Chemva’s Materials Selection service combines expertise in chemistry, polymer science, biocompatibility, and toxicology to guide clients through critical material choices. We help you select the most appropriate materials based on intended use, regulatory frameworks (e.g., ISO 10993, MDR), processing methods, and long-term behavior — reducing risk and accelerating approval.

Comprehensive Materials Expertise

Chemva brings hands-on experience with nearly every major class of materials. Examples include:

• Polymers: Including silicones for flexible implants, polyurethanes for elastic components, and high performance thermoplastics like PEEK for strength and stability.
• ‍Metals: Stainless steels, titanium alloys, and shape-memory alloys (e.g., nitinol) for strength, corrosion resistance, and specialized functions.
• ‍Ceramics: Alumina, silica, and hydroxyapatite for hardness, wear resistance, and tissue integration.
• ‍Bioresorbables: Polymers like PLGA and magnesium alloys designed to safely degrade over time in the body.
• ‍Composites: Carbon-fiber reinforced polymers and polymer-ceramic hybrids for tailored performance.
• ‍Surface-Treated Materials: Drug-eluting, antimicrobial coatings and surface modifications to enhance functionality.

Manufacturing and Processing Considerations

Our materials evaluations also factor in how materials behave during manufacturing and sterilization:

• Processing: We ensure materials are compatible with injection molding, extrusion, thermal curing, UV curing, or chemical curing. We recommend optimal conditions to process a material for an intended purpose while considering the safety profile of the finished product such as amount of extractables/leachables.
• Sterilization Resistance: Materials are ensured for compatibility with steam autoclaving, gamma irradiation, ethylene oxide (EtO), and chemical disinfection.

‍

Comprehensive Material Evaluation

Every material we recommend undergoes a rigorous, multi-factor evaluation:

• Biocompatibility & Safety: Assessment for toxicity, irritation, sensitization, and extractables/leachables risks meeting ISO 10993 and FDA/MDR requirements.
• ‍Chemical Stability: Resistance to degradation from bodily fluids, medications, sterilization processes, and environmental exposure.
• ‍Degradation & Aging: Predicting material aging, mechanical property shifts, and safe degradation profiles for bioresorbable materials.
• ‍Functional Performance: Testing guidelines for strength, flexibility, fatigue life, wear resistance, and any specialized properties (thermal, optical, electrical).

Smart Vendor Qualification

We identify and qualify suppliers across a wide range of chemistries, including silicones, polyurethanes, epoxies, adhesives, coatings, excipients, and actives.
While our approach is multi-faceted, our technical evaluation includes polymerization methods, curing systems (thermal, UV, moisture), molecular weight control, additive compatibility, solvent computability, as a few examples.

‍

Supply Chain Built Around Materials
Our team understands how material behavior, performance requirements, device life cycle, shelf life, and compliance requirements impact sourcing decisions. We proactively identify potential supply limitations and secure alternative vendors or materials to protect your timelines and quality targets.

End-to-End Risk Mitigation
We manage lead times, minimum order quantities, buffer stock strategies, and logistics planning. Chemva also implements supplier change control, raw material risk assessments, and continuity plans aligned with FDA, REACH, ISO 10993, ICH, and EU MDR expectations.

‍

Global Readiness
From R&D through commercialization, Chemva supports global scale-up by coordinating with third-party manufacturers, onboarding regional vendors, and navigating shifting supply conditions.

Business Impact
With Chemva, you gain a strategic partner who understands materials, manages vendors, and builds a reliable, regulatory-ready supply chain, so you can focus on product innovation and market growth.

Degradation Analysis:

We predict and/or design studies to assess chemical and physical breakdown mechanisms, hydrolysis, oxidation, chain scission, corrosion, and UV degradation, for polymers, metals, ceramics, and composites.

‍

Mechanical Stress and Fatigue Modeling:

We design experiments to assess how materials respond to loading, flexing, and repetitive stress to prevent fatigue failures in products like catheters, stents, and wearable devices.

‍

Environmental Resistance:

We design studies to evaluate material stability under humidity, temperature cycling, UV light, bodily fluids, and chemical exposures.

‍

Sterilization Compatibility:

We predict and/or design studies to predict material changes under sterilization processes like gamma or E-beam radiation, EtO gas, autoclaving, and chemical disinfection.

‍

Shelf-Life and Aging Simulation:

We apply accelerated aging and Arrhenius modeling in our study designs to predict long-term performance, guiding expiration dating and stability claims.

‍

Benefits to Your Products

• Reduce Product Failure Risk: Predict and mitigate risks like cracking, delamination, corrosion, and leaching.
• Strengthen Product Design: Inform smarter material and structural decisions, avoiding potential failures at late stages of a product development process
• Optimize Testing: Focus validation efforts where the risks are highest, saving time and costs.

‍

Safety & Compatibility Assessments
We recommend risk-based strategies considering the extent of change and all data sources. When needed, we design Extractables & Leachables studies and perform toxicological risk assessments, suggest and material compatibility evaluations, supporting packaging, devices, and product contact components in line with ISO 10993 and related standards.

‍

Regulatory-Aligned Strategy
We align your CMC data with FDA, EMA, ICH, and EU MDR requirements. Our team prepares and reviews CMC sections for INDs, NDAs, DMFs, 510(k)s, and technical files — ensuring your documentation meets global standards and avoids delays.

‍

Scientific Justification & Risk-Based Approach
Chemva applies a risk-based CMC strategy using ISO 10993 and ICH guidelines. We help design right-sized testing plans and provide scientifically sound justifications to waive or reduce unnecessary studies, without compromising safety or compliance.

We combine chemistry and polymer science expertise to tailor adhesives and coatings that meet your device’s unique performance needs while envisioning biocompatibility and extractable toxicological profile, whether you’re prototyping a new concept or enhancing a market product.

Custom Lubricious Coatings

We develop hydrophilic, low-friction coatings that improve device usability. These lubricious coatings reduce surface friction to ease insertion of components like catheters, minimizing patient trauma and facilitating delivery​.
Our team balances lubricity and durability in coating design, so the slippery surface remains intact under use and does not shed or degrade​.
With our extended expertise, we have formulated moisture, UV, and heat cured and/or dried coating systems.

‍

Custom Adhesive Formulations

We formulate medical-grade adhesives tailored to your application. We adjust chemistry for optimal tack and bond strength.
Our adhesives are engineered for substrate compatibility, securely bonding diverse materials (plastics, metals, fabrics) without adverse reactions or delamination.
With a deep understanding of interfaces, we have developed solutions for most challenging bonding questions. 

‍