It is a widely held belief that the pharmaceutical and medical device industries lag behind other industries in their application of automation. But the uses of automation, the benefits of integration, the impact of mechatronics, and the needs for a skilled workforce are all as potentially impactful in these industries as they are for any other.
At the same time, our evolving new digital reality offers the potential to distribute manufacturing functions back toward the user, raising a real question about what automation will look like a decade from now, not only for healthcare manufacturers, but for all of us.
The belief that healthcare manufacturers lag others is not new. Going back to 1980 when process control was all the rage (rather than mechatronics and OEE), ISA (Intl. Society for Automation), then the Instrument Society of America, was organized into about 13 industry divisions. There was no division for the pharmaceutical industry. I led the Food Industry Division at the time.
Over the course of a couple of years, we invited the pharmaceutical industry to join us and we formed the Food and Pharmaceutical Industries Division (FPID), with the result that it became the fastest-growing division within a growing ISA. There seemed to be some hunger on the part of both industries to learn about process control from each other. This sharing of practices was good for both industries for a time, but as the emphasis shifted from process control to automation and ISA's influence waned overall, the impact declined and no other organization has stepped in to supplement their work.
We are just now seeing some renewed interest in bringing these groups together as PMMI and ISPE (Intl. Society for Pharmaceutical Engineering) plan for co-locating Pack Expo International and Pharma Expo in Chicago Nov. 2-5, 2014.
As with all generalizations, there are certainly exceptions to the rule. Many pharmaceutical packaging lines are every bit as automated as the best consumer packaged goods (CPG) lines. There are some fine examples of the application of mechatronics in machines from the likes of PharmaWorks or the Marchesini Group. Advances in tamper-evident packaging flowed from the pharmaceutical industry to the food industry, driven by urgent need. Advances in serialization will likely flow in the same way.
There are legitimate reasons why automation may advance at a different pace in one industry than in another. If we think about these reasons, then it may not look so much like one industry lags the other, but more like a rational and justifiable difference.
Medical device manufacturing
For example, medical device manufacturers (MDMs) should typically be thought of as discrete manufacturers. (read here for more explanation of the distinctions between the three primary manufacturing segments—process, hybrid and discrete).
MDMs machine parts, form parts, assemble parts, package kits, and so on. They have some additional requirements put on them relative to a typical discrete manufacturer that may be building industrial pumps, but not so different, from a machine shop making parts for a nuclear submarine.
Discrete manufacturing, in general, is the least automated of the three manufacturing segments. My guess is that as discrete manufacturers go, MDMs are already as automated as their non-medical peers. It's important to compare them to the right companies. There will be plenty of automation opportunities and challenges for all discrete manufacturers over the next 10 years.
Nano-manufacturing will bring new materials to bear on old products, open up potential new products based upon new material properties, and usher in a whole new device segment of nano-machines. Automation will not be an option with nano-manufacturing.
New materials will continue to be developed for additive manufacturing, no-doubt expanding the growing possibilities for printed medical devices. This technology will facilitate the quick and easy customization of devices to a particular patient.
Boeing has developed metals that can be printed and approved for use as passenger jet engine fuel nozzles and the major machine tool builders in Germany and Japan have delivered or announced machining centers with integral parts printers. Sending a design from a 3D scan to a 3D model to printing and machining is not a process that you do without automation.
Once parts are made, assembly and kitting often follow. The hard robotics that we have become accustomed to takes too long to implement, too long to reconfigure and is too costly for the low volumes or short runs that many discrete manufacturers see, including medical device manufacturers. But the new collaborative robotics that are beginning to emerge offer potential solutions to each of these issues. The clean and orderly environment of a medical device manufacturing plant is probably the ideal place to implement early collaborative robotic applications.
Pharmaceutical plants are hybrid manufacturing operations. Hybrid manufacturers batch up product, form it, and move it on to discrete packages in a continuous or semi-continuous manner. Hybrid manufacturers are the second-most highly automated of the three manufacturing segments and also the fastest-growing automation segment. Process manufacturing went through their growth spurt already. CPG companies are hybrid manufacturers along with cement and fertilizer producers and others who batch or continuous process materials for packaging in some sort of container.
A couple of things immediately come to mind that distinguish a hybrid pharmaceutical manufacturer from a typical CPG manufacturer. The first is people. Pharmaceutical manufacturing projects are more often orchestrated by scientists than by engineers. It would not be uncommon for an automation engineer to be in charge of implementing new production capacity in a CPG company. That is not so likely in a pharmaceutical company. People will do what they are comfortable with and avoid what they are not.
Another people issue is where responsibilities begin and end. In a CPG company, the responsibility of the packaging machinery engineering department begins further upstream than in a pharmaceutical company. In Pharma, responsibility lies with the process engineers until the product has been put into its primary package. This difference in handoff has implications for the automation and the integration of the line.
Other issues affecting automation include production volumes, manufacturing margins, and product lifetimes. It is easy to justify automation of a proven brand that sells millions of packages per day. It is much more difficult to justify automation of a product with no track record and with a potentially limited life span.
CPG companies can plan a suite of lower-volume products, product variations, or new product generations that will run on the same production line, making automation easier to justify. I expect that is a less likely option for a big segment of the pharmaceutical industry. I also expect that overall profit margins are less sensitive to manufacturing efficiencies in a pharmaceutical company than in a food company. The bigger the impact manufacturing has on profits, the bigger the focus will be on manufacturing processes, and the more likely you are to utilize automation.
Regulation, uncertainty, and investment
Finally, regulation is a huge distinguishing factor for a healthcare plant. Automated systems are more complex than manual systems. As a result, they have been more difficult to validate, adding to time and cost. Increased application of international standards, improved physical design, better software development methodologies, and experience will all tend to mitigate these differences going forward, making automation more doable for pharmaceuticals and devices. Increased information handling demands and increased liability risks will make automation more necessary and justifiable.
The other side of regulation is that when it is absent but anticipated, it leads to uncertainty. Uncertainty is the enemy of investment. Manufacturers do not invest when things are uncertain because returns are unpredictable. Industry in general has been holding back on investment due to uncertainty in the economy. This uncertainty has been magnified for pharmaceutical companies by proposed serialization regulations and for medical device companies by new taxes adopted with the Affordable Care Act. Once all of this becomes clear and stable, there may be a pent-up demand for automation in healthcare manufacturing that will relieve itself through the coming decade.
It is important that we don't contain our thinking of the next 10 years to what may or may not take place within or manufacturing plants based upon what we see taking place now.
Manufacturing is being reinvented by the Internet of things (IoT), where services allow interaction with “smart objects” over the Internet and where physical objects can become active participants in business processes, taking into account security and privacy issues.
The Internet is having tremendous impact on the way we do and purchase everything. Retail clerks are among the entry-level jobs that are being replaced by mechatronics technicians as more of our purchases are being handled by automated order fulfillment systems. I recently judged an engineering fair where the winning entry was an automated medication dispensing system, designed and built by a high school career center team using printed parts and two PLC's. Their market research showed interest in these automated devices in places such as nursing homes.
The expectations that these kids will bring to manufacturing and the supply chain will differ greatly from ours. They are growing up with the Internet of things and believe that almost anything that they may need can be delivered to or printed where they are. Where we may see more automation in centralized manufacturing plants, they may see the automation being used right at the consumer's easy chair. The reality will probably be a combination of both.
The future of automation for healthcare manufacturers is huge, both in the way we have historically thought of it and in ways that we are yet to think of. If healthcare manufacturers are a bit behind others, it is probably for valid and explainable reasons to which valid and explainable solutions exist. Identifying those solutions will be a priority for some. There may be some ground to make up, but more than that, there are new opportunities that will impact all of us, because of the changing landscape being driven by computers, the Internet, additive manufacturing, nano-manufacturing, collaborative robotics, and the Internet of things. On this, the 10th anniversary of Healthcare Packaging magazine, I predict that the next 10 years will be far more interesting than the last 10, and automation will show up both where we expect it and where we don't.
Keith Campbell ([email protected]) has been a shaper of opinion on manufacturing automation for 40 years. He worked for 28 years with The Hershey Company, and has served the broader industry in numerous roles including as Director of ISA's Food and Pharmaceutical Industries Div., and as the founding Director and later Executive Director of the OMAC Packaging Workgroup, originally called the OMAC Motion for Packaging Workgroup. Since retiring from Hershey as Director of Automation & Integration, he has devoted much time to defining and promoting mechatronics education for incumbent workers, high school, community college, and university students. He participates in youth science, technology, engineering, and math (STEM) programs, and is an active supporter of and contributor to PMMI's Mechatronics Certification Program. For the last 10 years, he has authored OnTheEdgeBlog.com and contributed to Summit Media Group's Packaging World, Automation World and now Healthcare Packaging.
In collaboration with Summit, Campbell is about to release the Manufacturing Workforce Development Playbook to highlight proven strategies and solutions to solving the manufacturing workforce crisis in America.
Process control: An engineering discipline that deals with maintaining physical parameters within some desired range. A typical application is the control of a steam valve to keep a vessel of material at some constant temperature.
Automation: An engineering discipline that deals with maintaining operating sequences in a safe and predictable manner. A typical application is the picking up of a component and the placing of that component into box through mechanical means.
Integrated manufacturing: The interconnection of various parts of a production process, usually through digital networks and computers, to allow the sharing of operating states and parameters between the machines and processes, and with operators.
Mechatronics: The synergistic integration of electrical, mechanical, controls, and computer engineering to make useful products. Also, a design process that combines mechanical, electrical, control, and computer engineering to integrate machinery and facilities.
Process manufacturing: A branch of manufacturing associated with long runs of 24/7 production that typically involve a change in the chemical state of materials. Process manufacturing frequently relies on process control strategies using large distributed control systems in a control room environment to control production parameters and maintain efficiencies. Changeovers are relatively infrequent
Discrete manufacturing: A branch of manufacturing associated with production operations that turn out discrete components or assemblies and that typically result in mechanical transformation through material removal or addition, bending, or assembly. Discrete manufacturing relies heavily upon sequential control of individual machines or groups of machines using CNC controllers and PLCs to perform repetitive functions. Changeovers may be frequent, with product cycles as small as one part.
Hybrid manufacturing: A branch of manufacturing associated with operations that move continuously from batching or processing operations; may proceed through some physical transformation such as extrusion and frequently end in continuous packaging and aggregating. Hybrid manufacturing relies on combinations of instrumentation, motion, and PLC controls that are often integrated with supervisory control systems to enable continuous flow from operation to operation. Changeovers occur at an intermediate frequency.
According to a study completed by the author, U.S. annual manufacturing output of $5 trillion is split almost equally between process, discrete, and hybrid manufacturers.