Top 5 Testing and Development Tips for Medical Device Manufacturers

Bringing a medical device to market isn’t just about innovation—it’s about precision, compliance, and confidence in your product’s safety and performance. Whether you're launching a novel device or scaling production, there are critical areas where manufacturers can stumble. That is where Broughton comes in.

As a global Contract Research Organisation (CRO), we work with companies worldwide to ensure medical devices are robustly tested, regulatory-ready, and commercially viable. Based on our experience, here are the top five testing and development tips to help you avoid common pitfalls and bring your device to market.

1. Get Serious About Biocompatibility Early

Biocompatibility is not just a regulatory checkbox—it is about patient safety. Many companies underestimate the complexity of ISO 10993 compliance, especially when multiple materials or complex devices are involved.

What to do
Start biological evaluation planning during early development. Consider not just toxicity but also irritation, sensitisation, and degradation pathways.

How Broughton helps
We support clients through extractables and leachables testing, degradation and chemical analysis, and ISO 10993 compliance strategy, minimising unnecessary studies and fast-tracking approval.

2. Don’t Underestimate Material Interactions

It’s not enough to select the right materials—you need to know how they will behave in the real world. Sterilisation, ageing, and exposure to biological fluids can compromise safety and performance.

What to do
Evaluate material compatibility with sterilisation methods (e.g. gamma, ethylene oxide) and assess long-term stability under real-world use conditions.

How Broughton helps
Our scientists conduct comprehensive stability studies, sterilisation compatibility assessments, and ageing tests, ensuring your materials are fit for purpose from production to end use.

3. Build Resilience Into Your Supply Chain

Even the best device design can fail if components vary from batch to batch. Inconsistent suppliers, inadequate traceability, or overlooked process variability can lead to product failures, or regulatory non-compliance.

What to do:
Establish robust supplier qualification and traceability systems. Audit processes regularly and validate critical manufacturing steps.

How Broughton helps
We offer support aligned to ISO 13485 requirements, helping clients qualify suppliers, establish traceability protocols, and document compliance across the supply chain.

4. Validate Processes Before You Scale

As you scale up, manufacturing errors become magnified. Validating your production processes and conducting rigorous QC testing is essential for consistency, performance, and compliance.

What to do
Design validation studies, implement QC testing at batch release, and ensure your analytical methods are properly developed and validated.

How Broughton helps:
We provide method development and validation, in-process and final product QC testing, and full documentation support, so your production process is reliable and repeatable.

5. Ensure Scalability Doesn’t Compromise Safety

Balancing cost, efficiency, and compliance is one of the biggest challenges when moving from pilot to commercial scale. If you cut corners here, you risk recalls, delays, or regulatory enforcement.

What to do:
Plan for scalability from the start. Choose partners who can support you through development, validation, and commercial rollout.

How Broughton helps:
We take an integrated approach, combining regulatory insight, advanced analytical testing, and scalable study protocols. Whether you need stability storage, E&L studies, or regulatory submission support, we are with you every step of the way.

Let’s Bring Your Device to Market—Safely and Confidently

Every development journey is unique, but the need for reliable, compliant, and science-led support is universal. At Broughton, we offer a flexible, collaborative partnership tailored to your product and your goals.

Contact us to speak with our medical device experts and explore how we can support your development and testing needs.