Taking an Engineering-First Approach to Medtech Innovation—A Medtech Makers Q&A

By Sean Fenske, Editor-in-Chief

The medical device manufacturing industry is increasingly utilizing engineering support to accelerate product development and shorten development cycles. As a result, contract manufacturers are expanding their engineering capabilities to better position themselves as CDMOs. Other supply chain partners have also incorporated this into their offerings to ensure they are meeting OEM needs.

Some companies have supported this for some time, well before the more recent trend. They’ve embraced an engineering-first approach to guarantee decisions are made early that will enable a smooth transfer from design to manufacturing. This strategy also ensures the most critical aspects of a product design are identified and addressed before becoming more expensive challenges later.

To help further explain the benefits of an engineering-first approach, Sean Kramer, Applications Engineer at MicroLumen, participated in this interview. In the following Q&A, he explains what this approach is, why it can be valuable to medical device manufacturers, important considerations, and how it smooths the pathway through manufacturing.

Sean Fenske: What is an engineering-first approach in terms of product development? What does that mean exactly?

Sean Kramer: At MicroLumen, our engineering-first approach starts by bringing together medical device engineers and our in-house team of applications engineers at the very beginning of every project. By fostering collaboration from the outset, we focus on solving customer challenges and developing customized tubing solutions rather than promoting existing products.

Fenske: Why does the MicroLumen team prefer to approach projects in this way? What benefits are realized?

Kramer: Our engineering-first sales approach increases the likelihood of customer success. Our team works efficiently to provide accurate quotes, reduce project risk, and identify potential design challenges early in the development process. By leveraging our engineering expertise, we help align tubing characteristics with our customers’ desired outcomes, including material selection, reinforcement options, and in-house manufacturing capabilities, with typical responses within 24 hours.

The result is a more transparent, responsive, and collaborative experience for our customers. They gain direct access to technical expertise from an engineering team with nearly four decades of experience, helping accelerate development, improve design outcomes, and streamline the path to production.

Fenske: Are customers involved in this approach? If so, how? What is their feedback on this approach

Kramer: All our projects begin by defining the boundary conditions and performance requirements of the desired lumen design. These requirements may include anatomical dimensions, sterilization temperatures, and mechanical properties such as flexibility and kink resistance.

Customers consistently value our engineering-first approach because it provides direct access to technical experts, fast response times, and collaborative problem-solving. This is especially beneficial for startups seeking FDA approval, helping reduce design iterations, lower development risk, and accelerate time to market.

Fenske: Does an engineering-first approach consider manufacturing aspects such as design for manufacturability, testing, and automation?

Kramer: MicroLumen achieves some of the tightest tolerances possible through our engineering-first approach. From the initial review, our team thoroughly evaluates the limitations of our manufacturing processes as well as our suppliers’ capabilities, from custom assemblies to mandrel wires. This enables us to identify potential concerns early and collaborate with customers to develop solutions.

Fenske: Does an engineering-first approach complement related activities such as the regulatory submission and commercialization strategies? If so, how?

Kramer: Most regulatory submissions require that the manufacturing processes used to produce our tubing are validated and proven to be repeatable. This is why the initial manufacturability assessment we perform is critical. Ultimately, a product that cannot be manufactured consistently will not successfully pass Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) validation requirements.

Fenske: Are there ways for a company to prepare before approaching you with a project to be ready for an engineering-first approach? What are the best practices?

Kramer: Customers should come prepared to discuss key requirements such as inner diameter, outer diameter, wall thickness, mechanical properties, and validation requirements. The best way to get started is through our sample request form. Our team will review your application, discuss validation requirements, and often provide free R&D samples within 24 hours.

Fenske: Do you have any additional comments you’d like to share based on any of the topics we discussed or something you’d like to tell medical device manufacturers?

Kramer: MicroLumen works closely with customers to determine whether we are the right partner for their project or if an alternative supplier would be better suited to meet their needs. I encourage engineers in the medical industry to reach out to our team. We are always eager to discuss your designs, understand the challenges you’re facing, and explore how our in-house manufacturing capabilities and global supplier network can help bridge those gaps and support your success.

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