I know it’s risky but if we play nice this could be a productive conversation.

With one Presidental debate behind us, which candidate would be better for the medical devices industry? Or will either candidate be equally good (or bad) for industry?

The Medical Device Tax suspension still has more than a year left in it. Will the election help determine whether the suspension is permanent? (We had a related conversation at http://bit.ly/medtax-suspended a few months back.)

Lastly, do you think the next few years for the medical device industry will be better than the last few? If so, why?

And again, remember this is a professional forum. Respectful comments only, please.

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SEATS ADDED TO THE 13485:2016 WEBINAR

In the five years I’ve led the group, we’ve never had 1100 people register for a webinar so quickly.

If you tried to register and got locked out, please try again at http://medgroup.biz/iso13485 now that I’ve added another thousand seats.

Jon Speer from greenlight.guru will discuss all the changes ISO made in its long awaited revision to 13485, the global standard for medical device quality management systems.

This is the first revision of the standard since 2003, and it represents some major changes including the inclusion of risk management throughout the QMS, greater emphasis on quality management throughout the entire product lifecycle and supply chain, and much more.

Specifically you will learn:
• What exactly changed in the new ISO 13485:2016
• How leveraging technology can help simplify your compliance
• 5 steps to take now to make for a smooth transition
• Live Q/A to answer all your questions

The live event will be Tuesday, October 4 at noon, New York time. We’ll record it and make the replay, slides, and transcript available to all who register.

That link again: http://medgroup.biz/iso13485

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Discussions You May Have Missed

Where to find a list of CE-marked devices?
http://bit.ly/CE-list

Need Guidance for HIPAA Safe Harbor Requirements and compliance
http://bit.ly/HPAsafe

Recommend a good notified body?
http://bit.ly/recomNB

Whatsapp Group for Indian Medical Device Market
http://bit.ly/supIndia

Busting Standard of Care
http://bit.ly/StdoCare

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Make it a great week.

Joe Hage
Medical Devices Group Leader

P.S. For the library of webinars we’ve hosted, visit http://MedicalDevicesGroup.net/webinars

Julie Omohundro
Principal Consultant at Class Three, LLC
If you go to the Group’s web page, you will find that Joe has started a more recent, post-election discussion on this topic.

Peg Graham
Improving the Caregiving Experience, Chair of the YANA Health Forum
Hoping for a thoughtful approach to healthcare, companies recognizing that the open wallet approach of years ago is unsustainable and that they continue to rethink their strategies in terms of value-based payment frameworks.

Ken Powell
President
With Donald winning, you can toss out the idea of phama price controls and possibly the medical device tax. We are going to make America Great Again, just like my late father did.

Dave Gaisser
Quality and Regulatory Consultant, Geyser Medical Consulting
Interesting question, Joe. To Rian and Steve’s point, most of my clients are startups with fewer than ten employees. These innovative companies generally find the device tax burdensome and would like an answer. My initial thought is that since the repeal had broad bipartisan support, the suspension might be extended regardless of the final choice. However, since an opinion was sought:

I have seen no mention by Ms. Clinton, but since the ACA policy was established by the current Democratic administration, one might expect the tax to be reinstituted if given the chance.

On the Republican side, while Mr. Trump also has not expressed an opinion, Mike Pence is on record as being firmly against the tax, so that might be the better option.

If I can open a can of worms, Gary Johnson, with his desire for eliminating taxes on both personal income and corporations, might be the best solution for this topic. Of course, that is a long shot and he would then have to work with Congress…

Steve Bixby
Director, International Sales & Marketing at MorTan, Inc.
I agree with Bo–there is a perception that all medical device companies are huge corporations investing millions on R&D. While those do exist, what’s the percentage of medical device companies with fewer than 10 employees? For those, I don’t see the immediate future as improving. And I don’t see any mention of the medical device excise tax, but as I recall it wasn’t repealed but is just on hold. I’m betting that will be back as soon as possible if one party is elected.

Georga A. Linkous-Long ⚓️🇺🇸
Owner/ Consultant/ Ostomate for 38 years/Public Speaker/Reye’s Syndrome Survivor of 44 years
Hey Joe Hage I don’t get over to a lot of the forums but you ask a great question. Being in the DME World I can tell you Trump will be the better. The reason is Dr Ben Carson. They will make Medical History in getting rid of soooooo much red tape. Also get rid of this bidding crap. I can barely get my Ostomy supplies as it is. But since the bull that Clinton put in place back in 94 and 97. This is the mess we have.

Burrell (Bo) Clawson
I research patents & design products to get a patented competitive position: Over 30 patents.
Industry in one thing, but what YOUR company does could be entirely different.

A company supplying commodity medical devices with half a dozen competitors may be squeezed on profits & declining sales.

A company innovating with better, simpler, less expensive products or ones giving unique usability may be growing leaps and bounds.

Julie Omohundro
Principal Consultant at Class Three, LLC
Regarding the short-term, that’s business, with a focus limited largely to the next quarter and annual earnings. Long-term is economics. People in business often think they are doing themselves a great favor by supporting “pro-business” candidates and policies, when what business actually needs is a strong economy. All the “pro-business” whatever isn’t worth a thing to businesses in a bad economy, and all the “anti-business” whatever can’t make a dent in a strong one.

I’m not sure about either candidate on economy, but it probably doesn’t matter, because I don’t think either one will actually be running the country if they are elected. Nor do I think that what either candidate says while campaigning will correlate much with what actually happens post-election.

Julie Omohundro
Principal Consultant at Class Three, LLC
Lynn:
http://www.investopedia.com/terms/i/industrylifecycle.asp
It seems clear to me that the traditional US device industry is well into the Maturity phase at this point. I also wonder how many of the “growth areas” people cite are really examples of pushing into adjacent markets, an indicator of Decline.

Julie Omohundro
Principal Consultant at Class Three, LLC
I’m inclined to think most of the views here (and elsewhere) are myopic in terms of both time and scope. It seems to me that what has been higher healthcare expenditures (not to be confused with costs) in the US is the same thing that has been driving them since the 70s and the same thing that drove the sub-prime fiasco…Americans wanting to have that which they cannot afford. What drives that desire is media, which is driven by those who want to sell something to people who can’t afford it. This requires getting someone else to pay for it, at least in the short term. To be continued…

Lynn M. Little
Dean, College of Science and Mathematics at Midwestern State University (Retired)
I do not see the US or international medical device industry declining any time soon, with huge technical advances being made in 3D printing, robotics, nanotechnology, telemedicine, and other areas. But I agree that reforms are needed within the US Government for greater support of scientific developments.

Julie Omohundro
Principal Consultant at Class Three, LLC
Oh…”countries,” not “companies.”

Julie Omohundro
Principal Consultant at Class Three, LLC
I think it may be useful to distinguish the outlook for the US medical device industry from that of other companies. In many companies, it looks to be a high-growth industry. In the US, the huge market for medical devices may continue to be strong for some time. I’m not inclined to think it will fare well over the long haul with the US government as an increasingly major payor, but time will tell on that. As for the US medical device industry itself, I think it is likely to continue along the path of consolidation and decline, with a few exceptions. The one in which I have most confidence is IVDs.

Julie Omohundro
Principal Consultant at Class Three, LLC
My perspective as a life-long unaffiliated voter with a good bit more than average experience with US presidential elections is that it doesn’t matter much who gets elected; the long-term results will be the same, and most of the difference will be in how they spin the same facts to different voters. I think healthcare and related industries have been on the same basic paths, undeterred by election results, for decades, and I don’t see this changing.

Laisley Zhou
Bank
I think it better for the following year that medical devices production.

Sean McDermott
CERTIFIED FINANCIAL PLANNER™ at Summit Investment Advisors Wealth Advisor for the Health Tech community.
Here is a recent economic outlook commenting on Healthcare stocks:
http://www.summitinvest.com/blog/what-a-trump-victory-might-look-like-for-markets

Jeremy Y.
Senior Engineer
I think the growth and size of the medical and healthcare industry both domestically in the US and globally worldwide will eventually drive the way forward. A wise government will choose to facilitate growth and create greater job opportunities from it.

Ananth V.
Technology services
A persuasive and smart president can push for positive changes. But as I understand the president alone cannot bring any major changes. I am not sure how good of an administrator Trump is behind all his demeanor. Definitively the old way of doing business in DC need to change to keep this great country reach greater heights. The last 4 years nothing useful got done by the elected officials. Also the voting public need to actively engage with their local senators and representatives so we(Public) can push for and make the real change happens. Corporate taxes are important and I wish we find a way to plug all the holes in the tax code so everyone contribute to the tax pool fairly. I will push heavy for small, efficient and integrated governance in state and federal level.

Sean Harz
Sr. Director of Business Development & Strategy at Cirtec | Neuromodulation | Implantable | Contract Manufacturing
Based on her campaign’s response to the Mylan Epipen controversy (and other pharma demonizing), it seems that HC is more focused on the politics of healthcare rather than the actual facts of why costs are increasing (70% increase to our deductibles, and 30% increase to our premiums). She has a love affair with ACA but fails to acknowledge that it is one of the (but not the only) major culprits in these price jumps. It’s far more entertaining and salacious to drag big Pharma through the mud.

I’m not necessarily saying DT will be any better for the future of medical devices, but certainly his pro-business, anti-regulation attitude, is a step in the right direction. However, he hasn’t said or done anything specific toward our industry that would indicate a much brighter future.

Mark Kowal
President/CEO at IBL-America
Trump is an enigma relative to the medical device industry. Although I do not like him in general I do see him as having a better business sense and therefore much more pro-business. HRC will, more than likely, continue the path taken by the present administration and this, at least to my company as a provider to various clinical laboratories, has been costly and unproductive.