The road to bringing a medical device to market is fraught with potential regulatory pitfalls and decisions that can delay—or even derail—your efforts. The choices you make regarding histopathology are especially critical to the success of your medical device program.

For companies navigating this road, overlooking the nuances of histopathology can lead to costly setbacks and inconclusive results. This is where specialized guidance becomes essential for achieving accurate data needed for regulatory success. Here are the four common procedural mistakes we see companies make when it comes to histopathology—and how you can steer clear.

Mistake #1: Delaying the pathologist meeting

If you wait too long to discuss your program with a pathologist, you could end up with a poor study design and inconclusive findings. An on-track study could suddenly be delayed, missing critical deadlines and failing to meet data requirements.

Consult with pathologists early and often. Doing so will increase your chances of a well-designed study that is robust from the start and tailored to your specific therapeutic area and modality.

Mistake #2: Leaving vendor selection to the last minute

Select your histopathology services vendor sooner rather than later. Wait too long to decide on a vendor and you’ll leave little time for protocol review, consultation, scheduling, and budgeting. Ultimately, the quality of your study will suffer.

Mistake #3: Inadequate biomarker selection

Choosing the right biomarker is fundamental to generating meaningful data. Have you identified the most relevant marker? Does your chosen method require development, or are there established markers that would be more effective?

Questions around whether you will need techniques like multi-plex staining are best answered with a pathologist's input to ensure your data meets rigorous regulatory standards.

Mistake #4: Falling short of regulatory expectations

Regulatory requirements are not static. Your Contract Research Organization (CRO) partner must stay current with evolving regulatory and international standards. A failure to do so could place your entire submission at risk.

Take a proactive approach to histopathology—and avoid the hidden risks

Many promising studies stumble due to avoidable procedural missteps. Engaging pathology experts early in the process is key to mitigating these risks and ensuring your project remains on track.

Our philosophy is to provide our clients with a head start. By reviewing projects early, we can de-risk the study, establish clear schedules, and carefully understand the objectives to deliver the precise data our clients need for a successful submission.

Our team is built to guide you through these challenges:

• Deep Expertise: We have more than 20 board-certified veterinary pathologists with experience across multiple modalities and therapeutic areas.
• GLP-Compliant Labs: Our state-of-the-art labs in the US and Germany are GLP-compliant and have the capacity for rapid turnaround times.
• Extensive Medical Device Experience: We have successfully completed histopathology for thousands of studies for class I, II, and III medical devices across various therapeutic areas.
• Advanced Techniques: We offer specialized services like micro-computed tomography, customized morphometry, and IHC on plastic-embedded tissues to provide you with the endpoints you need.
• Seamless Integration: We work as an extension of your team, easily integrating with your existing CRO to add a layer of specialization that strengthens your submission.

Case Study: From Setback to Success

A sponsor developing a cardiovascular device approached us late in their study after facing issues with tissue processing from another supplier. The project was at risk of failing to meet regulatory deadlines and data quality expectations.

StageBio pathologists immediately stepped in to rescue the study. We reprocessed the remaining samples and worked with the sponsor to develop a restructured plan that aligned with regulatory expectations. Our guidance provided critical project insights, helping the sponsor get back on track. The result was a successful submission, delivered on time and within budget, turning a potential failure into a success story.

Let’s partner up for your histopathology needs

Don't let histopathology be a hidden risk in your development pipeline. Partner with a team that has the foresight and expertise to provide you with customized medical device histopathology services. Get in touch.