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  Running head: PROCESS IMPROVEMENTS IN MEDICAL DEVICE MANUFACTURING1 PROCESS IMPROVEMENTS IN MEDICAL DEVICE MANUFACTURING SNEHA IYER Westcliff UniversityBUS 500 – Organizational LeadershipDr. Shirley  PROCESS IMPROVEMENTS IN MEDICAL DEVICE MANUFACTURING  Process Improvements for Medical Device Manufacturing I work as a Manufacturing process engineer for a Medical device company thatmanufactures class III neurovascular implants. These are implanted in the brain to help cureAneurysms while some of these devices also help in the removal of clots in the patients sufferingfrom Ischemic Stroke. Situation  Some of my job responsibilities include performing failure analysis for Medical devicereportable complaints, work closely with Post market surveillance team to track failures, performtrend analysis (statistical data analysis) and provide feedback to the Research & Development,Manufacturing Teams, and clinical teams for potential Product/ Process Improvements. There were few cases of this one particular complaint that we kept getting often, where a part of the implant gets separated and detached in the brain. The physician then needs to use anancillary device to snare the other half out of the brain. This occasionally resulted in thrombosisand ultimately in patient death. On performing the root cause analysis of the implant separationon the returned device, it was figured out that it spurred from one of the manufacturing processes. On further investigation, it was reckoned that, the SOP’s used to perform this processhad some inconsistencies. Becoming a Better Leader  An SOP in full Standard Operating procedure is a documented process that helps a companyensure consistent delivery of products or services. Since the manufacturing processes werelacking accurate information and possessed discrepancies, I decided to start with it. I observedthat one of the SOP’s containing a certain equipment was the main contributing factor for theimplant separation observed in the field returns. I took the risk of shutting down the production2  PROCESS IMPROVEMENTS IN MEDICAL DEVICE MANUFACTURINGline for that equipment and established a sense of urgency. I calibrated all the equipments thatwere used to produce those parts, standardized them to yield the exact same results all the time, performed testing on the parts created from them, to verify if they met the confidence andreliability requirements. By performing this I was able to improve the repeatability andreproducibility of the process. Planning Process for the Process Change  Leading all these changes did require a lot of planning and collaborative team effort. I hadto create a guiding coalition with production planners, production floor leads and supervisors,technicians who helped me perform the bench testing. I faced a lot of resistance for initiating thischange, as it was affecting the daily yield, however, I had to communicate a compelling messageto upper management as to why doing things the old way cannot result in a sustained andeffective product. I enlisted an army of Interns and engineers to help me perform parallelverification test cases to enable quicker implementation. Building Commitment  The final stage, as Lewin calls is “refreeze”. “At this stage, it is important to manage for consistency so that the changes are internalized by staff, monitored for reinforcement andadjusted if needed.” (Smith, 2018). I witnessed short term wins in the initiatives I undertook. Onthe brighter side, processes started improving, we observed fewer rejects in the manufacturingfloor, the rolled throughput yield increased in number. The only cons were increased in-processtime, however, the benefits outweighed the added lead time. Commitment was also ensured by mandating documented procedures during the start of each shift on a daily basis. Six-sigma methodologies were put in place to eliminate the defects3  PROCESS IMPROVEMENTS IN MEDICAL DEVICE MANUFACTURINGand to exceed or meet customer requirements. This data driven approach employed by empiricalstatistical methods, served to solve the organizational and operational commitments. Conclusion  My case study involved a poorly implemented process that resulted in discrepant productscausing fatality in patients. This affected not only the organizational goals but the company’sreputation in offering good quality products. A good performance management system, whenimplemented well, would help provide analytical and critical information permitting organizationto make wise decisions and develop a sound contingency plan for strategic development. Kotter anchored new change in the culture by incentivizing on small wins and attributedthem as motivators. According to Lewin, there are high chances that the organization may revert back to old traditional methods if strict commitments are not reinforced, which he termed as‘freezing’. Both approaches when used in tandem, can streamline the process, aim in reducingthe cost, reduce duplicated effort and avoid bottlenecks that could result in missing deadlines. 4  PROCESS IMPROVEMENTS IN MEDICAL DEVICE MANUFACTURINGReferences:Hayes, R. (1978, January). How Should You Organize Manufacturing? Retrieved from, J.P. (1996). Leading Change. Harvard Business School Press. ISBN 9780875847474. Retrieved 1 January 2015.Kotter, John P. "John P. Kotter - Faculty - Harvard Business School". Retrieved 24 August 2014.Kouzes, J. M., & Posner, B. Z. (2017). The leadership challenge – how to make extraordinary things happen in organizations (6th edition). San Francisco: Jossey-Bass.Singh, P., & Twalo, T. (2015). Effects of poorly implemented performance management systems on the job behavior and performance of employees. The International Business & Economics Research Journal (Online), 14(1), 79. Retrieved from, C (2018, Oct 17) Battle of the Change Theories: Lewin Change Management Model vs. Kotter 8 Step Process. Retrieved from :
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