Interview

Exclusive Interview: EU MDR 2020: Impact, Implementation, Challenges and Strategies

Exclusive Interview: EU MDR 2020: Impact, Implementation, Challenges and Strategies

Ahead of the Combination Products Forum, we had the opportunity to speak with Steve Binion, Ph.D., MBA, Principal from SB RegConsult LLC, regarding the impact and implementation challenges surrounding the EU MDR 2020.

Steve gives his insights into how current combination product market challenges, including the requirement for an NB opinion, can be overcome and shares tips on how to ensure successful commercialisation of a combination product.

Read this interview and gain insights into: 

  • How the EU MDR 2020 will impact the industry
  • Effective strategies that companies can adopt going forward
  • Biggest regulatory challenges faced by the industry and how to overcome them 
  • Key ingredients for successfully launching combination products in the market
  • Key steps for ensuring your combination product becomes a commercial success
  • How will industry trends impact competition and growth 
  • Plus more.

Fill in your details to download this free interview 

Embracing Digital Platforms for Combination Products

Embracing Digital Platforms for Combination Products

Although still in the early stages of their development, digital healthcare platforms have the potential to improve patient outcomes, reduce healthcare costs, and allow communication and collaboration between doctors on a global scale. Pharma IQ spoke exclusively with Helene Gustafsson, Head of Regulatory & Clinical Compliance, LEO Pharma to discuss the utilisation of digital platforms alongside drug-device combination products.

Changes & Collaboration in Lifecycle Management: Insights from Jane Wilson, Owen Mumford

Changes & Collaboration in Lifecycle Management: Insights from Jane Wilson, Owen Mumford

In this exclusive interview conducted ahead of this year’s Drug-Device Combination Products conference, Jane Wilson, Product Safety Manager at Owen Mumford shares her top tips for how to successfully manage the entire product lifecycle, from planning and design to process and manufacture.

Download the interview for free to get Jane Wilson’s answers to the following questions:

  • What are the biggest challenges you experience when collaborating between medical device and pharma companies?
  • What works well for you when collaborating across the whole lifecycle management?
  • Is it common for pharma and medical device companies to miscommunicate with the language they use? Are you able to clarify what some of the fundamental terms are?
  • What would be your top tips then for anyone successfully trying to work together?

Split across three days, the event will focus on one key question: Can you successfully launch and manage a combination product? With this in mind, our expert speaker panel will take you on a journey through a 100% interactive programme, helping you to:

  • Ensure multi-functional stakeholders are bought into the lifecycle
  • Improve your medical device and pharma team collaboration
  • Learn how to interpret risk management requirements
  • And much more…

You can download the full agenda of the conference here. To request a copy to be sent via email, please click here.

Jane Wilson will also participate in a round table discussion at this year’s conference to identify the key strategies required to optimise lifecycle management processes, from concept to market. More information on the session can be found here.

Below is a preview of the interview:

Pharma IQ: What are the biggest challenges you experience when collaborating between medical device and pharma companies?

Jane Wilson: Developing a product whilst keeping the full product lifecycle in mind can be a challenge. There is just so much to focus on. The two teams are busy working to deliver the product to specifications and deadlines. We find with big pharma in particular that the teams who work on the development of a product often…

Top Tips for Collaborating on Combination Products with Amanda Mathews, Pfizer

Top Tips for Collaborating on Combination Products with Amanda Mathews, Pfizer

Amanda Matthews, Senior Director, Regulatory CMC for Combination Products & Medical Devices at Pfizer, provides an exclusive insight into the challenges of working between medical device and pharmaceutical companies, following the transition from development to commercial.

  • Ahead of this year’s Drug-Device Combination Products conference, Amanda Matthews answers the following questions:
  • What are the biggest challenges you experience when collaborating between medical device and pharma companies?
  • What works well for you when collaborating across the whole lifecycle management?
  • Is it common for pharma and medical device companies to miscommunicate with the language they use? Are you able to clarify what some of the fundamental terms are?
  • What would be your top tips then for anyone successfully trying to work together?

Amanda Matthews will also participate in a round table and panel discussion at this year’s conference to discuss the impact of the EU MDR and how you can improve the collaboration to optimize processes. More information on the session can be found here.

Optimising Combination Product Development Using the E-Health Wave

Optimising Combination Product Development Using the E-Health Wave

Steve Dew, Associate Director Medical Devices and Combination Products, Biogen offered his insights into Optimising Combination Product Development Using the E-Health Wave, providing delegates with some thoughts about how digital health will transform the way we view combination products in patient care.