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Medical Devices: Achieve the Case for Quality Featuring Novo Nordisk and Tech-Clarity

This live interview webinar featuring speakers from Novo Nordisk and global analyst Tech-Clarity will review current industry trends in the medical device industry and how medical device companies should use them to improve competitiveness and profitability. It will also focus on how manufacturers should respond to stringent regulations from the FDA or the European and global standards and regulations authorities.

Date: May 9, 2017
Time: 10 AM EDT (7 AM PDT / 4:00 PM CEST)
Duration: 1 hour
Presented by:


Join Lisbeth Sivertsen, expert at Novo Nordisk for product quality strategy and Michelle Boucher, Vice President for Research at Tech-Clarity, for a 50-minute live interview webinar discussing current industry trends.

With lives at stake, patient safety is of the upmost importance. As such, the medical device industry faces heavy regulations. Compliance is so critical that if medical device companies do not adhere to FDA, EU and other worldwide standards and regulations, they will not be profitable. However, so much time, effort, and cost goes into compliance documentation, it takes efforts away from innovating and ensuring high quality products. Consequently, it is harder to take advantage of opportunities that will boost profitability.

On the other hand, medical device companies who adopt practices focused on high quality devices can expect greater patient satisfaction, improved competitiveness, and higher profits. In fact, McKinsey estimates that companies who adopt quality focused best practices can increase profits by 3% to 4% of revenues. They estimate the revenue increase alone could be a $3.5 billion opportunity for the industry and this doesn't even factor in profitability improvements by avoiding costly quality issues.

To achieve this, companies need to be empowered to shift from a document centric process to one that focuses on high quality, innovative products that meet patient needs. The good news is that with investments in the right technology, this is possible.

Key Takeaways

  • Learn the case for quality and how manufacturers can effectively bridge current gaps
  • Understand how manufacturers should respond to stringent regulations from the FDA or the European and global standards and regulations authorities
  • Discover Novo Nordisk's approach to the Case for Quality and how they apply current trends in practice


Michelle Boucher, Vice President for Research, Tech-Clarity

Michelle Boucher is the Vice President of Research for Tech-Clarity. Michelle has spent over 20 years in various roles in engineering, marketing, management, and as an analyst. She has broad experience with topics such as product design, simulation, systems engineering, mechatronics, embedded systems, PCB design, improving product performance, process improvement, and mass customization. Ms. Boucher is an experienced researcher and author and has benchmarked over 7000 product development professionals and published over 90 reports on product development best practices. She focuses on helping companies manage the complexity of today's products, markets, design environments, and value chains to achieve higher profitability.

Lisbeth Sivertsen, Team Leader, Novo Nordisk

Lisbeth Sivertsen has worked at Novo Nordisk A/S in Hilleroed, Denmark for the past 15 years. Today, she heads up a specialist group to focus on management for IT systems for Mechanical Engineering and Test Equipment. User support and regulatory compliance is central to her activities. This requires a strong balance to ensure the freedom in IT systems to effective development of drug delivery systems and the controls in systems to ensure license to operate. One of her key responsibilities is to develop her stronghold as a member of R&D IT coordination reference group. This is key to ensuring product quality is at the center of Novo NordiskĀ“s product strategy from an IT perspective. Prior to her work at Novo Nordisk, Lisbeth worked in the CAD and PLM area of shipbuilding as well as the aerospace and defense industry.