Every year, healthcare and other wellness companies across the world come up with innovative products, such as medical devices, drugs, medicines, patient operating machines, etc. They all must go through the regulatory compliance of the Food and Drug Administration (FDA) to get their approvals. To get the go-ahead from the FDA, various processes need to be followed.
The FDA studies, tests, and approves a wide range of entries for medical use. Companies or individuals need proper guidance to go through the FDA’s inspections and policy changes. Having these approvals on time is important for every stakeholder so they can bring their product on time to the market. To get this guidance, hiring a consulting services firm is the most effective solution.
MDI Consultants, Inc. is a leading healthcare consulting services provider worldwide. It has extensive expertise in assisting medical device, pharmaceutical, biotechnology, and food companies’ complete compliance with U.S., European, and Canadian regulations. Its services can effectively help you in understanding and speeding up the FDA approval process.
We interviewed MDI’s Alan Schwartz, Founder, and Executive Vice President, to get more detailed information about the services provided by the consultancy.
Below are excerpts from the interview:
Please brief our audience about MDI Consultants, its values, and the key aspects of its stronghold within the healthcare consulting industry.
MDI Consultants, Inc. has been providing Food and Drug Administration (FDA) regulatory consulting services continually since 1978. In the 1990s, we expanded our services to assist our clients with both the European Union (EU) and Health Canada requirements. This was when those countries’ regulations started to affect the US medical device companies marketing their devices to Canada and Europe.
In 2002, MDI set up US Agent services to assist foreign companies to have an address and access to the US FDA. MDI prides itself on our customer service and the strong relationships we develop with our clients and with the regulatory agencies. MDI has worked with companies worldwide and has retained clients going back over 30 years.
Tell us more about the services that make your company stand out from the competition?
We feel that MDI not only has the regulatory expertise to understand and deal with the regulatory agencies, but we also work with our client companies by providing various options and pathways that may make more sense for them when bringing their devices to market.
We have assisted with over 4,000 applications in all areas of the medical device industry. We are now working with cutting-edge companies that develop AI (Artificial Intelligence) devices and provide strategies for successfully getting these devices through the FDA review.
What is your opinion on the impact of the current pandemic on the global healthcare sector, and how has your company fared during the pandemic and subsequent lockdowns?
MDI was very concerned about the business turn-down when the pandemic hit, as did the rest of the FDA-regulated industries. Instead, we were hit with a sudden tsunami of inquiries to assist companies with the FDA EUAs (Emergency Use Authorizations) for COVID-19 diagnostic kits, masks, gowns, thermometers, gloves, ventilators, and hand sanitizers.
MDI was successful in helping numerous companies understand the FDA requirements for EUA and bring their devices to the U.S. market expeditiously. In addition, many companies wanted to establish a permanent market presence, and we assisted them with obtaining a 510(k)-market clearance for their devices.
In your opinion, what could be the future of the healthcare consulting services sector post the pandemic? And how are you strategizing your company’s operations for that future?
MDI has expanded its base of clients as a result of the last several years where we have been involved with the COVID-19-related devices. At this time, we are continuing to work with companies trying to get their COVID-19 test kits, Point of Care (POC), and/or Rapid OTC.
MDI has learned to be very flexible to assist our clients’ needs. We have now partnered with a CRO (clinical research organization) to conduct clinical trials in the USA, which must be done to get the OTC rapid test claim.
We always look to see where the medical needs change along with the regulatory requirements as changed by the FDA. The regulations do not change fast, but the FDA’s policies can change overnight.
As an established leader, what would be your advice to the budding entrepreneurs and enthusiasts aspiring to venture into the healthcare consulting services sector?
Interesting question. Over the past 20 years, MDI has provided internships to many regulatory specialists so that they can get an idea of what it is like to be a regulatory consultant. We have had graduates of master in regulatory affairs programs and biomedical engineers come to MDI for internships.
This is one of the ways of entering the industry that we highly recommend. Often time, it leads to full-time positions. For example, at MDI, we have had around ten interns over the years, and several of them were given full-time positions.
How do you envision scaling your company’s operations in 2022?
Currently, MDI is in a position to handle the workload that comes along. In addition, MDI has always had access to many external senior consultants that can assist our clients in times of crunch.
We do see that with the FDA restarting on-site inspections, there are many new companies in the medical device industry that will be receiving the FDA for the first time or after a long time. This will shock many companies trying to deal with the FDA. MDI is ready to assist these companies in understanding and dealing with the FDA inspections and assure full FDA compliance.
Alan Schwartz, EVP, and Founder of MDI, have been working with the FDA regulatory and quality assurance since 1972. He started with the FDA as an investigator working out of the New York District Office and rose to a Supervisory of Field investigations before he left the Agency to start MDI.
MDI was set up to assist the small, regulated companies to understand and comply with the FDA requirements. Small companies do not always have the expertise and internal support to deal with FDA issues.
MDI is built on assisting companies to set up and implement quality systems, deal with FDA regulatory problems (483 and warning letter responses), and assist with submissions to the FDA for new devices (510(k) ’s, DeNovo’s, and PMA’s).
In its many years in business, MDI has assisted on over 4,000 medical device applications and helped implement over 400 quality systems worldwide. MDI has clients in multiple countries.