Multiple facets of PLM

Geometric provides solutions that enable the management of critical quality processes on an enterprise PLM backbone along with the NPDI processes.
Advancements in technology and device modalities, along with increased application of software, have re-drawn the boundaries for exploring the human anatomy and brought a significant change in diagnosis and treatment procedures. This has lead to an increase in the complexity of devices and related software applications. A continuous demand for rapid development and high quality treatment, while reducing overall healthcare costs, is forcing the medical devices vendors to review their R&D strategies. The need is to cost-effectively shorten the already intensive R&D cycle – to speed up innovation to market – while accounting for patient safety and comfort.
Healthcare equipments providers today invest to develop complete systems – hardware and software for multiple operations to drive differentiation among vendors and enable increased adoption of new systems in the industry. This further brings in product data management complexities in terms of managing the software lifecycle and versions along with the device R&D lifecycle and variants.
 
According to research estimates, more than 25% of annual revenue gets spent on remediating warning letters and recalls from regulatory authorities and, in cases of recall, damage to reputation is immense. If organizations focus so much on the compliance process, where is the needed edge for critical elements like inherent quality management and product innovation?

PLM (Product Lifecycle Management) systems have seen good success in the automotive and heavy engineering industries. But does PLM have answers for the challenges faced by the medical devices industry?

The answer is yes, with a well mapped PLM application with limited customizations and required integrations into other systems.

Leading PLM solutions provide capabilities for managing the basic activities of the NPDI process along with stronger solutions that provide the capability to manage an entire portfolio of programs. A well mapped PLM backbone can provide complete data traceability for all activities – from concept to retirement – by linking compliance requirements with engineering and specification data. A dashboard provides senior management the visibility and analytics required to balance complex product portfolios across assets and resources. At the product team level, PLM strategies help streamline collaboration and PLM systems provide a platform for product, document, and change management.

Medical devices, and especially life sciences companies, rely on contract manufacturing organizations (CMOs) for their new products. Any requirement for collaboration takes place mostly on an ad-hoc basis. Industry trends have shown CMO engagement in the early stages of product and process development as a critical success factor for manufacturers. PLM holds good promise for this need as well; facilitating collaborative innovation, communication, and performance management.

Taking a look at Geometric’s recent experience with some leading medical devices companies, what adds to complexity is the growth of healthcare practices in new geographical markets that need the same or similar products, but have a very different consumer behavior in terms of cost appetite, energy sources, and infrastructure. From an R&D perspective, this means localizing devices for the particular geographies. From a product management perspective, it means configuration and calibration of the devices for the local requirements – language, user interface, features, etc. This means that PLM systems today have to go beyond managing the somewhat well defined NPDI processes and manage the complex mix of product portfolios.

Innovations
The ability to accurately route segmented customer needs and ideas to realization without sacrificing innovation for convenience is a critical need. Medical device companies have to move from self capability lead innovation to customer needs driven innovation; from insular to collaborative, networked innovation models; from big-bang R&D projects to quick market hits with shorter success milestones involving reallocation or sourcing of R&D resources. An effective PLM strategy will enable all this including:

• Open Innovation: Listen to all possible ways through which innovation may happen – customer feedback, quality issues, quality feedback, social networks, external innovation, etc;
• Tie the voice of the customer to critical to quality (CTQ);
• Enable structured approach for innovation management;
• Ensure early supplier involvement in product development;
• Integrate program/project management; and
• Build better decision support mechanisms including evaluation metrics and means to easily monitor them.

Geometric has very strong relationships with the leading PLM product providers. However, to leverage a PLM backbone to the extent discussed earlier in this article, we take a more holistic approach and work with the industry to design solutions that address their needs. To synergize our industry best PLM capabilities with strong domain capabilities required to service the medical devices industry, we have partnered with a medical devices specialist company to better address the needs of this industry.

With this knowledge in place, Geometrics understands each client and their specific needs, providing complete PLM solutions with a road map for achieving the PLM strategy.

Geometric Technologies
Scotssdale, AZ
geometricglobal.com