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I was the first graduate from UT Austin EE department with a biomedical degree many years ago. Worked in EE labs, Marconi and TI during my undergraduate school years, then I went to biomedical graduate school in Houston for a PhD that I did not complete. An opportunity to work with Michael DeBakey arose and I took that path instead and worked in ORs and ICUs with open heart surgical patients for the next four years. Left and founded a company with some medical center professionals and we built that into a medium size company over the years and created hundreds of instruments, consumables, electrodes, etc. That was fun! No FDA submissions for almost 6 years and we grew very fast. The profits on medical device sales were very high because there was no FDA RA and GMP overhead. We were headed by a physician and never, to my knowledge, every caused a patient injury. In 1976, we had to write a letter to the FDA that we were going to market a new device. A one page letter. Over the decades that changed, the high profits were diverted to adding documentation to substantiate we were ethical professionals. Fun became drudgery. Trust became GMP visits. Costs escalated – Hyatt Regency became Motel 6. ROI fell. I left to go to high tech. More like the early days – speed, fast thinking, decisions made to support fast releases in high volume markets. However, your job was dependent on how well the quarter was and sales projections. Fun for ten years, but living a 24/7 job can be both exciting and stressful. Then back to Medical Device job. The FDA and GMP requirements along with the ACA made that ten years commitment end in company financial failure. I often ask myself if I would recommend a Medical Device Career to a high school student today. I usually answer maybe depending on your goals – don’t count on being rich and it is a tedious profession. What do you recommend? source: https://www.linkedin.com/groups/78665/78665-6149649637465747458 Marked as spam
 Posted by Asked on June 17, 2016 12:00 am
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I think the Medical Device Space has evolved to accommodate obvious regulations but also market variances. Your experience is vastly different than most. Frankly there are maybe a handful or two that can speak from your perspective. Nevertheless, this industry is what it is in no small part due to people just like you. We are no longer in the Halcyon Days.
Is that bad? Depends on who you ask. But to answer your primary question, yes we should and yes you should. But set the expectation early. Don't give them pie in the sky misrepresentations of the industry. Too many millennials currently wishing they knew more before diving into this space. Marked as spam
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Andrew Kyle
Software would be a better choice in my mind. A lot of development is going to outsourced development - so those companies will benefit from economy of scale. The cost of entry into this business is very high and the chances of failure to hit a defined timeline are next to impossible. Big corporations will be the norm. Nothing wrong with the profession, just not as exciting as it used to be.
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Yes, I would and will continue to recommend Medical Device careers in the future as I have in the past, any career will have tedious times. But what kind of career are we discussing..not everyone is cut out to deal with VC or Angels; sometimes the startup route is appropriate ( but not for everyone) now that there are regulatory and quality and registration specialized requirements and professionals to work those issues who is to say they are not good or worthwhile careers? Engineers, designers, HR specialists, advertising and marketing specialist for med tech and med devices are all reasonable careers, so are reimbursement specialists and patent support...lots and lots of career spaces.. The opportunity to work in a field where delivery of devices and services that hop people and patients and medical practitioners is highly rewarding.
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I have to see how the bureaucrats took the control of this business in Spain.
When I started repairing medical equipments, we had the respect of our employers, because they understood only a few people could do this job successfully, and they were conscius of complexity of the equipment. However , the human race is very brave, too much may be ?, I saw gradually how absolutely ignorant people star to take the control of relevant possition in the medical companies, most of them without any technical formation, I saw how this people, because they did not know, in their laptops , in a exel graphic, seemed obvious that the money used for technical service could be dramatically reduced therefore , they estarted to reduce the salary or fire the good technician and replace them with very low profile "technicians", in prevention of any complains, they explain this changes to the responsible of the hospitals , on they way to a "working tryp" to Cancun, or with a new car , etc, etc Sudenly I awoke in a business that the people in charge to made the decisions, did not know anything about the business the were running, but they where fantastic making reports, statistics, and power point presentations. So, not in Spain, not recommended . Marked as spam
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The obvious answer is "of course!". It is an arena where you are "doing good" and that brings with it an internal sense of job satisfaction, even on the bad days. The honest answer is that it depends on the temperament of the person. I do believe that you need to have a certain personality trait to deal with regulated industries and for some it is too frustrating. For others though it suits their need for detail. Not everyone is the same, so the answer is tailored to the enquirer.
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Andrew Kyle
Esteban - what great insight! Regulators and most C-levels cannot understand the technical complexities that now the norm I would like to ask a simple question.
When will IEC 60601 be finished? Probably never because it is profitable to change it often. However did your boss ever ask when a project is scheduled to be done? In the Requirement - define what 'done' means Marketing always likes to add work and expect the same end date Another reason 'tedious' could be phrased 'political'. Marked as spam
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I'm in the very first phase of starting a career in medical device industry with Masters degree in Biomedical engineering. To my knowledge, I assume all the companies wish to hire an experienced individual and has no chance for an entry for a recent graduate. For now I regret choosing this field though unsure of future.
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Julie Omohundro
Srilekha, this has been true of pretty much every profession in every industry for at least the last 40 years. And yet, most new graduates find a way in, sooner or later...
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Andrew Kyle
Dear Srilekha, I have had this discussion with recent graduates many times. For a company, hiring a newly graduated engineer adds more learning time. I found that my lofty degree and ability to solve engineering test questions was really far different from what was expected from an employer. I remember being asked by my relatives to "fix" their TV - their looks when I failed suggested I had wasted my money on my college education.
I would recommend you look at FDA or Medical Safety Inspection or a in-house biomedical engineering team for employment. That will add greatly to your skills when you transition into a medical device company. FDA regulatory experience is not usually part of engineering education - and if you want your company to succeed, it will need resources that understand those needs. Marked as spam
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Bill Watson
I'd absolutely recommend that any recently graduated electrical, mechanical or software engineer look at the medical device field for at least the beginning of their career. It's a lot easier to gain experience with FDA regulated product early on and possibly transition into and out of medical device jobs than trying to break into the market later in life.
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As long as the products are still needed by people, and the company is committed to keep up with the advancing "market" situations and current development so that the technology and the company won't become obsolete, then yes I would recommend the medical device field to my future children :)
The medical device industry is not as ancient and established as the pharmaceutical industry (in my humble opinion), therefore there are still plenty of rooms to play around with, there are many crafts that can be done, ethics-wise and creativity-wise. As someone whose passion is in medical (whatever the industry is), I think career in medical device industry is one of the intellectually challenging and rewarding (network-wise and financially). The company just need to put the right people in the right place. The proper strategy, operations, and people processes are what make a business successful 😃 Marked as spam
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Julie Omohundro
Grace, industries have lifecycles, just like products:
Early Stages - alternative product design and positioning, establishing the range and boundaries of the industry itself. Innovation Phase - Product innovation declines, process innovation begins and a "dominant design" will arrive. Cost or Shakeout Phase - Companies settle on the "dominant design"; economies of scale are achieved, forcing smaller players to be acquired or exit altogether. Barriers to entry become very high, as large-scale consolidation occurs. Maturity - Growth is no longer the main focus, market share and cash flow become the primary goals of the companies left in the space. Decline - Revenues declining; the industry as a whole may be supplanted by a new one. http://www.investopedia.com/terms/i/industrylifecycle.asp?layout=infini&v=5B&adtest=5B&ato=3000 The traditional medical device industry is nearing the end of the shakeout phase. Marked as spam
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Robert Barber
Until such time as we can genetically engineer perfect bodies and eliminate all diseases and accidents, yes!
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I get weekly calls from graduates who want to enter the industry after completing a Medical Degree but being able to find the right way for them to enter the industry is another hurdle. Recommending and attracting the next generation is one thing but finding them an opportunity to start their career is no small feat. Can anyone recommend companies that take on graduates looking to get into medical devices apart from RB?
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Andrew Kyle
Katrina - same for me - lots of graduates who cannot find jobs. Earlier, the reason is that medical devices represent a mature industry. Fewer exhibitors each year as consolidations and the inability of small companies to afford the increasing costs of regulations are the result. Look at automobiles - fewer manufactures and cross company uses of parts. Or imaging systems. Three really big ones and then a couple of second tier brands. All produce good devices. So they compete with price and only the efficient who squeeze their suppliers, outsource development and manufacturing prosper. It would be difficult to start another major radiological company today. Without growth and with consolidation, the number of jobs in the industry fall for creators and grow for regulatory and QA resources to meet the regulations of a world industry. So I recommend focusing on RA and QA when asked. The regulatory requirements are likely to increase as creativity dwindles and jobs will follow accordingly.
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Marc Timothy Smith
These days, and into the future it's hard to say. Medical devices isn't the only field that is suffering, and there is no field a person can go into where there is a good chance of ending up "rich" (and of course what "rich" is is relative, anyway).
My GF and I were reading a story about pilots recently. I used to fly in the 1970's and 1980's. Pay was good. These days entering pilots are lucky to get $15K/yr. Same with automotive in the US - Used to be good paying jobs. These days entry level isn't much more than minimum wage. My daughter is an athletic trainer. She likes it. She will probably never be rich, but she makes a decent living. As to medical devices being a "mature field", what field these days isn't? Marked as spam
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Robert Christensen
I found that the field of innovation and designing of medical implants and devices was what I truly was called to do along with the surgery, but was very disappointed in the heavy hand of the FDA.
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Jeff McGovern
I would say yes. There are hundreds of thousands of medical equipment jobs in the healthcare industry. Biomed techs working with equipment and their chain of command. Support companies for the major manufacturers. R and D will still be going on and new technologies will come along. Federal QA requires there be qualified technicians so there will be.
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Julie Omohundro
Marc, the most commonly mentioned are genomics, robotics, AI, personalized medicine, digital health, energy (new and old, for as long as the old lasts), environment, and food.
But the best career for a high school student today might be in an industry that no one is even talking about yet. When I was in high school, no one could have suggested I go into the software industry, because there wasn't one. Marked as spam
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Marc Timothy Smith
I agree with you, Julie O. I took programming in college in PL1, FORTRAN and cobol - But I took programming courses as tools (and for fun, actually) so that I could use computers, such as they were at the time, to solve biology and chemistry problems. I had no thought of programming as a profession. Not to mention, no PCs back then. All punchcards and terminals.
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Marie Suetsugu
I'm sorry but, if the person is 'count[ing] on being rich', please don't. I'm rather shocked to learn here that anyone wanting to be involved in the medical world is primarily interested in money :-o Yes, one must survive and have a decent life, but shouldn't ethics come first...
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Andrew Kyle
No - however you are investing time and money getting an education and may have loans to pay. It is not unreasonable to look at the consequences if you make those decisions. Physicians make a lot of $ and have ethics too.
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Art Pichierri
Interesting conversation. After 40 years in biotech my modest company is poised for new energy and business growth. I am planning for retirement. Our product designs are Class III and mostly exempt. Use once and destroy. Easy to sell for expansion within existing markets. The employee market within a hospital is a vertical unto itself. My 'hurdle' is finding the 'old school' work ethic. Sweat equity over time equals 'getting rich'. It doesn't happen overnight.
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