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Complex product designs, stringent regulatory requirements, and the need to consistently deliver safe and reliable products are making product lifecycle management (PLM) technology essential for medical device manufacturers. Throughout the product lifecycle, PLM software provides companies with a central and secure means to track and manage product information, including component data, bills of materials, product documentation, engineering changes and revisions, and quality and compliance data.
Although it was once seen only as an enterprise solution for large manufacturers, PLM technology has become more prevalent in the medtech industry thanks to the growth of the cloud, allowing PLM software to branch out into smaller medical device organizations. Indeed, small and medium-sized businesses are moving to the cloud faster than large enterprises.
Despite the many advantages of cloud-based PLM systems, many companies have been apprehensive about moving to the cloud to manage highly sensitive intellectural property information. However, as more and more manufacturers adopt a cloud-based approach, new business technologies and more evolved IT computing environments are beginning to emerge. And as cloud-based PLM platforms flourish, medical device manufacturers in particular are taking advantage of this technology to help develop innovative, safe, and compliant products.
Four types of cloud strategies are deployed in PLM software applications: public, private, community, and hybrid. Public clouds are typically shared by multiple companies that have no control over who their fellow users are. In contrast, private clouds are secure and protected systems that function for the sole benefit of a single company or entity. Community clouds encompass specially selected companies with common or related goals, such as partners, channels, and supply or design chains. And hybrid clouds are private clouds that enable particpants to use public clouds as needed or to perform specific functions. The benefit of a hybrid approach is that it provides extra performance scalability for the private cloud.
In addition to these four types of clouds, cloud-based technologies are divided into three segments: software as a service (SaaS), platform as a service (PaaS), and infrastructure as a service (IaaS). The oldest and most mature segment of cloud computing, SaaS deploys over the Internet and is available to users upon request. Used to extend the capabilities of existing SaaS solutions, PaaS combines a development platform and a solution stack that is delivered as an on-demand service. Encompassing service, software, a data center, and network equipment as a single bundle, IaaS provides an environment for running user-built virtualized systems.
Get on My Cloud
When choosing a PLM cloud strategy, companies should consider a range of factors, bearing in mind that not all options are suitable for all manufacturers. However, implementing a well thought-out plan can provide great returns.
For example, Mevion Medical Systems Inc., a radiation therapy company dedicated to advancing cancer treatment, implemented a hybrid cloud solution in order to scale quickly and efficiently at dispersed cloud data centers. Because the company’s workforce is distributed across the globe, its operations must be available 24/7 on all company-supported platforms, including PCs, Macs, Linux, DROID, and IOS. By opting for a hybrid system, it was able to meet its data-storage and -retrieval needs for far less money than it would have cost to purchase expensive equipment or to rent or build dedicated corporate data centers. In addition, the move enabled the company’s IT department to leverage the advanced international infrastructures in place at leading cloud computing companies while paying only for the services it needs.
Cloud computing has enabled Mevion to expand quickly while providing a range of data communication solutions. It has also allowed the company to decrease overall technology costs while providing a reliable IT infrastructure. The firm’s hybrid cloud computing architecture utilizes both internal and external structures that provide SaaS, PaaS, and IaaS capabilities. This architecture also supports a dispersed workforce that utilizes key security measures, integrates with the corporate data center to ensure data integrity, and scales across multiple external platforms to ensure reliability and uptime.
Benefits of a Cloud PLM Approach
Among the advantages of leveraging a cloud-based PLM solution are accessibility, cost, and scalability. A cloud-based model facilitates collaboration with such external partners as contract manufacturers and suppliers. Time zones and language barriers are no longer an issue. Information can be accessed anytime from anywhere. Cloud solutions also lower IT investment and overhead costs, particularly for smaller companies.
A case in point is LoneStar Heart Inc., a developer of cardiac restorative therapies for patients with heart failure. When the company began searching for a PLM solution, it decided that choosing a hosted PLM model made the most sense because its existing infrastructure—including email and data warehousing—was already cloud based. The company’s objective was to adopt a scalabe system that would prevent it from having to install and maintain local servers, saving substantial sums of money annually.
Because many of the company’s employees travel frequently and are based outside of the company headquarters, a cloud PLM system enables all employees to access necessary product information and documentation while eliminating potential issues associated with using VPN connections to access local servers. In addition, a cloud-based model offers employees secure access to such external partners as consultants, development partners, and suppliers in order to improve and speed communication processes.
Not Every Cloud Has a Silver Lining
When moving to the cloud, medical device manufacturers should exercise caution when opting to transition their product design and manufacturing software to the cloud. They must also understand that product upgrades can impact software validations required by FDA and the International Electrotechnical Commission. In addition, while SaaS solutions typically deliver automatic upgrades, such upgrades can alter the customer’s environment and processes, necessitating revalidations to maintain compliance and requiring large infusions of time and money. When all is said and done, manufacturers may find that very few cost-effective cloud-based PLM/document control systems exist that completely provide the features and controls required for meeting regulatory requirements.
Especially where compliance is concerned, manufacturers must be aware of both the advantages and disadvantages of cloud-based options. Nevertheless, when properly leveraged and deployed, such systems offers the power and potential to significantly improve medical device manufacturers’ ability to conduct business. As cloud computing continues to evolve, the risks associated with current-generation systems will be mitigated, holding the promise that PLM in the cloud will eventually go mainstream in the medtech industry.
Chuck Cimalore is CTO of Tewksbury, MA–based Omnify Software. Reach him at [email protected]