Who

We Are

Agilis Consultants

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Agilis consultants represent a team of experienced and passionate experts committed to excellent client service to produce measurable results amid a constantly changing technological and regulatory environment.

Agilis Team

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pat-patterson

Pat Patterson, CPT

President and Co-Owner
  • Currently serves as an instructional design technical expert to FDA
  • Industry advisor to FDA’s Home Healthcare Initiative
  • Member of AAMI’s Home Healthcare Standards Committee
  • Primary author of AAMI’s TIR 49:2013 Design of training and instructional materials for medical devices used in non-clinical environments
  • Faculty for AAMI’s Human Factors course for evaluating instructional materials
  • Co-author of the Documentation and Training chapter in HE75: Human Factors Design for Medical Devices
  • Member of Women Business Leaders in Healthcare

Areas of Specialty:

– Client care and success
– Human factors and regulatory strategies
– Instructional design and user training strategies

melissa-lemke

Melissa Lemke

Director of Human Factors Engineering and Co-Owner
  • Biomedical engineer
  • 14+ years in Human Factors, home healthcare and accessible design of medical devices
  • Member of AAMI’s Human Factors Engineering Standards Committee and Home Healthcare Standards Committee
  • Co-author of HE 75, including lead author of Accessibility Considerations
  • Faculty for AAMI’s Human Factors course for evaluating instructional materials
  • Lecturer in Design and Disability at the University of Wisconsin – Milwaukee
  • Managed Research Center on Accessible Medical Instrumentation at Marquette University

Areas of Specialty:

– Designing sound human factors strategies for early and late stage formative evaluations and validation studies
– Managing cross-functional and technical teams for human factors initiatives
– Conducting expert reviews of client internal human factors and product development processes

renee-bailey

Renee Bailey

Director of Instructional Design & Creative Solutions
  • 20 years designing and developing instructional materials for companies including medical device manufacturers and pharmaceutical companies
  • Certified expert practitioner in evidence-based instructional design methodology
  • Faculty for AAMI’s Human Factors course for evaluating instructional materials

Produces:

– User performance supports, such as:

User Guides/Quick Guides
Instructional videos
Other print and digital aids

– Training content including individual courses and comprehensive training curricula
– Print based or digital/electronic materials including blended learning solutions
– Instructional support plans to evaluate and track training effectiveness

Area of Specialty:

– Working with cross functional product teams
– Project management of large, complex projects
– Developing instructional strategies that support user performance

bob-north

Bob North, PhD

Strategic Partner
  • Former manager of HF group at Medtronic Cardiac Rhythm Division
  • Consultant to FDA/CDRH in post market analysis methods for isolating HF problems
  • Member of AAMI’s Human Factors Engineering Standards committee
  • Co-author of HE75
  • Conducted over 50 sponsor pre-market HF submission audits for CDRH/CDER/OCP approvals
deb-billings-broky

Deb Billings Broky, PhD

Human Factors and Usability Consultant
  • 11+ years of experience, including simulation-based training & usability of medical devices
  • Former Research Fellow (US Army Research Institute) and Institutional Review Board (IRB) committee member

Areas of Expertise:

– Research planning & experimental design
– Quantitative and qualitative research methods
– Applied statistics & analysis
– User-centered design
– Preliminary analyses, including task analysis, PCA analysis, and heuristic analysis
– Formative evaluation and validation testing plan development consistent with FDA guidance
– Moderation/study facilitation, data collection, and data analysis
– HFE/UE report development

Stephanie Quinn, PhD

Human Factors and Usability Consultant
  • 9+ years of experience in applied cognitive research, including the investigation of perceptual and behavioral responses in simulation-based environments
  • Previous Department of Defense experience includes tactical decision making under stress and training effectiveness evaluations
  • Extensive experience in qualitative and quantitative tools and data collection, including task analysis, focus groups, usability testing, and statistical methods

Specialties include:

– Applied Human Factors
– Physiological measurements
– Data collection/analysis
– Immersive virtual environments
– Human-computer interaction
– Human performance (or “Human factors performance testing”)

ashley-french

Ashley French

Human Factors and Usability Consultant
  • Biomedical Engineer
  • Former clinical engineer specializing in surgical technology
  • Software design and tester
  • Currently pursuing MS in Human Factors

Specialties include:

– Medical device design
– Software engineering
– Accessible design
– Usability testing

Leah Taylor

Human Factors and Usability Consultant
  • Master’s Degree in Biomedical Engineering  with applied biomechanics research experience
  • Former research engineer at Mayo Clinic experienced in quantitative and qualitative research with participants
  • Experienced working with large research teams such as surgeons in the operating room environment, including IRB approvals, recruitment, facility coordination, and data management.

Specialties include:

– Project management
– Validation testing and technical writing
– Multidisciplinary and multi-center collaborations
– Surgical skills training and operating room data collection

Sophia Kalita

Human Factors and Usability Consultant
  • Biomedical Engineer
  • 10+ years of product development experience in medical device industry
  • Cross-functional team leader with focus on design controls and project management

Areas of Specialty:

– Project management
– Product design and usability testing
– Data analysis and technical writing
– Industry standards and best practice

chloe-leibowitz

Chloe Leibowitz, R.N. B.S.

Clinician/Educator
  • Technical healthcare advisor
  • HCP educator during HF studies
  • Former Senior Clinical Site Monitor for BMS
  • Former Clinical Investigative Representative for Eli Lilly
  • Former Certified Diabetes Educator

Other therapeutic areas:

– Oncology
– Infectious Disease
– Neuroscience
– Immunology
– Pediatrics
– Cardiovascular
– Respiratory

kari-rice

Kari Rice

Human Factors and Usability Consultant
  • 15+ years in design of medical devices and combination products both as an employee and as a consultant
  • Lead human factors efforts on defibrillators, ultrasound systems, implantable neurostimulators, insulin delivery products, and aesthetic devices
  • Experience working in diverse teams with competing demands

Areas of specialty include:

– User research
– Physical and ergonomic design
– Usability testing
– Validation testing

Damon Cook

Damon Cook

Human Factors and Usability Consultant
  • Over 10 years of Human Factors experience, focused on medical devices and combination products
  • Master’s Degree in Human-Computer Engineering

Areas of specialty include:

– Human Factors for surgical workflow and technologies
– Human Factors for home-use combination products
– Process development and project planning for Human Factors
– Rapid prototyping and assessment for Agile processes

Human Factors Experts

The Agilis process prepares our clients to answer Regulatory’s most fundamental bottom line question: “Show us the body of evidence that provides a compelling, comprehensive and valid case that your device and IFU support safe and accurate user performance.”