After working for the FDA for over 6 years and developing a thorough understanding of how the organization works, Alan Schwartz identified an interesting opportunity to build a strong consulting practice. With a special affinity for small businesses and businessmen, he realized the need for regulatory expertise that small companies could not afford. This realization led to the formation of mdi Consultants, Inc., established to assist small companies in understanding the FDA functioning and ensuring compliance. While pioneering fixed-price and risk-sharing consulting models, mdi Consultants Inc. fostered innovation in the consulting business to drive long-term client impacts.
Alan Schartwz’s Journey from Recession to Consultation
During the 1972 recession, when Alan graduated, there were no jobs for someone with a biology degree and high aspirations, except for two job roles: one was at Museum of Natural History in the herpetology department sorting reptiles, and the other was with the FDA. “I decided to deal with the government and not dead lizards and snakes.” Taking the job at the FDA was a new experience, especially since I had never heard of the FDA shared Alan. After learning the Agency’s mission and work approach, Alan became interested in becoming an FDA consultant in the future.
Working for more than 6 years, and moving from an entry-level investigator to GS-13 supervisor and periodically serving as an acting director of field operations, responsible for the NY District investigations branch, Alan learned about the FDA’s operational approaches and how companies can successfully navigate the Agency. He resigned as an FDA supervisor and decided to pursue his ambition of becoming an FDA consultant and businessman. At that time, Congress passed new regulations for the FDA that pertained to the medical device industry, and there were no consultants specializing in medical devices. This was a very good opportunity to build a strong consulting practice.
Innovation in FDA Consulting
At the onset of mdi business, it dealt with clients as Alan witnessed how attorney’s were dealing with their clients, and all work was performed on an hourly basis. However, the approach was not a very comfortable one for the clients as they were afraid of being billed each time they called. This led to bad decision making on their part. mdi Consultants never wanted to operate like that. The company kept the clients informed about potential financial costs before projects start. This was done by offering clients proposals on a flat-fee basis, a new concept in this industry back in the 70s. “We would also provide our clients a monthly retainer so that they could use our services as needed, without additional billing,” mentioned Alan. That being said, mdi Consultants had clients on a monthly retainers basis, with some companies maintaining mdi on a retainer for over 30 years, to address all the regulatory needs: regulatory strategies, dealing with the FDA, internal auditing, submissions to the FDA, and providing due diligence on new ventures and acting as expert witnesses in possible legal cases.
Acing Regulatory Problem-Solving
The FDA has a very important function in protecting the public. It has to report back to Congress annually on what they have been doing in order to get the Agency their necessary funding. They need to show their worth, and to show this, they need to show “numbers”, regulatory actions. Once the FDA takes their legal actions against a company for lack of compliance, for example a warning letter, the FDA does not want to shut a company down. They would like to allow the company to achieve compliance. Alan also learned by experience that there were areas where the FDA would deal with companies in negotiating situations to bring that company into compliance.
”You learn what the FDA is looking for and how to provide the FDA a level of confidence the subject company will address the pending issues to ensure they can stay in business and get past the regulatory problems”, said Alan. mdi Consultants brings this experience to the clients with all its projects.
Consistency & Quality at Work
Quality is a very consistent term worldwide. Basically, there were two main quality systems, the FDA QSR and the ISO13485, and these were merging over time to be harmonized. The FDA had just recently instituted the QMSR, Quality Management System Regulations (this makes the FDA quality system and the European Standards much closer together in terminology). Having the ability to visit and consult to 100s of companies worldwide, Alan has seen many well-managed companies as well as those that get themselves into messes needing to be addressed. The main issue is to see how these companies are managed from the top down.” Other than certain situations that are product-oriented, problems are usually generated by a lack of management commitment. Sometimes, it takes a major regulatory problem for management to see the “light and address their short-sightedness ”, pointed out Alan.
Navigating Regulatory Uncertainty
Alan believes that a good business person ensures that they understand the regulatory risks involved in any venture. mdi Consultants has worked with 100s of start-up companies, providing this understanding with the best approaches for proceeding. One way of assuring success, being competitive and compliant, is to understand the company’s regulatory responsibilities, pathways, timelines, and estimated costs. Having been involved with this situation over and over again, mdi Consultants can provide its clients with these parameters for their special situation.
Preparing for Future Changes
The FDA has imposed new quality management system regulations (QMSR) as of February 2,2026. This new quality system is the first major change since 1997. This now makes the ISO13485 the basis of the FDA quality management regulations for medical device manufacturers, with added requirements for companies marketing their devices in the USA. This will definitely affect smaller companies with a lack of expertise to understand the new requirements, making compliance more complicated. By working closely with our clients, mdi helps them bring their existing quality system in line with the new QMSR and making sure they know how to implement it.
“Find strong people to work with, treat them fairly, give our clients our best advice, always work with them closely, and ENJOY yourself in the process.”
