CASE STUDIES

Design and Manufacturing Outsourcing - Medical Device

Life Warmer (LW) was a start-up medical device company focused on trauma care.

The experience involved:

1) Contract Design
2) Contract Prototyping
3) Contract Manufacturing

Contract Design

Identifying the Right Design Firm

LW needed medical device design engineering assistance to determine if and how we could accomplish heating fluids and blood in infusion tubing. Each design firm provided the same answer without listening to the problem: that they could handle anything that was a medical device. All of them would have completely missed the mark had we attempted to engage.

An industry colleague referral eventually led us to an individual who owned an electrical and software engineering firm. He and his team listened to the challenge and then he asked, “So you realize you have a physics problem?”

Yes, exactly – finally someone who listened and understood. It was not about simply designing a medical device. He asked us to come back in a week and he would let us know if what we wanted could even be accomplished. A week later he explained how it could be accomplished and provided data as to why and how.

This firm did not actually design medical devices. Working with a design firm who had never done medical devices offered its own challenges, but their understanding of the physics issues with which we were faced and their approach to resolving was critical to overcoming the primary key obstacles.

Because of the way that firm listened and worked, we built a strong and trusting relationship quickly. That firm had done a great deal of collaboration with a particular mechanical and process engineering firm as well as another firm in Taiwan, who did industrial design and rapid prototyping. We met with all of them and determined that we had found the right resources in order to advance immediately.

Contract Manufacturing + Prototyping

Contract Manufacturing (CM)

As much as possible, work with the external resources like they are part of the internal team; transparent and consistent ongoing communication.

Once engaged with the engineering firms, we moved into a proof-of-concept phase. We had the key engineers from the design firms attend critical meetings with us. What we were developing was a life-saving device. They needed first-hand stories and understanding from experienced individuals helping set the requirements. We knew that just hearing it from us would not be enough.

As we narrowed our choices for contract manufacturing firms, we had the key engineers from the design firms attend final meetings with us. We needed everyone communicating in order to accomplish what was necessary in the timeframes we needed. We sought resource partners who could eventually ramp and be involved in our ongoing manufacturing efforts as well.

Power
Power to run our system was going to be most difficult. We visited firms across the country who specialize in power design support and contract manufacturing. What we needed to do with battery cells had never been done.

We needed a firm who specialized in most unique battery designs and who was willing to explore new ground with us. Also willing to go to their suppliers to get special dispensations for construction. Safety was critical, so they had to have a most robust design process review and quality system. We finally identified one who could help design and build an exceptionally smart and encrypted battery and charging system. Also, at projected build levels, we would only account for between 15% and 20% of their overall business. Enough to be most worthwhile to them and enough to assure us of their continued attention. Additionally, they focused on high complexity; lower volume manufacturing, which fit for most of our system components.

Disposable
We identified a company interested in helping develop our specialized tubing. They had several other similar unique projects which provided the necessary expertise. In meetings, they included resources from multiple departments to participate so that everyone would understand the scope and be on the same page.

They shut down a processing line for two days, a huge investment for them, to experiment with us in order to optimize all critical elements and parameters of what they were to produce for us.

We found a contract manufacturer specializing in clean room sterilize manufacturing to assemble our disposable thermal tubing sets. They too involved everyone in meetings and calls and were relentless in their internal process design and review work. Quality system beyond reproach for this sterile component. Knowing how critical costs were to us, they helped reduce the cost of what they were manufacturing for us by 20% in the first year of manufacturing. And again, we represented a similar level of revenue production as previously discussed. So again, enough to be most worthwhile to them and enough to assure us of their continued attention.

System Controller
For the Controller (intelligence) for our system, we established the contract manufacturer in Dallas. Since we managed component tooling, printed circuit boards, software, encryption, specialized custom connectors and custom wire harness assembly in Dallas, it was important to keep this element close at hand. The contract manufacturer for the Controller aligned on all of the similar parameters as a fit to us for a CM.

To maintain timelines, continue to research; be prepared with backup plans, and seek and remain open to unique approaches. Be consistent and relentless with your SWOT analysis and project planning updates and meetings.

Since we wanted the design and development of the project to move as quickly as possible, we constantly reviewed every aspect. We had a minimum of weekly calls with each resource partner. Specific elements required more frequent communication. We developed back up plans for potential failure points well ahead of time.

As an example, we knew that ongoing prototyping would be critical to maintaining time-lines. We did simple 3D printing initially. Next, we searched for and identified a resources for high quality 3D printing, out-of-state. Geographic proximity is not necessarily the optimal route. There are just too many great ways to transfer files and communicate remotely to have to settle for local resources, if it is not optimal. Local high quality 3D printing had a three to four week schedule. Out of state, had a one-week schedule which included overnight shipping. And usually for less cost overall.

When we moved to machined and final prototypes, going offshore provided two-week schedules vs. onshore nine-week quoted schedules. Again, the quality was exceptional and the costing was lower.

Results

Accomplishment: Because of the diligence in determining outsourced partners and constant open communication and assessment, the resulting device exceeded all requirements:

  • Actual 22 oz. full system vs. requirement of 32 oz.
  • Double the originally projected heating flow.
  • More than double the original power capacity.

The system is now a best-in-class device in use internationally helping to save lives in military and civilian hands.

Engineering + Manufacturing Support

Do you have an idea for a new technological device? Need engineering or manufacturing support? Outsourcing specific elements of the project can be a solution, when you understand the steps in successfully utilizing outside assistance. That’s what we do. Contact us today: 505.805.5002.

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