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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. ___________________________________________ |
Archive for the ‘Product Liability’ Category
Determining Patent Eligibility – Part 5, Manufactured Articles
Monday, May 6th, 2013|
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. |
Determining Patent Eligibility – Part 4, Machines of a Different Kind
Sunday, April 28th, 2013|
During 6th grade science we had a chapter on Simple Machines, and my textbook listed a common lever as an example, the sort that can be used to make work easier. Its illustration showed a stick perched atop a triangular shaped stone, appearing very much like a teeter-totter in the playground. A man was pushing down on one end of the stick to move a large boulder with the other end. Staring at it I thought to myself, “That doesn’t look like a machine to me. Where are its gears?” That day I learned about more than just levers, I learned to expect the unexpected when it comes to machines.
Last time we learned that under patent law the machine referred to in federal statute 35 USC § 101 includes any physical device consisting of two or more parts which dynamically interact with each other. We looked at how a purely mechanical machine, such as a diesel engine, has moving parts that are mechanically linked to dynamically interact when the engine runs. Now, lets move on to less obvious examples of what constitutes a machine. Would you expect a modern electronic memory stick to be a machine? Probably not. But, under patent law it is. It’s an electronic device, and as such it’s made up of multiple parts, including integrated circuit chips, resistors, diodes, and capacitors, all of which are soldered to a printed circuit board where they interact with one another. They do so electrically, through changing current flow, rather than through physical movement of parts as in our diesel engine. A transformer is an example of another type of machine. An electrical machine. Its fixed parts, including wire coils and steel cores, interact dynamically both electrically and magnetically in order to change voltage and current flow. Electromechanical, the most complex of all machine types, includes the kitchen appliances in your home. They consist of both fixed and moving parts, along with all the dynamic interactions of mechanical, electronic, and electrical machines. Next time we’ll continue our discussion on the second hurtle presented by 35 USC § 101, where we’ll discuss what is meant by article of manufacture. ___________________________________________ |
Determining Patent Eligibility – Part 3, What Constitutes a Machine?
Sunday, April 21st, 2013|
One of my favorite toys as a kid was Mr. Machine. He was a windup mechanical man that swung his arms when he walked while repeatedly squawking a strange YAK! sound. His body was transparent, so all the gears and levers inside were visible, and he even came with his own repair wrench. Alas, his wrench was of little use when Mr. Machine took a tragic fall down the basement stairs. Mr. Machine was aptly named. There’s no question but that he was a machine, because his inventor received a US patent, No. 3,050,900. In order to accomplish this he had to have met guidelines set out in federal statutes, specifically those contained in 35 USC § 101. He had to prove that Mr. Machine was a bona fide machine.
If you’ll recall from last week’s discussion, in order to secure a patent, inventions must prove to be original technology that is classifiable as a machine, an article of manufacture, a composition of matter, or a process, or an improvement upon same. Last week our focus was on utility, the first hurdle that an invention must jump for it to be patent eligible. Let’s continue our discussion on patentability by examining the second hurtle. When you consider the word machine, you might imagine something containing mechanical parts, like my childhood mechanical friend. But in the world of patents that’s not necessarily the case. There, a machine can be mechanical, electrical, electronic, or electromechanical in nature. In other words, a machine can include anything from a cell phone to a rocket. To be precise, under patent law the definition of machine includes any physical device consisting of two or more parts which dynamically interact with each other. For example, a purely mechanical machine, such as a diesel engine, has many moving parts. Those parts, the pistons, connecting rods, etc., are mechanically linked to dynamically interact, or move together, when the engine runs. Next week we’ll consider less obvious examples of what constitutes a machine under patent law. ___________________________________________ |
Systems Engineering In Medical Device Design – Utilization
Sunday, March 24th, 2013|
Who hasn’t finished a project, only to discover that you’d done something wrong and the whole thing would need to be redone? Perhaps you hadn’t checked your work along the way, confident that all would be well in the end. Imagine the costs involved if this scenario were to take place on a commercial production line. The Systems Engineering Approach to things helps ensure this doesn’t happen. Last time we wrapped up our discussion on the Production stage of the systems engineering approach to medical device design, and today we’ll cover the final stage, Utilization. The Utilization stage marks the point at which the medical device has been sold and is in actual use in the marketplace. Despite the fact that the product has at this point undergone many reviews and revisions and a great investment has been made into deciding whether or not to put it into production, changes can still take place in its design. Markets aren’t static, and products may be made to change due to stakeholders’, that is, those with a vested interest, changing requirements, whether those are aimed at further cost reduction, or perhaps to implement innovations to make the product more appealing to end users. Other reasons for change may be initiated by the sales and marketing departments. They keep their fingers on the pulse of consumer trends, and they may want the design modified according to market research and feedback they receive from dealers, service technicians, and end users. For example, the sales staff may have been apprised by end users that the keypad to their electronic muscle stimulating device needs modification. Patients have voiced they would prefer to here a clicking sound when depressing the buttons, in order to receive some auditory feedback. In addition, distributors of the device reported that although the electronic stimulators were functioning as intended, end users didn’t like the feel of the buttons. The lack of tactile feedback often led to confusion because they weren’t sure whether they had depressed the button or not. Another interesting discovery concerning lack of feedback was that product service technicians were reporting premature wearing out of the keypads. Absent the satisfying click sound, users were inclined to push on the pads too strenuously, which drove up warranty service costs. The medical device manufacturer’s stakeholders are always concerned with costs, and increased service costs definitely raise the red flag. Considerations like these typically arise after a medical device enters the Utilization stage. Fortunately, the objective of the systems engineering approach is to ensure that stakeholders’ needs are met in view of ever-changing requirements, even after the device has entered the marketplace. No matter what may happen during the life cycle of a product, the systems engineering approach is used every step of the way, from the Concept stage through to Utilization. That ends our discussion on the systems engineering approach to medical device design. Next time we’ll begin unraveling some of the mysteries and misconceptions behind patenting inventions. ___________________________________________
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Systems Engineering In Medical Device Design – Production, Part 3
Sunday, March 10th, 2013| 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. ___________________________________________
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Systems Engineering In Medical Device Design – Production, Part 2
Sunday, March 3rd, 2013| Last time we began our look at the Production stage of systems engineering. We learned that cost reduction is a frequent component of this stage due to market fluctuations and ongoing stakeholder requirements to cut costs, and that savings can be made through substitution of plastic for metal parts. In fact, there are many faces to cost reduction. We’ll explore another of those today.
Cost reduction isn’t limited to material expense. Within the manufacturing process itself there are often ample opportunities for cost reduction. As an example let’s say we’re manufacturing a medical device known as a percussion therapy device on an assembly line employing 21 workers over three shifts. This line assembles 300 devices per day at a combined material and labor cost of $2,100 per unit. Percussion therapy devices are frequently used within the medical setting as they perform the very important function of helping to dislodge mucous from patients’ lungs. As such, they are in high demand and the market for them competitive. In our scenario some stakeholders in the device’s manufacture, in this case sales and marketing managers, specify that a cost reduction of $200 per device is necessary to avoid losing ground to competitors. In response to this directive, design engineers take a fresh look at the assembly process. They identified several bottlenecks at key junctures during which manual labor is involved. They note that due to the painstaking work required at these stages, production is slowed. Assembly lines operate dynamically, meaning any disturbance in the flow of activities has vast repercussions down the line. Bottlenecks in flow slow production lines, just as they do traffic on key arteries. A tie-up on assembly lines equates to production delays, and these may lead to difficulty in filling customer orders. Impatient customers have been known to turn to competitors when their orders aren’t filled, and this translates to lost revenue to our manufacturer. Next week we’ll see what manufacturing changes are employed to solve identified problems, and we’ll see how man’s best friend is not a dog, but a robot. ___________________________________________
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Systems Engineering In Medical Device Design – Production, Part 1
Sunday, February 24th, 2013| Done any remodeling lately? If you have, you’ve been faced with countless choices regarding design and materials. Even a relatively simple decision such as putting in hardwood flooring requires many considerations. What type of wood? What grade? How about the stain? Should it be factory stained and sealed, or should the flooring be installed by single board, then stained and sealed in place? Ultimately, your decision is based on your requirements with regards to cost, durability, and personal style.
Now imagine the decision making process that is required to produce a medical device. We’ve been discussing this complex process during our series on medical device design utilizing the systems engineering approach, a systemized approach to product development, design, and manufacture that is used within many manufacturing arenas. Its objective is to relate the requirements for manufacture, regulatory compliance, sale, use, and maintenance of the product to specific design criteria for functionality, durability, and safety. By doing so, the systems engineering approach ensures that the product meets or exceeds all requirements. Last time we wrapped up our discussion on the Development stage of systems engineering by discussing field testing of medical devices assembled during Preproduction. Problems encountered during this phase result in a comprehensive review of the device design and instructions. When all issues have been resolved, things move on to the manufacturing phase and full commercial production. During the Production stage, engineers make continual assessments of the manufacturing process and ongoing adjustments are made to the device design and manufacturing protocol as necessary, this due primarily to changing stakeholder requirements regarding cost reduction. In the competitive marketplace, cost reduction is a never-ending quest to maintain profitability in view of changing economic and market conditions, and this must be done without compromising the quality, safety, and effectiveness of the device. For example, suppose a medical diagnostic imaging machine was designed to be fitted with a machined metal gear in one of its mechanisms. The manufacturer specifies that a $10 decrease must be made in production costs so it can continue to be sold at an acceptable profit margin. After reviewing the design, engineers discover that substitution of a molded plastic gear would reduce manufacturing cost per machine by $12. This is a common scenario, as plastic parts are often substituted for metal to save on cost. Plastic versus metal? How can that be an acceptable swap? In many cases, it can be. Mechanical stressors are analyzed, and if the plastic gears meet durability requirements as well as their metal counterpart, they are substituted. During the Preproduction phase these plastic gears are used in both lab and field testing, where they are put through the rigors of real world use. If they perform acceptably, they are made a permanent part of the device’s design and used in commercial production. Next time we’ll continue our look at the Production stage to discover another way that systems engineering can facilitate cost reduction to meet stakeholder requirements. ___________________________________________
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Systems Engineering In Medical Device Design – Preproduction, Part 3
Monday, February 18th, 2013| 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. ___________________________________________
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Systems Engineering In Medical Device Design – Preproduction, Part 2
Monday, February 11th, 2013| Last time we began our discussion on Preproduction, the final aspect of the Development stage of our systems engineering approach to medical device design. This is the point at which a small amount of devices are put into actual production, then evaluated for full production possibility. It is also the final juncture at which problems will be evaluated and corrected before full commercial production can begin.
Once the medical devices produced during Preproduction are assembled, they’re subjected to rigorous testing in both a laboratory and the field. This testing is necessary to see if stakeholder requirements are satisfied. At this stage devices constructed en masse on the factory assembly line are compared to prototypes built by hand by design engineers earlier in the Development stage. During Preproduction laboratory test data is gathered and analyzed by engineers to assess how the device will hold up during actual use. Real-life conditions are simulated in the lab environment to facilitate this process. For example, lab testing of a Preproduction kidney dialysis machine can determine whether its blood pump flow rate falls within acceptable range during hundreds of hours of operation. Other factors, such as durability of materials are evaluated during lab testing. In the case of the dialysis machine, there is a component called a dialyzer that filters toxic waste from blood. Over the duration of the lab test, the material used in the dialyzer filter membranes would be inspected and evaluated for durability. Next week we’ll conclude our discussion on Preproduction to see what happens when testing is moved outside the lab environment into the field. ___________________________________________
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