Exclusive Content

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 

2019 Challenges and Opportunities in the Combination Products Market

2019 Challenges and Opportunities in the Combination Products Market

Ensuring that combination products are effectively managed throughout their development, implementation, launch and post-market surveillance is critical to their long-term success in the market.

However, the interaction between medical device manufacturers and pharma companies arguably still has considerable room for improvement and both face various challenges throughout the product lifecycle. In order to facilitate an efficient development process and launch combination products successfully, the two partners must be fully aligned throughout the product lifecycle.

Ahead of the 2019 Combination Products Forum, Pharma IQ surveyed the industry experts to understand what are the biggest challenges faced by them at each stage of the lifecycle management as well as what’s stopping them from implementing new solutions.

Download this exclusive and new infographic to gain insights on: 

  • What are the biggest challenges affecting supply chain? 
  • What are the most difficult challenges in the regulatory landscape? 
  • What are the challenges with collaboration between medical device and pharmaceutical companies? 
  • What are the common issues with the usability of combination products? 
  • What are the problems with post-market surveillance?
  • What are the difficulties with implementing new solutions? 

Click on 'download' to view the infographic. 

Combination Product LCM: Johnson & Johnson Presentation

Combination Product LCM: Johnson & Johnson Presentation

Johnson & Johnson’s Senior Director of Global Value Chain Quality Design, Susan Neadle shares her insights on how to effectively streamline your end-to-end combination product lifecycle management process.

Her presentation will give you insights into: 

  • Combination product development: Where should you start? 
  • Creating a control strategy for your combination product lifecycle management processes
  • How to better understand your customer ecosystem 
  • How to effectively deliver product risk management integration
  • Key considerations for human factors and usability engineering
  • Identifying the essential purchasing control requirements 

Fill in your details to download this free presentation.  


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.

Expert Insights: Lifecycle Management for Combination Products

Expert Insights: Lifecycle Management for Combination Products

Ensuring that combination products are effectively managed throughout their development, implementation, launch and post-launch is critical to long term success in the market. However, there is arguably still considerable room for improvement throughout this process, and in order to facilitate efficiency all parties must be fully aligned throughout the product lifecycle.

In order to explore this topic in more detail, Pharma IQ spoke exclusively to Dr. Tina Rees, Associate Director-Human Factors, Ferring International Pharmascience Center to discuss product lifecycle management and the areas where simple process improvements could make a significant difference to the overall success of a combination product.  

2017 Delegate List

Download the sample delegate list for a glance at who's attending so far
Overcoming Combination Products Regulatory Challenges

Overcoming Combination Products Regulatory Challenges

Until now, combination products are more often handled inconsistently in different jurisdictions as drugs and/or devices. The determination as to which regulations, submission procedure and pathway to market is followed for the product is largely based on the its Primary Mode of Action, a new concept in itself. 

Ahead of the Combination Products Forum 2018, we spoke exclusively to Viky Verna, Co-Founder and Vice President at confinis, in order to discuss the biggest challenges relating to the combination product regulatory landscape, the best compliance management approaches, and the industry’s outlook and direction towards regulation harmonisation.