Plan for Success with Sustaining Engineering in Medical Device Development, Manufacturing

When your medical device development project is under pressure to get to market and the project is critical to your company’s success, you'll need a dedicated outsourcing partner who can provide engineering expertise that includes sustaining engineering. How can sustaining engineering ensure successful handoff to manufacturing?  KMC's  executive director of engineering, Scott Leon, weighs in.  Those in the field of medical device development and manufacturing have heard the old mantra, “There’s never enough time to get it right the first time, but there’s always time to get it right the second time.” Should you go with the partner who promises quick development turnaround and rapid prototyping then seek a high volume manufacturer to speed commercialization? How much risk are you willing to take on for the sake of speed? What's the trade-off? Why can't you have it all? 

When you plan ahead with sustaining engineering, you can get development and design done right the first time, and smooth the transition to manufacturing. It's a win-win. Here's how:

Including sustaining engineering for medical devices into your total product development program can reduce cost and add features that would otherwise wait until the post-production support phase.

How do you plan for success with sustaining engineering?

  1. Design for manufacturability. Determine which features need to be implemented in the design phase and which features can wait. Collaborate with your outsourcing partner up front on negotiables and must-haves. 
  2. Develop, design and manufacture your medical instrument under one roof - no hand-off! This signifigantly reduces risk and ensures smooth transition to manufacturing. Retain the engineers who worked on your project for sustaining engineering throughout the life of the project.

Sustaining engineering activities should begin in the medical device design phase. Start with the requirements: regulatory compliance (RoHS, REACH and WEEE), performance, reliability, manufacturability and software requirements. Proceed from there to determine the most important design features. If you don’t have development, design and manufacturing together in-house, find a medical contract manufacturer experienced in the total product life cycle who can be involved in the development phase of your project. 

KMC's Executive Director of Engineering, Scott Leon, weighs in: scott leon on KMC sustaining engineering

"Our engineers are co-located into one engineering and manufacturing cell for each dedicated project. At some companies, the engineers are disconnected from manufacturing – with a literal wall between manufacturing and engineering. We don’t do that at KMC because we believe in team collaboration throughout all aspects of the project. The engineering and manufacturing teams co-exist, so each team member is living with the product that is being developed and manufactured. Some companies may have product development completed with one company, then hand the product off to be manufactured overseas. There's a lot of risk involved during the hand-off. Because our sustaining engineers are the same ones who developed the product, they’re very comfortable on the manufacturing floor as well. Risk mitigation and designing for manufacturability are integral throughout the life of a project. Our dedicated teams get it. They understand the pain that you have in manufacturing and the urgency that’s required to fix things in a timely manner. That’s very understood at KMC but not the case in a lot of other places."

Collaborating engineers are successful engineers

Yes, sustaining engineers are key to your project. Yes, retaining the same engineers who worked on your medical instrument from design through transition to manufacturing - and every design input, requirement and verification in between - may sound costly, but can certainly save time and money when you consider the cost of errors, issues and failures in the longrun.  

Nobody can beat the qualifications or efficiency in sustaining engineering than the project’s own design engineers who have the knowledge and skills and dedication required for a successful project. Using the same resources throughout the total product life cycle allow those engineers to pull sustaining engineering activities into the earlier stages of design, through transition to manufacturing.

Often times, even those other, "nice to have" design features that would have had to wait can be implemented sooner because of the firsthand knowledge of a co-located, collaborative team of engineering and manufacturing professionals. 

Retaining your engineering team requires planning ahead for sustaining engineering so they aren’t moved onto other projects once your medical instrument is in production and launched. Sustaining engineering teams should work with the medical contract manufacturer throughout the project and agree on allocation of resources as part of the overall plan.

As you know, this method won’t eliminate the need to keep up with improvements, obsolescence and compliance throughout the life of the product. But when design for manufacturability and sustaining engineering are part of the process, you will minimize the amount of time and money required to fix issues during the maturation phase.

More importantly, planning ahead for sustaining engineering will eliminate a detrimental, large-scale overhaul of your medical instrument.

How does your company implement sustaining engineering for medical devices? How do you ensure that your medical product is done right the first time? Join the discussion online. Share this article via Twitter, Facebook and Linked In

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Topics: software engineering, medical sustaining engineering