Dave Sheppard, CMAA Randy, how about a story or two about real world experience ? That type of information transfer cannot be transferred unless you write a book. The younger professionals are very smart. What will help them most, in my opinion, is examples of what to do or what not to do (and why) from experienced professionals like yourself.

Randy Wilfred Rapin Hi David; Yes I agree. I am looking for several nuggets young Bio-Mechanical engineers, ages 25 to 35 will not easily find on Google. Example; Titanium work hardens during metal forming.

Stephane Morvan Randy, if you could take them from beginning to end on a product development cycle - with all its hiccups (keep it simple and narrow it down to supplier/regulatory and customers) - I think this could make for an interesting presentation...

Randy Wilfred Rapin Hi Stephane; Yes simple is the goal. I am still looking for a few nuggets of process wisdom we can pass on to the young engineers. We need them to solve the problems we did not solve and the new ones we created.

Goldy Singh From a regulatory perspective, most design challenges rises from scientific uncertainties and/or process uncertainties. It would be beneficial to share examples of such uncertainties which attributed to usability failures.

Randy Wilfred Rapin Hi Goldy; So If I understand you. We need to look at each mechanical feature to make sure it brings value to the patient. Simple and elegant, while addressing Scientific and Process uncertainties. This will fit in very well for Design for Manufacturability.

Goldy Singh Hi Randy, agree with your comments. If we look at value based engineering, design for usability creates "value" and good design for manufacturability creates "profit". Market adoption of a design depends on what value it brings to the end user and and profits to business depends on how scaleable manufacturability is! Your wisdom may help young engineers to make such connections.

Burrell (Bo) Clawson As a side note, I would emphasize the need to look outside the bio-medical field for both inspiration and new products and sources doing things in new ways that have not made it into bio-med yet.

Hi Randy,
Speaking from experience, I'd emphasize "Design Inputs" for new engineers. Prior to creating prototypes and performing analysis ("Design Outputs"), simply connect with key physicians in the field. Doctors love to work with engineers (and every doctor is a closet engineer/creator !). Ask vital questions about the clinical need for the device, the necessary features and outputs, performance/problems with similar devices already available, user risks, design risks, cost/reimbursement/size constraints, etc.
As a young R&D engineer, I received product specifications from Marketing dept, and designed to those requirements.... and the devices did not meet customer requirements. The lesson was: do your own homework ! The valuable insight will guide you through the long design path, and help answer many minor questions along the way (ergonomics, size, colors, intuitive controls, etc).
Again, emphasize the first phase of Design Control (design inputs). The rest is fairly easy, once you have a good target.

Michael Lehmicke I would tell them that no one person can know everything, and to a great extent their future success will depend on their ability to build relationships with others in the biomed field, and also (to echo Bo's point) individuals in different technical disciplines. It took me a long time to really understand this.

How finicky and temperamental it is working with physicians. Each one is different, with uniqly undiviual preferences and practices. Pleasing them seems impossible at times. They're always right, and without patience and ultimate cooperation they can abruptly turn their back on your project and and walk away. Even you succeed in saisfying one, then try for two. Don't be surprised if the second one wants the exact opposite of the first. "Feel" is everything to them and if it doesn't feel right to them they shy away from it. If physicians are the end users of your products, as an engineer developing products for them requires a special skill-set that you are not taught in school.

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I agree with Dave. Knowing the design requirement and input is essential to ensure that the product meets all stakeholders requirements. On top of the list that Dave has listed which is more related to user and cost, I would suggest pointing the way to identifying risk and its mitigation (with reference to international guidelines and standards). Not many engineers are aware of regulatory constrains during the design phase which may lead to costly changes and rework at the later stage.

Randy Wilfred Rapin Hi All; This is a very useful discussion. Keep adding Input and check back May 3, If I return from my Skydiving trip in San Diego I will send a comment summarizing the ideas covered. Thanks for all the good ideas.

I am still looking for a few nuggets of process wisdom we can pass on to the young engineers. We need them to solve the problems we did not solve and solve the new ones we created.

Dave Darley My son is about to graduate in Mechanical engineering, and my nephew graduated a few years ago and is in his first bio-medical engineering position now. You don't get the whole 10 minutes, and my advice is more on the personal level, (Maybe even strange) but:
"Do all you can. Volunteer. Learn all you can from each opportunity. Become the expert. My most rewarding and interesting experiences in Engineering came to me because I was given an assignment that nobody else wanted. Call it the road less traveled. These led to other greater assignments. Some Engineers are conservative, and don't stray from their comfort zone (skill set, core competencies, interests...whatever). The half life for knowledge in your career is short. It is changing, evolving. What you know today won't be enough in a few years. Always be learning, weather it is immediately relevant or not. Help everyone you can, and mentors will come and go as needed. Oh yes, and know the design requirements before you begin."
That's what I would say (That's actually what we call an "elevator speech" )

Randy Wilfred Rapin Hi Dave; Very inspiring. To get knowledge you need to share what you know and it will come back 10 fold.

Chris Melton I would agree with the above comments that place a high value on communicating real world experience. One thing I wish I had available during my graduate engineering studies is incorporation of courses relevant to business development, entrepreneurship, and the regulatory environment. I never wanted an MBA but having a few courses of "business for engineers" would have certainly been nice to have as I started my own company, but would also have been priceless as I navigated the politics of big science and engineering in large organizations with which I've contracted over the years.

Randy Wilfred Rapin Hi Chris; Another great nugget. Innovator, Engineer, and Entrepreneur. This makes so much sense. Yes our young engineers need to understand they need to approach every design project with the spirit of these 3 disciplines. I am moving this nugget to the top.

Randy, great discussion and ideas. I would want to convey that one of the most under valued skills for Bio-Mechanical engineers and especially when designing for manufacturability is taking the time to reach out and listen to stories from inside and outside the company. Effective listening is a unique skill to master as it allows you to keep from repeating mistakes but also listening to discover precursor events and thought processes disclosed in the stories that brought about success or failure.

Goldy Singh "business development", an excellent point Chris. As a young engineer, if you get hired by a large corporation, your exposure to business is very limited. You are become a subject matter expert and only focused on delivering your part of the project on-time. On the other hand, if you get hired by a small start-up company, you get to see other aspects of the business and how your work fits in overall company's growth. And if you are "innovator, engineer and entrepreneur", your will require skill-sets that are not taught as part of engineering discipline. It is important to know "your apatite for growth" and willingness to take charge of unknown territories and skills. Collaboration is the key.

Burrell (Bo) Clawson Dave Darley noted "Learn all you can from each opportunity. Become the expert."

When kids are young and starting out, they often think their memory will hold every key piece of information they need to succeed. Life doesn't work that way. There is too much to hold it in our heads. We do that for names and addresses in various address book software, but many don't set up their own "Engineering DB."

I would encourage mentioning the use of an organized system of files of source info, facts, methods, systems and details in a way that will survive 40 years of work. That means it likely needs to be in some open source type files or in an SQL data base that can be exported.

The information will become highly diverse and include screen shots, pdfs, videos, text and even links to 3D files, so it has to be able to handle the widest arrangement of details.

Burrell (Bo) Clawson And to add to Kyle's comment, once you have a failure, it turns into a form of a success when you can describe & document exactly why it failed, and so you and others don't repeat that failure mode again.

Failures lead to new thinking about how to get around to a successful end point.

Carolyn LaWell What a great conversation. Thanks for sharing your experiences. Randy, we look forward to hearing your final thoughts at OMTEC. www.omtecexpo.com

Andrew Kyle A. Expect most of your career days will be filled with failure
B. Expect that a few career days will be filled with success - after overcoming the failures
C. Write and organize your development output - a good way is to use a database tool that is powerful... MS Project is OK but Manage Pro is much better. You can schedule and keep your work associated within the database. What you don't write down will be lost or vague even if you don't believe you can ever forget it. After a few hundred projects, your memory will be less reliable.
D. Listen to the older resources - they have lived the adventure and know the pitfalls of development. You are young and have enthusiasm - we are older and have experience and scars from our own mistakes we can help you avoid if you will listen.
E. Never assume anything...
F. Become a Professional Project Manager (PMP) - that is how you will learn how to break down a project into many parallel and simultaneously executed paths toward an integrated solution.
G. READ the FDA medical device regulations... dull reading but great information .... www.fda.gov. You will obtain some idea of what to expect if you are asked to explain why you did something and then once explained, be asked where is that "written down"? FDA mantra - if it is not written down, it did not happen. Forget that and you place your employer at risk of a 483 and misery at your job.

Robert Christensen As an old and retired surgeon-innovator I would let them know that as one is willing to get in God's will for their life that they will be successful by following those paths which are likely innovative and useful in helping others, whether as an engineer or physician or Entreprenuer.

David Lim, Ph.D. RAC, CQA A failure can be a key ingredient in paving the road of success. When I was a Ph.D. graduate student, there was a mountainous amount of data/files/folders for the past several years accumulated by many others in the past. I had inherited all of these to work on. Despite the fact that I had been discouraged by all others around to work on the project, I took the project and tossed all data/files/folders except one page of the map. I started all over. My message to young people: my first message; "please have some gut to be ready, willing and able to do things that interest you." I recently had a chance to advise few students/innovators from a top institute of technology, they were trying to seek how to cut short. My second message; "please don't try to cut short or you may never be able to cut short or even long again." My third message: please don't try to be cheap on expensive things (e.g., ethics and integrity)." Always (try to) focus on what and how in view of what is being good, better or best!

David Mrak When it comes to designing for manufacturing. Tell all of them to get onto a manufacturing floor. Learn about mills, lathes, cutting tools etc. Learn the capabilities of the manufacturing equipment. When designing, the first question I always ask myself is how am I going to make this? Is it molded? what about draft? is it machined? what about radii for inside corners etc.

Also, everything is not a Rolex watch. Every dimension does not need a +/-.0001" tolerance. I see parts that are designed with tolerances that exceed the capability of the current technology. Do a tolerance stack up, figure out what is needed. Help out the manufacturing folks with realistic tolerances. Be tight where you need to be and only where you need to be.

They should also consider another issue. How do I measure this? Learn about measuring equipment, gage error and gage R&R. I might be able to make a tight tolerance on a part but can I measure it? Do I lose half or more of the tolerance to gage error. I have seen parts with tight tolerances and then watched a machinist chase his tail making adjustments because the ability to measure a dimension is difficult and the best available technology to measure has 150% gage error against the tolerance. The machinist ends up making adjustments that are not needed. These things need to be considered. I hope it helps.

Andrew Kyle David,

For Engineers, I would recommend using metrics devices and dimensions. Remember, you design products for the world market place. Use metric screws and other metric parts that can be found in the EU or Asia. If you have never searched for a 6-32 screw in Taiwan, you have never lived.

David Mrak Andrew, yes we do use metrics. Some of the products are mature and were done in the English system. I just recently had a print come across my desk with a +.005mm/-.000 tolerance. I had no takers to manufacturer for both reasons. Holding the tolerance and measuring the part. after doing a tolerance stack up study it was found that +/-.025mm was just fine. These are the things that young engineers need to know. Not only is it important for manufacturing but for cost as well.

Randy Wilfred Rapin Great Discussion. Great Ideas. Another nugget that stands out. Yes David Lin, Ethics and Integrity are the values we need to pass on. They start with a simple commitment 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.

Besides the obvious and classical recommendation for the younger professionals to continue their learning due to the rapid progress of science and technology, I would like to offer a slightly different topic from what has been mentioned already. Please allow me to justify my suggestion by describing my person experience. I had the "bad luck" of being abandoned by my first graduate supervisor because her husband suffered a car accident and was comatose. So I was handed to my co-adviser, the Chief of Neurosurgery. Thus I became a Neurosurgical resident because I was the first engineer to come under his supervision. For six months I attended surgeries, participate in patient rounds, went through ICU, etc. It turned out that was the best introduction I would ever have hoped into the design of medical devices. I learned how clinicians view and use technology, what where their wishes and needs, how they cope of inadequately designed devices, etc. This helped me learn what is now known as Human-Factors Engineering (HFE) and the futility of getting precisions beyond intrinsic physiological variations. Often the design requirements do not include unspoken needs and wishes, as well as perceptions of the clinicians. Furthermore, little time is typically allowed for field tests before products are pushed through to be the first on the market. Only after the device is on the market for some time, HFE issues become evident and often contribute to reportable incidents. So my suggestion is for all engineers to spend considerable amount time working together with the clinicians in order to truly understand and appreciate the clinical environment.

Randy Wilfred Rapin Hi Binseng, "Human-Factor Engineering" Makes a statement that we sometimes forget the experienced people around us that can bring value to a project. Talk to the Surgeon, Nurse, patient and understand the problem from the stake holders position. Great nugget. I apologize if it looks like I am compressing the generous ideas from everyone but, my presentation will be limited by time.

Burrell (Bo) Clawson Randy, in my experience, you often need someone with a credible connection to a doctor who believes "your story" to make the referral to get into a discussion with a doctor. Docs are always pushed for time and don't want to waste it by getting into hypothetical or discussions outside their area of interest, as they will shut off those discussions quickly.

Some doctors are upfront in saying they will do it if they can come on board as consultant or on as an advisory board member, so you should know whether you would offer such a position or not and whether you would offer compensation or not from your company's point of view.

I have seen many doctors listen for 30 seconds or a minute and pronounce my new product as a loser because XYZ Company already does that, turn around and leave instantly without waiting for me to point out that XYZ Company DOES NOT accomplish what my product does.

Such a doctor just doesn't want to talk. Sometimes the doctor doesn't want to talk "on the record" because his employer doesn't want information going outside. Sometimes the doctor himself is involved in an outside venture and he doesn't want to compromise himself. These things ought to be considered.

Young engineers need to be well prepared on companies, products & patents before you stand in front of a doctor and discuss a new product's potential features. You need a 30 second "Elevator Pitch" for a doctor to be interested. If you don't know that Baxter or whatever company is already in the market, your stature in front of the doctor will plummet.

It usually takes finding the doctor with a specific interest in your product where he sees benefit to himself in his professional work in some way to be interested in your product.

Yes, there are doctors who are not so abrupt, but I don't see that so often.

Edward (Ted) Reesor As a healthcare practitioner who is now involved in product development, I admit I have no formal engineering education so I can't say what is lacking. That being said, human factors is a must as well as an understanding that healthcare is still too full of the "this is what "we" need because this is how "I" do it here" mentality. Being closely involved with the healthcare profession certainly helps knowing what problems need solving, however several opinions on the same matter may shed light on the industry at large and not one site's needs.

Randy Wilfred Rapin Hi Contributors; My summary date has been moved back to Friday April 17, 2015. I guess they dont think I will survive my next skydiving. I have received many great nuggets. Just a few more would be great. I will be writing my summary Saturday morning April 18, 2015. Keep those ideas coming. This thread will be referenced in my review so you will all get credit.

We need the young engineers to solve the problems we did not solve and the new problems we created. https://plus.google.com/u/0/+RandyWRapin/photos

Rick Stockton I cannot wait to see your summary. There is some great stuff here.

I'd go with,

1. If you want to do design, then get process experience, and take all of the Integrated Product Design courses that you can.

2. Network like crazy. Build your relationships. You'll get valuable help, you'll do good for others, you will be more valuable to your firm, and you'll have more employment options down the road.

If I had to give advice to young engineers I would go with David Mrak.
Going to the workshop and talking to the people there made my work a lot easier. They know the machines and the materials. They can tell you what can and what cannot be done, what is easy and what ist hard to make. Together, we came up with designs that were easier (and faster) to manufacture and cost less. And the good connections were absolutely invaluable in really urgent cases.

I also support Dave Goetz and and Binseng Wang about getting design input from physicians. If you want them to buy your product, you should know what they really need. - Unfortunately, what they really need is not always what they tell you they need. That is not even bad intention from their side, but sometimes they themselves do not realize what they really want. And what they tell you they want is just an expression of the true underlying need.
For example, for one concept I worked on, some physicians wanted the evice to have a sharp blade, while others wanted it to be dull. - What they all really wanted was safety and control over the device during the application.
Figuring out the real needs is critical.

1. Reverse engineer the current products that address the ailment. This is the equivalent of studying history learning from past mistakes and failures.Once you understand why designs are the way they are you will understand where to go next. Also, learn from redesigns, recalls and product failures.

2. Look outside the design space and industry for solutions to similar problems. Aerospace, automotive and especially nature have probably already solved similar issues eloquently.

Pat Ridgely, MD Wow. A lot of great stuff here!

Healthcare providers will probably recognize this old admonition from their training: "Treat the patient, not the X-ray or the lab value." The counterpart from my days in engineering was something like "Never confuse the model of something with the thing itself." Also, an old line from the old days of computing: "The purpose of computing isn't data. The purpose of computing is ultimately insight."

As a student (currently seeking employment in the biomedical field), I would love to hear about the following.

* How you see the future of the biomedical field and why this should be so exciting?

* What keeps you motivated to be in the industry for so long?

In regard to process engineering (I assume your audience is existing bio-mechanical employees)

3) Junior members will be getting their hands dirty and making a lot of mistakes. They are learning their tradecraft. Talking about your "problem solving strategy" used to overcome past tradecraft issues could be beneficial.

Robert Christensen I would add that as the first to innovate both the earliest TMJ implant and first three dental implants...perhaps we all needed to first gain a law degree so we might take on a corrupt FDA in our desire to help patients.

My story as a surgeon-innovator s fully told in.my book ...FDA You Were WRONG!

Or. should be read by all who choose to be helpful in this field. It truly is a great asperation..but some hazards along the way must be fully undedstood...before advancing along this patb.

Randy Wilfred Rapin As Promised here is my summary. Thank you for your input.

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..... (more) http://www.bonezonepub.com/component/content/article/1190-what-would-you-tell-a-young-engineer

Well done, Randy!

Randy Wilfred Rapin Thanks Binseng; So many great comments. I really enjoyed this discussion. Do you think is worth asking the Young engineers what they would say to their Guides?