The Agilis Team

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pat patterson
President & Co-Owner

  • 20+ years in the medical device/product industry

  • 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

  • Faculty for AAMI Instructional Design Course

  • Key contributor on the AAMI TIR 49:2013 Design of training and instructional materials for medical devices used in non-clinical environments writing team

Areas of Specialty:

  • Client care and success

  • Human factors and regulatory strategies

  • Instructional design and user training strategies

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melissa lemke
Managing Director, Human Factors Engineering &
Co-Owner

  • Master’s Degree in Biomedical Engineering

  • 15+ years in HFE, home healthcare and accessible design of medical devices

  • 19 years as a lay caregiver for brother with spinal cord injury

  • Faculty for AAMI HF Course and Instructional Design Course

  • Member of AAMI’s Human Factors and Home Healthcare Standards Committees

  • Co-author of original HE-75 (2009) and leading committee revisions for 2019 update

  • Invited author for 4 chapters in Elsevier/AAMI HF book and HF chapter in AAPS/Springer Combination Products book (2019)

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

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renee bailey
Director of Instructional Design & Creative Solutions

  • 20 years designing and developing instructional materials for Fortune 100/500 companies including medical device manufacturers and pharmaceutical companies

  • Certified expert practitioner in evidence-based instructional design methodology

  • Experienced working in cross functional product teams

  • Instructional design expertise includes developing:

    • User performance supports, such as:

      • User Guides/Quick Guides

      • Instructional videos

      • Other print and digital aids

    • Individual courses as well as comprehensive training curricula

    • Print based or digital/electronic materials including blended learning solutions

    • Instructional support plans to evaluate and track training effectiveness

Areas of Specialty:

  • Working with cross functional product teams

  • Project management of large, complex projects

  • Developing instructional strategies that support user performance.

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Deb Billings, phd
Senior Consultant, Human Factors Engineering

  • 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 Specialty:

  • 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

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Jessie Huisinga, Phd
Senior Consultant, Human factors Engineering

  • Doctorate in Biomechanics with extensive research experience

  • Former research laboratory Director and Primary Investigator with extensive IRB experience

  • 12+ years of experience in human movement performance and human subjects study design.

  • Experience leading large research teams including multidisciplinary and multi-center collaborations in Neurology, Rehabilitation Medicine, Movement Disorders, Physical Therapy, Occupational Therapy, Kinesiology.

Areas of Specialty:

  • Research planning & experimental design

  • Quantitative and qualitative research methods

  • Applied statistics & analysis

  • Human movement analysis

  • Moderation/study facilitation, data collection, and data analysis

  • Physiological measurements

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Sophia Kalita
Consultant, Human factors Engineering

  • Master’s Degree in Biomedical Engineering

  • 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

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Leah Taylor
Consultant, Human Factors Engineering

  • 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.

Areas of Specialty:

  • Project management

  • Validation testing and technical writing

  • Multidisciplinary and multi-center collaborations

  • Surgical skills training and operating room data collection

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Kristen Breunig
Client Support Specialist

  • Bachelor’s degree in business marketing

  • 10+ years working in Marketing and Communications across multiple industries

  • Manage strategic communication with either external partners or internal team to deliver effective project results

Areas Of Specialty:

  • Email Marketing

  • Website Management

  • Customer Support both internally and externally

  • Research and Analysis