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.