YourEncore Insights - Life Sciences

Executive Briefing: EU Medical Device Regulation | 5 Ways EU MDR Will Impact Your Business [White Paper]

Posted by Patrice Napoda on 2/15/17 8:00 AM

The European Union has agreed on a new Medical Device Regulation meant to improve patient safety and data  transparency. The regulation is extensive and impactful – it touches many functions within the company and  companies that fail to comply will not be allowed to sell products into the EU. With the legislation expected to  publish in 2017, companies will have three years to bring medical devices into compliance and, under a separate new regulation for IVD’s, five years for these products.

With the EU finally reaching the agreement, the compliance clock is ticking. Although many functions are impacted, regulatory leaders will most likely be responsible for driving corporate compliance.  If you’re just starting the process, download Executive Briefing: EU Medical Device Regulation to learn five ways EU MDR will impact your business. 

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Topics: Regulatory, Medical Device, EU MDR

Medtech Valuation Killers: 10 Regulatory & Commercialization Traps to Avoid (Ep. 11 on The Pharmcast)

Posted by Jim Combs on 2/8/17 8:00 AM

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Topics: Regulatory, Medical Device, Med Dev, Pharmcast

No Surprises: Improving Medical Devices Due Diligence (Ep. 9 on The Pharmcast)

Posted by Jim Combs on 1/25/17 12:00 PM

This week on The Pharmcast, we discuss areas often overlooked in due diligence efforts that can lead to expensive or even show-stopper surprises once the acquisition is complete and later development and commercial efforts are underway, with two former Johnson & Johnson medical devices executives, Donna Godward and Dr. Janet Vargo.  Understanding what to look for (or present) during due diligence will reduce risks and lead to a better evaluation for the transaction.

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Topics: Medical Device, Med Dev, Pharmcast

FDA 483 Responses: Avoiding Common Pitfalls and Deficiencies (Ep. 8 on The Pharmcast)

Posted by Jim Combs on 1/12/17 8:00 AM

This week on The Pharmcast, we explore best practices and common pitfalls in FDA 483 Responses. 

In 2015, there were an average of 175 inspections and 10 warning letters issued per month by the Center for Devices and Radiological Health alone.  Regulatory inspections and 483 findings are a part of being a life sciences company.  However, how companies respond can have a major impact on patient safety and business performance.

To share best practices, we held a special presentation with two of our top medical device experts, Victor Chance and Judy Meritz, to outline what they’ve learned over the course of their 20+ year careers in the medical devices industry.

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Topics: Medical Device, Med Dev, FDA, Supply Chain, Pharmcast

Navigating Drug-Device Combination Product Approval

Posted by Judith Meritz, J.D. on 11/3/16 11:11 AM

 

The popularity of drug-device combination products has been soaring. These products — which comprise combinations of drugs, biologics and devices — had sales reaching $22 billion in 2014, and the market is expected to grow to $31 billion by 2019.1

However, growth in this sector is threatened by a lack of alignment within the FDA, which is slow to approve drug-device combination products.  For those considering developing a combination product, I thought it helpful to provide an FDA primer to help people navigate the approval process and understand where the challenges are.    

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Topics: Medical Device, FDA, Combination Products

Pharm-ers Almanac 2016: The Butterfly Effect

Posted by Tim Franson, MD on 9/27/16 8:30 AM

There is a saying, coined by the late Edward Lorenz, an early pioneer of the chaos theory, that “the flap of a butterfly’s wings in Brazil can set off a tornado in Texas.” This observation is known as the butterfly effect: the concept that small changes can have large downstream effects.

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Topics: Pharmaceutical Industry, Regulatory, Medical Device

Are You Ready for EU MDR?

Posted by Minnie Baylor-Henry on 9/15/16 12:47 PM

Back in 2010 when European regulators announced plans to overhaul legislation on how the European Union oversees medical devices, the industry knew that it would take time for changes to take effect. With the EU reaching agreement on the regulation, it appears that the final Medical Device Regulation (EU MDR) may take effect as early as January 2017. 

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Topics: Life Sciences, Pharmaceutical Industry, Regulatory, Medical Device

FDA 483 Response: Four Tips to Avoid a Warning Letter

Posted by Victor Chance and Judith Meritz on 8/25/16 12:05 PM

The receipt of a 483 at the conclusion of a facility inspection notifies a company of conditions the FDA believes are in violation of the Food, Drug & Cosmetic Act. If 483s are not properly addressed, the FDA can take further enforcement action to protect the public health – including issuing Warning Letters. Warning Letters not only indicate potential risks to patients, but also bring unwanted publicity, erode patient trust, and potentially restrict the approval of future products significantly impacting revenue. Therefore, companies must know how to mount a competent response.

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Topics: Quality & Safety, Medical Device, FDA

[Watch] No Surprises: Improving Medical Devices Due Diligence

Posted by Minnie Baylor-Henry on 5/11/16 9:30 AM

Donna Godward and Dr. Janet Vargo recently presented a lunch briefing on improving medical devices due diligence.

Acquiring and selling innovative medical devices or diagnostics is standard business for small and large device companies – but doing it well is not standard business.

In this session, Donna Godward and Dr. Janet Vargo discussed the areas often overlooked in due diligence efforts that can lead to expensive or even show-stopper surprises once the acquisition is complete and later development and commercial efforts are underway. Understanding what to look for (or present) during due diligence will reduce risks and lead to a better evaluation for the transaction. 

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Topics: Medical Device, FDA