In high school chemistry class we watched a movie in which nothing less than a magical transformation took place. A scientist mixed two parts hydrogen gas and one part oxygen gas in a clear, sealed container, then sent an electrical charge into it. It created a spark, which provided the energy to force the two gases to join together in an explosive chemical union. The result was that they became a composition of matter which we recognize to be water.
Composition of matter is a term within the federal statute that determines patent eligibility, that of 35 USC § 101. It, along with the other terms we’ve been discussing, such as machine, and article of manufacture, is yet another consideration which must be addressed on the road to patentability.
To get a handle on the meaning of composition of matter, we have to go back to the Supreme Court’s ruling in Diamond v. Chakrabarty, a landmark case introduced in last week’s blog. Here the court defined composition of matter as, “compositions of two or more substances and all composite articles, whether they be the results of chemical union, or of mechanical mixture, or whether they be gases, fluids, powders or solids.” The Court’s definition of composition of matter covers chemical compounds and composites.
The Merriam-Webster Dictionary, defines a composite as something “made up of distinct parts.” Composite articles include most of the man-made products modern society is so familiar with and can’t seem to live without. Examples include plywood, concrete, and fiberglass. They’re typically made up of a myriad of components, some of which are raw materials, some man-made chemical compounds.
Chemical compounds are commonly made by uniting two or more chemical elements, the basic building blocks of matter that you might be familiar with from the Periodic Table always on display in a high school chemistry classroom. When a chemical union takes place the elements are forced, by way of mixing and heating, to bind together at the atomic level. If you’re not quite sure what “atomic” means, visit this site for a brief refresher: Atom Definition
Chemical compounds include man-made things like fuels, plastics, fertilizers, food preservatives, pesticides, and cleaning solutions. They’re all things that require human intervention to produce.
You may not realize it, but metal alloys are also essentially chemical compounds. These alloys are formed when two or more metals, or a metal and nonmetal, are fused together. Steel, for example, is an alloy composed of multiple elements, including iron, nickel, and carbon, which mix together during heating and become molten. During cooling the elements firmly unite and form atomic bonds to produce a new solid, one not available directly from nature.
Next time we’ll wrap up our discussion on 35 USC § 101by discussing the meaning of process with regard to patent eligibility.
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Imagine having freshly baked pastries available to you all day long, every day, while at work. I’m not talking about someone bringing in a box of donuts to share, I’m talking about baked goods on a massive scale. This is what I experienced in one of my design engineering positions within the food industry. These baked goods constituted the articles of manufacture of the food plant, and they presented a constant temptation to me.
Just what constitutes an article of manufacture is another aspect of the second hurtle which must be passed to determine patent eligibility. It is addressed under federal statutes governing the same, 35 USC § 101, and is contained within the same area as the discussion of what constitutes a machine, a subject we took up previously in this series.
Why bother defining articles of manufacture? Well, while hearing the patent case of Diamond v. Chakrabarty regarding genetically engineered bacterium capable of eating crude oil, the US Supreme Court saw fit to define the term so as to resolve a conflict between the inventor and the patent office as to whether a living organism could be patented.
The net result was the Court declared that in order to be deemed a patentable article of manufacture the object must be produced from either raw or man-made materials by either hand labor or machinery and must take on “new forms, qualities, properties, or combinations” that would not naturally occur without human intervention. In other words, a creation process must take place and something which did not previously exist must be caused to exist.
The court’s definition of articles of manufacture encompasses an incredible array of products, much too vast to enumerate here. Suffice it to say that the defining characteristic is that if it should consist of two or more parts, there is no interaction between the parts, otherwise it could be categorized as a machine. In other words, the relationship between their parts is static, unmoving. An example would be a hammer. It’s made up of two parts, a steel head and wooden handle. These parts are firmly attached to one another, so they act as one.
Next time we’ll continue our discussion on the second hurtle presented by 35 USC § 101, where we’ll discuss what is meant by composition of matter.
Did you know that from the early days of the Industrial Revolution until well into the 20th Century it was common practice for all aspects of a product to be built entirely under one roof? For example, a wheelchair manufacturer in the 1890s would buy the various raw materials needed to construct component parts, everything from bars of steel and wooden boards to rattan stalks and gum rubber, then produce every part of the wheelchair in one facility. Items as diverse as chair frames, footrests, wicker seat cushions, springs, wheel rims and spokes, and tires would all be constructed from the raw materials purchased, then assembled into the finished product.
Doesn’t sound like an efficient process to you? Henry Ford didn’t think so either. In fact, he is credited with pioneering mass production in manufacturing when he observed during the production process of his line of automobiles that inefficiencies abounded.
Inefficiencies in manufacturing are common, as they are in everyday life. Last time we saw how robots, i.e., the introduction of industrial automation, can be used during the Production stage of our systems engineering approach to medical device design to increase efficiency and reduce manufacturing costs. Today we’ll take a look at another inefficient practice, along with its solution.
Returning to our wheelchair manufacturer, the problems associated with manufacturing and assembling all aspects of a product are many. At the top of the list is the substantial cash outlay that’s required to buy and maintain a huge factory complex and all the specialized equipment required to make each and every part. In addition, there’s the ongoing expense of employing and training employees needed to fabricate each component. In other words, the wheelchair factory has a lot of fixed overhead expense to carry, and the more overhead there is, the more expensive the end product. Expenses such as these are almost always passed on to the buyer.
The solution? Outsourcing. That is, using outside manufacturers to produce many, perhaps even all, of the component parts. Then our wheelchair manufacturer would simply assemble the purchased parts into the finished product, resulting in lower manufacturing costs and higher profits. The benefits of outsourcing were widely recognized in the decades following World War II, when the post-war economy was booming and demand for consumer goods increased dramatically.
That ends our look at the Production stage. Next time we’ll move on to the Utilization stage to see how the systems engineering approach is put into play once the medical device has been introduced into the marketplace.
| When I was a kid I had a toy robot that captured my attention like no other toy. I thought it was so cool to have something animated that looked both humanoid and machine-like at the same time. It couldn’t do much, just walk in a stiff, jerky way and move its arms up and down, but that was enough to keep me fascinated.
Today’s generation of robots do not often take on the humanoid form, but they’re capable of so much more. Robots on assembly lines perform a variety of tasks like welding and placing electronic components on circuit boards, and they do it much more quickly and accurately than any human could, so they’re often employed in manufacturing.
We’ve been discussing the Production stage of the systems engineering approach to medical device design. We learned that within the manufacturing process there are often opportunities for cost reduction, and today we’ll see how robots can be used to reach those goals.
Last week we presented a sample scenario involving the manufacture of a percussion therapy device. In their quest to reduce manufacturing costs, engineers identified bottlenecks along the assembly line which led to idle worker time and the inability to keep up with orders.
In addition to these production woes, it was discovered that the tedious, repetitive manual labor that occurred at each bottleneck created opportunities for assembly mistakes. As many as 30 devices per day were being rejected by quality control inspectors due to issues such as faulty wiring and improper parts usage. This led to expensive rework to correct mistakes.
After further evaluation, design engineers determine that bottlenecks can be eliminated by installing automated assembly equipment in the three distinct assembly stages represented on the line, those involving wiring harnesses, printed circuit boards, and the motor drive mechanism.
The potential for human error is high during many facets of manufacturing, and this can be minimized or eliminated through the use of robots, that is to say, mechanized equipment capable of automatically performing a complex series of specific tasks. These robots never tire of performing tedious, repetitive work, and their efficiency is unparalleled. Their introduction at key junctures on the assembly line has benefits across the manufacturing process, enabling workers to keep continuously busy and reducing the incidence of human error.
The introduction of robotics is known as industrial automation. Robots efficiently increase manufacturing speed, and along with it profits, so their introduction more than compensates for the investment costs associated with purchasing them.
Next time we’ll continue our look at the Production stage to discover another way that systems engineering can simplifying the assembly process, by eliminating some functions altogether.
| We’ve been discussing the Preproduction aspect of the Development stage of our systems engineering approach to medical device design. Last week we learned that once the medical devices produced during Preproduction are assembled, they’re subjected to rigorous testing, first in the lab, then in the real world.
Once devices produced in Preproduction pass the test in a controlled laboratory environment, it’s time to place them into field testing. The objective is to place Preproduction devices within actual working environments, such as healthcare facilities. These facilities must be willing to cooperate with design engineers during testing on a number of items, including but not limited to evaluation of product performance and clarity of instructions.
In order for this to happen, design engineers must coordinate their efforts with their company’s sales and marketing departments to locate, qualify, and enlist suitable facilities. To qualify, a facility must be able and willing to put enough hours of use onto the test device to effectuate a thorough and complete analysis of its effectiveness. Depending on FDA regulatory requirements and the complexity of the design, field testing could take as little as several months or as long as several years.
During field testing valuable data is gathered to enable engineers to evaluate the performance of the Preproduction devices. This data will then be measured up against stakeholder requirements. What this process might entail in a dialysis machine, for example, is that test data is analyzed to make sure all operational parameters fall within the desired range. Data would be derived from measurements of such things as the pressure of blood flowing pre- and post- introduction to the dialyzer. Measurements are dutifully recorded by engineers and field personnel onto data sheets for later evaluation back at the manufacturer’s engineering office. Persons contributing data vary widely, from healthcare facility end users and maintenance personnel, to the medical device dealer’s service technicians.
End users also provide feedback to design engineers regarding the field test device’s functionality, effectiveness, reliability, and maintainability. Feedback can include specific information about things like glitches in software, unusual noises, erratic operation, breakdowns, and even difficulties encountered during repairs.
If any problems are discovered with the device during lab and field testing, revisions are made. Design engineers and technical writers get back to the drawing board to rework things and find resolutions until all issues have been addressed. Only then is the design presented to stakeholders for final approval. If all goes well, manufacturing will now take over and place the device into full commercial production.
We have now concluded our discussion on the Development stage of systems engineering as it relates to medical device design. Next time we’ll move on to the Production stage where we’ll examine post-production concerns.
| If you’ve been following along with our blog discussion on the systems engineering approach to medical device design, you should by now be convinced that instructions are important. In fact, the meticulous instructions produced during the manufacturing, operating, and maintenance phases of the Development stage are also crucial to later stages, that of Production and Utilization. Let’s finish up our discussion on the Development stage by taking a look at its final aspect, Preproduction.
The Preproduction aspect is instrumental to nipping potential problems in the bud before the medical devices go into actual production. In the initial Preproduction stages, systems engineers coordinate with the manufacturing and purchasing departments within the company as well as outside suppliers. The goal is to acquire all parts and equipment necessary to build a limited number of medical devices on the assembly line. Subjects such as preference in molded plastic components, motors, gears, pumps, springs, electronic components, circuit boards, wire, and tubing are discussed and agreed upon. Vendors are assessed with regard to their ability to produce parts when they are needed and that meet design specifications, satisfy quality requirements, and have costs that fall within budgetary constraints.
The assembly of Preproduction devices provides an opportunity for systems engineers to validate manufacturing and quality control instructions and assess the device design with regard to manufacturability, meaning, the extent to which devices can be manufactured with relative ease, at minimal cost, while maintaining maximum reliability. Devices manufactured during this aspect of the Development stage serve as a test. Are instructions clearly written? Do the device parts fit together as they should? Are parts strong enough to withstand the assembly process? Can the devices be assembled as quickly and easily as expected?
If the answer is “no” to any of these questions, then the device design and instructions must be returned to the design engineers and technical writers. Heads come together to rehash things and work out the bugs.
Next time we’ll continue with the Preproduction aspect of the Development stage to see how laboratory and field testing enables systems engineers to shake out any more bugs from the medical device design, operating instructions, and maintenance instructions.