Tag Archives: Life-Sciences

28Oct/19
Cloud Comfortable

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.

29Apr/19
Image Source: Tel Aviv University

Taking 3D Printing to Heart…New Steps in 3D Printing Medical Applications

Is 3D Printing Still a Phenomenon… or Not?

By: Eric M. Luyer, Industry Research Analyst

3D Printing has been used for some time now for printing very specific surgical tools or patient-specific parts to complete full functioning of the human body.  But is 3D Printing still a phenomenon… or not?

In my opinion it is certainly amazing when you see the latest developments and you apply biomedical engineering to 3D Printing.  Specifically, in the medical field there are various use cases adopting this rather futuristic technology – you may now print entire organs for practical surgical use!   I have read that scientists and researchers have successfully printed kidney cells, sheets of cardiac tissue that have something like a heartbeat, and foundations for a human liver.

Other relatively new examples are:  bio-printed stem cells which has been done by the Heriot-Watt University of Edinburgh, Scotland-UK of human skin, that can be used for burn victims, skin cancer patients or other kinds of diseases that affects the skin in a negative way. Scientists have also successfully created tests for 3D Printing artificial bone tissue(!) and the hope is that such tissues may assist in helping with limiting sporting accidents that so many athletes suffer from.  I have also seen that medical researchers and scientists are well on their way to printing an entire human organ. Continue reading

22Apr/19
Modern-Pharma-Mfg-Small-400by360

FDA is Enabling Innovation and Modernization

By: Thomas O’Connor, Sr. Chemical Engineer, US FDA

FDA is committed to supporting and enabling pharmaceutical innovation and modernization as part of the Agency’s mission to protect and promote public health. FDA recognizes that continuous manufacturing is an emerging technology that can enable pharmaceutical modernization and deliver potential benefits to both industry and patients. Continuous manufacturing can improve pharmaceutical manufacturing by, for example, using an integrated process with fewer steps and shorter processing times; requiring a smaller equipment footprint; supporting an enhanced development approach (e.g., quality by design (QbD) and use of process analytical technology (PAT) and models); enabling real-time product quality monitoring; and providing flexible operation to allow scale-up, scale-down, and scale-out to accommodate changing supply demands. Continue reading

13Jul/18
Lucky 13-700x400

Lucky 13! What’s in a Number?

At Axendia, We Consider 13 More Than a Lucky Number!

We are quickly approaching our 13 Year Anniversary!  Since 2005, we have been providing trusted advice to Life-Science Industry Executives on Business, Regulatory and Technology Matters. It’s more than just luck, our analysts help a diverse set of clients achieve positive disruption through primary research and deep industry experience in a complex and highly regulated Industry.  Not only is our staff passionate about what they do, they average 20 years of Life-Science industry experience.

As a result, Axendia has proudly built long-term relationships across a broad industry ecosystem including:

Life-Science and Healthcare Organizations 68530 Connected Doctor

We provide strategic advice on key initiatives and understand the issues and priorities facing Industry Executives. We architect strategic road-maps to support positive disruption.

Examples include:

Continue reading