Life sciences sector uses PLM to shorten “innovation-to-registration” cycle

Like so many other kinds of companies, medical device manufacturers are under pressure to innovate, says Todd Hein, senior director of life sciences for product life-cycle management (PLM) vendor Agile Software. What adds a level of complexity is that they also must document their processes for regulatory bodies around the world.

09/01/2007


Like so many other kinds of companies, medical device manufacturers are under pressure to innovate, says Todd Hein, senior director of life sciences for product life-cycle management (PLM) vendor Agile Software . What adds a level of complexity is that they also must document their processes for regulatory bodies around the world.

“Competition and globalization are cutting away at their profit margins, so medical device manufacturers need to automate PLM processes to cut costs,” says Hein. “Use of PLM also speeds innovation-to-registration cycles. These companies must register their devices with a country's regulating body—such as the FDA in the U.S.—before they can sell the device there. Consequently, time-to-registration—rather than time-to-market—becomes a key metric.”

A PLM system engineered for the medical devices market meets these requirements as it enables managing information from R&D, manufacturing engineering, production, and suppliers. Agile's solution, for example, allows users to add quality assurance to prove that the manufacturer followed design processes in accordance with FDA requirements.

HeartWare is a Framingham, Mass.-based device manufacturer with a portfolio of left-ventricular-assist devices used for long-term treatment of advanced heart failure. Its success hinges on the ability to rapidly innovate its product offerings while supporting rigorous compliance directives for electronic documentation.

With its parent company in Sydney, Australia, and facilities in the U.S., HeartWare normally conducts clinical trials throughout Europe and Australia. Its trade secrets, technology, and design history are among HeartWare's key assets. Product information was housed in a consortium of hard drives scattered throughout the organization, and access was limited. Manual documentation control systems also required time-consuming tracking and revision control.

To remedy the situation and enhance information security, HeartWare selected Agile's Advantage PLM solution for its flexible licensing options, deep domain expertise, configurable solutions, and extensive customer references. The result is a single application to view the product record, quality system compliance, and knowledge archives across its global enterprise.

“We deployed Agile Advantage because we didn't want to lose the flexibility and agility of a start-up company, but needed a world-class solution that would allow us to communicate and exchange information—based on a robust security model—with our global skilled partners in manufacturing, regulatory, research, and clinical advisory capacities,” says Jeff LaRose, chief science officer, HeartWare. “Agile Advantage frees us of the inherent burden of an inefficient documentation control process, manual quality management processes, disjointed historical knowledge, and unnecessarily complex supply chain communications. Now we have a system to effectively manage growth as we move from clinical trials to commercialization of our ventricular assist technologies worldwide.”

HeartWare is using Agile OnDemand—Agile's software-as-a-service (SaaS) version of Agile Advantage—to securely collaborate with key stakeholders throughout the company's product network. This type of delivery model offers the flexibility to migrate, as business needs dictate, from an SaaS model to an in-house solution without the expense and problems of reconfiguration.





Engineers' Choice Awards
The Engineers' Choice Awards highlight some of the best new control, instrumentation and automation products as chosen by Control Engineering subscribers.
System Integrator Giants
The System Integrator Giants program lists the top 100 system integrators among companies listed in CFE Media's Global System Integrator Database.
System Integrator of the Year
Each year, a panel of Control Engineering and Plant Engineering editors and industry expert judges select the System Integrator of the Year Award winners in three categories.
How to Maximize Factory Automation Efficiency with Low Cost Machine Vision
This eGuide illustrates solutions, applications and benefits of machine vision systems.
Wireless Reliability in Harsh Environments
Learn how to increase device reliability in harsh environments and decrease unplanned system downtime.
Human Factors and the Impact on Plant Safety
This eGuide contains a series of articles and videos that considers theoretical and practical; immediate needs and a look into the future.
June 2018
Discrete and process sensor fundamentals, autotuning controls, system integrator roundtable
May 2018
Salary and Career Survey, IT and OT convergence, robotic standards and safety, secure circuit protection
April 2018
Cybersecurity best practices, artificial intelligence, robotic additive manufacturing, embedded systems, IIoT integration, energy efficiency
Edge Computing
This article collection contains several articles on how today's technologies heap benefits onto an edge-computing architecture such as faster computing, better networking, more memory, smarter analytics, cloud-based intelligence, and lower costs.
IIoT: Machines, Equipment, & Asset Management
Articles in this digital report highlight technologies that enable Industrial Internet of Things, IIoT-related products and strategies.
PLCs
Programmable logic controllers (PLCs) represent the logic (decision) part of the control loop of sense, decide, and actuate. Featured articles in this digital report compare PLCs and programmable automation controllers (PACs), industrial PCs, and robotic controllers.
SIDB

Find and connect with the most suitable service provider for your unique application. Start searching the Global System Integrator Database Now!

June 2018
Machine learning, produced water benefits, progressive cavity pumps
April 2018
ROVs, rigs, and the real time; wellsite valve manifolds; AI on a chip; analytics use for pipelines
February 2018
Focus on power systems, process safety, electrical and power systems, edge computing in the oil & gas industry
John O. Ayuk, PE, CFSE, PMP, CAP
Automation Engineer; Wood Group
Doug Baker
System Integrator; Cross Integrated Systems Group
Jose S. Vasquez, Jr.
Jose S. Vasquez, Jr.
Fire & Life Safety Engineer; Technip USA Inc.
Data Centers: Impacts of Climate and Cooling Technology
This course focuses on climate analysis, appropriateness of cooling system selection, and combining cooling systems.
Safety First: Arc Flash 101
This course will help identify and reveal electrical hazards and identify the solutions to implementing and maintaining a safe work environment.
Critical Power: Hospital Electrical Systems
This course explains how maintaining power and communication systems through emergency power-generation systems is critical.
Engineers' Choice Awards
The Engineers' Choice Awards highlight some of the best new control, instrumentation and automation products as chosen by Control Engineering subscribers.
System Integrator Giants
The System Integrator Giants program lists the top 100 system integrators among companies listed in CFE Media's Global System Integrator Database.
System Integrator of the Year
Each year, a panel of Control Engineering and Plant Engineering editors and industry expert judges select the System Integrator of the Year Award winners in three categories.
How to Maximize Factory Automation Efficiency with Low Cost Machine Vision
This eGuide illustrates solutions, applications and benefits of machine vision systems.
Wireless Reliability in Harsh Environments
Learn how to increase device reliability in harsh environments and decrease unplanned system downtime.
Human Factors and the Impact on Plant Safety
This eGuide contains a series of articles and videos that considers theoretical and practical; immediate needs and a look into the future.
June 2018
Discrete and process sensor fundamentals, autotuning controls, system integrator roundtable
May 2018
Salary and Career Survey, IT and OT convergence, robotic standards and safety, secure circuit protection
April 2018
Cybersecurity best practices, artificial intelligence, robotic additive manufacturing, embedded systems, IIoT integration, energy efficiency
Edge Computing
This article collection contains several articles on how today's technologies heap benefits onto an edge-computing architecture such as faster computing, better networking, more memory, smarter analytics, cloud-based intelligence, and lower costs.
IIoT: Machines, Equipment, & Asset Management
Articles in this digital report highlight technologies that enable Industrial Internet of Things, IIoT-related products and strategies.
PLCs
Programmable logic controllers (PLCs) represent the logic (decision) part of the control loop of sense, decide, and actuate. Featured articles in this digital report compare PLCs and programmable automation controllers (PACs), industrial PCs, and robotic controllers.
SIDB

Find and connect with the most suitable service provider for your unique application. Start searching the Global System Integrator Database Now!

June 2018
Machine learning, produced water benefits, progressive cavity pumps
April 2018
ROVs, rigs, and the real time; wellsite valve manifolds; AI on a chip; analytics use for pipelines
February 2018
Focus on power systems, process safety, electrical and power systems, edge computing in the oil & gas industry
John O. Ayuk, PE, CFSE, PMP, CAP
Automation Engineer; Wood Group
Doug Baker
System Integrator; Cross Integrated Systems Group
Jose S. Vasquez, Jr.
Jose S. Vasquez, Jr.
Fire & Life Safety Engineer; Technip USA Inc.
Data Centers: Impacts of Climate and Cooling Technology
This course focuses on climate analysis, appropriateness of cooling system selection, and combining cooling systems.
Safety First: Arc Flash 101
This course will help identify and reveal electrical hazards and identify the solutions to implementing and maintaining a safe work environment.
Critical Power: Hospital Electrical Systems
This course explains how maintaining power and communication systems through emergency power-generation systems is critical.
Engineers' Choice Awards
The Engineers' Choice Awards highlight some of the best new control, instrumentation and automation products as chosen by Control Engineering subscribers.
System Integrator Giants
The System Integrator Giants program lists the top 100 system integrators among companies listed in CFE Media's Global System Integrator Database.
System Integrator of the Year
Each year, a panel of Control Engineering and Plant Engineering editors and industry expert judges select the System Integrator of the Year Award winners in three categories.
How to Maximize Factory Automation Efficiency with Low Cost Machine Vision
This eGuide illustrates solutions, applications and benefits of machine vision systems.
Wireless Reliability in Harsh Environments
Learn how to increase device reliability in harsh environments and decrease unplanned system downtime.
Human Factors and the Impact on Plant Safety
This eGuide contains a series of articles and videos that considers theoretical and practical; immediate needs and a look into the future.
June 2018
Discrete and process sensor fundamentals, autotuning controls, system integrator roundtable
May 2018
Salary and Career Survey, IT and OT convergence, robotic standards and safety, secure circuit protection
April 2018
Cybersecurity best practices, artificial intelligence, robotic additive manufacturing, embedded systems, IIoT integration, energy efficiency
Edge Computing
This article collection contains several articles on how today's technologies heap benefits onto an edge-computing architecture such as faster computing, better networking, more memory, smarter analytics, cloud-based intelligence, and lower costs.
IIoT: Machines, Equipment, & Asset Management
Articles in this digital report highlight technologies that enable Industrial Internet of Things, IIoT-related products and strategies.
PLCs
Programmable logic controllers (PLCs) represent the logic (decision) part of the control loop of sense, decide, and actuate. Featured articles in this digital report compare PLCs and programmable automation controllers (PACs), industrial PCs, and robotic controllers.
SIDB

Find and connect with the most suitable service provider for your unique application. Start searching the Global System Integrator Database Now!

June 2018
Machine learning, produced water benefits, progressive cavity pumps
April 2018
ROVs, rigs, and the real time; wellsite valve manifolds; AI on a chip; analytics use for pipelines
February 2018
Focus on power systems, process safety, electrical and power systems, edge computing in the oil & gas industry
John O. Ayuk, PE, CFSE, PMP, CAP
Automation Engineer; Wood Group
Doug Baker
System Integrator; Cross Integrated Systems Group
Jose S. Vasquez, Jr.
Jose S. Vasquez, Jr.
Fire & Life Safety Engineer; Technip USA Inc.
Data Centers: Impacts of Climate and Cooling Technology
This course focuses on climate analysis, appropriateness of cooling system selection, and combining cooling systems.
Safety First: Arc Flash 101
This course will help identify and reveal electrical hazards and identify the solutions to implementing and maintaining a safe work environment.
Critical Power: Hospital Electrical Systems
This course explains how maintaining power and communication systems through emergency power-generation systems is critical.
click me