2. Launched Products
• AccuChek Mobile (2010 Europe only) – Roche
– IP for Test tape, 50 tests and 6 lancets.
• Roche Lancing cap for off-finger use – Roche
• AtLast II Blood Glucose System – Amira
Medical
• AtLast I Blood Glucose System – Amira
Medical
• WhisperSoft Lancing Device – Amira
Medical
• OneTouch SureStep Blood Glucose System – LifeScan
3. Duties and Responsibilities
• Manage medical device development - meters, disposables,
catheters, and implants from concept through market launch
ensuring that product meet performance specifications,
regulatory and manufacturing requirements.
• Project management - preparing project plans that specify
project milestones, tasks, durations, resource assignment, and
costs. Communicate task assignments to responsible
individuals, and track to ensure that tasks are completed within
the planned time.
• Generate innovative concepts - satisfy device performance
specifications. Lead and participate in concept generation then
refine, rate, rank and evaluate concepts.
• Interact with strategic partner companies in a professional
manner while ensuring an ongoing two-way exchange of
information.
4. Skills
• In-depth knowledge of Spectroscopy, Optical and
Electrochemical Instrumentation, Blood sample
extraction, collection and testing in a reliable, low
volume format, Sterilization, IP management and
Tissue Physiology
• Familiarity with FDA Quality System / GMP and ISO
13485 medical device regulations.
• Familiarity with animal testing, IRB, clinical protocol
and clinical trial design.
• Familiarity with Process Development to minimize
disruptive design changes, reduce product and
process design cycle time, reduce time-to-market
and better meet customer needs and quality
expectations.
5. Open Access Publications
• Glucose concentration difference between arterial,
capillary, and venous blood, J. Roe, open
access e-publishing Scribd (2010)
• Concerns when measuring small samples of
capillary blood obtained by a skin lance, J.
Roe, open access e-publishing Scribd (2010)
• The medical impact of disposable lancet or syringe
use on the skin, J. Roe, open access e-publishing
Scribd (2010)
6. Technology Experience
• Micro-patterned plates for cell growth to speed
drug discovery (micropatterns, adhesive)
• Heart attack panel test (magnetic bead
immunoassay)
• Implantable glucose sensor using etalon system
(refractive index and ConA chemistry)
• Bacteria water monitoring using flow cytometer
(immunofluorescent tagging)
• Blood oxygen saturation levels in micro-
capillaries for health status of tissue (Raman
spectroscopy)
7. Technology Experience
• Cellular NADH testing with endoscope for tissue
health / end organ perfusion monitoring
(fluorescent)
• Microfluidic cartridge and fluorescent reader for
POC immunoassay testing (fluorescent
immunoassay)
• Off-finger blood collection system (mechanical
blood expression)
• One-step blood glucose collection and testing
system (reflectance spectroscopy)
• One-step ISF glucose collection and testing
system (electrochemical)
8. Technology Experience
• Noninvasive glucose analysis of skin (NIR
absorption)
• AtLast II Blood Glucose Meter (reflectance
spectroscopy, enzyme)
• Blood lithium monitoring for Bipolar Disorder
(reflectance spectroscopy, ionophore)
• AtLast I Blood Glucose Meter (reflectance
spectroscopy, enzyme)
• WhisperSoft Lancing Device (mechanical blood
expression, skin physiology)
9. Technology Experience
• Noninvasive glucose analysis in eye (Raman
spectroscopy)
• Prothrombin time / blood coagulation monitoring
(Near Infrared or NIR)
• Noninvasive water detection in SureStep
glucose test strip manufacturing line (NIR)
• CO2 detection using micro-machined etalon (IR
absorption)
• Total organic hydrocarbon detection with fiber
optic sensor (absorption spectroscopy)
10. Technology Experience
• Membrane, adhesive and surface
treatments for microfluidic system
• pH, CO2, and O2 blood gas fiber optic
sensor (fluorescent spectroscopy)
• Drug testing - cocaine blood analysis
(Raman spectroscopy)
• TCE and chloroform fiber optic sensors for
ground water contamination monitoring
(fluorescent spectroscopy)
