In the world of medical device development, not all pathologists are created equal. While many can competently read slides and generate reports, truly exceptional preclinical pathologists offer something far more valuable: comprehensive expertise that spans from initial concept through regulatory submission.
For medical device innovators today, among the limited pool of device pathologists, only a handful possess the knowledge and ability to guide a device from early research and development through final GLP studies. Most pathologists work in isolation, receiving prepared slides without understanding the broader context of device development, animal model selection, or the critical decisions that occur long before tissue reaches their microscope.
This knowledge gap becomes particularly problematic for startups and companies developing novel devices. When no predicate device exists, when established animal models don't apply, when the very nature of the innovation requires creative problem-solving, that's when the difference between a competent slide reader and an exceptional preclinical pathologist becomes a substantial competitive advantage in overall cost-efficiency, quality and velocity to market.
In addition to the minimum requirements of test results interpretation and report writing, exceptional preclinical pathologists help create the conditions for meaningful results. This means working alongside surgical teams and interventionalists to develop animal models for devices that have never been tested before. It requires hands-on surgical skills, from complex 90-minute procedures like maxillary artery dissection to developing entirely new approaches for novel device categories.
Consider the challenge of testing a stroke intervention device designed to navigate vasculature and extract clots. The animal model for this application was originally developed for atherectomy catheters in the 2000s, but adapting it for modern stroke devices requires deep understanding of both the historical context and the unique requirements of the new technology.
Related reading: The Strategic Science of Optimal Preclinical Model Determination, Selection and Development.
In preclinical research and medical device testing, success hinges on finding a preclinical model that strikes the right balance between scientific rigor and operational feasibility. You need a model that mimics human anatomy and physiology just enough, without adding unnecessary complexity, cost, or time. Check it out.
The foundation of reliable results begins at necropsy. Exceptional pathologists understand that errors at this stage cannot be corrected downstream, potentially requiring expensive, time-consuming study repetition. This expertise extends to understanding biomaterial processing requirements: knowing whether a device component can withstand paraffin processing or requires plastic embedding, testing processing parameters to prevent melting or crushing delicate test articles, and ensuring that tissue harvesting preserves both device integrity and biological response.
Perhaps most importantly, exceptional preclinical pathologists serve as strategic advisors on study timing and design. They understand the critical difference between rushing to GLP studies and taking the measured approach through R&D and pilot studies that ultimately leads to success. Preclinical pilot studies refine or validate models and techniques, including necropsy, so that the high cost GLP study has a high likelihood of success including cleanliness of data ‘extraction.’ This guidance prevents the costly mistake of premature GLP studies or regulatory submissions that result in rejections and expensive restarts.
The most valuable preclinical pathologists have the ability to shepherd companies through the complete development arc. Some of them have founded and built innovative medical device companies with histories of successful commercialization or exits themselves.
This begins with R&D work [non-GLP], where animal models are developed and refined, where device-tissue interactions are first characterized, and where fundamental questions about safety and efficacy are addressed.
From there, they can guide the transition to pilot studies, often small, focused investigations that validate the approach before committing to large-scale studies. Only after this careful progression do they support the definitive GLP studies that form the backbone of regulatory submissions.
This comprehensive approach is about both scientific rigor and a business’ success regardless of its size or legacy. Companies that work with pathologists who understand this complete journey are more likely to achieve their milestones, maintain their funding, and ultimately bring their innovations to the market successfully.
Exceptional preclinical pathologists think beyond individual studies to build lasting partnerships with innovators. They understand that medical device development is rarely a single study but rather a series of investigations that evolve with the device and the company's understanding of its application.
These relationships often span years, following devices through multiple iterations and companies through growth and expansion. The pathologist who helps develop the initial animal model for a startup's first device becomes the trusted advisor for subsequent products, and the relationships built during early-stage development often extend throughout entire careers as team members move between companies.
For medical device innovators, particularly those developing novel devices without clear predicates, partnering with truly exceptional preclinical pathologists represents a strategic advantage that extends far beyond report quality. It's about working with professionals who understand the complete innovation ecosystem, who can anticipate challenges before they become costly problems, and who can guide companies through the complex journey from concept to regulatory submission, approval or clearance and commercial success.
The difference between competent and exceptional in preclinical pathology is comprehensive understanding, strategic thinking, and the ability to be a true partner in the innovation process. Evaluate your prospective preclinical pathology providers carefully and demand validation of excellence.
About the author: James "Butch" Stanley, DVM, MS, DACVP is Vice President of Research Pathology. He possesses over 23 years of experience and expertise in the preclinical assessment of medical devices, including protocol review and writing, the development of the necropsy procedures and techniques necessary and required for the novel/emerging technologies and the histopathological processing and assessment of medical devices for regulatory submission. Pathology may be the last step in the preclinical process, but the pathologist is one of the first person medical device developers should consult.