Archive for the ‘Professional Malpractice’ 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.

engineering expert witness food manufacturing

      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.

engineering expert witness in patent infringement cases

      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.

patent eligibility machine patent eligibility 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.

___________________________________________

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.

___________________________________________

medical device manufacturing

Systems Engineering In Medical Device Design – Preproduction, Part I

Monday, February 4th, 2013
     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.

___________________________________________

Medical Device Design

Systems Engineering In Medical Device Design – Instructions, Part 4

Sunday, January 27th, 2013
     Last time we wrapped up our discussion on the development of quality control instructions for use during the Development stage of the systems engineering approach to medical device design.  These instructions are used to guide quality control inspection and testing during the Production stage.  Now let’s continue our discussion on the development of instructions for the Utilization stage, the stage when the medical device is actually put into operation by the end user.

     In the systems engineering approach to medical device design, design engineers must work closely with technical writers, those responsible for writing operating and product service instructions.  The objective here is to share the engineering staff’s intimate knowledge of the medical device’s design with the writers in order to ensure that instructions are clearly written, comprehensive, and follow a logical progression.  Instructions must be written so as to be easily understood by lay people outside of the engineering profession and medical device industry, because most of the individuals using the device will be healthcare professionals and service technicians, individuals lacking a background in engineering or medical device development.

    Instructions are not only meant for the eyes of end users.  They are also subject to review by governmental agencies.  This fact acts as a safeguard to ensure device compliance both with regulatory requirements and industry standards as regards cautions and warnings.  For example, instructions may be required to caution the user to allow the device to warm up for a certain period of time before use to avoid patient discomfort when coming into contact with cold metal.

     Instructions might also warn against a harmful interaction if the device is used in conjunction with other devices. For example, an electronic muscle stimulator may send electrical pulses into a patient’s body that can interfere with the operation of their heart pacemaker.  No doubt this is something that the operator of the device and the patient would want to be informed of.

     At this point our medical device design has been completed, and instructions and procedures written, but the Development stage is not yet complete.  Next time we’ll continue our discussion on this stage to see how a systems engineering step helps us to be safe rather than sorry after full production of the device has begun.

___________________________________________

medical device design

Systems Engineering In Medical Device Design – Instructions, Part I

Monday, January 7th, 2013
     You know those instructional inserts that come in just about everything you buy?  If you’re lucky they’re a one-pager, showing a simple illustration of how your purchase works.  But sometimes they’re multiple pages long, even approaching the length of a short story.  This is often the case when the item in question is complex and contains many parts.

      If you’re like some people you try to avoid reading these instructions, preferring to forge ahead to the assembly/usage stage as quickly as possible, and you’ve probably had your fair share of times that this approach didn’t pan out.  You were forced to re-do things and crack open the instruction manual anyway.  If the instructions were written clearly, you may have eventually come to regard them as indispensable.

     Clearly written instructions are one of the desired end results of the Development stage of the systems engineering approach to medical device design that we’ve been discussing.  These instructions flow naturally from the finalized detailed design which has been produced earlier in this stage.  Instructions aid consumers in the assembly, usage, and maintenance of the device, making for a satisfied customer. 

     Instructions also aid in the efficient and proper manufacture of devices.  Without them assembly personnel wouldn’t work as efficiently, and the end result might not be a desirable one.  It’s easy for parts to end up where they don’t belong, adjustments to be off, etc.  Just think about the last “assemble it yourself at home” project you were involved in.

     The desired result is for instructions produced to be well defined and capable of instructing line assembly personnel in the actual construction of the medical device that takes place during the Production stage.  Subjects such as parts identification, assembly procedures, and layout of assembly lines are discussed, all of which are needed to plan out the manufacturing process effectively.  The objective is to manufacture the devices in a cost effective manner and with minimum probability of defects.

     Next week we’ll continue our discussion on instructions, focusing on those that are produced during the Development stage that serve the purpose of guiding quality control technicians during the Production stage.

___________________________________________

Systems Engineering Development of Instructions

Systems Engineering In Medical Device Design – Finished Design

Sunday, December 30th, 2012
     Last time we opened our discussion on the Development stage of the systems engineering approach to medical device design and discovered that the best design concept is the one that meets all stakeholder requirements.  Let’s use the flow chart shown in Figure 1 to illustrate what comes next in this stage.  

 Systems Engineering Detailed Design Process

Figure 1

     To begin the transformation from concept to completed design, engineers review documentation created during the Concept stage, including design notes, concept sketches, and of course the final requirements specification which has been approved by all stakeholders.  

     Once the review is completed, it serves as a guide to the creation of detailed design documentation, including mechanical drawings, electrical schematics, and wiring diagrams.  A bill of materials, or BOM, is also created, listing all parts needed to produce the final product.  Each part designated within the BOM is associated with a specific manufacturer or supplying vendor, and each has been qualified with regard to price, availability, functionality, and quality.

     The design documentation and BOM are also subject to a review by a fresh set of eyes, engineers who have no involvement in the project.  If they should discover a problem, the design is rejected and sent back to the design engineers for revision.  This process of evaluation and correction are repeated until the design successfully passes a final review.  Only then can the fully approved finished design move on to the production stage.

      Next time we’ll continue our discussion of the Development stage, moving our concept medical device further along its journey to the Production stage.   

___________________________________________

Transistors – Digital Control Interface, Part II

Sunday, June 24th, 2012
     Not too long ago I was retained as an engineering expert to testify on behalf of a plaintiff who owned a sports bar.  The place was filled with flat screen televisions that were plugged into 120 volt alternating current (VAC) wall outlets.  To make a long story short, the electric utility wires that fed power to the bar were hit by a passing vehicle, causing the voltage in the outlets to increase well beyond what the electronics in the televisions could handle.  The delicate electronics were not suited to be connected with the high voltage that suddenly surged through them as a result of the hit, and they overloaded and failed.

     Similarly, lower voltage microprocessor and digital logic chips are also not suited to directly connect with higher voltage devices like motors, electrical relays, and light bulbs.  An interface between the two is needed to keep the delicate electronic circuits in the chips from overloading and failing like the ill fated televisions in my client’s sports bar.  Let’s look now at how a field effect transistor (FET) acts as the interface between low and high voltages when put into operation within an industrial product.

     I was once asked to design an industrial product, a machine which developed medical x-ray films, utilizing a microprocessor chip to automate its operation.  The design requirements stated that the product be powered by a 120 VAC, such as that available through the nearest wall outlet.  In terms of functionality, upon startup the microprocessor chip was to be programmed to first perform a 40-minute warmup of the machine, then activate a 12 volt direct current (VDC) buzzer for two seconds, signaling that it was ready for use.  This sequence was to be initiated by a human operator depressing an activation button.

     The problem presented by this scenario was that the microprocessor chip manufacturer designed it to operate on a mere 5 VDC.  In additional, it was equipped with a digital output lead that was limited in functionality to either “on” or “off” and capable of only supplying either extreme of 0 VDC or 5 VDC, not the 12 VDC required by the buzzer.

     Figure 1 illustrates my solution to this voltage problem, although the diagram shown presents a highly simplified version of the end solution.

microprocessor control

Figure 1

     The illustration shows the initial power supplied at the upper left to be 120 VAC.  This then is converted down to 5 VDC and 12 VDC respectively by a power supply circuit. The 5 VDC powers the microprocessor chip and the 12 VDC powers the buzzer.  The conversion from high 120 VAC voltage to low 5 and 12 VDC voltage is accomplished through the use of a transformer, a diode bridge, and special transistors that regulate voltage.  Since this article is about FETs, we’ll discuss transistor power supplies in more depth in a future article.

     To make things a little easier to follow, the diagram in Figure 1 shows the microprocessor chip with only one input lead and one output lead.  In actuality a microprocessor chip can have dozens of input and output leads, as was the case in my solution.  The input leads collect information from sensors, switches, and other electrical components for processing and decision making by the computer program contained within the chip.  Output leads then send out commands in the form of digital signals that are either 0 VDC or 5 VDC.  In other words, off or on.  The net result is that these signals are turned off or on by the program’s decision making process.

     Figure 1 shows the input lead is connected to a pushbutton activated by a human.  The output lead is connected to the gate (G) of the FET.  The FET is shown in symbolic form in green. The FET drain (D) lead is connected to the buzzer and its source (S) lead terminates in connection to electrical ground to complete the electrical circuit.  Remember, electric current naturally likes to flow from the supply source to electrical ground within circuits, and our scenario is no exception.

     Next time we’ll see what happens when someone presses the button to put everything into action.

____________________________________________