joel b. myklebust, p.e., ph.d. (powerpoint)
TRANSCRIPT
FDA
CVM CFSAN CDRH CBER CDER
ODE OSM OSB* OSEL OCER OC OIVD
DB
DP
DIAM
DCMS
Electromag EPES
Opt Ther Opt Diag
DAGID
DCD*
DGRND*
DOED*
DRARD*
DESE
DSFM
Who We Are
Device Classification
• Classification determines extent of regulatory control
– Class I – general controls, GMP and labeling – Class II – special controls, to assure safety
and effectiveness, e.g., X-ray machine – Class III - premarket approval needed with
clinical data
Regulatory Review: Main Pathways to Market
• Premarket Approval (PMA) (Class III)
• Premarket Notification 510(k)(Class II)
• Company (not product) Registration (Class I)
CDRH’s Office of Science & Engineering Laboratories
• Applied Mathematics & Medical Imaging • Biology • Chemistry and Material Science• Electrical & Software Engineering• Fluid and Solid Mechanics• Physics
Approximately 200 laboratory scientists working in
Some Potential Collaborations
• Wireless technologies
• Optics• Neurophysiology• Fluid mechanics• Mechanical
engineering• Robotics• Software reliability
Materials Tissue engineering Nanotechnology Toxicology/biocompatibility Medical imaging Computational modeling Epidemiology/statistics Acoustics/ultrasound
Microvacuoles in
Foldable Intraocular Lenses
Electrophysiological model of the human torso
• Unique Model– Ability to simulate
non-linear dynamics & electrophysiology as well as application of strong shocks
• Initial validation of simulation using data from rabbit heart.
EXAMPLE: Neural stimulation technologies
• Cochlear implants• Prosthetic retinas• Spinal cord stimulators• Deep brain stimulators• Functional electrical stimulation • Vagus nerve stimulators• Magnetic stimulation• Stimulators for evacuation/incontinence
Stimulation Issues • Heating
(energy)• Dielectric breakdown
(E-field strength)• Electrochemical toxicity
(charge density)• Excitoxicity
(pulse rep rate, E-field)• Physiologic interference
(rep rate, E-field)• Electromagnetic Interference
RFID Testing
71%
29%
11%
89%
0%
100%
0%10%20%30%40%50%60%70%80%90%
100%
125-135 kHz 13.56 MHz 915 MHz
RFID Frequency Band
Percentage of ICD Tests with Reaction(s)
Reaction No Reaction
Computational Modeling
• 8000 Processors• 8 Terra Flops• 3 FTE support
ASK CHILDREN Study
Anticipate Specific Kinds of CHILDREN Challenges for Neurologic Devices STUDY
Kristen Bowsher, PhD, Co-Investigator
Victor Krauthamer, PhD, Co-Investigator
Carlos Peña, PhD, Primary Investigator
Joy Samuels-Reid, MD, Co-Investigator
Objectives• Collect clinical data related to neurologic device prostheses
(prosthetics) for children to help identify human factors, safety, usability, and adverse events associated with prosthetic devices;
• Collate and analyze clinical data associated with prosthetics for pediatric use that are important to bringing devices expeditiously to market, organized by multiple headers including (but not limited to) device type, pediatric subpopulations, disorder, condition, and intended use;
• Plan, organize, and execute a meeting of subject matter experts (consultants) in the field to further evaluate data and propose recommendations concerning overcoming regulatory challenges associated with bringing pediatric prosthetics to market; and
• Establish a framework of science based recommendations important towards helping expedite pediatric prostheses to market.
Eliminate disparities between people with disabilities and the general population in:
employment,participation &
community livingandhealth and
function.
Policy
Practice
Behavior
System Capacity
NIDRR Logic Model: Planning for Research OutcomesSituation: Significant gaps exist in knowledge, skills, policy, and practice and system capacity that prevent people with disabilities from
having equal access to opportunities for employment, health and function, and participation.
Long-term Outcome Arenas
– Changes in Overall
Conditions
Short Term Outcome Arenas – Advances in Understanding,
Knowledge, Skills, and Learning Systems via:
Intermediate Outcome Arenas –
Adoption and Use of New Knowledge Leading to
Changes/ improvements in:
Major Domains of NIDRRResearch
Contextual Factors: Variable funding; scientific and technological advancements; societal attitudes; economic conditions; changing public policies; coordination and cooperation with other government entities.
Performance Assessment & Outcomes Evaluation
Intended Beneficiaries
Intermediate Beneficiaries
R&DC-B KT
People with
disabilities& family
members
• Researchers• Clinicians• Service providers• Educators• Policy experts• Federal & non-federal
partners• Industry reps &
product developers• Employers• Media• Consumer advocates• People with
disabilities & family members
Discoveries
Interventions, Products, Devices, & Environmental
Adaptations
Theories, Measures, & Methods
05/05/05
St. Croix Med-El
Soundtec
Otologics
Implex
IMEHD
Technologies
Inside the High Bay
Evaluation of Applied Forces and EMG of the Young, Aged & Stroke Population in a 3D Arm Workspace
EMC of Powered wheelchairs
• Many models experienced sudden unintended motion when exposed to RF fields of a few volts/meter.
• This could cause persons to be thrown from their wheelchairs, or to be thrust into traffic in a busy street.
• FDA lab and outdoor tests demonstrated that RFI from nearby high-power police-car transmitters could induce unintended motion in several models of powered wheelchairs.
• Witters, D.M.; Ruggera, P.S., "Electromagnetic compatibility (EMC) of powered wheelchairs and scooters," Engineering in Medicine and Biology Society, 1994. Engineering Advances: New Opportunities for Biomedical Engineers. Proceedings of the 16th Annual International Conference of the IEEE EMBS, vol.2, pp.894-895, 1994.
• ANSI/RESNA WC Vol. 2-1998 and ISO 7176-21
RESEARCH OPPORTUNITIES
• Faculty members
• NIDRR grantees
• Graduate students, post-docs
• Senior OSEL research collaborators
• Unique medical device lab facilities
• Synergistic research