|By ACN Newswire||
|November 7, 2012 04:30 AM EST||
New York, NY, Nov 7, 2012 - (ACN Newswire) - Medical device manufacturers can improve compliance with the Food and Drug Administration (FDA) by better communication and understanding of the regulations from the start. Setting product development goals at this stage will also improve the end product and reduce costs, says Tom Black, Vice President, Original Equipment Manufacturer & International Divisions Sales and Marketing, B. Braun Medical Inc. Complete alignment of the customer and the FDA's requirements needs will allow for innovative products to follow a smoother path, he adds.
A speaker at the upcoming marcus evans Medical Device Manufacturing Summit Fall 2012 and the Medical Device R&D Summit Fall 2012, in Colorado Springs, Colorado, November 27-28, Black talks about the difficulties facing the industry at the moment and how new manufacturing methods can help remedy these setbacks.
- What difficulties are there within the medical device manufacturing industry?
The current challenges lie in providing customers with affordable products while meeting all of the new documentation requirements. An example of this is all of the new material control information that is being requested. Outsourcing partners are also feeling the pressure of delivering documentation and support that require resources that are costly. These additional costs must be offset by continuous focus on improving manufacturing processes.
People within the industry are continuously searching for new methods to improve patient safety with new products or processes. An organization can take advantage of this by being prepared for new ideas and having a culture that continuously looks for improvement. This focus throughout an organization will enable new products to be developed and placed into the market. New opportunities will be driven even further if the focus is on better outcomes that also lead to lower overall healthcare costs.
- How can medical device manufacturers comply with FDA requirements?
The process of compliance can be improved by improving communications with the FDA in order to obtain a clear understanding of their requirements upfront. This will save time and costs, by avoiding any misunderstanding before the development of new products and new processes.
This communication process can then be carried forward into innovation. If we understand what is required from a patient safety, cost and practitioner standpoint, then research can be done into what products customers want. This can then be aligned with the manufacturing capabilities of the organization, thus better and more innovative products will be produced.
- What advice can you give for developing excellence with quality assurance systems?
First, define the objectives of the organization, and continue to focus on quality. There must be a holistic culture of understanding that quality and continuous improvement are the first priority. The most innovative and adaptable companies who continue to focus on quality and efficiency will succeed.
For more information please send an email to [email protected] or visit the event websites below:
Medical Device Manufacturing Summit Fall 2012: www.medicalmanufacturingsummit.com/TomBlackInterview
Medical Device R&D Summit Fall 2012:
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.
About marcus evans Summits
marcus evans Summits are high level business forums for the world's leading decision-makers to meet, learn and discuss strategies and solutions. Held at exclusive locations around the world, these events provide attendees with a unique opportunity to individually tailor their schedules of keynote presentations, think tanks, seminars and one-on-one business meetings. For more information, please visit www.marcusevans.com.
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- YouTube: www.youtube.com/user/MarcusEvansGroup
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Source: marcus evans Summits
Maria Gregoriou, Journalist, marcus evans, Summits Division Tel: +357 22 849 400 Email: [email protected]
Copyright 2012 ACN Newswire. All rights reserved.
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