Keeping Ahead in the Medical Device Sector

Donald DeLauder, Executive Director - Corporate Innovation, Bayer Radiology and Interventional, a business of Bayer Healthcare, 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.

New York, NY, May 17, 2012 - (ACN Newswire) - "Medical device industry executives often develop products that are deemed safe and effective by the FDA, but that do not sell as they are not reimbursable," says Donald DeLauder, Executive Director - Corporate Innovation, Bayer Radiology and Interventional. They must spend more time on developing their products, he adds.

The chairman at the upcoming marcus evans Medical Device Manufacturing Summit Spring 2012 and Medical Device R&D Summit Spring 2012, DeLauder shares his views on product development and the complex regulatory environment.

- How can executives in this industry ensure that their products are reimbursable?

Medical device industry executives often develop products that are deemed safe and effective by the FDA, but that do not sell as they are not reimbursable. This means that companies are spending time and money on developing products that go nowhere. It is crucial to take the time to get the data right and understand the reimbursement path. Although they aimto get to market faster, there is much more to it than simply developing the technology.

Unfortunately, very little has been done in terms of improving the research and development (R&D) process. Product data management tools, for example, helporganize information, but they have also allowed processes to become more complex and inefficient.

- What are the regulatory concerns that medical device industry executives are currently facing? How can they be prepared for what lies ahead?
Over the past 20 years, the industry has evolved immensely; however, there are complex challenges with regulations. Gaining 510(k) approvals is becoming a difficult task, and is driving companies away from the US market.

The industry is troubledwith the difficult economic environment, and very few venture capitalists are investing in early stage opportunities. There is not enough capital to fund the increased requirements in the regulatory space for early stage companies. It is a tough environment, and medical device executives must spend time trying to improve R&D, launch, and commercialization processes.

- With globalization being a major trend in the industry, what does it take to prosper in today's competitive marketplace?

The US market is facing intense competition from countries that are producing sophisticated medical devices at lower costs, and of the same, or at least sufficient, quality. Although emerging markets are not typically direct competition, they do holdlarge opportunities due to the phenomenal growth rates of up to 15 per cent, which is tremendous compared to the US, Europe and Japan.

Organizations must change their mindset and become more connective. If they want to be successful in emergingmarkets, they probably have to do it by developing products in those markets.

- What is your outlook for the future?

Medical device industry executives will begin to see more interaction between devices, which provide opportunities and complicates development and approval. Generally, digital technologies keep getting faster and cheaper, and from a mechanical perspective there will be more miniaturization.

Manufacturers must stay focused on the clinical environment and their customers' needs. It is crucial for them to spend more time in the clinical environment, learning rather than selling, as devices have got to become more effective for better patient outcomes.


For more information please send an email to info@marcusevanscy.com or visit the event websites below:

Medical Device Manufacturing Summit Spring 2012:
www.medicalmanufacturingsummit.com/DonaldDeLauderInterview

Medical Device R&D Summit Spring 2012: www.medicalrdsummit.com/DonaldDeLauderInterview
marcus evans group - manufacturing sector portal - http://tiny.cc/FWbg2b

Please note that the Summit is a closed business event and the number of participants strictly limited.

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