Enough Is Enough: Deciding When Your Safety Evaluation Is Complete

For any MedTech company, the goal of developing products that are both effective and safe is at the heart of their mission. But as these companies build their products, they inevitably encounter testing challenges. Comprehensive testing, while crucial, often comes with a hefty price tag and developmental bottlenecks. 

Given these constraints, it's no surprise that companies question their safety evaluation, leading them to ask: "When is enough, truly enough?" In this article, we'll provide an answer. But first, let’s explore how regulatory concerns ensure that any answer we do arrive at is likely to change sooner rather than later.

The Regulatory Landscape is Constantly Shifting — Just Like Your Safety Requirements

Over the last few years, dramatic changes to MedTech standards and regulatory requirements have placed new demands on safety evaluations. 

In the EU, for instance, MDR now mandates that qualified toxicologists lead toxicological risk assessments — previously engineers could take on this role. Recent standards updates, such as ISO 21726:2019, ISO 10993-18:2020, and ISO 10993-17:2023 further underscore these rapid changes and raise the bar of safety and efficacy. 

This evolution has introduced advanced sensitivity levels in testing, including novel considerations that didn’t exist a decade ago. As the landscape shifts, MedTech companies need to grapple with both written and unwritten, ever-changing expectations. In this environment, agility is essential for companies to remain compliant and competitive. 

Keeping pace with change is, therefore, key to aligning your product with current and future demands — and to knowing whether your safety evaluation is complete. 

Is Biocompatibility Testing or Chemical Characterization Good Enough? 

To improve efficiency, many MedTech companies wonder if biocompatibility testing or chemical characterization is sufficient to prove the safety of their products. Of course, every scenario is unique. But trying to get away with performing one test over another can leave areas of weakness in your safety evaluations.

Different testing methods are often relevant to different product development stages. For instance, material characterization — a process that’s distinct from chemical characterization — is prioritized during early research and development. At this point, testing focuses on functional concerns and finding the right material. 

As development progresses and a prototype is created, traditional biocompatibility is needed to assess biological reactions caused by extracted materials.

As the product nears its final design and before it goes to market, the focus shifts to chemical characterization. This method is key to meticulously identifying and quantifying the chemicals that a device may release, while assessing their associated toxicological risks. By revealing a device's detailed chemical profile, chemical characterization directs manufacturers to specific areas that necessitate further biocompatibility evaluation.

To Test is to Iterate

Just as a clinical investigation report doesn't equal a complete clinical evaluation report, multiple biological compatibility tests don't automatically result in a comprehensive biological safety report. These evaluations feed into broader risk assessments, leading to subsequent tests, and culminating in an overarching biological evaluation.

Ultimately, MedTech safety isn't about cherry-picking evaluations but cohesively blending them. This rigorous approach helps create bullet-proof safety evaluation reports — leading to time and cost savings as the product enjoys fewer regulatory hurdles and a faster time-to-market. 

A Checklist for Complete and Accurate Safety Evaluations

It can be difficult to determine when your safety evaluation is ready for regulatory submission. Here are some points to consider:

1. Regulatory Alignment:

• Is your testing in sync with the latest regulations and standards?
• Have you accounted for region-specific testing requirements?

2. Holistic Evaluation:

• Does your safety evaluation strategy incorporate all necessary testing, e.g. both biocompatibility testing and chemical characterization?
• Have you sidelined any testing phases or evaluations, thinking they might be redundant?

3. Expert Review:

• Do you have the right experts performing tests and evaluating the product?
• Have you consulted industry experts to validate your safety evaluation strategy?

4. Product Lifecycle Consideration:

• Have you tailored your testing approaches according to the product development stages?
• Are you capturing the right data at each stage of product development?

5. Continuous Regulatory Monitoring:

• Are you updated with the latest changes in standards and regulations?
• Have you set up mechanisms to keep pace with evolving regulatory expectations, both written and unwritten?

6. Future-proofing Your Processes

• Are your safety evaluations robust enough to withstand anticipated regulatory shifts in the near future?
• Is your approach proactive, ensuring your product remains relevant and compliant in the years to come?

How RQM+ Can Help You Submit Complete Safety Evaluations

The MedTech regulatory ecosystem is anything but static. Ensuring products conform to current standards isn't just about meeting present-day requisites; it's about foreseeing shifts and being prepared for the future. 

This is where RQM+ can help. As a full-service CRO, RQM+ provides a seamless pathway to accelerate the MedTech product journey from concept to commercialization.

Our comprehensive testing, analysis, and validation services to support regulatory compliance while minimizing delays in product development. This, in turn, minimizes risk to both end users and your company, thereby protecting your brand and reputation for the long haul.

From designing a comprehensive safety evaluation strategy and performing lab tests to preparing and submitting the biological evaluation report, our expert Lab Services team can help you develop complete safety evaluations. 

Don’t let regulatory challenges hold you back. Contact our team now to find out how we can support your safety evaluation process.