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Design Services
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Accelerating design & development
The success of your interventional medical component or device starts in the earliest stages of design. Our goal is to partner with you to design and develop a component or device that meets your requirements and can be manufactured at your target product cost. Our vertically integrated Centers of Excellence allow us to iterate quickly during development and offer deep technical expertise in a single partner, simplifying your supply chain.
Fast & flexible
Our customers tell us that we’re faster and less bureaucratic than other companies. As a midsize partner with a small-company approach, we have the agility to make and execute decisions quickly, as well as the ability to work flexibly.
  • We’re open to co-developing from scratch or working with your existing design.
  • We invite you to come to our labs and work with us on prototype builds, prototype testing, test method development and product assessment.
  • We delight in developing IP for our customers — and you retain the IP.
Vertical depth & an integrated approach
Our Centers of Excellence give you access to all the technologies you need for your interventional medical component or device, from molding and extrusion to micromachining and laser processing. This vertical integration speeds the prototyping process and streamlines your supply chain. Our Centers of Excellence also give you access to world-class R&D labs and experts with decades of experience to help solve your toughest medical device challenges. With 12 facilities and the brain power of more than 250 NPD/NPI engineers, we have the resources to rapidly scale to meet your needs.
Focus on DFM

To keep your project moving forward, we focus on design for manufacturability (DFM) from the start and throughout the process. While we work with customers at any stage in the product lifecycle, starting at the earliest stages of design helps to reduce iterations, save time and cost, and smooth the way into the manufacturing process. Our design services comprise two workstreams:

World-class design & development process ensures alignment throughout

Our product development process provides a systematic, phase-gate approach to new product development and commercialization. It’s tightly aligned with our Quality Management systems. We proactively guide our customers through the key design engineering, quality, manufacturing and regulatory deliverables for each stage of the process.

Concept

Transform an idea, thought or sketch into a design with a working and functioning prototype that simulates the intended device and its intended use in the market.

Feasibility

Establish ”design freeze” that presents a working engineering-level sample with initial evidence supporting the design feasibility.

DFM

Ensure using an iterative process that the product is manufacturable and meets quality and cost targets.

Design qualification

Verify and validate that the device meets design requirements and is safe and effective.

Clinical validation

Obtain clinical feedback to ensure that the device specifications align with user needs and intended use.

Regulatory submission/approval

Obtain regulatory approval. Our in-house regulatory affairs specialists can help you prepare your regulatory submissions for the FDA and other notified bodies as required.

Project management: You’re in good hands
We assign each new project a project manager as your single point of contact to facilitate regular communication, drive project execution to committed timelines, and ensure we meet project deliverables. We’ll work with you to ensure projects move forward with speed, accuracy, and efficiency. The long-term success of our customers is how we measure our success.