Alan Schwartz is a visionary leader and globally recognized expert in FDA regulations and qualification assurance. Based in Great Neck, New York, United States, Alan has transformed his expertise into a thriving consulting career, guiding organizations through the intricacies of regulatory compliance. With over 53 years of diverse experience and a proven track record of success, he leads MDI Consultants as the President/Founder at MDI Consultants Inc., delivering innovative solutions that drive growth and ensure regulatory excellence. Under his leadership, MDI has emerged as a go-to partner for companies seeking guidance on FDA Regulatory Matters, ISO Certifications, and more.
The Remarkable Transition to Consulting and Entrepreneurship
Alan’s transition from the FDA to consulting was inspired by a desire for the business world and a need for excitement. He joined the FDA in the spring of 1972, shortly after graduating from college, when the country was in the midst of a recession. With limited job opportunities available for biology majors, Alan chose the FDA over the Museum of National History, despite having no prior knowledge of the agency’s mission and functions.
On his first working day, Alan found the FDA’s purpose and identified a consulting opportunity in this field. He grew rapidly, starting as an investigator at the GS-5 level and becoming a supervisor within 5 ½ years. After 6 years and 4 months, Alan resigned from the FDA and started his consulting.
Before leaving the FDA, Alan considered several options, including transferring to another FDA office, joining the FDA in Washington, or taking on a regulatory or quality management role in a corporation. However, his business minded nature and desire for excitement led him to pursue entrepreneurship. The expertise and knowledge earned during his tenure at the FDA, mainly as a supervisor, proved invaluable for his future consulting work with clients.
The Early Inspiration: Shaping Professional Values
Alan believes that working with the FDA helped shape his professional values, mainly learning how to deal with companies during inspections. Dealing with different companies, different management styles, and their problems taught Alan valuable lessons about compliance and solid communication. Being on the other side of the table during meetings between the companies and the FDA, he realized many small companies had no idea what the FDA was trying to say or understand the Agency’s mission and how to comply.
This insight presented an opportunity to start a consulting career, capitalizing on the new medical device regulations introduced in 1976, the Good Manufacturing Practices for Medical Devices went into effect in the spring of 1978. The shift from working at the FDA to consulting allowed for a fresh perspective on the industry, and it became clear that numerous companies need expert guidance to navigate regulatory needs.
Mentoring Rising Professionals
MDI Consultants’ approach to mentoring rising professionals involves hands-on experiences through internships. Students who were getting an advanced degree in regulatory affairs assist senior consultants with research, client communication, and follow-up, building confidence and skills.
Students learn how to deal with government agencies and their staff and get things done. In some cases, the firm has provided several interns full-time positions as well, harnessing their experience and skills gained during their internship to excel as consultants.
Effective Leaders in Regulated Industries
Effective leaders in regulatory industries focus on compliance and collaboration with regulatory agencies like the FDA. According to Alan, one can learn more from companies that face hurdles than from those that generally avoid challenges. A major differentiator is management’s approach to regulatory needs and their willingness to address problems immediately. Unfortunately, like everything in life, FDA inspections are not uniform. For some reason, some companies get inspected every two years, and others may not have an FDA visit for many years.
Navigating FDA Challenges
MDI Consultants has observed that companies with small problems can escalate them into major issues when dealing with the FDA. This often occurs when companies become “arrogant” and attempt to outmaneuver the agency. In contrast, companies that acknowledge their issues and approach the FDA with a willingness to address them can often negotiate impactful solutions.
Top management’s understanding of regulatory needs and commitment to compliance are essential. When management is listening to their regulations and quality team, they can maintain an efficient quality system and reduce FDA-related issues. A collaborative approach with the FDA, instead of an adversarial one, generally generates better results.
Alan’s Leadership Style over the Years
Alan has refined his approach over the decades, and these years have given him a good sense of how to deal with problems and work with company management to make them understand that he has seen their problem before and they can get this situation solved and remedied.
Years of experience have taught Alan the value of patience and confidence in navigating regulatory challenges. This approach has proven to be effective when dealing with smaller companies and less experienced management teams.
A Legacy of Teamwork and Success
MDI Consultants’ greatest achievement stems from building a strong team and reputation over the years. The company’s team-oriented approach has fostered long-term relations, with some members working for over three decades. MDI Consultants’ achievement is also marked by its support in obtaining FDA 510(k) clearance for over 3,500 medical devices, supporting companies in navigating complex regulatory processes and avoiding disastrous situations.
The Evolution of MDI Consultants’ Goals
When MDI Consultants entered the consulting landscape, survival was the primary objective. Over 47 years, the company has developed a strong marketing campaign and social media presence, attracting new leads and showcasing its expertise.
MDI Consultants’ history of success with the FDA and proven track record make it challenging for competitors to match its reputation. The company’s ability to harness its past success has enabled it to stand out in its field.
Navigating Global Regulatory Alignment
MDI Consultants has witnessed notable shifts in the regulatory landscape due to increased alignment between global regulatory agencies like the FDA and EMA. This harmonization streamlines the entire process for global companies.
With 53 years of regulatory experience, MDI Consultants’ seasoned consultants stay updated with the latest changes, providing clients with informed guidance and support. The firm helps companies navigate the international market by understanding and addressing regulatory nuances.
Emerging Technologies in Compliance Strategies
MDI Consultants recognizes the transformative role of emerging technologies, including AI, in reshaping compliance strategies. With extensive experience navigating the regulatory landscape for AI-driven devices, MDI Consultants has obtained 510(k) clearance for innovative products.
A primary obstacle is educating sponsors about the limitations of AI devices, which assume numerous indications for use without extensive studies. The firm offers hand-holding throughout the regulatory process, assuring clients understand the necessity of targeted studies for particular indications.
MDI Consultants’ expertise positions the firm as a trusted partner for companies looking to bring cutting-edge technologies to the market.
Making Way for a Unified Regulatory Framework
The US FDA is moving towards a unified regulatory framework, evident in its acceptance of the MDSAP certification in lieu of their audits. The FDA is now planning to revise the 21CFR820, QSR/cGMP to align the terminology with the ISO13485 standards (which is also found in the MDSAP). This will definitely pose challenges for smaller companies to understand and implement. Another key trend is the growing importance of validating software used in AI-driven devices that will need a solid validation process to ensure safety and efficacy and pass FDA review to market.
The New Horizons for Success
With more than 53 years of FDA regulatory expertise, Alan has been recognized worldwide for his work as an expert witness for many legal cases involving FDA-related issues. Having testified in cases globally, including a remarkable appearance in London, he continues to leverage his experience in diverse legal matters. His potential future project may include writing a book about his experiences as a consultant and an expert witness and sharing insights into his career and travels worldwide.