Medical device companies’ demand for clinical evidence has upsurged like never before. Professionals want to see more clinical data before and after approving marketed devices. This task often lies on the shoulders of Contract Research Organizations (CROs), such as NAMSA, a global company providing Sponsors with trusted end-to-end development services.
Driven by its global regulatory expertise and in-depth therapeutic knowledge, NAMSA is dedicated to accelerating medical device product development, offering only the most proven solutions to move Clients’ products through the development lifecycle efficiently and cost-effectively as possible.
NAMSA is the industry’s premier, trusted partner for successful development and commercialization outcomes: from medical device testing to regulatory, reimbursement, quality consulting, and clinical research services. NAMSA employs over 1,700 Associates across 20 locations throughout the Americas, APAC and the EU.
An Inspirational Journey
In 1967, a glass manufacturer in Toledo, Ohio approached a clinical laboratory to test polymeric materials for pharmaceutical container testing. Dr Theodore Gorski, a scientist-entrepreneur, recognized the opportunity and accepted the project.
By following methods outlined in the United States Pharmacopeia, he successfully performed the requested testing. Thereafter, Dr Gorski established Science Associates, a Contract Research Organization (CRO) focused on medical device and materials testing. Nearly a decade later, the United States Congress authorized the U.S. FDA to regulate medical devices.
By that time, North American Science Associates (NAmSA) had already developed a testing matrix to assure the biological safety of medical devices and materials, which was later incorporated into the Tripartite Guidance, TC194 and is part of today’s ISO 10993 requirements.
Over the last several years, while regulations have continued to evolve and become more complex, NAMSA has proudly played an integral role in developing domestic and international standards for testing medical devices, materials, and In Vitro Diagnostic (IVD) products. In addition to medical device laboratory testing, NAMSA’s services have grown to include regulatory, reimbursement, quality consulting, product development strategy and clinical research solutions.
These service additions have helped pave the way for NAMSA to become the industry’s premier choice global manufacturers seeking CRO services—offering established, strategic solutions throughout the full development continuum—to allow Sponsors to fast-track commercialization efforts while achieving time and cost efficiencies in every major market of the world.
Guided by Strategic Leadership
Dr Christophe Berthoux began his career in the healthcare industry in 1990 with Charles River Laboratories, an international company dedicated to early-stage development and safe manufacture of novel drugs and therapeutics. Throughout Dr Berthoux’s 19-year career at Charles River, he held several leadership positions, ultimately serving as Executive Corporate Vice President of Global Sales and Marketing and Chief Commercial Officer.
Following this, he acted as the Chief Executive Officer of Synexus, a firm assisting global medical device Sponsors with patient recruitment for clinical trials and research site challenges.
In March 2021, NAMSA named Dr Berthoux Chief Executive Officer (CEO), where he brought his many talents and expertise in the areas of strategic vision, M&A, diversification, operations and leadership of global, multicultural teams.
Today, his dedicated focus is on supporting NAMSA as the world’s leading full-continuum MedTech Contract Research Organization (CRO), including growth through significant outsourcing deals and helping Clients understand the incredible benefits of working with a partner that provides full-service development solutions under one roof.
“NAMSA provides unparalleled medical device testing capabilities, strategic guidance and tactical support to fast-track market introduction of innovative MedTech products around the world. I’m excited to work with a team committed to helping Clients overcome development hurdles, mitigate concerns, streamline commercialization efforts and deliver exceptional outcomes throughout every stage of the development journey,” Dr. Berthoux stated.
“I’m inspired by the work our global team of 1,700+ Associates conducts each and every day and the direct impact it has on accelerating the delivery of life-saving medical technology and improving healthcare outcomes around the world,” he concluded.
Dr Berthoux is a Doctor of Veterinary Medicine and also holds an Executive MBA from Purdue University and a Microsurgery Degree from Lyon Medical School-Alexis Carrel.
A Well-Planned Product Development Process
While elaborating on development and testing in the healthcare industry, Dr Berthoux observes, “In the product development process, a key, essential factor is creating a robust Product Development Plan and executing that plan.”
He further explains that it should integrate the key pillars of medical device commercialization, including manufacturing and prototype development, regulatory and quality requirements, preclinical and clinical research, reimbursement, and scientific communications to receive regulatory approval based on expected launch/market introduction markets.
One of the most critical factors in the testing process is compliance with global regulatory requirements. This can be highly challenging for MedTech Sponsors due to constantly shifting global regulatory environments. The risks of non-compliance are several: significant time delays, increased cost and potential market erosion from competitive product entry.
In addition, experience is a key factor of success for any testing laboratory. At NAMSA, the organization utilizes over 55 years of experience in assisting Clients with virtually every development hurdle/obstacle to help them achieve success. Based on this experience and real-world knowledge, NAMSA offers only the most proven development solutions to allow Clients to achieve cost-efficient, timely, successful development outcomes.
Flexibility is critical to product development and testing. While this sounds contradictory in a highly regulated environment, it is because of the intense scrutiny that flexibility is necessary. Starting with a well-thought-out plan is the first step, but then once data is produced, understanding the implications and acting quickly is the key to success.
The device development process takes a considerable amount of time in the best-case scenarios. Still, when unexpected challenges arise, NAMSA moves swiftly to address each situation and provide a path forward that will set the stage for safe, accelerated and effective market introduction.
Dr Berthoux concluded by stating, “while patient safety is everyone’s goal, the regulators must be satisfied first. Sometimes, the only solution is doing more testing or having extensive written justifications. A company must know when and how to apply these tools.”
Catering to the Global Medical Industry
The medical device testing industry continues to grow. It has a positive outlook as MedTech companies focus on product development of new and innovative devices to drive growth, revenue and profitability.
A key driver of success in the product development process is speed-to-market. Today, many companies are experiencing launch delays as the market is still recovering from COVID-19-related demand, placing extreme constraints on Sponsors’ internal resources and those of their outsourced development partners (including the global testing industry).
As a result of this increased demand, companies are observing delays of weeks to months in certain parts of their projects that could be weeks to months in duration. NAMSA is acutely aware of the current global constraints on the laboratory testing market and continues to be committed to doing their part to find a resolution. This has been done by making significant investments in both NAMSA’s future and the future of the medical device industry through the continued adoption of technology, service advancements and expansion of global laboratory capacity.
Integration of Technological Know-How
When speaking about the inculcation of technology, Dr Berthoux asserts, “Advances in technology are changing how testing is accomplished.” He further states that early in silico models can rule out certain materials very early in the process, so time and effort are not spent on biological testing. In vitro testing models are continuing to evolve, replacing animal testing. And last, improvements in chemical characterization approaches are leading to better quantitative safety assessments and the avoidance of in vivo testing in certain cases. These shifts provide more actionable data that allow for early and better product development decisions.
For the Product Development Process:
The advancement and increased use of technology in the MedTech marketplace certainly impact the product development process. Software as a Medical Device (SaMD), use of Artificial Intelligence (AI), Human Factors Engineering and cybersecurity—to name a few—are creating significant improvements in saving and improving human lives.
However, these advancements also create challenges for MedTech Sponsors and the global regulatory institutions that are continually evolving requirements to keep pace with the rapid change in technology. As a result, MedTech companies need to closely monitor and understand these regulatory changes and quickly adapt product development plans to ensure success in such an environment.
Dr Berthoux believes, “At NAMSA, we maintain a dedicated team of regulatory and testing experts specifically focused on such issues to ensure we are at the forefront driving international regulatory requirements, as well as implementing those requirements for Clients so they may streamline the product development process and be equipped with the necessary tools for success.”
Complexities on the Way
Today, NAMSA has significant opportunities in the growing MedTech CRO space. Many of today’s challenges are similar to those seen in most areas of the global MedTech market, which include high demand (many COVID-19 related), limited global capacity, supply chain constraints and a limited pool of qualified talent.
Additionally, the growing complexity of both medical devices and testing that is required to suitably address safety and efficacy in a changing regulatory environment means that capacity is a critical management point. The complexity of testing can demand more resources and time; for example, chemical characterization today identifies far more chemical entities than the basic screens conducted a mere five years ago.
Note Worth Remembering
When Dr Berthoux was asked about his advice to budding entrepreneurs, he suggested, “Invest in multi-disciplinary education and spend time understanding how all of the various testing modalities contribute to the overall understanding of safety and efficacy.”
He further asserted that this should also be balanced by a rock-solid foundation in understanding testing guidance and how the regulatory decision-making process is achieved. It is imperative to understand that regulatory bodies need high-quality data and insightful and detailed analysis of that data.