volume 07 issue 01

One uses process when expressing an activity "What we mean when we say "model" therefore, is the process of actually sketching it out. In this chapter, the construction of novel medical devices was specifically addressed. The analysis of 32 studies revealed a common theme, and it wasn't health technology assessment or human factors engineering. Therefore, there is a lack of studies examining the most effective methods of data presentation. We may "that no comprehensive model has been produced in the literature so far.

Organizations may get a competitive advantage and a greater financial return on their investment in product development by adopting a new approach "investments. Process modelling has also been found to aid in improving the efficiency and effectiveness of the process. The modelling of the medical device development process is thus anticipated to be a useful tool for businesses and designers. However, there are none "methods that are certain to bring products and services, such as medical devices, to market. In other words, this is hardly a miracle cure.

In the end, the designer and his or her company are responsible for picking the most appropriate development approach and tools "manner of presenting it. However, there are a few pointers that may be provided. However, protocols that are too tight may have a detrimental effect on development, so it's crucial to allow for some leeway for creativity and consider the lessons learnt from previous preview projects. In conclusion "up, the procedure needs to function as a blueprint, allowing for variations to be implemented in certain cases.

  • Medicinal Devices,
  • Treatment of Diseases.
  • Aguwa CC, Monplaisir L, Sylajakumari PA, Muni RK (2010) Integrated fuzzy-based modular architecture for medical device design and development. Journal of Medical Devices 4:031007. doi: 10.1115/1.4002323
  • Aitchison GA, Hukins DWL, Parry JJ, et al. (2009) A review of the design process for implantable orthopedic medical devices. The open biomedical engineering journal 3:21–7. doi: 10.2174/1874120700903010021
  • Alexander K, Clarkson PJ (2002) A validation model for the medical devices industry. Journal of Engineering Design 13:197–204. doi: 10.1080/09544820110108890
  • Altenstetter C (1996) Regulating healthcare technologies and medical supplies in the European Economic Area. Health policy (Amsterdam, Netherlands) 35:33–52.
  • Best M (2004) Ignaz Semmelweis and the birth of infection control. Quality and Safety in Health Care 13:233–234. doi: 10.1136/qshc.2004.010918
  • Beyer H, Holtzblatt K (1997) Contextual design: defining customer-centered systems. 496.
  • Boehm BW (1988) A spiral model of software development and enhancement. Computer 21:61–72. doi: 10.1109/2.59
  • Chuter T a M (2002) Stent-graft design: the good, the bad and the ugly. Cardiovascular surgery (London, England) 10:7–13.
  • Cookson R, Hutton J (2003) Regulating the economic evaluation of pharmaceuticals and medical devices: a European perspective. Health Policy 63:167–178.
  • Cooper RG (2008) Perspective: The stage-gate ® idea-to-launch process—Update, what’s new, and nexgen systems. Journal of Product Innovation Management 25:213–232. doi: 10.1111/j.1540- 5885.2008.00296.x
  • Dyadem Press (2003) Guidelines for Failure Modes and Effects Analysis for Medical Devices. CRC Press, Ontario, Canada
  • Eatock J, Dixon D, Young T (2009) An exploratory survey of current practice in the medical device industry. Journal of Manufacturing Technology Management 20:218–234. doi: 10.1108/17410380910929637
  • Fuchs S, Sandmann C, Gerdemann G, et al. (2004) Quality of life and clinical outcome in salvage revision total knee replacement: hinged vs total condylar design. Knee surgery, sports
  • traumatology, arthroscopy: official journal of the ESSKA 12:140–3. doi: 10.1007/s00167-003- 0401-8
  • Gad SC, McCord MG (2008) Materials in medical device design. Safety evaluation in the development of medical devices and combination products, 3rd ed. Informa Healthcare, pp 49–61
  • Gamerman GE (1992) FDA regulation of biomedical software. Proceedings / the. Annual Symposium on Computer Application [sic] in Medical Care Symposium on Computer Applications in Medical Care 745–9.
  • Hanna KE, Manning FJ, Bouxsein P, Pope A (2001) Innovation and invention in medical devices.National Academy Press, Washington DC
  • Holmes DR, Firth BG, James A, et al. (2004) Conflict of interest. American heart journal 147:228–37. doi: 10.1016/j.ahj.2003.12.001
  • Katzen BT, MacLean AA (2006) Complications of endovascular repair of abdominal aortic aneurysms: A review. CardioVascular and Interventional Radiology 29:935–946. doi: 10.1007/s00270-005- 0191-0
  • Kaufman J a., Geller SC, Brewster DC, et al. (1999) The vanguard stent-graft: practical approach.
  • Techniques in Vascular and Interventional Radiology 2:145–164. doi: 10.1016/S1089- 2516(99)80029-8
  • Maisel WH (2004) Medical device regulation: An introduction for the practicing physician. Annals of Internal Medicine 140:296–302.
  • Mankins JC (2009) Technology readiness assessments: A retrospective. Acta Astronautica 65:1216– 1223. doi: 10.1016/j.actaastro.2009.03.058
  • Miller BC (2012) Quick brainstorming activities for busy managers: 50 exercises to spark your team’s creativity and get results fast. 208.
  • Milner R, Kasirajan K, Chaikof EL (2006) Future of endograft surveillance. Seminars in Vascular Surgery 19:75–82. doi: 10.1053/j.semvascsurg.2006.03.002
  • Owens J, Cooper R (2001) The importance of a structured new product development (NPD) process: a methodology. Engineering Education: Innovations in Teaching, Learning and Assessment (Ref. No. 2001/046), IEE International Symposium on. pp 10/1–10/6
  • Puccio GJ, Cabra JF, Fox JM, Cahen H (2010) Creativity on demand: Historical approaches and future trends. Artificial Intelligence for Engineering Design, Analysis and Manufacturing 24:153. doi: 10.1017/S0890060410000028
  • Raab GG, Parr DH (2006a) From medical invention to clinical practice: the reimbursement challenge facing new device procedures and technology--part 1: issues in medical device assessment.
  • Journal of the American College of Radiology : JACR 3:694–702. doi: 10.1016/j.jacr.2006.02.005
  • Shah SGS, Robinson I (2007) Benefits of and barriers to involving users in medical device technology development and evaluation. International journal of technology assessment in health care 23:131–7. doi: 10.1017/S0266462307051677
  • Shah SGS, Robinson I (2008) Medical device technologies: who is the user? International Journal of Healthcare Technology and Management 9:181. doi: 10.1504/IJHTM.2008.017372
  • Sorenson C, Tarricone R, Siebert M, Drummond M (2011) Applying health economics for policy decision making: do devices differ from drugs? Europace 13:ii54–ii58. doi: 10.1093/europace/eur089
  • Sprague S, Quigley L, Adili A (2007) Understanding cost effectiveness: money matters? Journal of long-term 17:145–152.
  • Young KC, Awad NA, Johansson M, et al. (2010) Cost-effectiveness of abdominal aortic aneurysm repair based on aneurysm size. Journal of Vascular Surgery 51:27–32. doi: 10.1016/j.jvs.2009.08.004
  • Zenios S, Makower J, Yock P, et al. (2010) Biodesign : the process of innovating medical technologies.
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DONG YUQING, D. Y., DR. NORAISYAH TAJUDIN, D. N. T., & INAMDAR, D. M. N. . (2024). A case study of the advancements in medical instrumentation and health technology. International Journal of Multidisciplinary Research and Studies, 7(01), 01–13. Retrieved from

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