MDDI_Medical Device & Diagnostic Industry

MDDI, January 2013

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various software disciplines (embedded, application, etc.), and various HF disciplines (micro-, meso-, macro-, and mega-ergonomics).5 Practitioners of these disciplines speak different technical languages and have different perspectives of the engineering process. For instance, some software and HF practitioners might have no engineering background. This creates engineering management problems that are typically not resolved with standard project management methods. We often pretend these are problems with the hardware, software, and HF practitioners when in fact they are engineering management problems. Permitting hardware, software, and HF work to proceed unintegrated in individual silos is a regressive engineering management approach that thwarts efficient communication and coordination, thwarts the effective implementation of design controls, and reduces the quality of the product, process, or service—ultimately stifling innovation.2, 6 Design controls are the fundamental principles of classical systems engineering, a well-established branch of engineering in existence since the 1940s.7 Design controls are an engineering process; they produce documentation, but that documentation can be sticky notes, hand-written notebooks, or outputs from a word processor. There is no regulation that specifies the form of engineering documentation. The form of the documentation should not drive the engineering process. The documentation exists solely to demonstrate what process was followed and what decisions were made during that process. Forget about FDA audits; an important aspect of design controls is about preserving and protecting intellectual property and institutional knowledge. Engineering development is about learning, and humans do not learn in a linear waterfall; human learning is always nonlinear, incremental, and builds upon experience and repetition—usually gained from testing, which can be formal, informal, accidental, or experiential.6 The iterative process emphasizing the interdisciplinary character of mechatronics begins with identification of the stakeholders and their needs and is followed by the beginning of risk management. A subset of the discovered stakeholder needs, wants, and desires, which is deemed technologically and economically feasible, usually becomes the initial set of design inputs. Design inputs are a natural language, operationalized statement of the engineering problem (the engineering requirements).6 This engineering problem is posed to the hardware, software, and HF practitioners. Their work product is the set of design outputs. Design outputs are the engineering specifications that tell manufacturing exactly how to make and test the medical device. We will omit many other elements of the process to focus on engineering verifications and validation. The terms verification and validation have been misused, abused, and interchanged, and their definition can vary by industrial sector. In the medical device design control scheme, validation means that you developed the right system (the engineers correctly solved the problem captured by the design input process). Verification means that you developed the system the right way. 6, 8, 9 For example, if you are asked to build a noncontact blood pressure monitor and instead build a noncontact brainwave (EEG) monitor, you may have done everything correctly from an engineering perspective, but you did not develop the right system and would still fail validation. While there can only be one type of design validation, there are five types of design verifications (see Table I). Three types of verification are from classical systems engineering (verification of requirements, specifications, and implementation).6, 7 The other two types of verifi- Manufacture & Design Custom Molded Components ISO 13485 Certi ed Concerned about cost and quality of outsourcing? Let us help! We have manufacturing and assembly facilities in North America and China to assist with all your needs. MANUFACTURING FOR THE HEALTHCARE INDUSTRY t%FTJHO&OHJOFFSJOH t0WFSNPMEFE$PNQPOFOUT t&YUSVTJPOTBOE5VCJOH t $VTUPN.BUFSJBM'PSNVMBUJPO COMPONENTS FOR MEDICAL DEVICES t4JMJDPOF 1MBTUJDT 0UIFS.BUFSJBMT t-POH4IPSU3VO-43 t"TTFNCMJFT t3BQJE1SPUPUZQFT t.JDSPNPMEJOH 3PDLTJEF3E 4UFt*OEFQFOEFODF 0) t 216-631-7000 f 216-631-7002 See us at MD&M West, Booth #1815 MD+DI MEDICAL DEVICE AND DIAGNOSTIC INDUSTRY magenta cyan yellow black JANUARY 2013 | 61 ES180171_MD0113_061.pgs 01.18.2013 22:25 UBM

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