre-market phases?
Dr. Hartzfeld: When a small, medium, or large company begins the new product development process, there are several crucial first steps they should take. These include fact finding, information gathering, and determining which regulatory space the product will fall within under the FDA regulations.
All the information they need is free on the FDA website, so they need to gather up all the guidance documentation and the standards they will use in their R&D process. That includes gaining an understanding of the product code and any special requirements for any product they are designing. Before they start engaging in engineering studies, they need to have a basic knowledge of the regulatory world that they will be working within.
Crystal: Do you think it’s important for medical device manufacturers to build compliance into their early product development stage?
Dr. Hartzfeld: Most certainly compliance should be built into the product from day one. One of the first things to decide is will the product be sold domestically or international as there are many different sets of regulations that they must follow if they go outside the US. There are all different kinds of requirements that they must know before they start. All that required understanding must be built into their first project plan.
Avoiding Compliance Pitfalls
Crystal: It seems clear from what you’re saying that having a deep understanding of the requirements would help them to avoid some of the common pitfalls that smaller startups would fall into. What are some areas of compliance that these startups might typically overlook in ways that become pitfalls?
Dr. Hartzfeld: Many times, companies do not establish an initial budget for incorporating compliance into the product development lifecycle. It takes significant resources to build a product, and money is one of the main resources. If companies don’t set an initial budget, they often hit a wall very early in the pre-market compliance approval process because there is no money to buy the equipment necessary to perform the tests. They will also lack the necessary resources to perform the technical writing of protocols and summary reports.
Things That Medical Device Companies Should Be Aware of When Hiring A Consultant
Crystal: It appears that when these companies aren’t fully aware of the requirements, they will often reach out to a consultant with concerns. They may even have received a letter from the FDA and are looking for a consultant to help them through the process. What kinds of things should medical device companies be aware of when hiring a consultant or when the even begin thinking about reaching out to a consultant?
Dr. Hartzfeld: They must have a complete understanding of the scope of the work they intend the consultant to perform. Every consultant doesn’t know everything, so when you are initially resourcing a consultant you want to understand your needs and then seek out that skill set in the consultant world.
Repercussions for Non-Compliance
Crystal: What are some of the repercussions of being out of compliance with the FDA and what happens to these companies that are found to be out of compliance?
Dr. Hartzfeld: There are all sorts of repercussions that a company can face when they are trying to clear a device through the FDA. The application process will pass through a series of review cycles and if all the basic requirements in the application process are not met, then the FDA will not clear the device.
If the device is cleared for market and there is not an established quality system built within the company to adhere to compliance under the CFR 820 regulations for US distribution, then during an FDA inspection the company will receive a citation letter called a 483. This will list all the compliance observations where the company is not meeting the basic requirements. If the non-compliance issues are severe enough the company will receive a warning letter, which is very difficult to remediate and get out from under. That process takes an incredible amount of money and several types of consultants with different types of expertise to help the company get back on track.
Crystal: There is clearly a lot at stake for companies to meet compliance, and it’s a major challenge to get things back on track if they don’t meet compliance requirements in the process. What would you say are the main points they should take away from this conversation?
Dr. Hartzfeld: Companies must establish an initial budget and initial project plan where compliance and risk management plans are built into the design, controls, and engineering process. In the long term, the company will save money and be successful if they follow this path.
About the Author:
Dr. Hartzfeld holds a doctorate degree in PhotoOrganic Chemistry from Arizona State University and serves as an independent consultant for medical device companies on FDA related matters. She has more than two decades of experience in Quality and Laboratory compliance, API, pharmaceutical, medical device, biotech, combination products, biologics and dietary supplements industries.