Overcoming Barriers to Improvement in Product Development

By MedTech Intelligence Staff

Despite a clear need to get better development lifecycle management solutions in place, companies are restricted by tight budgets, validation overhead, and bureaucracy. In this Q&A, Matt Harp and Angie Pepiot at Seapine Software share their insights.

Despite a clear need to get better development lifecycle management solutions in place, companies are restricted by tight budgets, validation overhead, and bureaucracy. In this Q&A, Matt Harp and Angie Pepiot at Seapine Software share their insights.

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UDI: What You Need to Know About Timelines, Compliance and Submissions

By Yasser Mohammed

The legislated FDA Unique Device Identification regulation is a single device identification system that is invariable, absolute, standardized, and globally reconciled. All medical device manufacturers will be required to comply with the new UDI approach. Here’s some information for you to get started.

The legislated FDA Unique Device Identification regulation is a single device identification system that is invariable, absolute, standardized, and globally reconciled. All medical device manufacturers will be required to comply with the new UDI approach. Here’s some information for you to get started.

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How to Prepare Foolproof Supplier Agreements

By Sangita Viswanathan

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.

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Silicone Adhesives – Challenges and Solutions

By Sangita Viswanathan

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.

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Tapping 3D Printing Opportunities in Med-Tech

By Sangita Viswanathan

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.

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“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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