Medical Device Development Cannot Be Managed With Documents

Jama Connect for Medical Device Development Briefing Note

By Daniel R. Matlis

The Jama Software executive team recently briefed Axendia on its new Jama Connect for Medical Device Development platform.   The new solution is designed to help engineering teams manage medical device requirements, risk and design control in a single platform. The medical device offering also aims to make regulatory submissions and audit preparations a straightforward process, speeding time-to-market deployment while supporting device quality.

“We’re excited to introduce our new solution designed specifically for medical device developers which,  will help ease the development process from the start,” said Josh Turpen, Chief Product Officer at Jama Software.  “Jama Connect allows developers to hit the ground running with preconfigured templates and best practices built-in, saving engineering teams from the cumbersome and often frustrating process of filing paperwork,” he added.

Continue reading

Transforming Quality Management with a Modern Cloud Solution

Webinar Available On-Demand

By: Sandra K. Rodriguez, Market Analyst

For decades, life sciences companies have implemented on-premises quality management systems (QMS) to support regulatory requirements and replace paper-based processes. These systems were often implemented to mitigate regulatory findings rather than to create visibility, traceability and accountability throughout the product lifecycle. Today, companies are taking a different course and are adopting a cloud culture to modernize processes, improve supplier collaboration, and drive better quality and business outcomes.

I was recently joined by Joe Vigil, Director Quality Systems at Ultragenyx, and Mike Jovanis, VP Vault Quality at Veeva Systems, to discuss the achieved business benefits of a cloud-based quality solution on a webinar presented by Veeva Systems.

We discussed the internal and external factors that are contributing to the adoption of Cloud QMS and the benefits of an industry cloud platform including time to value and reduced validation efforts.   

With merger and acquisition activities a daily reality in the life sciences industry, companies are growing at rapid rates. “We started our journey to a cloud QMS about three years ago in 2017. At that time, we had about 350 employees and no commercial products. Today we’re over 750 employees and have two commercial products. So, we’ve grown quite a bit in a few years’ time, and we really were looking for a cloud solution that could grow with us,” said Vigil.

Continue reading

Product Success Platform

Propel Briefing Note

By: Daniel R. Matlis

Axendia was recently briefed by the Executive Management team at Propel following the launch of their Healthcare Manufacturer Community.   Propel is offering its technology and supplier community to accelerate the production of ventilators based on Medtronic’s PB560 open source design. Visit Propel’s Healthcare Manufacturer Community for additional details.

Founded in 2015, and headquartered in Santa Clara, CA, Propel provides a cloud-based product success platform that connects the people, systems and processes needed to deliver products from concept to customer.

Entirely built on Salesforce’s modern cloud, multi-tenant cloud SaaS architecture, Propel allows organizations to take advantage of a modern cloud native product success management solution.

“Propel was founded with the knowledge that a single platform for all product needs allows for greater collaboration, faster decision making and easy deployment. Building on Salesforce allows us to easily integrate the customer and product records on a single platform,” said Ray Hein, CEO & Co-founder.

Continue reading

Technology’s Role in Overcoming a Disrupted Life-Sciences Reality

The Watershed Moment for Modernization and Digital Transformation

By: Daniel R. Matlis, President

Life-Science companies are at the forefront in the fight against COVID-19.  However, many organizations are facing challenges managing their business in the new virtual and remote reality.  The demand for organizational visibility, control and collaboration to achieve resilience is a catalyst to modernization and digital transformation in our industry.

To explore technology’s role in overcoming a disrupted Life-Sciences reality, I was joined by Hugo Felix, Director at Pfizer and Sandra K. Rodriguez, Market Analyst at Axendia in a “Straight from the Source webinar presented by MasterControl.

This Event Brief provides key recommendations on opportunities to leverage technology to:

Continue reading

COVID-19 Black Swan Colliding with Your Supply Chain?

By: Daniel R. Matlis, President, Axendia, Inc.

Globalization and outsourcing have increased the volume of geographically dispersed partners, facilities, and suppliers in the Life-Science global supply chain. This has resulted in increased supply chain risk and decreased predictability due to variability and complexity and increasing the impact of ‘Black Swan’ events on the healthcare ecosystem.

In 2010 we started preaching about some of the risks associated with globalization, outsourcing and single sourcing in Life-Sciences (See Research Report Achieving Global Supply Chain Visibility, Control & Collaboration in Life‐Sciences: “Regulatory Necessity, Business Imperative”).

While many analysts focused on the rewards of these practices, Axendia took a holistic risk-based approach.

Globalization and Outsourcing allowed the COVID-19 Back Swan to Take the Crown:

In his book “The Black Swan: The impact of the highly improbable,” Nassim Taleb defines a ‘Black Swan’ as an event characterized by rarity, extreme impact, and retrospective (though not prospective) predictability.

Corona (Latin for Crown) is likely the largest Black Swan event to affect the Life-Science supply chain in a generation.

Continue reading