In medical device development, it’s easy to focus on the visible challenges—performance specs, manufacturability, clinical integration. But hidden within every polymer, coating, and adhesive lies a quieter, often underestimated risk: the migration of chemicals from materials into the human body.
These are known as extractables and leachables (E&L), and for medical device OEMs, they’re more than a regulatory checkbox. They’re a frontline risk to patient safety, product approval, and long-term brand trust.
What Are Extractables and Leachables, Really?
Let’s demystify the terms.
Extractables are compounds that can be pulled from materials under exaggerated conditions—think high temperatures or aggressive solvents.
Leachables, on the other hand, are what actually migrate out during real-world use. They show up in the bloodstream, tissues, or fluids of patients during normal operation of a device. Leachables are, in effect, a subset of extractables—less theoretical, more consequential.
Both matter. Both are scrutinized by regulators. And both must be addressed long before a product reaches a clinic or hospital.
The Regulatory Reality
Global regulatory agencies are putting increasing pressure on manufacturers to demonstrate chemical safety. The FDA’s latest draft guidance on chemical characterization emphasizes a more thorough accounting of materials, testing methods, and toxicological risk—all framed by ISO 10993-18 standards. This isn’t just about ticking regulatory boxes. The goal is to avoid the real-world risk of adverse reactions or material degradation that could undermine device efficacy or harm patients.
And the market is responding. The extractables and leachables testing industry, once a niche analytical service, is projected to top $2.5 billion by 2030, growing over 15% annually. That’s not a coincidence. It’s a reflection of how complex medical devices—and their regulatory expectations—have become.
Where This Leaves OEMs
Here’s the tricky part. Many device developers assume that extractables and leachables testing is a last-mile concern—something for the quality team to handle once prototypes are done. But waiting that long is a mistake. If material selections or bonding agents are flagged during testing, design timelines get pushed, validations fail, and costs balloon.
That’s why the most strategic OEMs bake E&L thinking into the earliest design phases. This doesn’t mean running full toxicological studies on day one—but it does mean choosing component suppliers who understand the chemical profile of their materials, and who can flag potential red flags early.
The Role of Component Suppliers Like MET
At Medical Extrusion Technologies (MET), we don’t offer extractables and leachables testing ourselves. That’s the domain of specialized analytical labs. But our work is deeply tied to the E&L profile of the final device.
We produce high-performance plastic tubing that becomes part of catheter systems, fluid delivery sets, and minimally invasive surgical tools. The polymers we use—PEBAX®, TPU, Nylon, HDPE—are selected and processed with an understanding that they’ll be part of a larger biocompatibility equation.
OEMs often come to us with specific material requirements driven by their E&L strategy. Others ask for guidance on what materials are most stable under gamma sterilization, or least likely to interact with drug coatings or blood chemistry. In those moments, we’re not just extruding tubing—we’re helping de-risk regulatory reviews.
Tips for OEMs Navigating E&L
Getting E&L right isn’t the responsibility of a single team or partner—it’s a cross-functional effort. From materials scientists and design engineers to testing labs and extrusion suppliers, every contributor plays a role in ensuring chemical compatibility and patient safety. All of these companies can, and should, play nice in the sandbox to produce safer, smarter medical devices. That collaboration starts with clarity and foresight.
Following are four practical ways OEMs can navigate extractables and leachables strategically:
- Design with the end in mind. If your device requires long-term implantation, drug delivery, or blood contact, assume E&L requirements will be stringent—and design accordingly.
- Engage suppliers early. The sooner you loop in component manufacturers like MET, the easier it is to align material selection with testing strategies.
- Don’t wait on toxicology. E&L studies can take months. Start them as early as feasible, and coordinate your test methods with FDA or Notified Body expectations.
- Be ready for surprises. Some leachables don’t appear until stability studies are well underway. Work with testing partners who can detect unknowns using high-resolution mass spectrometry.
Why It All Matters
Extractables and leachables don’t just live in the lab. They show up in FDA approval letters, in hospital procurement criteria, and—ultimately—in patient outcomes. OEMs that treat E&L as a core design parameter, not a post-hoc fix, will bring safer, faster-to-market devices to life.
And while MET doesn’t perform E&L testing, we are a critical link in that safety chain. The polymers we extrude are where many of these chemicals originate—or are safely avoided. That’s why we engage with E&L implications from day one.
Ready to talk about extrusion strategies that support your material and regulatory goals? Start a conversation with MET today.
