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Feature |
Published: November 21, 2011
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A Look at Medical Device Numbers in 2011
The medical device market is facing a number of hurdles, which are having a negative influence on job growth, the funding climate, and the industry’s overall prognosis.
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| Source: PwC: Reaching for Growth |
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| Source: AdvaMed: Sustain U.S. Leadership in Medical Technology |
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| Source: Accenture: Reinventing Medical Technology for a Dramatically Different Future |
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| Source: AdvaMed: Sustain U.S. Leadership in Medical Technology |
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| Source: AdvaMed: Sustain U.S. Leadership in Medical Technology |
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| Source: Ernst & Young: Pulse of the Industry Report |
510(k) and CE Mark Regulatory Timelines |
PMA and CE Mark
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| FDA reported 510(k) Review time (Office of Device Evaluation, Annual Performance Report, 2009) |
US companies’ Experience with 510(k) Review |
US Companies’ Experience in Europe (CE) |
FDA Reported PMA Review Time (Office of Device Evaluation, Annual Performance Report, 2009) |
US companies’ experience with PMA review |
US companies’ experience in Europe (CE) |
| 3 months “average total elapsed time from receipt to final decision” |
10 months from first filing to clearance 31 months from first communication to clearance |
7 months from first communication to certificate |
9 months “average total elapsed time from filing to approval for all original PMAs” |
54 months from first communication to approval (or to present) |
11 months from first communication to certificate |
Source: FDA Impact on U.S. Medical Technology Innovation
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Source: Ernst & Young: Pulse of the Industry Report |
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| Source: Ernst & Young: Pulse of the Industry Report |
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What is a Correlation and What is a Cause and Effect?
The linear decline in the growth rate of the medtech industry from 2004 to 2010 is disconcerting to say the least. In the little box associated with the 15.3-to-3.5% graph is the statement, "The annual growth rate of the industry is slowing as concerns about funding and the regulatory environment mount." Later on are the bleak FDA approval times and numbers, and so, one wonders if one causes the other, or, are the two things simply happening in parallel? There are some very loud voices who lay all of the blame on the FDA. I'm just not one of them. As a scientist, I know a correlation when I see one.
What about "funding"? Is cash really a problem? Who has the cash out there? Also in today's MD+DI Online Newsletter is the feature article titled, "Mergers and Acquisitions: Medtech Buyers and Sellers Win" by Clyde A. Burkhardt, illustrating a major focus on mergers and acquisitions. From the article, it can be seen that this past year, all the big companies are doing them. This contracture of the industry has been happening for quite some time, so I wonder if the drive towards mergers and acquisitions might be THE major cause of slowed growth. With such amazing amounts of cash going for simply buying and selling what already exists, what is left for growth?
After all the money has changed hands, someone has to pay, and it's usually the employees of one or both of the buyer or the sold. "Efficiencies" must be made, "costs" and "operations" must be streamlined, and that means 1,000 people here, and 2,000 people there, gone........and R&D budgets getting ever so smaller...................and reports of real innovations becoming fewer and farther between. When it comes to a slowdown in growth, I know cause and effect when I see it.
Paul Stein