The medical industry stands to benefit immensely from cloud-based product lifecycle management (PLM). The mountains of information that medical companies must manage when bringing a new product to market are truly massive. Every aspect of the product — and every change made to the product — must be carefully documented to ensure compliance with regulatory bodies such as the Food & Drug Administration (FDA) or the ISO (International Standards Organization).
Each step of the way can be defined and mapped out in advance — everything from creating the device master record of a product and ensuring validation testing follows an essential requirements checklist, to creating a 510(k) or Investigational Device Exemption (IDE) submission to the FDA and tracking any design changes that are made after the product has been commercialized.
For medical companies of any size, cloud-based PLM helps streamline business processes for more efficient product development, improved profitability, and ultimately, higher product quality.
Due to the widespread collaborative nature of business today, the processes required to commercialize and maintain products are increasingly complex and dispersed. Frequent interactions result in an overload of design, process, and business information that decision-makers and distributed teams must sort, prioritize, and manage over the life cycle of their products or projects.
Enter Product Lifecycle Management (PLM). According to global analyst firm Gartner, PLM is a discipline for guiding products and product portfolios from ideas through retirement to create the most value for businesses, their partners, and their customers. When PLM is truly realized, it can deliver a powerful and complete digital view of information and processes, so that the right information is accessible wherever and whenever it is needed. Unfortunately, the majority of PLM providers to date have failed to deliver on the concept’s potential.
Autodesk PLM 360: A New, Cloud- Based Alternative
In February 2012, Autodesk introduced Autodesk PLM 360: a complete, cloud-based PLM solution for the entire enterprise that includes engineering, business process management, program and project management, new product introduction, and quality and compliance capabilities.
The low upfront and ongoing costs of cloud-based collaboration present a more affordable path by eliminating unnecessary capital expenditures and deployment. Many manufacturing companies are already using cloud-based applications to assist with supply chain, procurement, or unit manufacturing.
Pura Medical: An Executive Q&A
The following is an excerpted interview with Andrew Armour, president and founder of Pura Medical (Swarthmore, PA).
Q: Tell us about your company.
A: Pura Medical is a startup company
with a focus on reducing healthcare-acquired infections.
Q: Why is PLM important to you
A: As a startup, there’s limited
resources and there’s limited time. Efficiency is really paramount—and a solution like PLM 360 makes you very efficient. You can have fewer people getting much more accomplished, while keeping in control and in compliance.
Q: What drew you to Autodesk PLM 360?
A: Having a cloud-based solution was high on my list for several reasons, not the least of which was the ability to avoid having to hire an IT department to manage servers and administer software. The cloud aspect makes PLM a much more affordable option, in addition to making it easier to deploy. Also, the configurability was key: the fact that we could customize the templates to support the way we do things, the way our processes work.
Q: How are you using Autodesk PLM 360?
A: PLM 360 is handling virtually all our business processes. We’re using it for change management and quality management. We have it set up to handle our regulatory audits and regulatory submissions, supplier audits, and even risk management. This solution is way beyond PLM, in my opinion.
Q: What are some of the most noticeable benefits of Autodesk PLM 360?
A: The fact that we can make the benefits of PLM available to anyone in our organization, anywhere, is incredibly powerful. A member of my team had some available time while he was out of the country in the Philippines, and he was able to access the system instantly, with no issues. That’s part of the beauty of the cloud.
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