Product Lifecycle Managament Integration in Life Sciences

Sitting in on some of the conference session yesterday, looking at interfacing Product Lifecycle Management (PLM) solutions, it was quite obvious that not all PLM solutions are created equal.

PLM is one area where Oracle has grown strong through acquisition, initially by acquiring Agile. This brings arguably the best PLM solution for medical devices companies - what many still know as the Agile A9 product. Oracle also had a process version but is mainly used in food and beverage and although there is some good process functionality it was not specialized enough to manage the drug development lifecycle.

Then in June this year Oracle announced its intention to purchase the IP of Conformia, bringing a strong product to manage the drug development lifecycle into their portfolio, with the intention to integrate this into the Agile product line.

This will provide large Life Sciences companies first rate products for either medical device development and design management or for managing the drug discovery and development process. This will also provide some flexibility to manage the lifecycle of products that are manufactured using either discrete or process manufacturing operations.

Although many take a simplistic view, the world isn't as simple as medical devices companies use discrete manufacturing and pharmaceuticals uses process. In some cases medical devices use batch manufacturing and pharmaceuticals need discrete. At the PLM level, the medical device Quality System Regulations have specific requirements for device development which Agile A9 meets very well, but not so Conformia.

Back to the topic of interfaces: While Oracle is doing a good job in developing standard process integrations between A9 and their core ERP systems (E-Business Suite and JDEdwards, using AIA PIPs), there is a growing realization that the combination of regulatory requirements for managing the various lifecycles of devices or drugs and discrete or process manufacturing means that there will need to be complete flexibility to interface either of the two 'flavors' of PLM to either discrete or process manufacturing solutions in Oracle's own (and competitors such as SAP) ERP systems.

Oracle's AIA framework certainly provides that opportunity and is no doubt the easiest way to develop such integrations. Indeed, Oracle has a roadmap to develop such Process Integration Packs, but it will be a while yet until the Conformia product is integrated into Agile and the AIA PIPs developed.

From a business perspective this means that Life Sciences companies looking to acquire PLM solutions (not only from Oracle) really need to understand:

• The nature of their product development lifecycle
• The regulatory requirements which govern their PLM processes (depending on device class or drug profile)
• The nature of their manufacturing process - discrete, process or possibly mixed mode for some product lines
• Exactly how they want to integrate their PLM systems to their manufacturing systems from a business process perspective

It is this that will drive the functional requirements of their interface and determine whether an out-of-the-box integration will deliver what is needed, or whether integration tools will be needed to develop some customer elements of the interface.

On a positive note, for Life Sciences customers who have taken the step to integrate their PLM and ERP systems and processes, there is a good return on investment both in terms of reducing costs and helping maintain compliance through the design, development and introduction of new products and new versions of products. With respect to this latter point, with regulatory authorities now looking at risks introducing during new product introduction (or scale up) it is good news that these concerns can be addressed at the same time these processes are made more efficient.