Category Archives: Latest

18Jan/18
woman with fitbit

How the Internet of Medical Things (IoMT) Supports Improved Patient Outcomes

Webinar Recording Available On-Demand

By: Sandra K. Rodriguez, Market Analyst, Axendia

The Internet of Medical Things (IoMT) and the transition to outcomes based reimbursements are changing the way medical device companies approach new product development. IoMT and connected healthcare can enable the transition to patient-centered, preventative care.  IoMT connected devices are going to play an important role in supporting improved quality of care, patient outcomes, and also improving the business of healthcare in the outcome economy.  Yet with smart, connected products comes a new level of complexity throughout the total product lifecycle

In a recent FDANews webinar, I was joined by David Wolf and Jordan Reynolds, both Senior Managers with Kalypso.  We discussed the impact the increased number of connected IoMT devices is having on outcome based healthcare models, the potential benefits and pitfalls, and how to best leverage PLM solutions and IoT in a changing healthcare environment.

Tricorder-MockupMedical device manufacturers are applying advanced technologies to support the development of complex, high quality, smart connected devices.   Jordan Reynolds added, “These include the ability to develop products that can be monitored in real time, that can be updated in real time, and that can be controlled in real time by the manufacturing organization that’s responsible for the product. These are really the three elements of IoT and Analytics technologies that, when coordinated together, are giving manufacturers the capability to enable an outcome-driven patient care model.”

In the Life Sciences industry, manufacturers are considering Product Lifecycle Management (PLM) strategies in support of the FDA’s Case for Quality (CfQ) when starting their Internet of Medical Things (IoMT) journey.  David Wolf pointed out, “Some of the most important CfQ metrics are centered around pre-production, production and post-production which will be used by the FDA to prioritize audit and pre-market approval inspections.  These Key Process Indicators (KPI’s) utilize PLM systems as the backbone when aggregating product changes over the product lifecycle, calculating non-conformances in order to determine if they got it right the first time, trending complaints, evaluating service records, understanding adverse event reports and when calculating failure rates. Not only can companies reduce the number of recalls and warning letters by harmonizing PLM and QMS, they can also significantly reduce the cost of poor quality and better unsure the safety and efficacy of their products.  PLM & QMS are used as the backbone for compliance, help ensure better product quality and can be used as a very important input to the IoMT and predictive analytics processes.”

We also discuss:

  • How IoMT and Big Data foster an environment that is conducive to Predicative Analytics and Machine Learning
  • What medical device companies are already doing to compete in a new ecosystem that includes at-home patient monitoring
  • How Cybersecurity threats are being mitigated

To learn more about how the Internet of Medical Things (IoMT) Supports Improved Patient Outcomes, access the on-demand webinar here.

11Jan/18
2017 Year end review

Award Winning Year for Axendia – Looking at the 2018 Crystal Ball

By Daniel R. Matlis

2017 has been an exceptional year for Axendia.  We were recognized by CIOReview magazine as one of the 20 Most Promising Pharma and Life Sciences Solution Providers.  We also had the opportunity to address audiences around the globe, including Asia, Europe, North and South America.

Our analysts had the privilege to provide insight and trusted advice to leaders across the Life Science and Healthcare ecosystems including executives in industry, technology & service providers as well as policy makers and regulators.
In the last year we advised our clients on critical topics such as:

11Dec/17
Moped

Compliance vs Quality – India Edition

By Daniel R. Matlis

In October, I had the privilege to visit Mumbai, India, to provide the keynote address at a series of Life-Science Executive Industry events on Quality and Manufacturing organized by Dassault Systèmes Biovia Corp.

GroupThis visit afforded me a great opportunity to meet with executives from many of India’s largest Life-Science companies, get a taste of Indian culture and share Axendia’s insights on trends impacting the global and externalized industry.

I also gained a new perspective on the Compliance vs Quality paradox.

During my keynote I emphasized the need for Life-Science Organizations to transition their focus from mere Compliance towards a culture driving Quality improvements across the organization.

Compliance is a Baseline, it is the cost of doing business in the Life-Sciences Industry.  Collecting documented evidence of compliance with regulatory requirements is an overhead cost for Life-Science companies.

By contrast, Quality is an Investment. Improvements in quality drive enhanced and consistent product performance.  In addition streamlined processes result in operational efficiencies and reduce waste.  Investing in improving product quality lowers costs and improves outcomes

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07Nov/17
CIO Logo square - smaller

Axendia Recognized by CIOReview in Pharma and Life Sciences Issue

Company Named to 20 Most Promising Pharma and Life Sciences Tech Solution Providers – 2017

From CIOReview’s special issue: A distinguished panel composed of CEOs, CIOs, VCs, analyst and the editorial CIOReview board, has selected the top pharma and life sciences tech solution providers. In our selection process, we looked at the vendors capability to fulfill the need for cost-effective and flexible solutions that add value to the pharma and life science landscape.

“We believe that there is no one standard solution that fits all clients, therefore our approach is to offer tailored solutions that take into consideration each client’s present, as well as their future needs,” said Daniel R. Matlis, President and Founder at Axendia.

To be recognized by CIOReview as a Most Promising Pharma and Life Sciences Solution Provider is powerful evidence of the effectiveness of our approach.

Axendia’s imposing reputation in the Life Sciences and Healthcare space can be attributed to our dynamic work culture built on the values of respect, integrity and  passion.  As a result, we offer a unique combination of hands-on experience, coupled with strategic vision. We are committed to building and nurturing long-term relationships with our clients and fostering a spirit of cooperation, collaboration and trust with every single engagement.

Pharma & Life Sciences CIOReview

It is an honor to be named to the 20 Most Promising Pharma and Life Sciences Tech Solution Providers – 2017.

Full Page Article Here.

03Nov/17
CLOUD IMAGE

ComplianceQuest Offers Cloud Native Enterprise Quality Management Solutions

By: Daniel R. Matlis

Axendia was recently briefed by ComplianceQuest’s executive team.  The team, 80% of whom have deep experience in the Enterprise Quality Management Solutions (EQMS) market, has developed a cloud native EQMS built on the Salesforce platform.

ComplianceQuest was developed on the Salesforce cloud solution to provide a worry-free infrastructure platform that can be available anywhere, anytime. In addition, Salesforce provides a reliable, versatile infrastructure that can scale for all size companies. Another benefit of developing on the Salesforce platform is the ability to leverage advanced capabilities such as mobility, social media, artificial intelligence and machine learning and be ready for future technologies.Network_Navy_F

“ComplianceQuest provides a unique combination of niche experience, solutions and services across multiple industries with comprehensive capabilities in quality, safety and compliance throughout the supply chain,” said Nikki Willett, Chief Strategy Officer at ComplianceQuest. “Suitable for small companies and secure, scalable and flexible to meet the needs of medium and global enterprises, ComplianceQuest is easy to implement, validate and use,” she added.

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