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Regulatory job in pharma vs. medical device

Watchcat

Trusted Information Resource
#11
As for RA in pharma versus devices, you can only have RA to the extent that you have regulation. Devices have never had much regulation, so the device industry doesn't have much RA. That's why in devices RA is almost always jumbled up with QA, with very few people knowing the difference. Seems like biologics should be more highly regulated than pharma, but it may be too soon to tell.
 
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Ed Panek

QA RA Small Med Dev Company
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#13
Do you have any thoughts on where is a good place to be right now? And/or in the long term?
No. I just talk to our partners in pharma and they are worried but that could because they were just acquired. I don't know if long term stability exists any longer. Is there such a thing?
 

Watchcat

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#14
I don't know if long term stability exists any longer. Is there such a thing?
No, I don't think there ever was. There are two concepts in math that I think are good analogies for many things...local minima and local maxima? The first are valleys in the curve and the second are peaks. If the peaks and valleys are wide enough, it is easy to see only the one you are in, and miss the larger context of the curve. I think anyone who has ever thought there was long-term anything was at one point or the other, and couldn't see the curve.

Still, decisions must be made by people like Shawna, who have a life ahead of them, and need to choose a path, or they will never be able to put one foot in front of the other and go anywhere at all.

I think all things biologic have a future...how long, how bumpy, how smooth, who can say.

I'm starting to think "tech," which exploded during WWII, has about run its course. Maybe just in time to save the world, as I see tech as the root cause of, among other things, the current and future pandemics. (Tech -> industrialization/mass production -> urbanization (the backbone of any epidemic) -> domestic market saturation -> globalism, including transportation for viruses). If anything is going to save the world, it has to be DNA, because what else is there? And, as luck would have it, viruses are all about DNA and RNA. Conspiracy or coincidence, who can say. :)

If I were going into RA today, and didn't want to strain my brain on DNA, I'd pick food. Or, today, food safety, which I think is the harbinger of food RA.

I think supply chain is just coming into its own and has a long run ahead of it, barring the collapse of globalism. Food supply chain, probably also a good choice.

I think the basic trades have always had a future and still do, if not a glorious one. Stable if they focus on residential, cyclical if they ride the housing economy. In the latter case, an understanding of local minima and maximum is critical.

Also all things financial, sigh. although perhaps a future fraught with peril.

I'm skeptical of all things Data, if only because of the hype. I usually think hype is not a good sign, for one reason or another, even if I don't know which reason applies this time. And the greater the hype, the more skeptical I become. Among other things, due to all the hype, it seems like most of the people eagerly pursuing Data don't understand it and probably never will. They just caught a train they thought might take them somewhere, because everybody said.
 
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Watchcat

Trusted Information Resource
#15
Oh...and an honorable mention to cybersecurity, which I think has a future, although like most new fields, will eventually (soon?) settle out as a commodity, but probably a pretty stable one for a good while thereafter. One of the better ways to combine an interest in software and an interest in medical devices, I think.
 

Shawna

Starting to get Involved
#16
If you can easily provide some links, I'd be interested to see these. The business reports were most likely written to persuade investors that the industry is on the rise, so they will continue to invest in it. The information on job websites is written to attract candidates, because the more candidates an industry can attract, the greater the labor supply, and the cheaper the labor.

In the meantime, here is my take on the medical device industry:

Both the pharmaceutical industry and medical device industries were essentially created by Congress, when it passed, respectively, the Kefauver-Harris Amendment in 1962 and the Medical Device Amendment of 1976. Previously, drugs and medical devices were mostly just product lines manufactured by various types of industries. (This division makes wood screws; that division makes bone screws.) Those industries were attractive mostly to conservative investors (e.g., retirees looking for stable dividends from "blue chip" companies) not to speculative growth investors. The amendments created new industries that would attract new investors.

Industries have life cycles just like products. The different phases of the life cycle are not clearly separated, some companies and sectors further along than others, but I think the medical device industry is in maturity, with some shake out still going on. The last phase is decline.

To restart the cycle, common wisdom says you need either a technological breakthrough or new markets. The latter, for both pharma and medical devices, are the global markets. (The alternative is a new patient population, so COVID-19 is causing a lot of excitement among the startup crowd, but the pandemic will be over before they ever get started up.)

Pharma first found new markets (the so-called "vanity" markets, e.g., hair and weight loss) and then its new technology. Now it is rapidly morphing into a biologics industry.

Medical devices has also gone global. This is a promising job market in the near term if you speak another language and/or are willing to relocate. Otherwise, the industry must find a new technology, which is why startups are always touting their new devices as "new breakthrough technologies," when they are really just devices, and not always very new.

IVDs are following in pharma's footsteps, with molecular genetics. If that's an area in which you have, or are willing to gain, knowledge and experience, it is rising.

For traditional medical devices, the "new" technology is currently software. This trend is actually being driven much more by the software industry than the medical device industry. Software has been in decline for a long time now. It is desperate for new markets, and healthcare is one of the few it hasn't saturated yet. So now it's all about EMRs, AI, robotics, and SaMDs. If you are a software expert, this area is rising. I don't think it is going to rise nearly as high, or last nearly as long, as the software crowd would like to think, so if you are early in your career, I wouldn't count on it to put your kids through college, and definitely not to secure your retirement.

I think over the long haul medical devices will finally board the DNA train, as we approach the singularity. I think this may be far too challenging a shift for the current industry to handle. Some of the larger companies have the resources, but someone has observed that their management seems to be far more knowledgeable and experienced at "financial manipulation" than product development, So they may lack the vision, as well as the long-term commitment, since this would be a shift extending beyond the careers of those currently serving as CEOs and VPs at these companies. Seems more likely the new biologics industry will acquire bits and pieces of the device industry, as it needs them.
Thank you so much. What you provided is really meaningful and useful for people who just stepped or plan to step into these two fields.
 
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