Preclintox Services, LLC
Simplifying Biological Evaluation of Medical Devices

Dr. Randy D. White, Ph.D., has spent the majority of his career in preclinical testing, working in and with major medical device and start-up companies. Dr. White is also the author of numerous publications and is a recognized content expert in toxicology domain. Dr. White has been involved with the International Standards Organization (ISO) for medical devices through the Association for the Advancement of Medical Instrumentation (AAMI) and has co-authored various ISO 10993 guidelines. This engagement speaks volumes of his vast experience in biological safety and risk assessment of medical devices. After spending four decades in the medical device industry, Dr. White observed that new medical device companies often misinterpret or have difficulty understanding the ISO 10993 standards. Companies often consider the ISO 10993 regulations as a checklist and fail to thoroughly understand and interpret them. Though some aspects of ISO 10993 are relatively straightforward, others often require specific expertise, which many device manufacturers lack. This lack of understanding results in regulatory compliance challenges that impede device development processes. Inspired to utilize his experience and guide medical device manufacturers, Dr. White founded Preclintox Services, LLC. Preclintox Services is a consultant group that provides consulting services on medical device toxicology, supporting product development, and empowers manufacturers to conduct safety evaluations in line with the general principles of ISO 10993. The company specializes in animal model development, toxicology and efficacy testing, biocompatibility testing, risk assessment, chemical characterization, and more.

Many MedTech companies are challenged with the chemical characterization of their devices and the associated procedures. The inconsistencies in the regulatory requirements and various auditors exacerbate the problem for sponsors.

Preclintox Services Has 150 Years of Combined Experience and is Still Counting

“Our group has 150 years of combined experience. We understand the requirements placed on our clients and the strategies needed to efficiently satisfy those requirements,” says Dr. White.

He has been a member of the Society of Toxicology and the American College of Toxicology for over three decades and was a member of the U.S. Technical Advisory Group for ISO/TC194 for over two decades. His company has successfully managed inquiries and concerns presented by regulatory agencies and notified bodies by evaluating the products and formulating suitable strategies.

By adhering to the steps suggested in the ISO 10993 standard, Preclintox Services enables clients to execute toxicity and biocompatibility testing, chemical characterization, and risk assessment of medical devices. This includes conducting gap analysis and determining the tests and information data sets needed for product evaluation and regulatory compliance.

“Whether it is for new or legacy devices, we conduct a gap assessment to help clients execute efficient strategy for safety evaluation and reporting. Along the way, we focus on the current requirements of ISO 10993, including chemical characterization and revisions in biocompatibility testing,” elaborates Dr. White.

Since each medical device has a unique use, Preclintox Services suggests focused compliance strategies that require minimal effort and achieve maximum regulatory compliance. For companies that have not begun safety evaluation planning, Preclintox Services helps design the most efficient planning/ strategy for safety assessment and reporting. For others, who have already begun their journey, Preclintox Services evaluates their strategies and supplements them with consultation services for gap analysis, planning, reporting, and audit resolution.

Due to their vast experience in the industry, the consultants are adept at troubleshooting and interpreting the reasons for test failures and the steps needed to ensure a successful evaluation.

Since the latest edition of ISO 10993 mandated specific testing— namely chemical characterization within risk management assessment—legacy medical device manufacturers may be required to do additional testing or update testing for existing devices. Preclintox Services also helps these companies conduct mandated tests and ensure regulatory compliance with their devices. With such a customercentric and systematic approach to resolving compliance challenges, Preclintox Services has been involved with the safety and development of hundreds of medical devices. Dr. White has personally interacted with over 300 device companies, guiding them through biocompatibility testing programs, analytical studies, toxicological risk assessments, and auditor inquiries.

Preclintox Services has mastered the art of ‘minimum requirements for maximum safety’ and enables its clients to ensure efficient compliance with ISO 10993 by conducting minimum additional testing. On several occasions, Preclintox Services has helped clients conduct gap assessments for their medical devices and justify not conducting additional testing. The company has also helped numerous clients formulate strategies for the safety evaluation of their devices.

KISS–Keep It Simple, Sponsors

What sets Preclintox Services and its client engagement strategies apart from other consulting companies is its adherence to the KISS principle.

KISS (Keep It Simple, Sponsors) is the cornerstone of Preclintox Service’s operation, and the company strongly upholds this principle. “If the compliance process is too complex, people don’t understand it. So we keep it simple and formulate strategies that are logical and easy to comprehend,” adds Dr. White. This simplification eliminates the confusion of medical device companies while attempting to comply with ISO 10993 and its 20+ parts. Having experienced the primary challenges associated with medical device safety evaluation, ISO 10993, and regulatory agencies, Preclintox Services enables its clients to cover the existing regulatory requirements of different auditors and addresses anticipated regulatory queries. The KISS principle allows manufacturers to streamline their biological evaluation processes and generate results that justify product compliance.

Staying abreast of the latest industry trends, Preclintox Services has a firm understanding of chemical characterization and the inadequacies of current analytical methods. The company is focused on helping its clients address those deficiencies and navigate the CRO and analytical testing landscape.

Preclintox Services is experienced in the EU MDR biocompatibility gap assessments, remediation, and preparation of chemical characterization toxicological risk assessments. It is evident that Preclintox Services, with its highly skilled and veteran industry experts, will help medical device manufacturers navigate the mercurial medical device landscape with cost-effective, timeeffective, and user-friendly evaluation approaches.