5 min reading time

We in America have a new president with a decidedly “America First” platform.

Will it help American medtech?

From the December 2016 LIMEDex Index:

• Stricter oversight of public spending with an “America first” bias could significantly affect procurement policies. Focusing only on cost of acquisition instead of long-term value via cost effectiveness or quality outcomes seems averse to the stated goals of the ACA.

• Increased on-shoring of production could erode the bottom line. It might cause US firms to re-evaluate the supply chain and drive repatriation of manufacturing to the US. For foreign companies it could trigger the need to make foreign direct investment to increase “US-based” production.

• Growth in exports is expected to slow down due to a stronger USD, higher uncertainties in trade agreements, and fierce competition.

The full report (free, no signup) at

ConCep+, the healthcare value chain think tank and strategy consultancy that authored the paper, did their quarterly survey of medtech managers and found North America, particularly USA, slipped from 2nd to a “least growth” (6th) region this quarter.

Do you share these medtech managers’ concern?

Will an “America First” policy help or hurt the US medtech industry?

As a corollary, will Brexit help or hurt the UK medtech industry?

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TWO TEAMS LEFT

You can win free admission to the 10x Medical Device Conference if you’re the first to correctly answer these two questions at http://medgroup.biz/superbowl –

1) Who will win, the Patriots or the Falcons?

2) What will be each team’s final score?

For everyone else, we’re still offering early bird pricing so register at http://medgroup.biz/10x before month’s end to save!

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Make it a great week.

Joe Hage
Medical Devices Group Leader

P.S. See you next week at the free http://medgroup.biz/mktaccess webinar!

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Bogdan Baudis
Prinicipal Software Engineer at Cambridge Consultants
We stopped believing in professional politicians so obviously the cure is to hire a non-professional one. I also will stop seeing my doctor and find myself a shaman.

Julie Omohundro
Principal Consultant at Class Three, LLC
Rick, like I said, I don’t think anyone has any compelling data to support or reject any of these claims. To borrow a phrase from someone who commented on the claim that the device tax cost jobs, I think these claims are based on nothing than having been repeated over and over and over.

Rick Stockton
Product Designer (Medical, Scientific, Consumer)
Sam Rutigliano, MBA, I actually spoke with a friend on the Regulatory side, yesterday, concerned about reducing the number of FDA regulations.

But I agree with you on this. Many have long complained about regulatory accretion, which exacts a substantial economic burden on medical device development and deployment.

Europe made its CE approval regulations more sensible and streamlined than FDA regs. As a result, many first-time device approvals moved from the US to Europe, together with many manufacturing jobs.

“America First” is all about, among other things, making the US the best place for manufacturing and development, including medical devices.

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By the way, I learned in detail about the FDA-to-CE regulation-induced migration at the 10x Conference, coming up in May, in San Diego.
http://medicaldeviceevents.com/?utm_keyword=LinkedIn10x is my “go to” for broad context, superior intellectual equipping, and exemplary professional intercourse.

Rick Stockton
Product Designer (Medical, Scientific, Consumer)
Some great thoughts.

“America First”, in Trump’s own words, is for America to represent its own interests at least as well as do our more clever trading partners. (cf. TPP) Less imbalance; more a negotiated trading equity. So radical economic isolation seems very unlikely, since trade is the goal.

In America and in UK, the electorate has made a decision toward self-government in the international arena. Very American. Very British. I think we will make it work.

Not to distract, but the Elephant In The Room may be American business tax, the highest in the world, creating an economic force, constantly pushing trade away from our shores. Bringing taxes in line with our trading partners will make doing business in America an outstanding proposition, overwhelming zero sum concerns, even on tax revenues.

Rich Wynkoop
President & CEO at Vision28
Julie O. – Right on the point! It will be interesting to see how this unfolds over the next year.

Julie Omohundro
Principal Consultant at Class Three, LLC
Rich, I think the important question is not how the EO might impact FDA’s rule-making, but the downstream question of how any impact on FDA’s rule-making might affect the pharma and device industries.

For me personally, the really interesting question is who, if anyone, has thought through this any further than Point A, or any deeper than the ink signature on the EO.

Mark Plait
Senior Principal QA Expert at Mark Plait
Regarding ” For each new regulation, two have to be rescinded,” I love it. If you look at the horrendous “proposed” changes the FDA is making to 21 CFR Part 58, this new regulation ” For each new regulation, two have to be rescinded,” will make the GLP regulations only about 1 page long based on the new Executive order….:)

Julie Omohundro
Principal Consultant at Class Three, LLC
Sam, I don’t think anyone really has any compelling data to either support or reject these claims.

Michael Helton
Team Lead at Viant Medical
Absolutely

Rich Wynkoop
President & CEO at Vision28
Interesting Executive Order today: For each new regulation, two have to be rescinded, with a zero based $$ impact!! How do you think that will impact FDA’s rule making?

Del Fredricks
R&D Systems Engineer at Smiths Medical
Will tax make building Stateside cheaper than using labor in Mexico? Then moving them here would be putting America first.

Del Fredricks
R&D Systems Engineer at Smiths Medical
If Mexican build of devices is due to cheaper labor, then import tax could negate that and make it more attractive to build Stateside, creating jobs and Putting America First.

Del Fredricks
R&D Systems Engineer at Smiths Medical
Joe Hage is the reason Mexico is importing so many devices because companies have chosen to built there under NAFTA rules due to cheaper workforce?

If so, then Putting America First would seem to hinge on logic of bringing those jobs back in country due to import tax offsetting cheaper labor.

Kimani Andrew
Senior Biomedical Technologist – (BTS) – Sunshine Coast University Hospital.
It’s very sad that a great nation like USA is building a wall … physical wall. .. businesses isolation. …. in this age…..

We as are better humans and smarter than this…. American is going backwards

Sam Rutigliano, MBA
On the flip side to the hiring freeze at FDA, Trump is looking at cutting regulations and bureaucracy (“big league”) that negatively impact business. From what I understand, one of the biggest issues facing medical device providers is the enormous time it takes in the U.S. to take a product from concept to sales (due to strict FDA regulations), which in turn negatively impacts their ability to compete with companies in other nations with less restrictions. T or F?

Robert Christensen
Medical Consultant
i would hope that they would drain the FDA swamp.
we were killed by their corruption as Dr. Statland knew full well.

Kevin Currier
International Sales Director at HARD Manufacturing Co., Inc.
Michelle Muldoon

James Williamson
Optical Engineer/Physicist | Optics | Design | Simulation | Test | Measurement | R&D | Zemax | SolidWorks|
If prices increase, will wages increase also? Will it be a zero sum gain?

TOHO HIEN
Sales Specialist – Life Care Solutions chez GE Healthcare Region : French Subsahara Africa
No comment

Sashi Bhushan Karmwar
National Sales Manager-Strategic Key Accounts at BPL Medical Technologies Private Limited.
Think where you will export if others also start thinking in the same way