CBSET Expands Leadership Team, Welcoming Michael C. John as Chief Regulatory and Innovation Officer (CRIO)

New role expands CBSET’s offerings to include professional consulting and FDA regulatory advisory services, and accelerates strategic diversification into new sectors

LEXINGTON, Mass.--(BUSINESS WIRE)--CBSET, a leading provider of translational research and product development services for the medical device, pharmaceutical, diagnostic, and biomedical research industries, is excited to announce the hiring of Michael C. John as Chief Regulatory and Innovation Officer (CRIO).

A New Regulatory Consulting Business and Expanded Service Offerings
In this new, dual role, Michael will be responsible for the development of a new Regulatory Consulting Business Unit that expands CBSET’s offerings to include professional consulting and FDA regulatory advisory services for IND, PMA, 510(k), and other regulatory submissions. His leadership will empower expansion of CBSET’s service offerings through targeted acquisitions and strategic partnerships, enabling CBSET to provide more comprehensive, end-to-end solutions for clients.

Michael brings more than three decades of experience to this critical role, including medical device R&D, regulatory strategy, and product development. This includes leadership roles at MedTech and regulatory consulting companies, and more than a decade at the FDA, where he served as Chief of the Interventional Cardiology Devices Branch (ICDB), supervising multi-disciplinary teams of scientists, engineers, biologists, statisticians, medical officers, consumer safety officers, and health care professionals, and holding signatory authority over a wide array of 510(K) and Class III (PMA) medical devices.

Expanding CBSET’s Reach within the Healthcare Ecosystem
“We are excited to welcome Michael to our leadership team as we continue to expand our global services,” said Peter M. Markham, CBSET President and CEO. “With Michael’s proven expertise in advanced medical technologies, FDA regulation, and Class III product development, we are poised to launch a premier regulatory offering and suite of testing services that will guide clients through every stage of the product lifecycle.”

“We have long admired Michael and are thrilled to have him join CBSET,” said Elazer Edelman, MD, PhD, CBSET Co-founder and Board Chairman. “He brings inspired vision, a legacy of achievement, and rich powers of leadership that will help propel CBSET to even greater heights in serving the development of advanced medical therapies.”

“CBSET has earned its distinguished position in the MedTech space for its academic rigor, technical expertise and scientific leadership, and is ideally positioned to offer an unparalleled scope of clinical, scientific and regulatory expertise to clients,” noted Michael. “I am honored to join CBSET at such a transformative time, and I look forward to helping the company increase its reach within the healthcare ecosystem through expanded service offerings and new strategic acquisitions and partnerships.”

About CBSET
Founded in 2006, CBSET is a leading Boston-area provider of translational research and product development services for the medical device, pharmaceutical, diagnostic, and biomedical research industries. In 2025, CBSET secured funding with Arlington Capital Partners to build new research and innovation facilities (>100,00 sq. ft) in Waltham MA, scheduled to open in Q4, 2026 (learn more about CBSET’s expansion). The company offers a broad range of GLP and non-GLP research services to the medical device, pharmaceutical, and biotech industries and is recognized globally for shortening product lifecycles and time-to-market for novel innovations. For more information, visit cbset.com and follow CBSET on LinkedIn.

About Arlington Capital Partners
Arlington Capital Partners is a Washington, D.C.-area private investment firm specializing in government-regulated industries. Focused on the aerospace and defense, government services and technology, and healthcare sectors, the Firm partners with founders and entrepreneurs to build platforms of strategic importance to national priorities. Operating in markets with high barriers to entry, Arlington looks to partner with organizations within these industries that save lives, improve effectiveness, and reduce costs. Since inception in 1999, Arlington has invested in approximately 200 companies, raised over $14 billion in committed capital and is currently investing out of its $6 billion Fund VII. For more information, visit Arlington’s website at www.arlingtoncap.com and follow Arlington on LinkedIn.