Our Services
Lingeman & Smith Medical provides engineering services that help medical device teams reduce uncertainty, shorten learning cycles, and make better technical decisions earlier in development.
Our services span the full product lifecycle—from early R&D through production sustainment and continuous improvement—unified by a single goal: generate high-quality, clinically relevant data that enables confident action.
-
Competitive & comparative benchmarking
User needs development & design input specifications
Design output definition and drawing/specification development
Risk management, FMEAs, and hazard analyses
Design selection support, verification & validation testing
-
New test method creation or legacy method modification
Method verification, validation, and revalidation
Design, fabrication, and qualification of custom fixtures and gauges
Gage R&R and measurement system analysis (MSA)
-
OEM–Design Owner and supplier relationship support
Process development, characterization, and validation
In-line and off-line inspection method development
Process and inspection equipment design, build support, and qualification
Manufacturing transfer, scale-up, and production line duplication support
Yield improvement and variation reduction for existing manufacturing processes
-
Competitive, prototype, regulatory, or clinical-support testing on devices, assemblies, and components
Mechanical, physical, and visual inspection testing
Novel and application-specific product performance assessments
Data analysis, interpretation, and technical reporting
-
Quality system development, implementation, and remediation
Design control and risk management support (FDA 21 CFR 820, ISO 13485)
Test method and process validation documentation support
Supplier quality and qualification support
Internal audit support and readiness assessments
Quality planning support across the product lifecycle, from development through production and sustainment
Change control and CAPA support
Our Approach: Integrated Product Development
Product design, testing, process development, and quality are deeply interconnected. When these activities are approached in isolation, teams often generate data that answers the wrong questions—or answers the right questions too late. Our work is guided by a simple principle: better data, generated earlier, leads to better decisions and smoother execution downstream.
Integrated Product Development is the framework that enables this approach. Rather than treating design, testing, manufacturing, and quality as separate phases, we evaluate them together—using data to inform decisions before they become difficult or expensive to change.
In practice, this means:
Translating clinical and user needs into measurable performance metrics
Evaluating multiple design concepts quantitatively before committing to a single path
Identifying key performance drivers and sources of variation early
Generating data that carries forward into manufacturing, verification, and validation
The same approach applies to legacy products already in production, where performance limits, variability, or reliability concerns must be understood before meaningful improvements can be made.
Clients often don’t experience Integrated Product Development as a methodology—they experience it as fewer surprises, faster decisions, and more confidence at every stage of development.