“Med-tech Innovation Happening at Speed of Technology, not Healthcare”

By Sangita Viswanathan

In this interview Brian Williams, Director, Healthcare Strategy and Innovation at PwC, talks about the impact of med-tech trends such as outcomes based reimbursement, lessons learned in emerging markets, and impact of the device tax.

In this interview Brian Williams, Director, Healthcare Strategy and Innovation at PwC, talks about the impact of med-tech trends such as outcomes based reimbursement, lessons learned in emerging markets, and impact of the device tax.

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Recent Pre-Market Activities at FDA

By Sangita Viswanathan

FDA recently released changes and updated guidance documents to its pre-market assessment of medical devices. Susan Alpert, M.D., Ph.D., Principal, SFA Consulting LLC, provides the perspective of the industry and offers suggestions on what can be done to improve pre-market risk management.

FDA recently released changes and updated guidance documents to its pre-market assessment of medical devices. Susan Alpert, M.D., Ph.D., Principal, SFA Consulting LLC, provides the perspective of the industry and offers suggestions on what can be done to improve pre-market risk management.

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Regulatory Expectations on Risk Management

By Sangita Viswanathan

Standards are never sufficient to identify all the risk and handle all the risks. Why? Because there are a lot of stakeholders, and by the time the standard is announced, it’s already outdated. That’s why risk management is the glue between standards, and it is critical to ensure that risk management is an ongoing and continuous process, explains Peter Havel, Senior Vice President and Global Head of Medical & Health Services, at TÜV SÜD.

Standards are never sufficient to identify all the risk and handle all the risks. Why? Because there are a lot of stakeholders, and by the time the standard is announced, it’s already outdated. That’s why risk management is the glue between standards, and it is critical to ensure that risk management is an ongoing and continuous process, explains Peter Havel, Senior Vice President and Global Head of Medical & Health Services, at TÜV SÜD.

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It’s Not About Faster Approvals, but About Better Availability, says FDA Commissioner Hamburg

By Sangita Viswanathan

Speaking to Advamed 2014 audience, the Commissioner tries to reassure device industry executives that the agency is working hard to ensure that U.S. is the leader for medical device innovation and manufacturing.

Speaking to Advamed 2014 audience, the Commissioner tries to reassure device industry executives that the agency is working hard to ensure that U.S. is the leader for medical device innovation and manufacturing.

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When Heart Valves Come from a Printer

By Klaus Jopp

As wearables for smart monitoring require efficient components, it is estimated that 67 percent more 3D printers will be sold this year, than in the previous year, and the medical field is an area of application with great potential.

As wearables for smart monitoring require efficient components, it is estimated that 67 percent more 3D printers will be sold this year, than in the previous year, and the medical field is an area of application with great potential.

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What Changes Should Manufacturers Expect From FDA?

With the advances in technology, FDA has higher expectations from manufacturers as data is more readily available. The integration of other technologies into a comprehensive MES system will drive costs down and quality up.

With the advances in technology, FDA has higher expectations from manufacturers as data is more readily available. The integration of other technologies into a comprehensive MES system will drive costs down and quality up.

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Fine Laser Cutting for Medical Components

By Geoff Shannon

Fine thin metal laser cutting is an ideal technology for the specialized cutting requirements found in the manufacturing of medical tube tools and components, which require an array of cut features with sharp edges, contours, and patterns within edges. From surgical instruments used in cutting and biopsy, to needles containing unusual tips and side wall openings, to puzzle chain linkages for flexible endoscopes, laser cutting provides higher precision, quality, and speed than traditionally used cutting t…

Fine thin metal laser cutting is an ideal technology for the specialized cutting requirements found in the manufacturing of medical tube tools and components, which require an array of cut features with sharp edges, contours, and patterns within edges. From surgical instruments used in cutting and biopsy, to needles containing unusual tips and side wall openings, to puzzle chain linkages for flexible endoscopes, laser cutting provides higher precision, quality, and speed than traditionally used cutting t…

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