Accomplished, Creative, Results-Oriented Executive

Tessa Yamut is an accomplished, creative, results-oriented executive. She has assisted numerous medical device companies in finding ways to rapidly introduce their medical devices into the clinic globally. Tessa particularly enjoys helping emerging companies efficiently navigate complex regulatory pathways and relies on a cost-efficient approach to clinical trial design and execution. She focuses on relationships in her negotiations with regulatory agencies and depends on her network of experts in clinical operations to build lean and dynamic teams. These strategies often result in rapidly securing medical device approvals for various indications.

Tessa started her career in the medical device industry approximately 30 years ago. She quickly realized her passion for innovation during her first year and appreciated the complex regulatory pathway in securing approvals. It was essential to her that patients continue to have access to less invasive procedures and devices for treating their diseases. She realized that she could help make this happen by assisting entrepreneurs in navigating through these regulatory hurdles by creatively formulating and executing regulatory and clinical strategies that would rapidly introduce these devices into the clinic and the market.

One of the companies Tessa has assisted is Applaud Medical, Inc., which has developed a breakthrough medical device technology, Acoustic Enhancer, which provides new methods for treating kidney stones. Thomas Kenny, Ph.D., a Stanford Engineering professor and Applaud co-founder & CEO, says, “Hiring Tessa Yamut was one of the most important and best early decisions that I made. I will always remember how she spent her first day with us getting on the plane to join our meeting with FDA and immediately contributed to negotiating some key elements of clinical study design for the company’s first pivotal clinical trial.

After that, her negotiations with FDA rapidly secured our first approval, which was instrumental in our ability to complete our Series B financing and keep the company moving forward. Tessa has been an effective advisor and mentor to key employees as all of us prepared for our most important trial. She quickly formed solid relationships with members of our team and found ways to leverage their individual skills and experiences, which helped realign the company to accomplish several big milestones: securing funding, the approval, launch and completion of the company’s first pivotal clinical trial.”

After the company secured its FDA approval, Tessa had a monumental task ahead of her. She needed to make moves to establish the company’s 3 critical departments, Regulatory, Clinical, and Quality Affairs, even as we were still working to close our financing. She initiated negotiations with vendors, contractors and clinical sites and gathered a lean and efficient team to be ready to spring into action as soon as the financing was closed. “It took this team less than 4 months from the arrival of our funds to reach the milestone of treating our first subject in the trial – an astonishing accomplishment for an FDA-regulated, US Pivotal trial initiated during the pandemic!” adds Thomas.

“Tessa’s leadership style is based on hiring qualified and experienced veterans, delegating responsibility and authority to make decisions regarding their deliverables, including reducing bottlenecks, watching closely and providing guidance and help at each step. She also took the time to recognize achievements and provide public praise. Through these methods, she built a loyal and dedicated team that pulled together and did amazing things.”

One of the achievements that Tessa is most proud of is the development and implementation of regulatory strategies that allowed the company to initiate and complete its first pivotal clinical study with a very lean operation and within the limited confines of its budget while working through a pandemic. Instead of delegating operations to an external Clinical Research Organization (which can be expensive and unwieldy), Tessa drew from her extensive network of experts and practitioners that she has worked with over decades of experience in medical device companies. “I strive to build a team of known performers who I can trust and will understand how to quickly find their role within the trial team and efficiently deliver on the tasks needed for success in our clinical study,” explains Tessa.

Two of Tessa’s best mentees, Vijaya Krishnamoorty, Ph.D., and Alexandra Kraenzlin, M.S., now Directors of Regulatory and Clinical Affairs, recently shared their views about the strategic leader. Dr. Krishnamoorty recounts, “Tessa is a motivational and empowering leader! When I first met her, she had just started as Vice President of Clinical Affairs at a new company. I was new to the medical device industry, but she recognized the transferability of my prior academic clinical research experience, valued the regulatory coursework I had undertaken and hired me as an entry-level consultant. As her responsibilities at the company expanded, under her leadership, mine did too as I grew into higher positions within a short time.”

Dr. Kraenzlin says, “I experienced Tessa as an exceptional leader and mentor who has helped me grow both, personally as well as professionally by encouraging me to take actions on my own, thinking out of the box and learning how to be creative when it comes to problem-solving while, at the same time, still being available to provide the needed support. I always felt trusted and that my opinion was valued.”

As a seasoned veteran, creative, results-oriented executive with 30 years of experience in the medical device industry, Tessa’s innovative approach and unique negotiation skill set have helped numerous companies secure clinical and regulatory approvals for Class I, II, and III medical devices globally. She is a frequently invited speaker and has spoken at the Silicon Valley Life Sciences Summit with Dr. Thomas Fogarty, a serial medical device entrepreneur, to discuss overcoming regulatory, clinical, and reimbursement challenges emerging companies often face. She was also a member of MedTech Cardio’s 2012 Advisory Board, where she advised compliance strategies to design and develop cutting-edge cardiovascular devices.