Buenaventura IEEE Engineering in Medicine and Biology

Case Study: Systems Engineering in Medical Device Development - Jim Leatham

Wednesday, September 28, 2016 7 PM
CLU Gilbert Sports and Fitness Center, 130 Overton Court, rooms 253/254 (second floor)

We will take a tour through a development cycle of a Medical Device in order to identify how systems engineering principles help to keep the design on-track and simultaneously conform to good manufacturing practices (GMP). This talk will follow the design process through a succession of milestones and illustrate how quality systems can streamline the product development cycle and result in a more efficient design cycle, when they are used to enhance the process.

Jim Leatham

Jim Leatham is founder/owner of Archimedal Products, a photonics product development company partnering and advising in system architectures and all phases of product development.  Jim has worked on defense, biotech, and biomedical product development, spearheading development of systems of various complexity.  Jim developed and presented short courses on System Engineering and Good Manufacturing Practices in Product Development to develop products to 510k approval for international clients and was a founding member of the committee that developed certificate program for medical device product development at UCSD Extension.

Biophotonic products include redesigning the flagship fluorescent reader for SNP assays, developing a breast cancer spectral probe (presented at Congressionally Directed Medical Research Program "Era of Hope" conference), acting as technical advisor to a cervical cancer classification instrument (the Hyperspectral Diagnostic Imager) based on fluorescence spectroscopy of elastically scattered fluorescence as well as leading an effort to develop an associated instrument to classify basal cell carcinoma, and developing a field instrument for discriminating Streptococcus A from Streptococcus B and from background organisms using fluorescence including proving out advanced discrimination algorithms.

Jim was a founding member of the National Institutes of Health (NIH) Network for Translational Research in Optical Instrumentation (NTROI) Corporate Advisory Board and Instrument Development team.  He is past president of the Optical Society of San DIego, and received US Congress "Certificate of Recognition" for commitment and exceptional efforts applying innovative technologies to DoD priorities.



Meeting Site: California Lutheran University Gilbert Sports and Fitness Center,
Second Floor, rooms 253/254, 130 Overton Court, Thousand Oaks, CA.
Meetings are free, and open to the public
Dinner: Available at 6 p.m. for $12 payable at the door, no RSVP needed.
Parking: Parking is free outside of the Gilbert Sports Center
Contact: Steve Johnson, sfjohnso@ieee.org
Our Sponsors: California Lutheran UniversityIEEE EMB SocietyThe Alfred E. Mann Institute for Biomedical Engineering at the University of Southern CaliforniaIEEE Buenaventura SectionAmgen FoundationAmeriprise Financial Services, Inc., D. F. Rick Speidel, Financial AdvisorMicroJoining SolutionsWabash Power