Viewpoints on Innovation

Technology Choices

Achieving Long-Term Transformational Success with PLM in Life Sciences, Part 8

IT Enablers Medical Device
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In this blog series, I provide insights as to why PLM has true potential to be so transformational for life sciences companies. Working across many companies in this industry, my observation is that many have toyed with PLM, at least through traditional PDM (Product Data Management). Now it’s time to get serious! Companies that truly embrace PLM over the next five to ten years have an amazing opportunity to leapfrog much of the industry and achieve many and impactful business benefits.

PLM Technology Choices

In the past, many out-of-the-box (OOTB) PLM solutions lacked support for critical life sciences areas such as research, marketing, quality and regulatory affairs management. So for many years, we would build a custom solution for each client directly on top of the PLM platform. These solutions could be anything from ideation filtering to quality issue tracking to operations planning and management.

For the PLM vendors that have maintained a focus on the life sciences industry, the OOTB solutions they offer continue to expand with smart integrations at the process level. This is true for everything from entry-level cloud PLM solutions that have added quality processes, to traditional engineering PLM solutions and high-end PLM platforms that continue to put serious investment into industry-specific products. High-end PLM platforms can now support biologic, chemical, and materials modeling. They support formulation management, integrate discrete manufacturing and design, and then link regulatory, quality, manufacturing, and supplier information. It’s truly outstanding what the possibilities are for our pioneers. The road, my pioneering friends, is finally opening up!

Others vendors in the industry who have only recently embraced a life sciences market strategy are playing catch up or sticking with a horizontal strategy. Nevertheless, PLM vendors should continue to focus on industry-specific capabilities and life sciences is a great candidate to continue to mature, largely because a lot of what is expected in the product lifecycle is defined by FDA regulations and ISO standards. This provides a standard base for vendors to work from.

None of the vendors, to my knowledge, have conquered all common aspects of the product lifecycle. For this reason, it’s very important to compare vendors - not just across the process and capability areas you’re considering in the short-term, but to consider the long term PLM strategy. This means you must compare module by module and understand what each vendor offers.

It’s important to accept that no one vendor is going to match all of your needs, nor your potential appetite for end-to-end product management. If you think otherwise (and many do), you will be disappointed. Instead, consider how many capabilities are offered out-of-the-box and whether those capabilities meet your needs. Then consider how extensible and configurable the platform is to meet your unique and evolving needs to fill in gaps. If you are a real pioneer looking to leap-frog competition, don’t bother with platforms that aren’t easily configurable and extensible; at best you will get a me-too capability set.

One thing I will admit I am concerned about is pushing everything to the cloud and oversimplifying for the sake of easy deployment. If vendors stop providing flexibility at the platform level, companies are stuck with what the vendor offers and nothing more. This will be a setback.

I can understand vendors being enticed by the commercial advantages of simple cloud solutions that are limited and don’t encourage extension, but this has limited benefit to our pioneers that recognize they will need to fill in some blanks themselves by extending into areas the vendor hasn’t focused on. Cloud approaches can be enormously useful for PLM, but vendors should not give up flexibility when doing so.  Even if some vendors move to an oversimplified (non-flexible) cloud model, not all will take that path. I believe that those who keep their platforms open will win by supplying our real pioneers with the capabilities to make it out west. 


More In This Series

The Missed Opportunity and How We Can Overcome It

-          PLM, the Great Missed Opportunity in Life Sciences

-          PLM Pioneers

-          Adoption Obstacles

-          It’s Time to Get Excited About PLM in Life Sciences

The Business Benefits

-          Risk Reduction

-          Cost Reduction

-          Innovation Enablement

The Basics of Technology and Strategy

-          Technology Choices

-          The "PLM Program" is Where We Went Wrong

-          Getting to a Business Transformation Strategy (with an Emphasis on Product Innovation)

PLM Strategy

-          Setting the Stage and First Release

-          Beyond the First Release

-          Automation Initiative Prioritization and Grouping

Solving Coming PLM Strategy Problems

-          Time and Cost

-          Upgrades

-          To Build or To Buy?

-          Vendor First or Strategy First?

Making it Real – People, Governance and Methodology

-          Transformational PLM is Hard – It’s Time to Rally the Troops

-          Amazing PLM Governance

-          Ten Traits any PLM Team Must Have

-          Three Characteristics of a Successful Implementation Methodology

Originally published on June 17th, 2015

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Topics: Innovation, Manufacturing, medical device innovation, medical device PLM, Medical Device Product Development, PLM, product innovation, product lifecycle management, Strategy

About the Author

Dave Hadfield

Dave Hadfield

Dave brings over 17 years of experience in product lifecycle management (PLM) to Kalypso's clients, with deep expertise in the medical device industry.
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