MDI Consultants: Assisting Medical Device Companies Achieve Regulatory & Standard Compliance with the U.S., European and Canadians Agencies

MDI Consultants | Alan Schwartz | Executive VP
MDI Consultants | Alan Schwartz | Executive VP

For new medical companies, it can be daunting to put up with FDA visits and longer inspection runs. They not only have to put up with it but often are unsure how to deal with it. mdi Consultants, a leading provider of FDA consulting, quality assurance, regulatory compliance and clinical services—offers services that are focused on assisting medical device, pharmaceutical and food companies across the globe. It is committed to helping its clients achieve regulatory and standard compliance with U.S., European and Canadian agencies and organizations.

The company’s approach to client service is to provide its clients with expert consultants who are armed with a proven and flexible consulting methodology. In an interview with Healthcare Everything, Alan Schwartz, the Executive VP, shares in depth about the company’s approach to providing its clients with a customized service that meets their specific needs.

Following are the excerpts from the interview:

Kindly brief us about the company. What inspired you to venture into the healthcare sector?

After coming out of college, I took a job with the USFDA. I was a field investigator going into companies and making sure that they were in compliance with the FDA regulations. That was in 1972. In 1976, the US Congress came out with the regulate the medical device industry. I left the FDA in 1978, after reaching the level of Supervisor of field operations.

The medical device industry was in its infancy, made up of many small companies and start-ups that had no idea how to deal with the FDA regulations. When I was with the FDA, I saw how small companies had a hard time understanding the FDA regulations, let alone how to deal with the agency. I felt that these small companies needed someone to come to their aid and provide the necessary expertise to get into compliance and have someone to represent their regulatory needs.

Shed some light on your journey as the guiding light of the company. How does your presence play an important role in the growth of the company?

Learning to be in business took several years, and going through several partners. No funding, no salary, no clients, what a start. I read a book, the Outlier, by Malcolm Gladwell and he said it takes 10,000 hours to become an expert. Well, it took five years of keeping the focus on developing a strong business following and building a strong client list. We took a different path than most consultants who look to have one project after another. The business is like a sine wave, hoping that the frequency between projects is short and that the altitude of the next project is higher than the previous one.

This is a very hard road to take. We looked to get most of our clients on a long-term retainer and this way to keep the cash flow coming in to cover the expenses of the operations. This reduced the risk of the sine wave business problems. Also, allowed us to grow with new employees as needed. This business plan had worked well when compared to many other consultants that I had met over the years in business. They had some great years and some very lean ones. mdi had very few problem years and many years of nice level growth.

As for having partners, or employees, I always wanted to work with a team. As you can see, we didn’t name the consulting company after my name, Alan Schwartz Associates or such, as you find many other consultants have done. The reason for this is that I never wants clients to hire me but I wanted them to seek our company. Having partners and/or employees also allowed me to get away from time to time and still have the company running.

Can you elaborate upon the core values, mission and vision on which the company is built?  

We always look to provide our clients with the assistance they need to get them to reach their goals. We pride ourselves in giving our clients the most advantageous way of dealing with the FDA. At times there are several options. One option would definitely cost the client more money and have them reach their goal. The other one is a little more creative and would save a ton of money and time. We look to do that for our clients many times with success that no other regulatory consultant or attorney could come up with.

What are the core products and services that your company has to offer? In what way do they serve the target population? How are these different from other forms of services that healthcare clients receive?

mdi has been providing FDA regulatory consulting services since 1978. We provide a very important service to smaller companies and start-ups, regulatory strategies. Many entrepreneurs know their device and maybe the market but have very little experience in navigating the FDA regulatory process, which could be the main obstacle to entering the marketplace. Most smaller and new companies have no idea of what it would take to get their device through the FDA review process. That is where mdi comes in to provide this guidance and understanding. mdi is also a consultant to mid and large companies to provide them with a second opinion and to provide the expertise that may be missing.

Another important service is assisting companies in dealing with the FDA inspection of their operations. This can be critical to a company’s survival to pass an FDA inspection. mdi can provide pre-inspectional assistance to prepare for the audit, and be present during an inspection. We also assist with responding to the FDA 483 List of Observations left by the FDA investigator after their inspection. This can be critical to avoid additional regulatory actions. mdi has been able to avoid warning letters to be issued as well as address the FDA’s concerns and negotiated issues with the Agency on behalf of the company. We have worked with companies worldwide on FDA inspections, and FDA submissions.

What operations and procedures does the company finds to be essential when supporting healthcare clients?

We have been determined to provide our client companies with personalized services. We learned that our clients want to receive returned calls and/or emails. We have maintained long-term relationships with our clients. Some clients have been using mdi for over 40 years. We are proud of this long-term relationship. We feel we are like an insurance policy, we are there when it is needed.

What endeavors is the organization currently pursuing to improve its measures and best serve your clients?

We constantly review what our clients need to be competitive and in compliance. We have added our US Agent services to our foreign clients. We provide Health Canada licensing for medical devices for marketing in Canada. We also assist our clients in preparing their Technical Files under the Medical Device Directive for marketing under the CE mark.

What advice would you like to give to budding entrepreneurs and enthusiasts who desire to venture into healthcare consulting?

This is a journey, not a sprint. Marketing yourself is essential for a successful career. It takes a while to build a large client base. It is difficult to assure a continued flow of business. Be ready for a long hard ride. It took me over five years to make a yearly living that met my expectations.

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