Innovation Agenda: Five Pillars to

Protect the MedTech Ecosystem

1. Improve

FDAs regulatory processes

so that American patients will have first access to new devices,

while maintaining the highest standards of safety and efficacy.
We can achieve this with better training for frontline reviewers and by revitalizing requirements to
use the least burdensome evidence requirements to
show safety and efficacy.

2. Restructure Medicare and Medicaids

coverage and payment processes

to support development of new technologies that improve

treatment, diagnosis, or prevention and provide patients
with prompt access to them.

Cuts to R&D

50%

More than
of medtech companies have
reduced R&D as a result of
the tax.2

Job Losses

2/3

of medtech
companies have
decided to slow or halt U.S. job
creation as a result of the tax,
reducing industry employmnet
by 39,000 workers and many
more lost jobs in companies
supplying the industry.3

A therapy that is considered for

Medicare national coverage today

is 20x LESS LIKELY

to receive a favorable decision
than it was ten years ago.1

3. Reform the U.S. tax

system to create a level
playing field, starting with
repeal of the medical device excise
taxa tax that is draining resources
from American manufacturing jobs
and research.

4. Improve access to
international markets
by insisting on free and fair
trade and working with foreign
governments to achieve
innovation-friendly policies.

Other countries are anxious to overtake the U.S. as the leader in medical
technology and innovationbut maintaining policies that encourage
worldwide innovation and patient access are critical for American patients.

Between 2007 and 2013, venture capital

investment in medical technology

DECLINED BY 42%.

5. Support the maintenance

and growth of an R&D
infrastructure second
to none.

1. James D. Chambers, et al., Medicare is Scrutinizing Evidence More Tightly for National Coverage Determinations, Health Affairs, February 2015.
2. Impact of the Medical Device Excise Tax: A Status Report from AdvaMed, January 2015.
3. Impact of the Medical Device Excise Tax: A Status Report from AdvaMed, January 2015.
4. PWC and National Venture Capital Association, Venture Capital Investments Q1. 2014Money Tree Results, April, 18, 2014.

AdvaMed.org