Lingeman & Smith Medical (LSM) is an engineering services firm supporting medical device teams across research & development, quantitative testing, manufacturing development, and quality management.

Founded in 2013, we help organizations reduce technical uncertainty and make better decisions earlier in the product lifecycle by generating high-quality, actionable data that connects design intent, manufacturability, and clinical performance.

Our team brings deep experience in urology and minimally invasive devices, including leadership roles in large OEM development environments and more than a decade supporting global medical device manufacturers through LSM. We operate with a strong commitment to confidentiality and do not publicly disclose client names or proprietary programs.

How We Work

We believe product performance, manufacturability, and measurement capability must be developed together—not sequentially.

Too often, teams move forward on limited data, discover issues late, and respond with unnecessary complexity.

At LSM, we practice integrated product development—connecting design choices, process capability, and verification strategy into a single development path. Quantitative evidence is used early and consistently to clarify tradeoffs, reduce rework, and support confident decisions across distributed development and manufacturing environments.

Differentiators

Product development, testing, process development, and quality are deeply interconnected. Decisions made in isolation often create downstream complexity.

Whether engaged early in R&D or supporting teams already in production, our focus is always the same: clarify uncertainty and enable action.

  • We are not a test house generating one-off results. Our platform-led approach isolates drivers of performance and variation so downstream solutions can be simpler and more robust.

  • When time, parts, and budget are constrained, more testing is not the answer. More powerful data is. We focus on clarity, fidelity, and confidence—often with smaller sample sizes.

  • We deliver complete data products structured for reuse in design history files, regulatory documentation, and manufacturing decisions

  • Strong physician relationships and access to a procedural hospital environment allow us to connect engineering data to real clinical context early in development.

eTRAVIS™ - Integrated insight platform

Our work is supported by a right-sized mix of in-house laboratory capabilities. When simple solutions are sufficient, we keep things simple. For more complex questions, our work is enabled by eTRAVIS, our adaptable test-bed platform.

Best thought of as a breadboard for physical device testing, eTRAVIS allows finished-good clinical performance to be measured quantitatively and then correlated to subassembly performance that predicts it—reducing unknowns and accelerating convergence.

Confidentiality & Trust

Much of our work involves highly competitive programs. We view discretion as a core value and apply the same rigor to protecting client IP as we do to generating data.

Quality System Alignment

LSM operates a quality management system aligned with FDA 21 CFR Part 820 and ISO 13485:2016. We support quality system installation, enhancement, and remediation, helping teams navigate regulatory expectations across regions while keeping engineering work practical and aligned.

Who We’re a Good Fit For

  • Teams making important decisions with unclear data

  • Organizations seeking to reduce risk without unnecessary complexity

  • Groups that value high-quality data over high-volume testing

  • Teams responsible for sustaining or improving manufacturing processes

Let’s Talk

If you’re facing a development or production challenge that feels harder than it should be, we’re happy to start a technical conversation.

Contact us