Category Archives: People

13May/15
Global-Puzzle

Innovation on a Global Scale. Are you Ready?

Quality, Regulations, Design and the Patient Experience

By Sandra Rodriguez, Research Associate, Axendia

Med-Tech companies are at an innovation crossroads. They must seek new ways to develop, design and manufacture products that meet the needs of both the “masses” and the individual patient – all while increasing quality of care and reducing healthcare costs.

According to our research, 72% of respondents report an increase in the rate of new product introduction (innovation) in emerging markets.

To learn how leading Med-Tech companies are applying innovation practices to address today’s global marketplace, Axendia hosted a discussion with Stuart Karten, Principal at Karten Design, Cathi Crist, Partner and Medical Device Industry Lead at Kalypso, in a webinar moderated by Daniel R. Matlis.Karten-Christ-Matlis Continue reading

13Jan/15
5-Years

Compliance-First Approach Still Obstacle to Product Quality

 After Five Years, Compliance-First Approach Still Obstacle to Improving Product Quality

SUMMARY

Five years ago we looked at the road blocks to improving product quality. In the intervening years there has been little change by most Med-Tech Companies. The matter of Product Quality vs. Compliance recently has been given a push toward the Quality side by efforts made by the FDA. The four-part whitepaper reveals how aligning process improvement initiatives with technology platforms and integrated approached to product quality can help Med-Tech organizations improve product quality, compliance and the bottom line. Continue reading

14Dec/14
Living-Heart-Inspiration-125x50

The Loving Heart Behind the Living Heart Project

By Daniel R. Matlis

“The 3DExperience” was at the core of Dassault Systèmes user’s conference in Las Vegas last month. “We are at the 4th horizon of Dassault Systèmes,” proclaimed Monica Menghini, EVP Corporate Strategy, Industry and Marketing at Dassault Systèmes. “We called it the 3DExperience, because 3D is the legacy of Dassault Systèmes, but Experience is [not only] our future, it is your future because today consumers buy experience, not products.”

Keeping with the Experience theme, the names of Dassault Systèmes’ products were noticeably absent from the main stage. Instead, Dassault’s executives and customers shared their experiences with the company’s products and the impact they are making on their customer’s experience.

For me, the highlight of the 3DS Experience was Dr. Steven Levine’s presentation recounting the journey of “Building a Living Heart: How Technology is Transforming Lives.” Levine is Senior Director of SIMULIA Portfolio Management at Dassault Systèmes. If you keep reading, you will find out that he is much more than that. Continue reading

27Nov/14
Global-Innovation-150

Med-Tech CEO’s turn to Emerging Markets for Double-Digit Growth

By Daniel R. Matlis

Med-Tech Companies are poised to capitalize on global opportunities; however, they must balance the risks and rewards of globalization. When Axendia’s research team surveyed Med-Tech executives we found that:Global-Innovation

  • 73% expect an increasing rate of new product introductions in emerging markets
  • 72% are globalizing to improve the rate of product innovation
  • 65% see the global regulatory environment as the top business threat
  • 55% are globalizing to speed up time-to-market

But you don’t have to take our word for it.  CEOs from leading Med-Tech companies are turning to emerging markets for double digit growth. Continue reading

02Sep/14
Regulatory -Insight

What Changes Should Manufacturers Expect From FDA?

By Daniel R. Matlis

I recently had the privilege to moderate a panel entitled: “Outlook for the Medical Device Industry 2014 and Beyond: Advice from Proactive Leaders” at Camstar’s 2014 Global Conference. The panel included Vice Presidents of Operations from Advanced Bionics, ConforMIS and Terumo Cardiovascular Group.

In this, the third and final in our series of articles, we share insights and perspective from these executives addressing Regulatory issues impacting the future of the Med Tech industry. Continue reading