DESIGN TRANSFER: A PROCESS NOT A SINGULAR EVENT

In the development process for medical devices, there comes a point when products transfer from design to production. Often this step doesn’t go as smoothly as it should and the project budget and schedule are adversely impacted. Companies may view design transfer as a one-time event, rather than an essential part of an ongoing process.

During the product development process, the Research and Development (R&D) team is under a tight deadline. They may not have the necessary resources or take sufficient time to create proper documentation. Team members may need to make decisions quickly without fully considering how they could take proactive steps to ensure design transfer will go more smoothly. Subject matter experts on the team may only focus on critical design decisions required to make the product work, without regard for manufacturing. Let’s take a look at some ways to improve design transfer.

Look at Design Transfer as a Process Rather than a Single Event

Design transfer is an integral part of the product development process, from conception through final manufacture. Highly reliable, cost-efficient medical devices require proper design transfer, and that starts with Design for Manufacturability (DFM) and Design for Manufacturing and Assembly (DFMA). In DFM and DFMA the focus is not only on the design itself, but also on the assembly method, ensuring manufacturing readiness for building Beta units, pre-production clinical units, and the pilot program. When the R&D team considers these factors and performs in-process testing, it can significantly improve product quality and reduce the overall cost of manufacturing.

Using DFMA 

The goal of DFMA is simple: to transfer product design into viable, robust production methods. To succeed, the team must establish and maintain procedures that ensure the device design translates into production specifications, including final test acceptance. The transfer should negate and/or identify remaining risks such as single-sourcing, long lead items, build timelines, and line/tooling capacity.

A Design Ready for Transfer:

  • Can be built reliably using known and proven manufacturing and assembly processes
  • Includes supporting cell/line qualifications through manufacturing validations such as Operational Qualification (OQ) and Performance Qualification (PQ)
  • Specifies and documents any inspection aids, assembly fixtures, and custom tools required for manufacture
  • Confirms completed agency testing and production target hardware meets regulatory requirements such as FDA, UL, and CE
  • Includes a complete product Bill of Material (BOM) that has been fully costed up to the customer Stock Keeping Unit (SKU) level
  • Includes packaging, labeling, and Instructions for Use (IFU)

At Sunrise Labs, we see Design Transfer as an integral process beginning early in the life of a product with many crucial steps for success. Communication between key stakeholders early and often is critical to turn innovative ideas into commercial medical devices.

Read more at sunriselabs.com

Follow us on social media for the latest updates in B2B!

Image

Latest

Class 8 trucks
Driving the Future at ACT Expo: Windrose Showcases Its Purpose-Built Electric Class 8 Trucks
July 1, 2025

At the ACT Expo, Hammer Down host Mike Bush dives deeper into the future of freight with a hands-on look at Windrose Technology’s electric Class 8 trucks. Joined by Joseph Jaramillo, Driver Supervisor at Talon Logistics, Mike takes a test drive to experience the smooth ride, dual digital displays, and unique features—like advanced regen modes and a…

Read More
ball valve
Zero-Friction Flow: Trillium Launches the Red Point® Non-Contact Rising Stem Ball Valve to Cut Downtime, Boost Safety, and Perform in Demanding Applications
June 30, 2025

Join host Michelle Dawn Mooney for this special episode of FlowCast by Trillium Flow Technologies, as she sits down with Fred Jansen, General Manager of Trillium’s Netherlands facility, and Pepijn Esman, Engineering Manager for Red Point, to unveil the non-contact Rising Stem Ball Valve (RSBV)—a breakthrough engineered for extreme-service applications across oil &…

Read More
student success
The AI-Powered Edge in Education: How LearningClues Is Enabling Student Success with Co-founder and CEO Dr. Perry Samson
June 30, 2025

As AI continues to reshape education, institutions face a growing challenge in ensuring students succeed without compromising engagement or integrity. Today’s college students are often juggling jobs, family, and coursework, leading to limited study time and increased dropout risk. According to the National Center for Education Statistics, 40% of full-time undergraduates and 74% of…

Read More
AI Strategist
Why Enterprises Need an AI Strategist and Why It Should Be a Marketer
June 30, 2025

In this episode of The Marketing AI SparkCast, Aby Varma, founder of Spark Novus, a leading consultancy that partners with marketing leaders to adopt and scale AI responsibly and strategically, talks with Nicola Smith, Senior AI Programs Advisor at Southwest Airlines. They explore how enterprises can move beyond tool experimentation to embed AI into…

Read More