Apeoples promised, here is my summary from LinkedIn Discussion, “If you had 10 minutes to speak”, started on LinkedIn in early April 2015. Link to Linkedin discussion https://goo.gl/SB2tZM

In just 10 Days the LinkedIn Medical Device community offered 41 comments. The Medical Device community has over a quarter of a million members and offered many insights. My request came as part of the preparation to speak at OMTEC June 17, 2015. I will be speaking to a group of young Biomechanical engineer, ages 25 to 35. I wanted some ideas on what would you share that could not easily be found in Google Search.

Here is a condensed list of insights that they offered. The full list of comments can be reviewed on LinkedIn. Please keep in mind we don’t want to be the Sage on the stage. We want to be the Guide by your side. I chose not to number then. I want the reader to put priority on the ones he sees as real gems.

An Engineer is also an Innovator and Entrepreneur. They all mean the same to me. You need to Nurture your inner Geek. We need the young engineers to solve the problems we did not solve as well as the new problems we created.

Become an Explorer Engineer by volunteering, give your time not your opinion. Use your hands and ears not your voice. Become an explorer that is showing 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?

As an Explorer Engineer you need to find a way to learn as many processes as possible. Don’t pass a pool of knowledge without peering in.

Let your pool of knowledge be shared. Find a way to do that and one day your knowledge pool will contain knowledge you did not add. Pools grow to be ponds. Ponds to lakes and lakes to oceans.

Ask your Engineering Guides to share their pool of knowledge and share yours. If they are effective Engineering Guides you will learn from each other. Become an Engineering Explorer and find your Engineering Guides in every process discipline that is willing to share their successes and failures. These are the people that truly care about the engineers and patients they are trying to help.

As a new Explorer in engineering offer new ideas from your heart. Then listen and watch what your engineering guides say and does. We become resources for both. Sometimes one of us has the answer and we don’t know it. We just need someone to ask the right question.

Be patient with process innovators. They need to know you are serious and may take several times to build that explorer guide relationship.

Share your successes and failures. Dont let a fellow explorer or guides make the same mistakes. Share what happened to you not, “Don’t do that, its wrong”. Its called “Gestalt Principles”. You can Google it later.

Ethics and Integrity are the values we need to pass on. They start with a simple life choice that turns into a life commitment. The investment into your “Ethics and Integrity” grows over the years. One day that investment will start to pay enormous dividends.

Don’t ask for an Engineering Guides time, show him you are willing to invest the time to learn and share. The process is ask the intelligent question and wait for the answers. Remember one mouth 2 ears. Bringing Value to the patient will yield market adoption.

Let your Ethic and Integrity direct you. Be the first dancer on a project that interests you. Dance with your hands in the air. Others will follow.

Spend time to review each feature and dimension. Do stack ups. Its your job to give the patient what he needs, what the doctor wants in the surgery, and the machinist what he can make. Is like going to a dance. If the beat is off, the lighting does not work, or your partner is dancing to different tune. No one is going to have a good time. Simple and Elegant, does it 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 the Biomedical community

Dont be put off by an individual that has experience but seem unwilling to talk. You just need to prove to them you are in it for the good of the patient. When they see that they will volunteer to be you guide.

If the science is uncertain the solution may contain uncertainty

Do your homework, Get Design Inputs from Stakeholder; Doctors, Nurses, and Patient

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

Get on the manufacturing floor. Start by watching. Then by listening. Last by talking. Learn how clinicians view and use technology, what where their wishes and needs, how they cope of inadequately designed devices, etc. 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.

Study Processes, Network with others, and build relationships.

To get knowledge you need to share what you know and it will come back 10 fold.

Use metric dimension. Do you really need +/- .0025 mm? That’s +/- 25 micron. Well beyond 90% of the inspection equipment on the market.

Treat the patient not the X-Ray or lab values. Are you willing to meet with the patient 6 months out and introduce yourself as the Engineer that helped with their surgery?

In conclusion; I want to thank everyone in the LinkedIn Medical Device Community for their insights. I am sure we will see more on this discussion.

Randy W. Rapin
About Randy W. Rapin

Randy W. Rapin has worked in design and process manufacturability since 1965. He founded www.RLTIndustries.com in Dayton Ohio in 1995. RLT Industries offers design and process manufacturability services to the orthopedic and automotive industry. He has extensive experience in metal, plastics and rubber component design. Originally from Detroit, Michigan he worked in the design and fabrication of automotive parts. He now offers bio-mechanical design and engineering support to the orthopedic industry. His current focus is on spinal implants. RLTGold (a division of RLT Industries) opened in 2015.