SYS-CON MEDIA Authors: Adine Deford, Cynthia Dunlop, Harry Trott, Xenia von Wedel, Peter Silva

News Feed Item

Upfront Communication Makes for Better Medical Device Manufacturing

Tom Black, Vice President, Original Equipment Manufacturer & International Divisions Sales and Marketing, B. Braun Medical Inc., 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.

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:
www.medicalrdsummit.com/TomBlackInterview

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.

- Twitter: www.twitter.com/meSummitsGlobal
- YouTube: www.youtube.com/user/MarcusEvansGroup
- SlideShare: www.slideshare.net/MarcusEvansSummits

Source: marcus evans Summits

Contact:
Maria Gregoriou, 
Journalist, marcus evans, Summits Division
Tel: +357 22 849 400
Email: [email protected]




Copyright 2012 ACN Newswire. All rights reserved.

More Stories By ACN Newswire

Copyright 2008 ACN Newswire. All rights reserved. Republication or redistribution of ACN Newswire content is expressly prohibited without the prior written consent of ACN Newswire. ACN Newswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
"We help companies that are using a lot of Software as a Service. We help companies manage and gain visibility into what people are using inside the company and decide to secure them or use standards to lock down or to embrace the adoption of SaaS inside the company," explained Scott Kriz, Co-founder and CEO of Bitium, in this SYS-CON.tv interview at 15th Cloud Expo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
15th Cloud Expo, which took place Nov. 4-6, 2014, at the Santa Clara Convention Center in Santa Clara, CA, expanded the conference content of @ThingsExpo, Big Data Expo, and DevOps Summit to include two developer events. IBM held a Bluemix Developer Playground on November 5 and ElasticBox held a Hackathon on November 6. Both events took place on the expo floor. The Bluemix Developer Playground, for developers of all levels, highlighted the ease of use of Bluemix, its services and functionalit...
The 4th International DevOps Summit, co-located with16th International Cloud Expo – being held June 9-11, 2015, at the Javits Center in New York City, NY – announces that its Call for Papers is now open. Born out of proven success in agile development, cloud computing, and process automation, DevOps is a macro trend you cannot afford to miss. From showcase success stories from early adopters and web-scale businesses, DevOps is expanding to organizations of all sizes, including the world's large...
Some developers believe that monitoring is a function of the operations team. Some operations teams firmly believe that monitoring the systems they maintain is sufficient to run the business successfully. Most of them are wrong. The complexity of today's applications have gone far and beyond the capabilities of "traditional" system-level monitoring tools and approaches and requires much broader knowledge of business and applications as a whole. The goal of DevOps is to connect all aspects of app...
SAP is delivering break-through innovation combined with fantastic user experience powered by the market-leading in-memory technology, SAP HANA. In his General Session at 15th Cloud Expo, Thorsten Leiduck, VP ISVs & Digital Commerce, SAP, discussed how SAP and partners provide cloud and hybrid cloud solutions as well as real-time Big Data offerings that help companies of all sizes and industries run better. SAP launched an application challenge to award the most innovative SAP HANA and SAP HANA...
When an enterprise builds a hybrid IaaS cloud connecting its data center to one or more public clouds, security is often a major topic along with the other challenges involved. Security is closely intertwined with the networking choices made for the hybrid cloud. Traditional networking approaches for building a hybrid cloud try to kludge together the enterprise infrastructure with the public cloud. Consequently this approach requires risky, deep "surgery" including changes to firewalls, subnets...
Want to enable self-service provisioning of application environments in minutes that mirror production? Can you automatically provide rich data with code-level detail back to the developers when issues occur in production? In his session at DevOps Summit, David Tesar, Microsoft Technical Evangelist on Microsoft Azure and DevOps, will discuss how to accomplish this and more utilizing technologies such as Microsoft Azure, Visual Studio online, and Application Insights in this demo-heavy session.
DevOps is all about agility. However, you don't want to be on a high-speed bus to nowhere. The right DevOps approach controls velocity with a tight feedback loop that not only consists of operational data but also incorporates business context. With a business context in the decision making, the right business priorities are incorporated, which results in a higher value creation. In his session at DevOps Summit, Todd Rader, Solutions Architect at AppDynamics, discussed key monitoring techniques...
Cultural, regulatory, environmental, political and economic (CREPE) conditions over the past decade are creating cross-industry solution spaces that require processes and technologies from both the Internet of Things (IoT), and Data Management and Analytics (DMA). These solution spaces are evolving into Sensor Analytics Ecosystems (SAE) that represent significant new opportunities for organizations of all types. Public Utilities throughout the world, providing electricity, natural gas and water,...
The security devil is always in the details of the attack: the ones you've endured, the ones you prepare yourself to fend off, and the ones that, you fear, will catch you completely unaware and defenseless. The Internet of Things (IoT) is nothing if not an endless proliferation of details. It's the vision of a world in which continuous Internet connectivity and addressability is embedded into a growing range of human artifacts, into the natural world, and even into our smartphones, appliances, a...
How do APIs and IoT relate? The answer is not as simple as merely adding an API on top of a dumb device, but rather about understanding the architectural patterns for implementing an IoT fabric. There are typically two or three trends: Exposing the device to a management framework Exposing that management framework to a business centric logic Exposing that business layer and data to end users. This last trend is the IoT stack, which involves a new shift in the separation of what stuff happe...
The 3rd International Internet of @ThingsExpo, co-located with the 16th International Cloud Expo - to be held June 9-11, 2015, at the Javits Center in New York City, NY - announces that its Call for Papers is now open. The Internet of Things (IoT) is the biggest idea since the creation of the Worldwide Web more than 20 years ago.
The Internet of Things is tied together with a thin strand that is known as time. Coincidentally, at the core of nearly all data analytics is a timestamp. When working with time series data there are a few core principles that everyone should consider, especially across datasets where time is the common boundary. In his session at Internet of @ThingsExpo, Jim Scott, Director of Enterprise Strategy & Architecture at MapR Technologies, discussed single-value, geo-spatial, and log time series dat...
An entirely new security model is needed for the Internet of Things, or is it? Can we save some old and tested controls for this new and different environment? In his session at @ThingsExpo, New York's at the Javits Center, Davi Ottenheimer, EMC Senior Director of Trust, reviewed hands-on lessons with IoT devices and reveal a new risk balance you might not expect. Davi Ottenheimer, EMC Senior Director of Trust, has more than nineteen years' experience managing global security operations and asse...
The Internet of Things will greatly expand the opportunities for data collection and new business models driven off of that data. In her session at @ThingsExpo, Esmeralda Swartz, CMO of MetraTech, discussed how for this to be effective you not only need to have infrastructure and operational models capable of utilizing this new phenomenon, but increasingly service providers will need to convince a skeptical public to participate. Get ready to show them the money!