78 > What is a medical device? J Medical Device - any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used on human beings for the purpose of: * diagnosis, prevention , monitoring, treatment or alleviation of disease, * diagnosis, monitoring, treatment, or alleviation of or compensation for an injury or handicap, + investigation, replacement or modification of the anatomy or of a physiological process, * Control physiological process WHAT IS DESIGN? y Design is the creation of the products and services that people use. / Design as an action verb is: *To conceive, invent « To formulate a plan for; devise * To have as a goal or purpose; intend. intend ° ° ° B fF PB edly Sela gto aor enedeill quis dgllaal wes wesss® glsitI Jot vLamocanner 4 L392 4Ga 4:0) 78] > Dil} THE ESSENTIALS OF DESIGN—OVERVIEW y A well product answers the following questions: Who? What? Where? When? Why? How? The process of design typically involves such considerations, with the addition of decision points in the design process as outlined in Figure 1.1. The generic design process, the flowchart on the left-hand side, outlines the process from design task initiation (from whatever source) to task completion. y The center section outlines the process of task clarification, the search for solutions and evaluations of the same, and the generally necessary repetitions of the same until an acceptable solution is reached. On the right-hand side are listed the who/what/why/when /where/ how questions normally asked at each phase, with the addition of the go/no decision part. VA generalized flowchart for the design process akation ° ° B fF PB euaslly Sulai JgAol ear 8 enedoall quis dgllaal esss®glsitI Js was vLamocanner 4 L392 478 > Dil} ¥ Specific schedules must be developed in order to maintain a competitive edge. Periodic design reviews are mandated to maintain schedules and to determine the validity and verification of the design. ¥ Hazard analysis should be done as a product is being developed, rather than later, when liability becomes an issue. ¥ If possible, a prototype of the device or process should be developed and used for testing purposes prior to final manufacture of a product. ¥ Design teams typically require technical skills and knowledge from a variety of disciplines; This is normally accomplished by the generation of multidisciplinary design teams. j Dependent on the particulars of a problem, the engineering team should include a required mix of electrical, mechanical, biomedical, computer, and chemical engineers. ¥/ Persons with these backgrounds, as well as with an engineering management background, might form the core of the engineering product development team. Manufacturing and industrial management engineers may or may not be included in the prototyping or concept development team but will be needed in the manufacturing part of the overall development. ° ° B F&F B measly Saletan! Ja a i eecell zug dalla eses® glsitI Jot vLamocanner 4 L392 4Nachine Tnsiated by Google y The most critical part of this listing is the initial “what?” Elucidation—if the design task is not adequately described at the offset, the entire process from then on is generally wasted time and money! y If one properly defines the problem (ie, understands the who/what/why/ when/where part), then one can hope for a tracing directly to the solution evaluation section. y If the solution is wrong, OF |f the problem definition is wrong, one will have to backtrack and rework the overall solution. y The most vital part of the design work will be to figure out what it is is that one is asked to do. y Part of this problem will hopefully be minimized by your (and/or your team's) prior educational experiences, which should have included “ medical nomenclature, some systems physiology, and medical instrumentation. ULallovarier = 92 aine Trarslatd by Googie How to Design and Develop Medical Device? * It takes a significant amount of effort to deliver the right healthcare solution that meets customer demands. e Aright healthcare solution demands, with strong scope definition from end user's need, collaborative efforts across the team, adherence to specification and requirements extracted from product definition, simultaneously mitigating risks and sticking to the best possible quality. Considering these. Uailouanner 2 whe 4WHAT IS DESIGN? y Design as a noun (thing) incorporates the following: ° A drawing or sketch, especially a detailed plan for construction or manufacture e The purposeful arrangement of parts or details ¢ The art or practice of making designs e An ornamental pattern e A plan or project e A reasoned purpose; intent ° Often a secret plot or scheme Udlllovdiiiel 2 woe &