Category Archives: Technology

26Mar/19
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New Whitepaper Series – Why MedTech Must Embrace Industry 4.0

Medical Device Companies Must Embrace Modern Manufacturing Execution System (MES) Strategies to Future-Proof Their Business

By: Sandra K. Rodriguez, Market Analyst

FDA’s upcoming guidance on Computer Software Assurance (CSA) paves the way for Digital transformation and Industry 4.0 in MedTech. The Agency recognizes that systems like MES provide manufacturers advantages for reducing or eliminating errors, increasing business value, optimizing resources, and reducing patient risk.

Need a roadmap to enable Industry 4.0 in MedTech?  Read this whitepaper series to discover:

  • How to use MES as the backbone to enable Industry 4.0
  • Why modern MES support the transition from compliance to excellence
  • How to enable a step change for your business and patient outcomes
  • Ways to utilize Industry 4.0 across your manufacturing network

Download the series here and start your digital manufacturing transformation.

This white paper series was sponsored by Critical Manufacturing.

22Mar/19
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FDA Shares Quality Considerations for Continuous Manufacturing

A Straight from the Source Webinar

 FDA is committed to supporting and enabling pharmaceutical innovation and modernization. The Agency recognizes that continuous manufacturing is an emerging technology that can enable pharmaceutical modernization and deliver potential benefits to both industry and patients.

Join FDA’s Thomas O’Connor, Ph.D. and Axendia’s Daniel R. Matlis for a live webinar.

Date and Time:  April 17th at 11:00 AM ET. 

We will discuss FDA’s perspective on pharmaceutical innovation and modernization including:

  • FDA’s draft guidance on Quality Considerations for Continuous Manufacturing
  • How continuous manufacturing can improve pharmaceutical manufacturing
  • Support of enhanced development approaches such as quality by design (QbD), process analytical technology (PAT) and models
  • Insights from dialogue with sponsors through the Emerging Technology Program, externally funded and internal research
  • Experiences from review and approval of five drug applications utilizing continuous manufacturing to date

Meet Your Trusted Sources

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Scheduling Conflict? Register and receive a link to view the on-demand recording after the event.

Participation is Limited!

register

21Mar/19
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Unstructured Tools Are Not A Good Fit For A Structured Process

Jama Software Brief

By: Sandra K. Rodriguez, Market Analyst

The Jama Software executive team recently briefed Axendia on its product development platform that is comprised of its flagship product – Jama Connect – and newly developed Jama Analyze.  Headquartered in Portland, Oregon, the company aims to help medical device companies modernize, digitize and transform an increasingly complex product development process.

Jama Connect allows companies to focus on quality from the standpoint of requirements, risk management and testing and brings it all together in a modern, collaborative and centralized way.  “Customers are coming to us to really drive innovation and quality in an accelerated time frame as they face competitive pressures,” said Joel Hutchinson, Product Manager at Jama Software.

Companies ranging from Merck to Boston-Scientific are managing requirements, risk, test and project volatility through the use of Jama Connect.

Please register to receive your complimentary copy of this Brief.

 

14Mar/19
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Rootstock Offers Cloud Native ERP Built for the Salesforce Platform

Briefing Note

By: Daniel R. Matlis, President

Axendia was recently briefed by Rootstock’s executive team.  The team has deep experience in the Enterprise Resource Planning (ERP) market dating to the 1970’s

Rootstock offers a cloud native ERP solution for companies that manufacture, distribute, service and/or repair goods built on the Salesforce (SFDC) platform. The company serves emerging growth, midsized and enterprise companies including those who are replacing legacy and entry level ERP systems.

“We built our ERP product right alongside Salesforce CRM to manage the entire customer relationship on one platform,” said Tom Brennan, Chief Marketing Officer at Rootstock.    “In the diagram below you can see the Salesforce Sales Cloud on the left managing the front end to acquire customers. Then to the right you see the Salesforce Service Cloud in place to run the customer call center and field service.  We manage everything in between.  We provide the ordering, sourcing, production, inventory, invoicing and accounting functions in between the customer acquisition and customer service functions.  We, combined with Salesforce, have an end-to-end process built around the customer life cycle. Life Science companies get more efficient processes, but also a 360° view of the customers and their entire business,” he explained.

Register to receive our latest Briefing Note and learn how Rootstock ERP provides features and capabilities that ease the burden and cost of regulatory compliance while improving efficiency and connectivity for its Life-Science customers.

 

 

12Mar/19
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eBook: CSA – A Streamlined Approach to Validation

Computer System Assurance in Support of Manufacturing 4.0

By: Daniel R. Matlis, President

Computer System Validation (CSA) is a streamlined approach to validation that supports Manufacturing 4.0 in the Life-Sciences.   Medical Device Executives believe this new approach will result in a 30% to 50% reduction in time and cost, and will increase and accelerate improvements and innovation.

This eBook includes success stories and first-hand examples by:

Axendia_Validation_P10-copyrightedFrancisco (Cisco) Vicenty, Program Manager – CfQ, US FDA

Jason Spiegler, Sr. Director, Industry Portfolio Development, Siemens PLM

Damien McPhillips, Sr. Quality Manager – Global Software and Digital Health, Boston Scientific

Ray Murphy, Principal Software Quality Engineer, Boston Scientific

April Francis, Director Global IT Quality and Compliance, Medtronic

Frank Melendandri, Sr., Manager, Quality Assurance, Zoll Lifevest

 

This paradigm shift has had an enormous impact on the industry.  Backed by the FDA, a new era of computer system validation is here. According to Cisco Vicenty, CfQ Program Manager at FDA: “All the recommendations that the Non-Product CSV Guidance is highlighting, is within scope of the FDA’s QSRs and is compliant.”
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