Category Archives: Latest

02Dec/19

FDA Discusses Challenges and Opportunities for 3D Printing in Life Sciences

A Straight from the Source Webinar 

The interest in 3D Printing (a/k/a Additive Manufacturing) has risen spectacularly the last decade.  The use of 3D Printing technology has wide-ranging applications across the Health Technology Ecosystem, including surgical, healthcare, pharmaceutical and medical devices.  In fact, over 100 medical devices using 3D printed components have been cleared by FDA. 

With the rise in utilization of 3D Printing in Medical Devices, FDA’s interest in additive manufacturing has significantly increased.  To address how the technology can affect the quality, safety and effectiveness of these products, FDA published guidance for industry titled: Technical Considerations for Additive Manufacturing Devices by Dr. Matthew Di Prima.

Join FDA’s Matthew Di Prima and Axendia’s Eric M. Luyer in for a live webinar on November 20th at 11am ET.  This webinar is now available on-demand.

Meet Your Trusted Sources 

Di-Prima-Luyer-Webinar-Twitter

In this webinar, we discuss FDA’s perspective on: 

  • Current capabilities of 3D Printing in Life Sciences 
  • Challenges and opportunities for 3D Printing in Life Sciences 
  • Case studies on FDA reviewed and approved devices on the market 
  • Collaborations Industry, Universities and Standard Development Organizations 
  • Regulations, guidance and Standards for 3D Printing  
  • Vision for future uses of 3D Printing in Healthcare  
  • Point of Care  
  • Personalized Medical Devices  

Register and watch this webinar on-demand.

register

21Nov/19

Samsung Biologics CIO Shares Vision for Modernizing Manufacturing Quality

By: Daniel R. Matlis, President

Samsung Biologics is a world-class contract development and manufacturing organization (CDMO) located in Songdo, South Korea.

James Choi, VP and CIO, Samsung BioLogics

James Choi, VP & CIO Samsung Biologics

Founded in 2011, Samsung Biologics has the largest total plant cell culture capacity in the world from a single location:  364,000 L.  The company employs more than 2500 employees including 100+ global expats from 12 countries.

To discuss the company’s vision for modernizing manufacturing quality, I sat down with James Choi, VP and CIO, Samsung Biologics, at the 2019 Veeva R&D Summit.

Continue reading

13Nov/19

Inventing New Horizons with Science as a Catalyst

Event Brief: Science in the Age of Experience 

By: Sandra K. Rodriguez, Market Analyst

I had the opportunity to cover “Science in the Age of Experience” in Boston in October.  The annual Dassault Systèmes conference brought together 500 attendees, representing 250 companies.  This year customer presentations focused on new ways of experiencing and shaping science in Life (better living), in Engineering (product innovation) and in Nature (sustainable planet).

Bernard Charlès, Vice Chairman and CEO of Dassault Systèmes opened the event by stating, You can’t have knowledge if you don’t have knowhow.” Charlès continued with, “The biggest challenge in innovation is over-communicating and under-understanding.”  The agenda was filled with presentations by members of MIT and Harvard, plus Dassault Systèmes’ clients who are seeking to not just understand the correlations between product, nature and life… but are inventing new horizons with science as the catalyst.

Standing on Solid Ground with SOLIDWORKS

Hugh HerrHugh Herr, Professor of MIT Media Lab and co-director of the MIT Center for Extreme Bionics; Founder of BionX, Inc., had both legs amputated from just under the knee after suffering from frostbite during a mountain climbing accident in the early 1980s. He pointed out the surgical procedure that doctors performed following his accident had not changed since the late 1800s.  As a result, although he could walk again with the help of his first set of prosthetics, he was unable to associate the feeling of pressure or movement in his ankles or feet.  With both pant legs rolled up to expose his bionic limbs he stated, “From the knee down, my legs are a bunch of nuts and bolts.”   He then informed us that in addition to the nuts and bolts are sensors, and an entire bionic ecosystem that gives him the ability to move, walk, jump and pivot naturally.  Continue reading

05Nov/19

Transforming Quality, a Top Priority for Customers at Veeva Summit 2019

Veeva Summit 2019 Event Brief

By: Daniel R. Matlis, President

Veeva has become a strategic technology partner to more than 775 customers across the globe, ranging from the world’s largest pharmaceutical companies to emerging biotechs.

Veeva-Summit-Check-In

I had the opportunity to cover the 2019 Veeva R&D Summit in Philadelphia, PA in September.  The event brought together more than 1,700 life science professionals and experts to share the latest market trends in the industry, experience innovative technology, and share best practices. The annual event has experienced 25% attendance growth compared to 2018.

This brief focuses on my first-hand interactions with leading industry executives leveraging Veeva’s quality offerings to modernize quality management in the cloud.

The following executives shared how they are leveraging modern cloud-based solutions to transform quality management:

  • James Choi, VP and CIO at Samsung BioLogics, shares his vision for modernizing manufacturing quality.
  • Chris Lamont, Director, Global QMS Programs at Bristol-Myers Squibb presents the company’s journey to achieve enterprise quality with Vault QMS.
  • Jennifer Trundle, Associate Director, Quality Management Systems at Gilead discusses the successful expansion of Vault QualityDocs across the global enterprise.

Continue reading

28Oct/19

Life-Science Companies Are Becoming Cloud Comfortable

… And You Heard It Here First

By: Sandra K. Rodriguez, Market Analyst

Based on our interactions with companies large and small, cloud solutions for Quality, Operations and Maintenance Management are being increasingly adopted to lower costs (implementation, validation and maintenance from a technology standpoint) and for improved process and people efficiencies.

Not convinced? Earlier this year, we published our findings in a report titled “See Who’s Soaring to the Cloud in Support of Quality and Compliance.” Most of the companies we spoke to already had experience implementing a variety of business systems in the cloud including: Email, CRM, ERP, Document Management, Serialization and HR systems.

Most, if not all, software vendors that we either met or conducted briefings with this year have cloud offerings to support: AI/ML, APS, CTMS, EAM, MES, PLM, RIM, etc.

Executives we interviewed for our Cloud QMS report agreed that:

  • Modern cloud platforms have a secure infrastructure with very high availability and uptime
  • Value can be quickly achieved by unifying business functions on a cloud platform
  • System accessibility and availability is necessary for today’s global workforce
  • Moving to the modern cloud is not only a strategic move but one that supports a sustainable digital transformation strategy
  • Taking a cloud-first approached supports improved business outcomes by eliminating the need for an internal IT army

Over seven years ago, Axendia published a report based on a survey of 125 MedTech Executives.  We sought to understand “Balancing the Risks and Rewards of MedTech Globalization.”  At the time, Axendia’s position was simple:

To mitigate globalization growing pains and attain sustained benefits, the Med-Tech ecosystem will need to implement new strategies, processes, and technologies to proactively manage risk across the life-cycle of Med-Tech Products in a global and outsourced environment.

Today, we are seeing the adoption of modern cloud solutions that offer:

  • Holistic control over governance, risk management, and compliance practices
  • Enhanced visibility across the Med-Tech ecosystem
  • Improved collaboration with all constituents across the total product lifecycle

Being cloud comfortable doesn’t mean that every aspect of a company’s business is being managed in the cloud but Maintenance, Manufacturing and Quality clouds (to name a few) are quickly replacing on-premises applications.

Need help with your cloud strategy? Contact our Analyst Team today.