Shawn Leo Hunsaker, MBA, has been honored by Marquis Who’s Who as founder and chief executive officer of Wolfe International Consulting LLC, where he specializes in helping medical device companies navigate complex regulatory challenges.
Mr. Hunsaker brings extensive experience from his role as senior vice president of global quality operations at Getinge from 2019 to 2023. Additionally, he filled the role of head of quality and regulatory compliance for the Getinge ACT business unit. During this period, Mr. Hunsaker played a pivotal role in steering Getinge through one of the most challenging chapters in its operational history. Under his quality and operational leadership, the company successfully navigated complex consent decree challenges while maintaining operational stability amid rigorous FDA oversight. His strategic guidance ensured continued compliance and organizational health, even as the company faced sustained regulatory scrutiny.
Prior to his tenure at Getinge, Mr. Hunsaker served as vice president of quality compliance at Philips PCMS division from 2017 to 2019, also managing extensive enforcement actions. His impact was profound: in 2019, he received the prestigious CEO Leadership Award from then-CEO Franz von Houten, recognizing his transformative contributions to quality improvement across the organization.
“My passion for this work comes from witnessing firsthand how medical devices successfully brought to market save lives,” Mr. Hunsaker shared. “That personal connection drives everything I do in this industry.” His commitment to safety and efficacy remains the cornerstone of his strategic approach and professional execution.
What sets Mr. Hunsaker apart in the consulting world is his deep, longstanding relationships within the FDA. These connections—earned through years of collaboration across multiple organizations—have become invaluable assets in his advisory practice. One FDA colleague jokingly remarked that he must have a “personality disorder” for his continued willingness to engage with companies facing serious enforcement challenges. But for Mr. Hunsaker, these relationships are a source of insight and influence – a testament to his unwavering dedication to complex cases where others might retreat. These experiences allow him to provide clients with insights that go well beyond standard regulatory guidance.
Mr. Hunsaker emphasizes that execution—not just strategy—is the true differentiator in regulatory success. “Companies need partners who understand both the technical requirements and the human dynamics of compliance,” he said. “A clear strategy is meaningless if it can’t be executed effectively and result in safe products reaching the hands of medical professionals.”
Through a blend of technical expertise, regulatory insight, and unwavering commitment to patient safety, Mr. Hunsaker continues to shape the future of medical device quality and compliance—one company at a time.
Mr. Hunsaker has outlined a clear trajectory for his professional engagement, planning to remain actively involved in consulting and business development for at least another decade. This sustained commitment ensures continuity for clients requiring long-term regulatory guidance and demonstrates his ongoing dedication to the medical device industry. He is currently engaged with Reliant Life Sciences LLC as an executive consultant operating globally from the greater Boston area.
Following this active consulting phase, he intends to transition his focus toward volunteer efforts, which he plans to pursue for the remainder of his career, including non-profit, education, and youth programs. This progression reflects his broader commitment to service that extends beyond commercial consulting into community contribution.
About Marquis Who’s Who®:
Since 1899, when A. N. Marquis printed the First Edition of Who’s Who in America®, Marquis Who’s Who® has chronicled the lives of the most accomplished individuals and innovators from every significant field of endeavor, including politics, business, medicine, law, education, art, religion and entertainment. Who’s Who in America® remains an essential biographical source for thousands of researchers, journalists, librarians and executive search firms around the world. The suite of Marquis® publications can be viewed at the official Marquis Who’s Who® website, www.marquiswhoswho.com.
