Medical Devices
Medical Device Chemical Characterization & Extractables and Leachables
BU Insights supports medical device programs with chemical characterization, extractables and leachables studies, analytical problem solving, and development-stage scientific support. We help teams generate relevant data, investigate unknowns, and build a defensible analytical understanding of materials, components, packaging, and product-contact systems.
Service Overview
From chemical data to scientific decisions
This page is designed for medical device and product-contact material programs where chemical characterization is central to biological evaluation, risk assessment, product development, change control, and regulatory documentation. Our role is not limited to routine testing. We support study design, analytical execution, interpretation, and technical problem solving so that results can be used in context.
Where appropriate, BU Insights can support work that references the ISO 10993 family and other applicable medical-device expectations for chemical characterization and biological evaluation. That support is provided carefully and contextually, without making blanket claims of compliance, certification, or regulatory outcome.
Core Scope
What this page covers
- Chemical characterization of medical devices and components
- Extractables and leachables study design
- Analytical evaluation threshold assessment support
- Organic chemical characterization
- Inorganic and elemental characterization
- Volatile and semi-volatile characterization
- Unknown constituent identification
- Material and packaging characterization
- Degradation product characterization
- Residual and cleaning-related analytical studies
- Biocompatibility-related analytical support
- Biological evaluation and toxicological assessment support where appropriate
- Biological Evaluation Plan and Report support
- Medical device regulatory analytical support and risk assessment support
Capabilities
Analytical support across the device lifecycle
Chemical characterization
We support chemical characterization of finished devices, subassemblies, components, raw materials, packaging, and product-contact materials. Programs may include targeted and non-targeted analytical approaches, comparative characterization, and investigations tailored to intended use, contact duration, route of exposure, and material composition.
Extractables and leachables
BU Insights develops extractables and leachables strategies that are specific to the device, material system, and development question. This can include extraction study design, solvent selection, exaggerated and simulated extraction rationale, sample preparation strategy, and analytical plans for organic, volatile, semi-volatile, nonvolatile, and elemental constituents.
Unknown identification
When unexpected peaks, unresolved signals, or unidentified constituents appear, we support structured unknown assessment and identification workflows. The goal is to move from raw analytical observations to practical scientific understanding that can inform toxicological review, risk assessment, and development decisions.
Material and degradation studies
We support characterization of polymers, elastomers, adhesives, coatings, inks, colorants, additives, and other material systems, including degradation product characterization and comparative assessments related to aging, sterilization, processing, reformulation, or supplier change.
Residual and cleaning studies
Analytical support may also extend to residual analysis, process-related residues, and cleaning-related studies where device manufacture, reprocessing, or product-contact conditions require a clearer understanding of chemical carryover or surface-associated constituents.
Elemental and inorganic characterization
Where appropriate, we support inorganic and elemental characterization for metals, catalysts, pigments, fillers, and trace constituents that may be relevant to material understanding, impurity assessment, or broader biological evaluation programs.
Approach
How BU Insights supports E&L and characterization programs
1. Define the analytical question
We begin with the device, materials, patient or product contact scenario, development stage, and intended use of the data.
2. Design the study strategy
Study design may include extraction rationale, analytical evaluation threshold considerations, analyte classes, controls, and reporting expectations.
3. Generate and interpret data
We support analytical execution, data review, unknown assessment, and interpretation in a form that is useful for scientific and regulatory teams.
This approach is intended to support practical decision making rather than producing isolated test outputs. It is especially valuable when teams are addressing complex materials, multiple components, change control, product development, or questions arising during biological evaluation.
Biological Evaluation Support
Support for biological evaluation, toxicology, and risk assessment
Chemical characterization data often needs to connect with broader biological evaluation activities. BU Insights can support analytical portions of programs that feed into biocompatibility-related assessment, toxicological review, and risk assessment workflows where appropriate.
- Analytical support for Biological Evaluation Plan and Biological Evaluation Report development
- Data packages intended to support toxicological assessment by qualified specialists
- Risk-based interpretation support for extractables, leachables, residuals, and degradation products
- Analytical input for packaging and product-contact material assessments
- Scientific support for medical device regulatory documentation and technical responses
References to ISO 10993 and related medical-device standards should always be applied in the context of the specific device, contact scenario, and regulatory pathway. Our content and support are therefore framed carefully and do not imply universal applicability or guaranteed regulatory acceptance.
Typical Applications
Programs we commonly support
- Patient-contact devices and components
- Fluid path materials, tubing, connectors, seals, and reservoirs
- Single-use systems and product-contact assemblies
- Packaging and barrier material characterization
- Supplier change and material equivalence studies
- Sterilization, aging, and degradation-related investigations
- Cleaning validation-related analytical questions
- Failure investigation and unexpected analytical findings
Need a scientific partner for device characterization?
Talk with BU Insights about your medical device, material system, packaging, or product-contact challenge. We can help shape a practical analytical strategy grounded in scientific characterization and development-focused problem solving.