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David Stambaugh forwarded me a thought-provoking paper on trends affecting medical devices. For today’s discussion, do you believe the aging population will benefit us most? The paper says, “According to the U.S. Department of Health and Human Services, the β60 years or overβ population segment in developed countries is expected to increase from 23 percent to 32 percent by 2050.” On the downside, do you believe increased regulation is the biggest obstacle? The paper says, “In a recent study conducted by the global medical device consulting firm Emergo Group, respondents, composed primarily of QA/RA professionals and senior managers, cited the βchanging regulatory environmentβ as their greatest challenge in 2014.” See http://medgroup.biz/5trends for the whole piece. The editorial discusses emerging markets as an offset to U.S. regulatory challenges, Chinaβs ambitious healthcare reform plan, and the pros and cons of healthcare consolidation. Thanks for sharing, David. That link again: http://medgroup.biz/5trends ++++++++++ SORRY ABOUT THAT… Our companion website went down for a while last week. But it’s all better now β so you can visit now to: β’ Join the Medical Device Sales Webinar tomorrow at http://medgroup.biz/meddevsales β’ Video of Kaiser Permanente’s CIO on what they need from device companies at http://medgroup.biz/Kaiser ++++++++++ Make it a great week. Joe Hage P.S. The Medical Devices Group will be at Medtrade (Atlanta, Oct 21-23). Want to meet? http://medgroup.biz/Medtrade-2014 Dale Yakin Funding trials (and any increase in trails cost) is still the biggest obstacle to new innovations advancing the standard of care, and I view this as a failure by the investment community – too often innovative products never move forward because those making the judgments miss the (often very valuable) differentiation and potential. Dave Sheppard Ee Bin Liew increasing and changing regulations – didn’t we just have a thread on equipment in economically or politically challenging areas and we were thinking of how to service or provide more equipment to them? what are the regulatory schemes there? how about during natural disasters/pandemics? didn’t certain things just go straight through? meantime, in other parts of the world, organisations talk passionately about regulatory harmonisation, yet the same countries come up with more and more unique requirements to make stuff more and more challenging for governments, industry, and people alike…. why create such conflicting approaches and complexities for ourselves? Will (Chidi) Onyenanu Joe Hage Shailendra Rao Nalige Joe Camaratta I believe the biggest threat is the changing business model regarding who pays for medical devices, and how much they are willing to pay. The article touches on this topic under “Trend 4: Hospital Consolidation”, but it is more than just consolidation. Value-based reimbursement requires to manufacturers to demonstrate the impact of their innovations on patient outcomes (not just safety) and cost effective care. Most companies do not have the processes nor resources in place to collect such information and bring it to market in a manner that enables providers to make appropriate decisions. I agree with their conclusion on this topic: “Investing in robust reporting tools will also allow [companies] to better illustrate the clinical value of their devices by tying their products to measurable health outcomes.” John Abbott As to the regulatory question, you equate “changing regulatory environment” with “increased regulation”. Is that assured? Also, it is in the emerging markets where much of the regulatory growth today is being seen so I don’t necessarily see that as a way to offset existing regulatory requirements such as in the US, Canada, Japan and EU. I also encourage respondents to first put themselves in the shoes of the average healthcare consumer – the family of 4 struggling with an annual household income of $60,000 in a major city. Do you as a consumer of medical technology really want less regulation? Personally, I am not so sure. To date, the public has been unwilling to compromise on healthcare. Maybe that will change… And maybe Congress will give up gridlock for compromise consensus legislation. Marked as spam
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