Tom Black a speaker at the marcus evans Medical Device Manufacturing Summit Fall 2012 and the Medical Device R&D Summit Fall 2012, on how being prepared and having an innovative outlook can bring about further opportunities in the medical device manufacturing industry. Interview with: Tom Black, Vice President, Original Equipment Manufacturer & International Divisions Sales and Marketing, B. Braun Medical Inc.

1. Upfront Communication Makes for
Better Medical Device Manufacturing
while meeting all of the new organization, thus better and more
documentation requirements. innovative products will be produced.
An example of this is all of the new What advice can you give for
material control information that is developing excellence with quality
being requested. Outsourcing partners assurance systems?
are also feeling the pressure of
delivering documentation and support First, define the objectives of the
that require resources that are costly. organization, and continue to focus on
These additional costs must be offset by quality. There must be a holistic culture
continuous focus on improving of understanding that quality and
manufacturing processes. continuous improvement are the first
priority. The most innovative and
Interview with: Tom Black, Vice People within the industry are adaptable companies who continue to
President, Original Equipment continuously searching for new methods focus on quality and efficiency will
Manufacturer & International to improve patient safety with new succeed.
Divisions Sales and Marketing, products or processes. An organization
B. Braun Medical Inc. can take advantage of this by being
prepared for new ideas and having a
culture that continuously looks for
Medical device manufacturers can improvement.
improve compliance with the Food and
Drug Administration (FDA) by better
communication and understanding of
the regulations from the start. Setting
This focus throughout an organization
will enable new products to be
developed and placed into the market.
New
product development goals at this
stage will also improve the end product
and reduce costs, says Tom Black,
New opportunities will be driven even
further if the focus is on better
outcomes that also lead to lower overall
opportunities
Vice President, Original Equipment
Manufacturer & International Divisions
Sales and Marketing, B. Braun Medical
healthcare costs.
How can medical device
will be driven
Inc. Complete alignment of the
customer and the FDA’s requirements
needs will allow for innovative products
manufacturers comply with FDA
requirements? even further
to follow a smoother path, he adds.
A speaker at the upcoming marcus
The process of compliance can be
improved by improving communications
with the FDA in order to obtain a clear
if the focus
evans Medical Device Manufacturing
Summit Fall 2012 and the Medical
Device R&D Summit Fall 2012, in
understanding of their requirements
upfront. This will save time and costs,
by avoiding any misunderstanding
is on better
Colorado Springs, Colorado, November
27-28, Black talks about the difficulties
facing the industry at the moment and
before the development of new products
and new processes. outcomes
how new manufacturing methods can This communication process can then be
help remedy these setbacks. carried forward into innovation. If we
understand what is required from a
What difficulties are there within patient safety, cost and practitioner
the medical device manufacturing standpoint, then research can be done
industry? into what products customers want.
The current challenges lie in providing This can then be aligned with the
customers with affordable products manufacturing capabilities of the

2. The marcus evans Summits
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the event websites below:
information on strategic matters,
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Medical Device Manufacturing Summit Fall 2012:
breakthrough innovations.
www.medicalmanufacturingsummit.com
Medical Device R&D Summit Fall 2012:
www.medicalrdsummit.com
Please note that the Summit is a
closed business event and the
number of participants strictly
Contact
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Tel: + 357 22 849 400
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