Cloud computing helps any kind of manufacturing with cybersecurity, efficiency, on-call scalability, and Industry 4.0. But for medical manufacturers, cloud computing brings additional critical benefits.
The cloud helps device makers be transparent with regulators through product lifecycle management, comply with privacy requirements by keeping patient data safe and conduct post-market surveillance.
Medical manufacturers often specialize in making certain types of devices, and they should think of cloud computing in the same way—but in computing infrastructure, Upchain CEO John Laslavic said.
“It means companies who are really good at it, like Amazon, take over the computing infrastructure, maintenance and upgrade needs of businesses who are not so good at it, so they can focus on their own core competencies,” he said. “It means that technology is much cheaper to acquire, use and update for manufacturing businesses; manufacturers can link together teams located all over the world; and teams of any size have really good access to the tools they need to make amazing products.”
Cloud providers are also very good at data security.
That’s a critical point for medical manufacturers who tap into users’ personal health information and must obey federal patient privacy laws. Cloud providers, in fact, are much better at protecting data from breeches than any on-premise information technology system can, said Steve McCarthy, VP of digital innovation at software provider Sparta Systems.
“They have billions of transactions a day, a very large team of dedicated testers and experts, far larger and more experienced than any customer could have in their information technology department,” he said. “They (also) have multiple disaster recovery locations and systems.”
Responsibility for protecting growing amounts of private health information (PHI) will only increase as medical device manufacturers use software to link their products to the Internet of Things (IoT) and adopt product-as-a-service models.
Healthcare device manufacturers, for example, are increasingly offering monitoring solutions as product services.
For example, Philips Healthcare offers telehealth technology for intensive care units that rely on the company’s proprietary clinical database. Philips even offers peer benchmarking so hospitals can compare their data with other facilities’.
There’s another way manufacturing software makes the product-as-a-service model possible, and that involves manufacturers offering big-ticket devices, such as CT scanners or MRI machines, as a service and not selling them outright. This model puts the risk for any machine downtime on the maker and not the buyer.
“It’s really in the interest of a manufacturer like Siemens or GE Healthcare to make sure the machine is always running, because if it’s down they’re not going to be making money,” said Bhagat Nainani, group vice president of IoT and blockchain applications development for Oracle. “With IoT and machine learning, the machine is always connected, and based on historical data, an algorithm can look at the machine and predict when the machine will fail.
“The whole idea of being able to collect data proactively, analyze it and do predictions really helps these companies with better customer service and with the product-as-a-service model that’s becoming critical,” he said.
Easy scalability is a major benefit
Cloud computing also offers easy scalability.
Software-as-a-service cloud computing lets manufacturers scale their usage as their business cycles or grows—and cut costs.
“Say you need 10 times your normal computing power once a month,” said Laslavic, who founded Upchain, a cloud PLM (product lifecycle management) provider for product developers and manufacturers. “If you were building an on-premise solution, you’d have to build for that times-10 need. With cloud computing, you can dynamically increase your computing power and only pay for the usage, rather than investing big and having that infrastructure sit unused 90 percent of the time.”
Such scalability also opens doors to newer cloud benefits, like IoT and Industry 4.0.
With IoT, manufacturers can use the cloud to analyze data from multiple systems in real time and learn more about their production.
Using the information from real-time visibility and analytics, manufacturers can tell if their factory is going to meet production goals.
They can also constantly analyze their machines and spot potential failures before they occur.
That eliminates unscheduled downtime.
Manufacturers that have embraced the IoT can also analyze field data coming from consumers using their devices, gain additional insights, predict problems and prescribe solutions.
Keeping data straight becomes easier
Cloud computing can also aid product development by making collaboration within a company, as well as with subcontractors and vendors, easier and more efficient. It also can lead to more advanced design and simulation.
The medical industry presents unique challenges to designers and engineers because they face many unusual constraints—certifications, FDA requirements, patient demands, physician stipulations and even insurance requirements—even as their products become ever more complex, said Sam Sattel, senior product marketing manager at the San Francisco location of Autodesk.
“So, the cloud enables us to do two major things—create a more seamless product development workflow with better collaboration and data management and open up access to computation-heavy technology like generative design and advanced simulation, which are too resource-intensive to run locally,” he said.
Some observers say medical manufacturing is developing into a tier system of suppliers and sub-suppliers, much like the automotive industry. Laslavic, of Upchain, said that happens naturally as an industry matures.
“A consequence of a value chain splintering into dozens of specialist providers, though, is that collaboration is more difficult because you can’t just ‘get in a room’ to solve some problem when your team is spread across five or seven locations,” he said. “It’s even more challenging when you think that the people you need ‘in the room’ might work for a dozen different companies.”
Clear communication, especially around product data, becomes crucial when production is outsourced, and cloud computing is the only real way to do that, Laslavic said.
“If you look at the automotive industry and the challenges they have keeping product data straight throughout the design and development process, and the staggering cost increases that leads to (if they don’t keep product data straight), you’ll see why cloud computing is so important,” he said.
As medical manufacturers know, keeping data straight is critical for certification, as well as for keeping on the right side of regulators and consumers.
“The products that cloud computing enable, specifically cloud PLM and PDM (product data management) systems, are the only real way to ensure the transparency that regulators demand throughout the entire value chain,” Laslavic said.
During required clinical trials, the IoT helps collect patients’ data and transmits it to the manufacturer. An on-premise system couldn’t easily do that with multiple patients from multiple sites—and share it with the device maker.
The efficiency inherent in keeping the data straight also helps get the product to the marketplace faster.
Development cycle compressed
In other words, cloud computing allows a manufacturer to integrate all of its functions, from planning through logistics, rendering a much more efficient supply chain.
Typically, before cloud computing, medical manufacturers had different IT systems for different parts of their supply chain—sometimes with different software for design, planning, procurement, manufacturing, maintenance and logistics.
Plus, by linking a manufacturer’s different aspects for more efficient workflow, a company becomes nimbler and gains a competitive advantage.
“Think of the process of design and development, validation, license application, technical transfer to manufacture, scale-up and launch,” Sparta’s McCarthy said. “All of these elements are made more efficient and more effective through cloud-computing capabilities. Thousands of design concepts can be virtually tested in a fraction of the time it once took. Multi-point collaboration across design partners around the globe is opened up. Dossier creation and submission is accelerated. Scale up and manufacturing simulation is simplified.”
Autodesk’s Sattel said cloud computing is bringing designing and engineering closer together than ever.
“Design and manufacturing are converging, and the cloud is at the heart of that paradigm shift,” he said. Better collaboration and data management, along with product development tools like Fusion 360 (his company’s software) that give you access to design, engineering and manufacturing in a unified platform—all of these things will compress development cycles and make it easier to get products to market.”
Laslavic said cloud computing, and the tools like cloud PLM and PDM that it enables, make collaboration easier for globally distributed teams. When teams collaborate effectively, they’re much more efficient, he said, offering evidence to support his claim. When Google commissioned Deloitte to examine collaboration practices in Australian businesses in 2014, it found that collaborative companies were twice as likely to outgrow their competitors. And a survey Engineering.com conducted for Upchain found that manufacturers that use the cloud are much more likely to launch their products on time.