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In preparation for OMTEC, I asked the LinkedIn Medical Devices Group members: If you had ten minutes to speak to a group of young engineers, what would you share that could not easily be found in a Google search? The question received 41 comments in ten days.

An engineer is an innovator and an entrepreneur. The titles are synonymous to me. We need the young engineers to solve the problems that we did not solve, as well as the problems we created. Please keep in mind that we don’t want to be the sage on the stage. We want to be the guide by our young colleagues’ sides.

Here I’ve compiled a condensed list of the insight offered by medical device professionals during that LinkedIn discussion. The full list of comments can be reviewed on LinkedIn. I chose not to number the advice to allow you to prioritize the ones you see as real gems.

Become an explorer engineer who volunteers. Become an explorer who shows the way. Current technology evolves. Relationships improve. Someday you will turn around and see people following you. Will you be up to the challenge of being a guide?

Share your successes and failures. Don’t let a fellow explorer or guide make the same mistakes you did. Share your experience instead of reacting with, “Don’t do that, it’s wrong.” Look up Gestalt Principles.

Possess and pass down the values of ethics and integrity.

Spend time to review each feature and dimension. Do stack ups. It’s your job to give the patient what he needs to recover, the doctor what he needs in surgery and the machinist what he can make. It’s like going to a dance. If the beat is off, the lighting does not work or your partner is dancing to a different tune, no one is going to have a good time. The most important step is: does this bring value to the patient?

Watch innovation in other industries to see if they will bring value and understanding. Build relationships with process innovators both inside and outside of the biomedical community.

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Don't miss
Mr. Rapin's presentation,
Design for Manufacturability,
at OMTEC this June.

Register here. 

Don’t be put off by an individual who has experience but seems unwilling to talk. When he sees you’re in it for patient betterment, he will volunteer to be your guide. 

If the science is uncertain, the solution may contain uncertainty.

Do your homework.

Keep an eye on risk and solution mitigation to control future costs. Is there a way to fix it if the design needs to be tweaked?

Keep successes and failures in an open company database for all to learn from and add to the list. Note how a failure was a success, even if the success was “Never do that again.” 

Walk the manufacturing floor. Start by watching, then by listening, then by talking. Learn how clinicians view and use technology. What are their wishes and needs? How do they cope with inadequately designed devices? Learn the human factors engineering (HFE). Often the design requirements do not include unspoken needs and wishes. Only after the device is on the market for some time, HFE issues become evident and often contribute to reportable incidents.

Share what you know and your knowledge will grow tenfold.

Treat the patient values, not the x-ray or lab values. Are you willing to meet with the patient six months post-operation and introduce yourself as the engineer who helped design the implant?


I want to thank everyone who has provided insight. The sharing of ideas is essential to better us as individuals and an industry.

Randy W. Rapin has worked in design and process manufacturability since 1965. He founded RLTIndustries in Dayton, Ohio in 1995. RLTIndustries offers design and process manufacturability services to the orthopaedic and automotive industry. Mr. Rapin has extensive experience in metal, plastics and rubber component design. He now offers biomechanical design and engineering support to the orthopaedic industry, with a current focus on spinal implants. RLTGold, a division of RLTIndustries, opened in 2015 for the implementation and training of ISO 55000. Mr. Rapin can be reached by at This email address is being protected from spambots. You need JavaScript enabled to view it..

RLTIndustries
www.RLTIndustries.com



4 COMMENTS

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Tiger Buford

05/13/2015 04:23 PM
Know the difference between working at a big company and a startup. Read... Life in an Orthopedic Startup – what’s it like?

http://orthostreams.com/2014/12/life-in-an-orthopedic-startup/
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