Medical Devices & Diagnostics

Access thought leadership from YourEncore Experts on the Medical Devices & Diagnostics industry.

Quality Best Practices From an IT Perspective

Tony Ettwein, Managing Expert of YourEncore's Quality Center of Excellence, provides valuable insights into audits in IT and the different AI systems that will soon affect the Quality landscape.
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State of the Industry: The Evolution of Quality and its Upcoming Challenges

Jane Wood, former Head of R&D Quality at J&J, and Principal of YourEncore’s Quality Center of Excellence discuss the current state of Quality and the future of regulation adaptation.
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48:10
How Smart Biotechs Scale Organizations Fast and Maximize Value
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A Kickstart for Your Development Programs

Joseph Lamendola, PhD and Timothy Franson, MD walk through the requirements for kickstarting a new development program in a Biopharma organization.
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Leveraging the Evolving Regulatory Landscape to Accelerate Drug & Medical Devices Development

The Food & Drug Administration has actively engaged in efforts to issue new regulations and guidance aimed at driving innovation, reducing risk, and improving patient safety.
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56:51
[WEBINAR] Leveraging Evolving Regulatory Landscape to Accelerate Drug & Device Development
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How Blockchain is Revolutionizing the World and Changing Healthcare as We Know It (Ep. 20 of The Pharmcast)

In this episode of The Pharmcast, we join YourEncore Expert, Darryl Glover, to discuss one of the hottest technologies on the market today: blockchain. We've heard some people...
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Ten Tips for Enterprise Technology Adoption in Pharma

The RFP processes are robust, the ROI models are compelling, the software is best of breed, and the expectations are high. So, why do so many software deployment programs in Pharma fail...
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57:47
[WEBINAR] Drug-Device/Diagnostics Combination Products: Understanding the Rapidly Changing Landscape
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State of the Industry: U.S. Regulatory Policy Improvements (Ep. 19 of The Pharmcast)

In this episode of The Pharmcast, we share a recording from our May 5th webinar, State of the Industry: U.S. Regulatory Policy Overview. Parthenon-EY and YourEncore recently...
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The Frontiers of Rare Disease Development: Advances in Regulatory Science with Dr. Tim Franson (Ep. 18 of The Pharmcast)

This week on The Pharmcast, we catch up with Dr. Tim Franson to discuss the leading edge of rare disease drug development. Dr. Franson has been actively helping Parent Project...
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56:51
[WEBINAR] State of the Industry Webinar: U.S. Regulatory Policy Improvements
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Finding the Right Fit: Q&A with YourEncore Expert Marcia Ellett

In an effort to expand our thought leadership, highlight Experts, and engage our Expert Community, we reached out to YourEncore Expert, Marcia Ellett, to help pilot a Q&A series as a...
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YourEncore Announces Addition of Michelle DeJonge and Dr. James Wood as Strategic Advisors for Medical Devices & Diagnostics Practice

INDIANAPOLIS, IN--YourEncore (www.yourencore.com), a company that helps firms in the life sciences, consumer products and food sciences industries solve complex innovation, compliance...
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Welcome to the Real World: A Reality Check for Digital Health with Dr. Ron Razmi (Ep. 17 of The Pharmcast)

This week on The Pharmcast, we tackle one of the hottest topics in the life sciences and healthcare industry: digital health. The promise of digital health is enticing, and a...
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The Future is Here: Using Big Data and Artificial Intelligence in Oncology (Ep. 15 of The Pharmcast)

On this week's episode of The Pharmcast, we talk with YourEncore Expert, Philippe Barzin, on the future of big data and artificial intelligence in oncology. Based off Philippe's...
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Working with the FDA: Developing a Regulatory Strategy That Works (Ep. 14 of The Pharmcast)

On this week's episode of The Pharmcast, we explore the key elements of an effective regulatory strategy and how to drive value to patient and shareholders by working with the FDA. We...
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Riding the Policy Roller Coaster in 2017: A Policy Update with Dr. Tim Franson (Ep. 13 of The Pharmcast)

We are at a time of great change and transition in the FDA. The sitting FDA chief stepped down, just when the 21st Century Cures Act passed into law; PDUFA 6 is up for renewal this...
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Executive Briefing: EU Medical Device Regulation | 5 Ways EU MDR Will Impact Your Business [White Paper]

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...
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NDA Mistakes to Avoid: An Interview with Dr. Joseph Lamendola (Ep. 12 on The Pharmcast)
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Medical Devices & Diagnostics

Quality Best Practices From an IT Perspective

Tony Ettwein, Managing Expert of YourEncore's Quality Center of Excellence, provides valuable insights into audits in IT and the different AI systems that will soon affect the Quality landscape.

State of the Industry: The Evolution of Quality and its Upcoming Challenges

Jane Wood, former Head of R&D Quality at J&J, and Principal of YourEncore’s Quality Center of Excellence discuss the current state of Quality and the future of regulation adaptation.

How Smart Biotechs Scale Organizations Fast and Maximize Value

A Kickstart for Your Development Programs

Joseph Lamendola, PhD and Timothy Franson, MD walk through the requirements for kickstarting a new development program in a Biopharma organization.

Leveraging the Evolving Regulatory Landscape to Accelerate Drug & Medical Devices Development

The Food & Drug Administration has actively engaged in efforts to issue new regulations and guidance aimed at driving innovation, reducing risk, and improving patient safety.

[WEBINAR] Leveraging Evolving Regulatory Landscape to Accelerate Drug & Device Development

How Blockchain is Revolutionizing the World and Changing Healthcare as We Know It (Ep. 20 of The Pharmcast)

In this episode of The Pharmcast, we join YourEncore Expert, Darryl Glover, to discuss one of the hottest technologies on the market today: blockchain. We've heard some people...

Ten Tips for Enterprise Technology Adoption in Pharma

The RFP processes are robust, the ROI models are compelling, the software is best of breed, and the expectations are high. So, why do so many software deployment programs in Pharma fail...

[WEBINAR] Drug-Device/Diagnostics Combination Products: Understanding the Rapidly Changing Landscape

State of the Industry: U.S. Regulatory Policy Improvements (Ep. 19 of The Pharmcast)

In this episode of The Pharmcast, we share a recording from our May 5th webinar, State of the Industry: U.S. Regulatory Policy Overview. Parthenon-EY and YourEncore recently...

The Frontiers of Rare Disease Development: Advances in Regulatory Science with Dr. Tim Franson (Ep. 18 of The Pharmcast)

This week on The Pharmcast, we catch up with Dr. Tim Franson to discuss the leading edge of rare disease drug development. Dr. Franson has been actively helping Parent Project...

[WEBINAR] State of the Industry Webinar: U.S. Regulatory Policy Improvements

Finding the Right Fit: Q&A with YourEncore Expert Marcia Ellett

In an effort to expand our thought leadership, highlight Experts, and engage our Expert Community, we reached out to YourEncore Expert, Marcia Ellett, to help pilot a Q&A series as a...

YourEncore Announces Addition of Michelle DeJonge and Dr. James Wood as Strategic Advisors for Medical Devices & Diagnostics Practice

INDIANAPOLIS, IN--YourEncore (www.yourencore.com), a company that helps firms in the life sciences, consumer products and food sciences industries solve complex innovation, compliance...

Welcome to the Real World: A Reality Check for Digital Health with Dr. Ron Razmi (Ep. 17 of The Pharmcast)

This week on The Pharmcast, we tackle one of the hottest topics in the life sciences and healthcare industry: digital health. The promise of digital health is enticing, and a...

The Future is Here: Using Big Data and Artificial Intelligence in Oncology (Ep. 15 of The Pharmcast)

On this week's episode of The Pharmcast, we talk with YourEncore Expert, Philippe Barzin, on the future of big data and artificial intelligence in oncology. Based off Philippe's...

Working with the FDA: Developing a Regulatory Strategy That Works (Ep. 14 of The Pharmcast)

On this week's episode of The Pharmcast, we explore the key elements of an effective regulatory strategy and how to drive value to patient and shareholders by working with the FDA. We...

Riding the Policy Roller Coaster in 2017: A Policy Update with Dr. Tim Franson (Ep. 13 of The Pharmcast)

We are at a time of great change and transition in the FDA. The sitting FDA chief stepped down, just when the 21st Century Cures Act passed into law; PDUFA 6 is up for renewal this...

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

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...

NDA Mistakes to Avoid: An Interview with Dr. Joseph Lamendola (Ep. 12 on The Pharmcast)