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While pursuing my engineering degree my professors provided me with a thorough understanding of mechanical and electrical design and instruction on how to build prototypes for testing. As far as technical skills were concerned, I was well equipped to turn my ideas into real inventions. Unfortunately, my engineering school, like most others, never went beyond these technical aspects of inventing. For example, we never discussed the business and legal aspects of manufacturing and selling an invention. The fact is, most first time inventors have little or no understanding of how to go about obtaining a patent to prevent others from copying and profiting from their inventions. They also tend to take a haphazard approach to inventing, neglecting important issues such as whether a market for their invention exists, or whether they will face competition already in place. A lot of time and money can be spent developing an invention, only to discover that it had already been patented by someone else. They do all the up-front work, blissfully unaware of the repercussions of negative possibilities, like getting sued by any existing patent holder, suits which are among the most expensive to defend. For most individuals the patent process is a hotbed of mysteries and misconceptions. Let’s start unraveling them by first gaining a basic understanding of what a patent is. In short, a patent grants you a legal right, much like other legal rights you may be more familiar with. For example, if you own property, say a car or piece of real estate, you’re provided with a legal document known as a title. This title defines your legal right to own that property. Similar to a title, a patent grants you the legal right to own intellectual property, or IP, as its inventor. IP is a term used in the business and legal arenas to refer to creations of the inventor’s mind. Once patented, these creations become the property of the inventor, and they have commercial value. This value is derived from the fact that the patent can be used to exclude others from producing the invention and profiting from it. The IP rights can also be sold or licensed to others for a profit. IP can encompass subjects as diverse as machinery, articles of manufacture, compositions of matter, and many diverse processes, all of which we’ll look into during the course of this blog series. ___________________________________________
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Posts Tagged ‘manufacturing’
Patents, Defined
Sunday, March 31st, 2013
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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