Representative Devices

CDRH Regulatory Research Ed Margerrison, Director, Office of

Science and Engineering Labs, CDRH

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CDRH

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White Oak Campus showing CDRH buildings

The First 150 things you see in a hospital are probably Medical Devices

CDRH in Perspective

• CDRH oversees: – 175,000 medical devices on US market – 570,000 proprietary brands on the US market – 18,000 medical device manufacturers – 25,000 medical device facilities worldwide

• Each year we receive – 22,000 premarket submissions (including supplements and amendments) – 1.4 million reports on medical device adverse events and malfunctions

• CDRH employees c. 1,700 staff

Cranial ion flux

• Example deep brain stimulators

CDRH Research

CDRH Mission:

– …We provide consumers, patients, their caregivers, and providers with understandable and accessible science-based information about the products we oversee. We facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.

Office of Science and Engineering Labs

Building 62, White Oak campus

Our job is to ensure that CDRH never has to say “I don’t know”

• Ensure readiness for emerging and innovative medical technologies • Develop appropriate evaluation strategies and testing standards • Create accessible and understandable public health information • Deliver timely and accurate decisions for products across their life cycle

Office of Science and Engineering Labs

Ed Margerrison, Director

Applied Mechanics Anton Dmitriev

Biology, Chemistry and Materials Science

Jose Centeno

Imaging, Diagnosis and Software Reliability

Kyle Myers

Admin and Lab Support Angie Clingerman

Biomedical Physics Vacant

Fluid Mechanics Solid Mechanics

Ultrasonics

Materials Performance Microbiology and Infection Control Toxicology and

Biocompatibility

Clinical Trial Design Image Analysis

Medical Imaging Software Reliability

Biophysics Electromagnetics (EMC)

Optics Cardiac Modelling

Areas of Potential Interest

• Computer Modeling and Simulation – Accepted scientific tool – Advances in modeling of biocompatibility – How do we make it an accepted reg tool

• Nickel and other metal ions – A continuing issue

Cardiovascular stent

Biology, Chemistry and Materials

Science Biocompatibility

Endoscope Cleaning Project

• RCA with Washington Adventist, Healthmark Inc, and GWU– Phase I

• Analytical based approach to measure cleanliness• Testing in real world at WAH, Takoma Park• Assessing the “cleanliness” of endoscopes after use and

cleaning, and comparing with new scopes

• Manuscript in preparation Example endoscope

Biology,Chemistry and Materials

Science

Cardiac Modelling

• Development of whole heart model – Part of a general shift to extend CM&S from a

scientific tool to a regulatory tool – Development of VVUQ models in parallel

Biomedical Physics

Model cardiovascular system

Predictable and Efficient Pathways

• Medical Device Development Tools – FDA validated methods that can be used for device approval and clearance

• Standards: ISO, ASTM – Publically accessible recognized standards

• ASCA – Conformity assessment for testing companies and CROs

Predictable and Efficient Pathways

• Medical Device Development Tools – FDA validated methods that can be used for device approval and clearance

• Standards: ISO, ASTM – Publically accessible recognized standards

• ASCA – Conformity assessment for testing companies and CROs

Facilitating Innovation

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Axial Compressive Stiffness of Cervical IBFDs (kN/mm)

• CDRH has a vast store of prior data – CDRH receives about 2 new 510(k) applications every week for CIBFDs – We are starting to collate these data to investigate uses for the scientific

community and our manufacturers – The first data set is now publically available – It can be used by both FDA to facilitate reviews and industry to aid design – Continuing pilot study to other devices

Division of Applied Mechanics

Cumulative distribution of axial compressive stiffness measurements from CDRH 510(k) files

Facilitating Device Innovation – >80% of device companies have <50 staff – CDRH/ OSEL wants to build a scientific bridge with the small,

innovative companies where so many new products will be designed

– Decoupled from any formal regulatory process – Intended to give early stage companies a look at questions that we will

be asking anyway (hopefully)

Representative device development path

CDRH Research Summary

• Crazy breadth of products are defined as devices, including software

• CDRH needs a crystal ball • CDRH/ OSEL is also the home of

– Advanced Characterization Facility – High Performance Computer – Advanced Additive Manufacturing

(3D Printing)

Example of depolarization

Example of 3D printing