LM Design, LLC

Engineering support from concept to commercial

Precision Engineering for Medical Devices

Engineering Services Offered

Concept Development

New product designs and unmet clinical needs take shape through collaboration with clinicians and marketing teams, translating early concepts into preliminary design inputs based on user requirements, risk analysis, and regulatory pathways.

Verification & Validation

Formal test protocols generate objective evidence that a device meets its design specifications (verification) and fulfills its intended use and user needs (validation), covering planning, test method development, execution, and reporting.

Design for Manufacturing & Test

Optimizing device designs for cost-effective, reliable, repeatable production and testing at scale requires working closely with supply chain and manufacturing teams to select materials, processes, tooling, and test methods while preserving design intent and performance.

Risk Management

CAD Design

Risk management activities are developed and maintained throughout the product lifecycle, including preliminary hazard analyses, design and process FMEAs, and risk management plans, identifying potential failure modes early and ensuring mitigations are verified and traceable through to final design.

Detailed 3D models and 2D engineering drawings of components and assemblies ensure designs adhere to GD&T standards and manufacturing requirements.

Process Development

Building the future state of manufacturing means detailed process flows, critical input/output identification, and robust analyses (e.g., DOE) to optimize processes and ensure consistent compliance with product specifications and quality requirements.

Feasibility Evaluations

Preliminary research, proof-of-concept testing, and material assessments determine the technical viability of a new device concept, often through rapid prototyping and small-scale lab testing to mitigate early-stage risk.

About me

I'm Stewart MacLean, and LM Design is my mechanical engineering practice. I work across the full development arc: concept, design, risk, and verification, translating what clinicians and patients actually need into designs that hold up in production.

My project experience spans surgical instruments, drug delivery, fluid management, catheters, in vitro diagnostics, and durable electromechanical equipment. Clients range from early-stage startups building their first device to established manufacturers scaling an existing line.

Based outside of Boston in beautiful Acton, Massachusetts.

Please reach out for additional information or to discuss your engineering support needs

info@lmdesignllc.com