ALS 425 Device and Diagnostic Product Development - Keck Graduate Institute Skip to main content
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      • Doctor of Philosophy in Applied Life Sciences
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      • Master of Science in Applied Life Sciences
      • Master of Science in Community Medicine
      • Master of Science in Human Genetics and Genetic Counseling
      • Master of Science in Human Genetics and Genomic Data Analytics
      • Master of Science in Medical Device Engineering
      • Master of Science in Physician Assistant Studies
      • Master of Science in Translational Medicine
      • Postbaccalaureate Premedical Certificate
      • Postbaccalaureate Pre-PA Certificate
      • Certificate in Bioscience Management
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      • Henry E. Riggs School of Applied Life Sciences
      • School of Medicine
      • School of Pharmacy and Health Sciences
      • Minerva Schools at KGI
      • Biocon Academy
    • Summer Programs
      • Application Boot Camp
      • Bioprocessing Summer Undergraduate Internship Training and Education
      • Botswana Summer Undergraduate Research Experience
      • Careers Beyond the Bench: Biotech Industry Summer Program
      • Clinical Genetics and Bioinformatics Summer Program
      • High School Summer STEM
      • Managing Science in Biotech for Postdocs
      • Medical Device Development Bootcamp
      • PA Summer Success Program
      • Pre-Occupational Therapy Program
      • Pre-Pharmacy Enrichment Program
      • Summer Explore Health Professions
      • Summer Undergraduate Research Experience
      • Undergraduate Summer Science Courses
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      • Find an Expert
      • Faculty Directory
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      • Amgen Bioprocessing Center
      • Center for Biomarker Research
      • Center for Rare Disease Therapies
      • Center for Training in Applied Genomics
      • Science Heritage Center
    • Lab Safety & Support
      • Institutional Laboratory Support
      • Lab Safety Plans
      • Lab Safety Training
      • OSHA Lab Standard
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      • Alumni Success Stories
      • Spin-Off Companies
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      • KGI Event Calendar
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      • Commencement
      • Orientation
      • White Coat Ceremony
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      • Student Accounts FAQ
      • 1098T FAQ
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ALS 425
Device and Diagnostic Product Development

Semester: Fall
Credit(s): 3.0
Instructor(s): Anna Iwaniec Hickerson
More information
  • Description
  • Pre-Requisites
  • Learning Objectives

This course covers technical and managerial aspects involved in the development of medical devices and diagnostics through a combination of lectures, classroom labs, and a team design project. Students will solve specific tasks from the perspective of a product manager, development engineer, industrial designer, or manufacturing engineer. Related aspects of market research, quality control, and the FDA approval process are emphasized in other complementary courses at KGI. The design project leads students through: (a) preparation of a problem statement and product design specification; (b) design and prototyping; (c) testing; (d) design for manufacture and assembly; and will conclude with (e) the preparation of a design master record. Specific technical skills necessary for the team project are each introduced using a combination of a concept video, brief lecture, and classroom lab. Students will receive an overview of general industry standards, quality systems, and certification processes.

none

  • Students will be familiar with and able to compose standard product development documentation
  • Students will be able to apply methods for project planning and product development
  • Students will be able to apply basic technical skills common to the design of medical devices and diagnostics such as data acquisition, associated hardware, and software processing
  • Students will be familiar with several COTS subcomponents used in medical devices and diagnostics, and be able to provide technical and financial comparisons of those components
  • Students will be able to discern the limitations and capabilities of common prototyping and manufacturing methods
  • Students will be able to specify appropriate quality and manufacturing standards for specific instrumentation types

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