With over three decades of experience, Insight’s President and CEO, Lauren Baker, is a recognized leader in clinical research, regulatory affairs, and biomedical engineering.
Before founding Insight, Lauren was the owner and CEO of Boston Biomedical Associates (BBA), a consulting firm specializing in clinical research and regulatory strategy for emerging medical technologies. BBA was acquired in 2018 and now operates as Avania LLC, a global contract research organization (CRO). Prior to that, she led the corporate clinical research group at Boston Scientific, overseeing global clinical trial operations and establishing a dedicated team to support regulatory, preclinical, and engineering aspects of IDE filings.
Lauren began her career in academia, serving as a research assistant professor in Cardiac and Vascular Surgery at the University of Massachusetts Medical School and as a professor of Mechanical Engineering at Worcester Polytechnic Institute. Her deep expertise spans cardiovascular, neurovascular, orthopedic, gastrointestinal, and genitourinary therapeutic areas, with a special focus on biologics, including cell and gene therapy.
A licensed professional engineer, Lauren holds a PhD and MS in Mechanical Engineering with a concentration in Biomedical Engineering, as well as a BS in Chemical Engineering, all from Worcester Polytechnic Institute.
Jake Martz brings over 25 years of experience in MedTech finance and operations to his role as Business Manager and CFO at Insight Medical.
He began his career at Boston Scientific, where he supported global expansion through finance integration for acquisitions, international start-up operations, SAP system implementation, and internal control initiatives in response to Sarbanes-Oxley. His broad expertise includes financial leadership, systems implementation, and strategic growth support.
Before joining Insight Medical in 2022, Jake served as CFO of Boston Biomedical Associates, a global CRO, where he led finance and business operations and established an international unit in Tel Aviv. He also supported the company’s acquisition by a Netherlands-based private equity group and continued as U.S. VP of Finance for the newly formed Avania LLC.
Jake holds an MBA from the D’Amore-McKim School of Business at Northeastern University.
As VP of Program Management, Kristin Goppel leverages her strong engineering and management background – which includes MedTech and biotech experience in R&D, facilities engineering, process engineering, and operations – to support the development and execution of medical device and drug product programs across a broad range of therapeutic areas.
Kristin focuses on ensuring strategic alignment of multiple parallel projects that support a Sponsor’s preclinical, clinical and commercialization programs. This includes program plans and timelines, stakeholder and resource management, risk management and performance monitoring. In her leadership role, Kristin collaborates closely with Insight’s Quality, Regulatory, and Clinical Operations teams, contributing to cross-functional project success and organizational growth. She is known for her ability to translate complex technical challenges into actionable strategies that drive innovation and compliance.
Kristin holds a Bachelor of Science in Chemical Engineering from Cornell University. She is committed to ensuring access to life science education and has served in executive leadership roles on the Board of Directors for the MassBioEd Education Foundation (MassBioEd) for almost 10 years.
Dr. Jennifer Sahatjian serves as VP of Clinical Operations at Insight Medical Consulting, bringing over 20 years of experience in managing clinical trials across a broad range of therapeutic areas, including cardiovascular, critical care, neurovascular, gastrointestinal, gynecology, and diagnostics. She oversees a team that includes clinical project managers, monitors, data managers, safety managers, and statisticians.
Jennifer began her MedTech career at Boston Biomedical Associates (BBA) and has since held senior leadership roles at both early-stage startups and global organizations. She served as Global Director of Medical Affairs for Baxter Healthcare’s Medical Delivery and Acute Therapies Business Unit and has successfully led clinical operations at multiple early-stage medical device companies, contributing to acquisitions by major firms including Hologic Inc. and Baxter Healthcare.
Jennifer holds a PsyD and master’s degree in Clinical Psychology and began her career specializing in psychological assessment before transitioning into clinical research after attending the University of Massachusetts Medical School in 2004. She earned her bachelor’s degree from Tufts University with dual majors in Psychology and English. A dedicated medical writer, she has authored more than 40 publications throughout her career.
Dr. Elaine Chiquette is a C-Suite life science industry executive who has over 25 years of academic and industry experience. She first graduated from Laval University (Quebec, Canada) and later completed her doctorate and post-doctorate in epidemiology at University of Texas Health Science Center (San Antonio TX). She held a senior position at the San Antonio Cochrane Center during which time she co-authored the first evidence-based NHLBI (National Heart Lung and Blood Institute) Obesity Guidelines. She has since held positions of increasing responsibility at Hofmann-La Roche, Aventis, Amylin Pharmaceuticals, Aegerion and, lastly, Gelesis where she was Chief Scientific Officer.
Dr. Chiquette has worked on numerous first-in-class metabolic drug, biologics and device assets that have spanned rare orphan disease through to diabetes and obesity. She has authored multiple peer-reviewed publications, meta-analyses, and book chapters. She is currently CEO of a life science consultancy that focuses on the clinical, regulatory and medical needs for both device and drug products.
Wanda Carpinella brings over 30 years of regulatory and quality expertise to her role as Head of QA/RA at Insight Medical Consulting. With a strong scientific background in chemistry, pharmacology, and toxicology, she has built a distinguished career supporting MedTech companies and contract research organizations across a broad range of technologies and therapeutic areas. Wanda is highly skilled in developing innovative regulatory strategies for FDA and EU submissions, with deep expertise in Class II and III medical devices. Her experience spans therapeutic areas including Interventional Cardiology, Electrophysiology, Urology, Dialysis, Neurology, Venous Access, and Oncology, as well as electromechanical devices incorporating software and cybersecurity.
A seasoned leader, Wanda routinely oversees complex regulatory engagements and negotiations with global health authorities, helping clients navigate and de-risk the path to commercialization. Under her leadership, Insight’s QA/RA team supports the full spectrum of regulatory documentation, including bench testing plans, risk analyses, device technical specifications, and global submissions to agencies such as the FDA, EU Notified Bodies, TGA, and Health Canada.
Prior to joining Insight Medical Consulting, Wanda held key regulatory roles at AngioDynamics, Navilyst Medical, and Boston Scientific. Most recently, she served as Vice President of Regulatory Affairs at Avania. She holds a Bachelor of Science in Toxicology from Northeastern University.
Mark Gosnell is a seasoned regulatory and clinical affairs consultant with over 30 years experience, including start-ups and large medical device companies. His consulting supports a diverse portfolio of U.S. and international medical device companies. His expertise spans preclinical, clinical, and regulatory strategy for complex cardiovascular technologies including structural heart, mechanical circulatory support, electrophysiology, and peripheral vascular. He is also experienced with orthopedic, renal, diabetes, and drug-device combination products.
With a strong focus on early-stage development, Mark has played a pivotal role in shaping strategies for Early Feasibility Studies (EFS) and First-in-Human (FIH) trials, while also planning and implementing pivotal trial designs. He has successfully negotiated with the FDA and international regulators to streamline regulatory pathways and reduce clinical and approval burdens, accelerating time to market for novel cardiovascular technologies.
Mark is also adept at building strategic relationships across the medical device ecosystem, working closely with scientific advisory boards, external opinion leaders, and clinical investigators to guide product development and study execution.
He holds a Bachelor of Science in Zoology from the University of Wisconsin.
The Insight Medical team understands the complexities involved in navigating regulatory and clinical pathways and have demonstrated success in all areas of the product development ecosystem.
We are your strategic partner, dedicated to optimizing your product’s path to market from concept to commercialization. We are guided by a shared mission to deliver innovative therapies to patients, and we are committed to achieving this goal with the highest levels of efficiency and effectiveness.
