25 YEARS OF EXPERIENCE
Specializing In:
Leading cross-functional teams,
With and without medical design experience,
Coordinating internal and outsourced resources,
Overcoming obstacles,
to Deliver Products On-Time, On-Budget
and
Successfully Transferring to Manufacturing
Michael Barsness
Top 5% most viewed LinkedIn profile.
(774) 922-7618
Introduction
25 Year Career in Medical Device Product Development
Vice President for Transfer to Manufacturing, Fluidnet
Senior Director of Engineering, Transport Pharmaceuticals
Senior Director of Instrument Development, Medtronic
Program Manager, Boston Scientific Contract
PMO, AspenTech
Software Engineering Manager, Medtronic
Senior Principal Engineer, Medtronic
Contract Software Engineer, Medtronic, Guidant
Medtronic World-Class Development Award
Medtronic
Bakken Award
Medtronic
Star of Excellence Nomination
Employees
Low Volume Capital Equipment
•
High Volume Disposable Embedded
•
Combination Products
•
Very-Low-Budget For-Clinical-Only Development
•
Program Management Office
•
Project Budgeting
•
Cost Reductions (64%, 20%, 58%)
Program Management
Cross-functional Teams: Leading Human Factors, Regulatory, Quality, Electronic, Software, Mechanical, Manufacturing
•
Internal and Outsourced Resources
•
3rd Edition: Gap Analysis and Team Leadership to Achieve Compliance FAST
•
Startups: Due Diligence Support. Financial Modeling, RFP's, Vendor Management
•
FDA Compliant Medical Device Apps
Telemetry, WiFi
•
NPI w/IDEO, Derivative Products
•
Defibrillator's, Pacing, Endoscopy, Robotic Instrument, ECG, Fibrillation Detection, Transdermal Drug Delivery, Production Machine Control Systems
•
60601 Safety, EMC Testing
•
Class II, Class III HW/SW
Quality Assurance
21 CFR 820, FDA, TUV, MDD, ISO 14971, IEC 62304, 62366, 60601-1
• Design control and PEMS compliant SOP's for product development
• 14971 Risk Management SOP's, risk management plans, reports
• Led multiple cross-functional teams through risk analysis, FMEA (HW/SW)
• At forefront of FDA Safety Case Initiative, AdvaMed/AAMI/FDA Mtgs
• Leading firm's to achieve 60601-1 3rd edition compliance
• Upgraded pre-GMP manufacturing SOP's to pass 2009 FDA audit
• Multiple FDA in-person pre-IND, pre-IDE meetings.
• Adapted Agile Software process for FDA compliance
• Developed and delivered design control training including software
• Software Validation.
Compliant Deliverable Matrix
FDA Compliant Agile Process
21 cfr 820 Training
Compliant Mfg Process SOP
Product Development SOP
ISO 14971 Compliant SOP
Software Development Plans
Product Development Plans
Risk Management Plans
V&V Plans
Mfg Process Qualification
Major Level of Concern SW
Configuration Management Plan
Software Compliance Audit
Software V&V Plan
Software Verification
Traceability Matrixes
IEC 60601-1 3rd Edition Audits
IEC 62366 Usability Audits
IEC 62304 Software Audits
Safety Case Analysis
FMEA, PFMEA
Gauge R&R Studies
Risk Analysis, Hazard Analysis
Stage Gate
3rd Edition
Steps to Compliance
STEPS TO COMPLIANCE
1. Upgrade Corporate SOP's for Compliance
• To 14971 Risk Management, 62366 Usability, 62304 SW
2. Map Risk Analysis to Over 120, 60601-1 Clauses
3. Compile Evidence for Each Product and the System
• Processes and Their Use: Risk, Usability, Software
4. Gap Fill
• And/Or Analyze Risks of Gaps for Legacy Systems
ISO 14971:2007
1. Policy and Procedures for Risk Analysis
2. Risk Management Plan
3. Risk Management Report
4. Risk Analysis
5. Evidence of Implementation and Verification of RCM's
6. Inclusion of Stds Driven Risks (62366, 62304, 60601-1)
7. 60601-1 RMF
IEC 62366
1. Application Specification
2. Frequently Used Functions
3. Hazards Related to Usability
4. Define Primary Operating Functions
5. Usability Specification
6. Usability Validation Plan
7. User Interface Design and Testing
8. Usability Validation
Clause 14 / IEC 62304
1. Safety Classification based upon Risk
2. Development Life Cycle
3. For Each PEMS/PESS:
PEMS: Plans
PEMS / PESS: Requirements
PEMS / PESS: Risk Analysis
PEMS / PESS: Architecture
PESS: Detailed Design
PESS: Unit Testing
PESS: Integration Testing
PEMS / PESS: Verification Testing / Traceability
COMPILE EVIDENCE
CONSULTING SERVICES
Gap Analysis (14971, 62304, 62366)
Compliance Plan
Compliance Team Leadership
SOP Revision and Upgrade
Facilitating Update of Risk Analysis
Risk Analysis to 3rd Edition Mapping
Technical Review File Completion
INTRO
STEPS
14971: RISK
62366: USABILITY
CLAUSE 14 / 62304
COMPILE EVIDENCE
SERVICES
FDA
as of July 1
14971
62304
62366
RMF
PUBLISHED AUTHOR: IEEE CONFERENCE ON MEDICINE AND BIOLOGY
• Studies in Drug Transport vs. Current In Iontophoretic Onychomycosis Treatment
PATENTS
• Single Use Applicator Cartridge for an Electrokinetic Delivery System and Method for Self Administration of Medicaments
• Controlling Drug Transport and Current in Iontophoretic Onychomycosis Treatment
• Telemetry Gain Adjustment Algorithm and Signal Strength Indication in a Noisy Environment
• Current Density Detection and Control System and Method for an Electrokinetic Delivery of Medicaments
• Current Concentration System and Method for Electrokinetic Delivery of Medicaments
• Method and System for Treating of Onychomycosis with an Application having a Gel Medicament Layer
• Other confidential provisionals
An iontophoretic treatment system for onychomycosis, using drug applicators targeting either toe nail only or nail and surrounding tissue, is analyzed. Phase 1 clinical data shows levels of drug delivery that differ unexpectedly from relative dosing level to multiple tissue types. Current monitoring and analysis techniques, coupled with assays of drug delivery into excised nail and cadaver toe, were used to evaluate drug delivery vs. current flow. The results indicate good correlation with piecewise linear models of current flow and extracted drug in the nail-only application. For the nail and surrounding tissue application, assayed drug levels indicate that on average, drug load per unit dose (mA-min) is more efficient into nail than into surrounding tissue (2.38:1 ug/mA-min nail vs. surrounding tissue, n=6, p=0.009).
INTRO
PROGRAM MANAGEMENT
QUALITY
3RD EDITION
PATENTS / PUB'S
29 Pine Ridge Drive, Oxford, MA 01540
(c) Barsness Medical Device Consulting Inc 2011-2013
