By TOM MARINER //
The U.S. Food and Drug Administration regulates 2 million medical devices and a $1.6 trillion pharmaceuticals industry, all with a nod to a longtime Long Island firm.
Originally created to protect the public from snake-oil salesmen, the FDA has been especially busy, biotechnologically, since James Watson, Francis Crick and their friends in Cambridge cracked the DNA code in 1953.
Much of what the agency reviews has already been reviewed by Great Neck-based mdi Consultants, which has been helping to set regulations and advising medical-product firms since the birth of the modern FDA. Their formula: topnotch quality-control systems overseeing development and manufacturing protocols, and an unwavering dedication to remaining current with ever-changing rules.
Covering a unique ecosystem stretching from discovery to development to production, mdi Consultants is an essential asset for Long Island’s largest combined manufacturing sector – uniting pharmaceutical, nutraceutical, biotechnology and medical-device makers, even clients across the food and beverage industries.
Tom Mariner: Eye on mdi.
The FDA was established by the Pure Food and Drugs Act of 1906 to regulate food, tobacco and medical products; in 1938, it started regulating cosmetics and medical devices. Through the 1960s, those devices were merely policed by the FDA, which could bring legal charges and take wayward manufacturers to court.
The Medical Device Amendment Act in 1976 gave the agency the power to approve medicines and devices before they could be used by the public, and created the Good Manufacturing Practice regulations that ensure quality design, manufacturing, labeling, testing, storage and distribution standards.
All of this was very important to mdi Consultant’s founder, Alan Schwartz, who joined the FDA as a field investigator in 1972 after earning a biology degree and completing graduate studies in regulatory affairs at the City College of New York – a direct education in producing safe and effective products.
In 1978, Schwartz used his unique skills and experience to launch his firm on Long Island, specifically to help medical device, pharmaceutical, biotech and food companies achieve and maintain regulatory compliance.
To this day, Schwartz (currently the company’s executive vice president) and colleagues use the GMP standards to construct and review an organization’s document and production systems, emphasizing safety and effectiveness while not only allowing for variations among types of products – devices, drugs, food – but encouraging innovation.
Their broad coverage includes categories as different as pills and X-ray machines. The medical device and pharmaceuticals markets, of course, are international today, and each country has its own “FDA” – so mdi Consultants collaborates with partners in other regions to better understand divergent regulatory rulings as it directly consults with firms around the world.
There is a movement to harmonize various global standards, because most devices and drugs these days service international clientele. In 2024, the FDA aligned itself with the International Organization for Standardization’s 13485 Medical Device Quality System, which – like U.S. regulations – emphasizes risk analysis, traceability and communications issues, and takes a similar stand similar to the FDA’s on non-conforming products.
Alan Schwartz: Do the right thing.
Schwartz’s company has a firm grip on all of this. To date, mdi Consultants has helped more than 500 companies achieve FDA and/or ISO certification and has successfully prepared and submitted 1,800-plus FDA pre-market applications.
Schwarz himself is often called as an expert witness before legislative and legal proceedings.
Despite myriad changes in how products and pharmaceuticals are researched and manufactured, and how they function, it’s a classic case of the more things change, the more they stay the same, according to the scientist and successful entrepreneur.
“In the 47 years since mdi Consultant’s creation, the product and therefore regulatory environment has grown infinitely more complex, with artificial intelligence, cybercrime, Software as a Medical Device and the burgeoning international environment,” Schwartz says. “But our goal is still the same – helping our clients get safe and effective products to our patients and medical professionals.”
Tom Mariner is the executive director of Bayport-based Long Island Bio.
