Donald DeLauder, the chairman at the marcus evans Medical Device Manufacturing Summit Spring 2012 and Medical Device R&D Summit Spring 2012, on prospering in the complex medical device manufacturing industry. Interview with: Donald DeLauder, Executive Director - Corporate Innovation, Bayer Radiology and Interventional, a business of Bayer Healthcare.

1. Keeping Ahead
in the Medical Device Sector
and understand the reimbursement growth rates of up to 15 per cent, which
path. Although they aim to get to is tremendous compared to the US,
market faster, there is much more to it Europe and Japan.
than simply developing the technology.
Organizations must change their
Unfortunately, very little has been done mindset and become more connective.
in terms of improving the research and If they want to be successful in
development (R&D) process. Product emerging markets, they probably have
data management tools, for example, to do it by developing products in those
help organize information, but they markets.
have also allowed processes to become
more complex and inefficient.
Interview with: Donald DeLauder, What are the regulatory concerns
Executive Director - Corporate
Innovation, Bayer Radiology and
that medical device industry
executives are currently facing?
Medical device
Interventional, a business of Bayer
Healthcare.
How can they be prepared for what
lies ahead?
executives must
Over the past 20 years, the industry has stay focused
“Medical device industry executives
often develop products that are deemed
evolved immensely; however, there are
complex challenges with regulations. on the clinical
safe and effective by the FDA, but that Gaining 510(k) approvals is becoming a
do not sell as they are not
reimbursable,” says Donald DeLauder,
difficult task, and is driving companies
away from the US market.
environment
Executive Director - Corporate
Innovation, Bayer Radiology and The industry is troubled with the difficult
and their
Interventional. They must spend more
time on developing their products, he
economic environment, and very few
venture capitalists are investing in early customers’ needs
adds. stage opportunities. There is not enough
capital to fund the increased
The chairman at the upcoming marcus requirements in the regulatory space for
evans Medical Device Manufacturing early stage companies. It is a tough What is your outlook for the future?
Summit Spring 2012 and Medical environment, and medical device
Device R&D Summit Spring 2012, executives must spend time trying Medical device industry executives will
DeLauder shares his views on product to improve R&D, launch, and begin to see more interaction between
development and the complex commercialization processes. devices, which provide opportunities
regulatory environment. and complicates development and
With globalization being a major approval. Generally, digital technologies
How can executives in this industry trend in the industry, what does it keep getting faster and cheaper, and
ensure that their products are take to prosper in today’s from a mechanical perspective there will
reimbursable? competitive marketplace? be more miniaturization.
Medical device industry executives The US market is facing intense Manufacturers must stay focused on the
often develop products that are deemed competition from countries that are clinical environment and their
safe and effective by the FDA, but that producing sophisticated medical devices customers’ needs. It is crucial for them
do not sell as they are not reimbursable. at lower costs, and of the same, or at to spend more time in the clinical
This means that companies are least sufficient, quality. Although environment, learning rather than
spending time and money on developing emerging markets are not typically selling, as devices have got to become
products that go nowhere. It is crucial direct competition, they do hold large more effective for better patient
to take the time to get the data right opportunities due to the phenomenal outcomes.

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