A Strategic Response to a Competitive Threat
Discover how we supported a client with a strategic competitive threat response when a competitor’s product launch posed a significant threat to their market position.
GOOD STORIES
Facing the risk of costly reclassification or losing critical marketing claims or product functionality, a client's need for a compliant, high-performance material solution became urgent. Our scientific consultants delivered a targeted material reformulation that ensured MDR compliance - while also reducing costs and improving performance.
THE CHALLENGE
Due to the EU Medical Device Regulation (MDR), a client was required to reclassify their Class I devices as Class III to maintain intended use and marketing claims. This regulatory shift presented two feasible options:
To preserve market position and product functionality, the client chose to pursue the second option – and brought in our scientific consultants to lead the material reformulation.
OUR APPROACH
Leveraging deep expertise in polymer science, MDR regulations, clinical applications, and persistence in the lab, we applied a structured innovation process that delivered more than just compliance.
Our multidisciplinary approach ensured the reformulated device not only met the requirements of MDR but also improved performance and reduced the cost of goods sold (COGS).
By combining technical understanding with strategic foresight, we enabled the client to move quickly and confidently – turning a regulatory challenge into a competitive advantage. What followed was a four-phase process, from initial formulation in the lab to full-scale implementation.
To enable rapid experimentation and clinical relevance, we established lab-scale production and testing facilities, including capabilities for accelerated aging. Our team designed and validated custom preclinical test methods aligned with the device’s intended clinical performance.
We conducted an in-depth review of academic research and patents to map the physico-chemical properties critical to the device’s function. Through targeted lab testing, we connected these material properties to measurable device performance, identifying a shortlist of high-potential candidates for formulation.
Using a data-driven, iterative approach, we formulated and tested multiple material compositions to quickly learn and refine. We evaluated the IP landscape to ensure freedom to operate, then optimized the final formulation to balance cost, performance, and regulatory requirements.
To support future growth, we benchmarked the device’s performance against competitors and aligned clinical evidence with unmet user needs. This positioned the client for expanding on the clinical claims while ensuring full MDR compliance, supporting documentation, and scale-up for production.
THE RESULTS
The result was a fully reformulated material composition that not only met MDR Class I requirements but also delivered measurable business and product benefits:
Ready to Future-Proof Your Medical Devices?
Our science-driven regulatory solutions are built to help MedTech innovators stay ahead. Whether you’re facing MDR challenges or exploring materials for next-gen products, we can help.
Reach out to Daniel to start a conversation.
Daniel Hansen
Scientific Senior Consultant
Material reformulation is the process of altering a medical device’s material composition to meet updated regulatory requirements, such as those in the EU Medical Device Regulation (MDR). When devices are reclassified to higher-risk categories — for example, from Class I to Class III — stricter safety, performance, and biocompatibility standards apply. Reformulation allows manufacturers to maintain product functionality, preserve market claims, and remain compliant, while also creating opportunities to improve device performance and reduce costs.
Reformulating for MDR Class III compliance involves several challenges: meeting rigorous safety and performance standards, validating materials through laboratory and clinical testing, navigating intellectual property constraints, and balancing compliance with cost targets. Failure to address these challenges effectively can result in lost market approval or reduced device claims. Engaging experts in regulatory strategy and material science helps mitigate these risks while keeping projects on schedule.
Polymer science allows manufacturers to fine-tune material properties — such as flexibility, tensile strength, and chemical resistance — to meet both regulatory standards and clinical performance needs. This targeted approach can improve patient outcomes; support expanded claims and strengthen a product’s competitive position in the MedTech market.
Developing a compliant, market-ready material formulation typically involves four stages: setting up laboratory and testing capabilities, mapping material properties to device performance requirements, conducting iterative formulation and testing, and aligning clinical claims with performance data. This process ensures that the final formulation meets MDR Class III requirements, is safe for its intended use, and can be scaled efficiently for production.
Strategic reformulation can lower costs by identifying materials that are more affordable yet meet or exceed regulatory and performance requirements. By optimizing sourcing, simplifying manufacturing processes, and eliminating over-engineered specifications, companies can achieve a cost-effective material solution that maintains quality. In many cases, reformulation also creates patent opportunities, offering additional competitive and financial benefits.
