Call it IoT, c
onnectivity, or whatever you want. IoT is not just one thing. It is an array of tools that can include Wi-Fi, Bluetooth, sensors, machine-to-machine, data analytics, cloud, mobility and augmented reality. That is just a short list.
Medical device companies are getting very good at designing medtech products that employ smart technology. The idea that hospitals, homes, and other points of care can be made better with connected, portable, and wearable medical devices is one that we see in the news everyday. But what are these medical companies doing in their own businesses?
They are doing quite a lot, actually. According to a report from Capgemini says that the medical device industry is mature in its application of IoT solutions compared with pharmaceuticals, and is second in maturity only to industrial manufacturing. The report, which came out in 2014, is called “The Internet of Things: Are Organizations Ready For A Multi-Trillion Dollar Prize?” It says that more than 60 percent of the medtech industry employs tools that provide basic information support (e.g., alerts and notifications) as well as performance improvement support (e.g., predictive maintenance and productivity enhancement insights). However, it has room to mature in remote control and configuration, noting that less than 40 percent of medical device companies use tool sets to support remote operability.
To get a better idea of what Capgemini means by “maturity,” Andreas Schmitz, a blog contributor for SAP puts it this way:
At the first level machines send information upon special request to a smart phone, but the device is not able to do anything with that information. At the second maturity level, technical devices can at least be configured and controlled externally. The third level comes closest to the vision of IoT, with companies using the sensor data to carry out predictive maintenance or improve productivity.
Early Days of Smart Architecture
Although many medical device firms have the networked sensors and other smart technology practices in place to capture data in their warehouses, some, particularly small and mid-sized companies still lack that connectivity on the manufacturing floor and a connected architecture to collect data across all systems and provide the analytics to control the supply chain.
Because of the diverse nature of medical device manufacturing, there really is no one solution for every company, says Wayne McDonnell. McDonnell is a Principal with PwC’s management consulting practice, specializing in supply chain and IT for life sciences. But regardless of the product line, all companies can benefit from what McDonnell calls total system architecture. To put it simply, total system architecture is the connecting of workflow and data capture tools such as manufacturing execution systems (MES), product lifecycle management (PLM), enterprise resource planning (ERP), and quality management systems (QMS). Having these disparate systems communicate and automatically organize data is the cornerstone of a smart manufacturing plan, and a key ingredient in the recipe for reducing errors and manufacturing the perfect batch.
McDonnell says most medtech companies have one or more of these tools already because of FDA oversight, which includes Quality System Regulations and management of device history records. However, “having MES, ERP, PLM, and QMS systems alone won’t get you to perfect integration,” he says. “These independent systems work very well, but they don’t automatically work together.”
Many of the large medtech companies have taken steps to marry the various systems, although McDonnell hesitates to call it IoT. “They don’t necessarily use the tools that automatically collect data, such as sensors.” But, he says, total system architecture is the first step to building a smart factory. It can automate manual error reporting and error resolution for example, reducing paperwork. And small companies, which often have complex supply chains can benefit from such a system exponentially. “Small manufacturers might produce 5 products, but deal with hundreds or even thousands of suppliers.”
“Plenty of medical manufacturing companies have automated systems, but the challenge is designing total system architecture that allows the systems to communicate, collect data, and create valuable analytics,” says McDonnell. To get a fully functional system in place, it helps to start with simple analysis, he says. Companies that want to start the process have to recognize where they have multiple systems and multiple functions. “They need to analyze where they are automated, and where they have manual error reporting and error resolution, for example.” Then they should identify to what degree they have manual systems that produced a high level of paperwork, versus where they are automated. “Once they identify where the gaps are, they can start to take steps to increase automation.”
Another thing to remember is that software suppliers don’t have all the answers. “If you go to an software provider, they will sell you the parts that they provide—and they will do a good job,” he says. “But no one can really give you a total solution if you don’t do your own investigation.” McDonnell suggests consulting an IT strategist to help develop a roadmap.
Moving to Mobile
Once the system architecture is in place, there are more challenges, but mobility tools make life on the manufacturing floor easier. Networked sensors are the lynch pin of mobile tools and on the manufacturing floor, they open the doors not just to smart, but hands-free.
Jason Prater, is Vice President of Development at Plex Systems, Inc. He says the change on the manufacturing floor is palpable. “It used to be that you would count how many PCs there were per person at a factory and that indicated how advanced they were.” Now, he says, PCs are becoming obsolete. “PC’s are dead on the shop floor. Wearable or mobile technology just works better because it fits the environment and the workflow.”
Mobile, hands-free tools such as Google Glass are slowly taking over. What’s great about Google Glass in particular is that collects data automatically, Prater says. And, because the technology is rooted in consumer design, it is easy to train various people on the floor. “For example, with Google Glass, you could set it up to point at a box and say ‘what’s in the box?’ and the Google Glass would tell you. You don’t have to train someone on that task,” he says.
What’s more, says Prater, “wearables are cheap.” Especially when compared with radiofrequency identification (RFID) systems. Prater says wearable tech can replace clunky and expensive RFID. “RFIDs are the biggest failure of the new factory,” he says. By comparison, “Bluetooth is inexpensive and works automatically.”
Prater gives some practical examples in which mobile devices, already in use on the manufacturing floor, led to the discovery of inefficiency. For example, Prater tells a story about a company that added another section to their facility, and despite it really have nothing to do with the original section, they saw a slow down in production. Line workers were leaving for lunch earlier and coming back a little later. It was a question of a few minutes, but it affected production. Turns out, the company had put in a new section and added employees, but had not expanded the lunch facility and had not added any more microwaves. There was a line everyday to use the microwaves to heat up lunch.
Another example Prater gives is a company that redesigned a facility but didn’t take into account how far employees had to walk to use the bathroom. “They redesigned their facility to better incorporate smart machinery,” he says. The wearables given to line operators captured the problem when they recorded an increase in the operators’ steps-per-day.
Mobile wearables can uncover more than work process inefficiency. It can also protect workers. Consider the forklift operator. “Forklift drivers need to be fast but not reckless,” Prater says. “If they are going around a corner, they may not see the supervisor that just stepped out of the safety zone.” But if the supervisor is wearing a Bluetooth enabled safety vest, the forklift driver will be able to note her presence on a tablet display and avoid a potential injury or death.
Prater also points out that wearables can also improve ergonomics of a job. Through automatic monitoring of workers’ vital signs, data analysts can identify job operations that require too much straining and represent an unhealthy or risky part of the process.
Data, Data, Data
One key challenge to mobile wearables and other IoT tools is that they lead to the creation of huge data sets. “We are talking terabytes per day,” says Prater. And without the system to parse and analyze those data, the ability to draw out meaningful information and respond is impossible.
A lack of analytics talent is the single biggest challenge facing companies, according to Capgemini’s report. That is, companies do not have the right skill sets in place. “Most organizations currently lack the analytics skill-sets required to effectively interpret sensor data,” says the report. Further, the report also mentions that many companies face internal resistance to the changes necessary to become a smart factory. “An executive at a medical technology company outlined how resistance can come less from the customer – and more from within the organization, explaining, ‘We only have 20% resistance from the customer and 80% from our own organization. Consequently, it is a significant challenge to align our existing business processes with new IoT-based service offerings.’”
Capgemini authors say that organizations should invest in data storage that can scale quickly and cost effectively. It also suggests cloud-based technologies offer affordability and efficiency in managing data. It also mentions stream processing applications to provide real-time data analysis.
Security
Security might be the biggest concern for medtech companies. Not only do medical technology companies have a significant need to protect IP, they also need to protect data to satisfy 21 CFR Part 11 regulations, as well as HIPAA for products in the field.
Prater says that cloud-service providers are motivated to protect customers’ data. He advises companies to look at security of data like money in a bank. “There is always a risk and there is always concern,” he says. “But a bank has far more resources to put toward security than an individual would have.” Likewise, cloud companies have invested in secure drivers that manufacturers simply could not match.
That said, Prater encourages users to dig a little deeper with a data supplier.” You do have to ask questions of data services.”
There various levels of privacy offered through cloud storage and individual firms must do the homework to figure out which type best fits the company needs. Mika Javanainen, senior director of product management with M-Files Corp. has suggested that for medtech, a hybrid cloud storage system might fit best in terms of viability and cost efficiency. In a hybrid model, some systems stay on a private cloud and more open cloud services are used for information management. For example, R&D data could be in the private system and only accessible through office computers, but marketing materials could be in open cloud storage so that sales teams can access information while traveling.
Off the Floor
“I haven’t personally seen companies use IoT to its fullest extent yet,” says McDonnel, which suggests there is more to come. Indeed, most market analysts believe IoT is a multi-trillion dollar industry waiting to happen.
Connected assembly lines, smart components and integrated production management systems will launch a new era of medtech manufacturing. “Connectivity has changed manufacturing completely,” says Prater. “It enables connections between facilities on a global scale, but it also helps connect up and down the supply chain.”
McDonnell concurs. “There is a growing recognition that these systems can help on both ends of the supply chain,” he says. “Integration of multiple systems can help connect suppliers with the manufacturing floor, the manufacturing floor with the warehouse, and the warehouse with the field.” He says he is particularly impressed with the capabilities down the supply chain, especially for small manufacturers. “Knowing where a device is going and when it is going to be needed is a significant advantage.” Further, being able to offer postmarket services, that is, selling a system rather than a product, in medtech could make the difference in whether a customer chooses your product or someone else’s.
There are still enormous challenges barring adoption and monetizing IoT. And there are still plenty of barriers before we reach the Industry 4.0. However, every market analyst agrees that IoT will affect every industry and every department. If your company hasn’t started yet, start now.
