Improving Compliance, Increasing Innovation

By Sangita Viswanathan
No Comments

From increasing focus on reimbursement and economic value, to impact of UDI and the medical device user fees, three industry experts discuss current market and regulatory trends and challenges shaping the medical device industry, and offer some effective strategies for companies to follow to remain competitive.

From increasing focus on reimbursement and economic value, to impact of UDI and the medical device user fees, three industry experts discuss current market and regulatory trends and challenges shaping the medical device industry, and offer some effective strategies for companies to follow to remain competitive.

Continue reading →

Managing Pain Points in the Healthcare Supply Chain

By Sangita Viswanathan
No Comments

Stringent regulations, increased product protection challenges, economic pressures and contingency management have been identified as the most significant contributors to uncertainty in the healthcare supply chain.

Stringent regulations, increased product protection challenges, economic pressures and contingency management have been identified as the most significant contributors to uncertainty in the healthcare supply chain.

Continue reading →

How to Prepare Foolproof Supplier Agreements

By Sangita Viswanathan
No Comments

Requiring clear supplier agreements can force some tough conversations. Acme Monaco’s Lucas Karabin, and Hogan Lovells attorney Jodi Scott, discuss the importance for such agreements, and what they should ideally cover.

Requiring clear supplier agreements can force some tough conversations. Acme Monaco’s Lucas Karabin, and Hogan Lovells attorney Jodi Scott, discuss the importance for such agreements, and what they should ideally cover.

Continue reading →

Silicone Adhesives – Challenges and Solutions

By Sangita Viswanathan
No Comments

Customers have basic goals and expectation of silicone adhesives that it can hold the device or dressing in place while the device performs the intended function, until the time the clinical objective in achieved – Kris Godbey, 3M Medical Specialties.

Customers have basic goals and expectation of silicone adhesives that it can hold the device or dressing in place while the device performs the intended function, until the time the clinical objective in achieved – Kris Godbey, 3M Medical Specialties.

Continue reading →

Tapping 3D Printing Opportunities in Med-Tech

By Sangita Viswanathan
No Comments

Additive manufacturing capabilities align well with the needs of the medical device segment, enhancing product customization and enabling efficient, cost-effective production and delivery, describes Deloitte’s Glenn Snyder.

Additive manufacturing capabilities align well with the needs of the medical device segment, enhancing product customization and enabling efficient, cost-effective production and delivery, describes Deloitte’s Glenn Snyder.

Continue reading →

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

By Sangita Viswanathan
No Comments

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.

Continue reading →

Recent Pre-Market Activities at FDA

By Sangita Viswanathan
No Comments

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.

Continue reading →

Regulatory Expectations on Risk Management

By Sangita Viswanathan
No Comments

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.

Continue reading →

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

By Sangita Viswanathan
No Comments

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.

Continue reading →

Are you Ready for a Notified Body Unannounced Audit?

By Sangita Viswanathan
No Comments

There has been a lot of discussion about unannounced audits, and how companies need to prepare for these. But how can you prepare for something that you don’t know about? In this discussion, four industry experts offer some suggestions.

There has been a lot of discussion about unannounced audits, and how companies need to prepare for these. But how can you prepare for something that you don’t know about? In this discussion, four industry experts offer some suggestions.

Continue reading →