3 Tips to Find the Best Medical Product Design Partner for Assay Development

Find the best medical product design partnerYou’ve worked non-stop on a brilliant chemistry project that will revolutionize the medical industry and drastically improve patients’ lives.

In fact, you may be still developing the chemistry, but you’re already under pressure to develop a platform to run it on.

Here are three tips for finding the best medical product design partner.

1. Make sure your medical design partner has in-house chemistry knowledge.

Finding a contract medical device design company with engineers trained in biochemistry saves time and money, especially when medical device development coincides with the assay development.

For example, KMC Systems Executive Director of Engineering Scott Leon explained that KMC often designs a medical instrument around the customer’s chemistry with the development of a reagent and the instrument happening simultaneously.

KMC’s engineering teams include cross-functional systems engineers, who are engineering jacks-of-all-trades, some with advanced degrees in biochemistry.

“Our engineers collaborate and work closely with our customers’ assay development scientists” Leon said.

KMC Principal Systems Engineer Jack Kessler, PhD in biochemistry, is an example of this collaboration.

Kessler works with customers to pull together detailed medical product requirements by mapping the chemistry into the engineering and vice versa.

A cross-functional background allows Kessler to project an error budget for the chemistry to determine which aspects of the design are critical to the results, such as timing flexibility.

Knowledge of both chemistry and engineering is critical because “a little thing can make a huge difference,” Kessler said.

This goes hand-in-hand with the next tip – communication. If your medical product design partner doesn’t have someone on staff who speaks chemistry, the communication barrier will cost more time and money, and introduce error into your medical product.

2. Evaluate program managers.

Along with knowing the chemistry language, look for a medical product design partner that has effective program managers.

How do you know an effective program manager?

Great program managers help the project run smoothly, facilitating communication and ensuring that there’s give-and-take in the relationship. As Kessler pointed out, small changes can make a huge difference, and sometimes those are chemistry changes. Often, KMC customers will modify the chemistry to fit design specs of the instrument for significant time and cost savings. You want a program manager who can communicate beneficial modifications to you and clearly explain the value.

You also want the program manager to communicate beneficial design changes to their own team, as well. You probably understand the needs of your end users better than a contract medical design partner. That knowledge should be incorporated into the medical product design.

KMC Systems Senior Program Manager Gregg Wilder, PMP, said that to reach a consensus, “The PM uses the appropriate technique based on factors such as time constraints, quality, budget, etc. Regardless of the technique, the key is to be an active listener to manage any conflict, overcoming resistance and secure problem resolution.”

Overall, medical device design requires give-and-take from both sides. There may be many approaches to medical product design, but discovering the best way to get it done right the first time requires close collaboration facilitated by a skilled program manager.

Wilder elaborates on the process, saying to “have a plan up front that outlines the who, what and when of project communication. This helps to determine the stakeholders early and to define the communication approach. Establish a routine for management reviews to address open issues and pending decisions. Establish communication channels with both the external and internal project team to set clear expectations and to define procedures for resolving conflict. At the outset of a project, schedule a Requirements “Workshop” that can bring key stakeholders together to define the product. This builds trust, establishes relationships and improves communication to increase stakeholder consensus. And don’t forget to have a plan to share successes!”

Also, look for medical device design partners with PMP certified program managers. Project Management Professional (PMP) certified program managers undergo rigorous training and testing that attests to their knowledge and skill.

3. Can your medical product design partner take your project through to completion?

Although your focus may be on medical product design at this time, choosing a partner with manufacturing expertise can make all the difference in quality and savings.

If your medical design partner can’t also manufacture the product, you will have to hand your project off to yet another partner.

It’s worth it to find a company that can take your medical product from concept to production. This allows you to plan ahead for sustaining engineering because the design engineers will work closely with the manufacturing team.

“Our engineers are practically co-located in the manufacturing cell. There are some companies where the engineers are disconnected from manufacturing – the literal wall between manufacturing and engineering. We don’t have that at KMC,” Leon said, “[Our engineers] 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."

Leon said that some of the projects we get at KMC began at companies that did not offer manufacturing services, which resulted in in costly redesigns. This can be avoided by partnering with a full-service medical device design, development and manufacturing company.

The price tag for sole medical device design contractors is appealing, but not at the risk of handing off a project midstream to a manufacturer or risking a total redesign because design engineers did not work directly with the manufacturing team.

Choosing a medical design partner with manufacturing capabilities means not only do you get a finished product, but the product can be reliability tested and redesigned based on those results in-house as well.

Look for a medical device contractor with custom testing that fits your needs.

For example, KMC offers a minimum reliability testing that includes running a few instruments round-the-clock (with redesigns to fix issues) to extensive testing that includes writing special software to mimic the customer experience - and everything in between.

Collaborate on chemistry

To find the best medical product design partner to build a platform for your chemistry, evaluate medical designers for in-house chemistry expertise, effective program managers and for medical manufacturing capabilities.

From there, you can go forth and save lives!

Do you have any other tips for evaluating medical product designers? Please share in the comments below!

 

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Topics: KMC Systems, medical device design, Medical Product Design, medical device development