TrainingOS

Marcus Johnson

Healthcare training specialist creating FDA-compliant learning experiences for medical device and pharmaceutical organizations.

Freelance Available
Boston, MA
6
Projects
2
Courses
5+ years experience
Member since January 2024
OverviewWork
6
CredentialsEvents
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ActivityTestimonials
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Healthcare Training
NDA Protected

FDA Medical Device Training Suite

Comprehensive training suite for medical device sales and clinical support teams meeting FDA requirements.

324 views
9/1/2024
FDA Medical Device Training Suite

Experience the Deliverable

Launch the interactive course built for this project.

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ADDIE Process

Analyze

Identify needs, learners, and goals

Design

Create learning objectives and strategy

Develop

Build content and materials

Implement

Deploy training to learners

Evaluate

Measure effectiveness and iterate

Analyze

Identify needs, learners, and goals

Design

Create learning objectives and strategy

Develop

Build content and materials

Implement

Deploy training to learners

Evaluate

Measure effectiveness and iterate

Project timeline

3 updates

Apr 1, 2024milestone

Legal & regulatory alignment workshop

Jun 10, 2024milestone

Pilot with clinical specialists

Sep 1, 2024milestone

National rollout + LMS packaging

Overview

A complete training program for medical device company sales and clinical support teams, ensuring full FDA compliance while providing deep product knowledge. Suite includes: - Product anatomy and function modules - Clinical application scenarios - Regulatory compliance training - Sales conversation frameworks - Competitor differentiation training

The Challenge

Field teams needed consistent, audit-ready messaging on a complex device portfolio while protecting confidential launch details under NDA.

The Solution

A modular curriculum mapped to FDA promotional guidelines: role-specific pathways, attestations, and downloadable job aids with version control.

Key Decisions

NDA-aware design choices: - Public portfolio shows role and outcomes only — artifact titles are abstracted - Screenshots use neutral wireframes; proprietary UI is never shown - Metrics are aggregated ranges approved by Legal

Results

Results (aggregated / approved for external sharing): - Audit-ready completion records across 12 regions - 98% course completion within launch window - Zero promotional review findings tied to training materials

Tools Used

Articulate 360
Adobe Captivate
Veeva Systems

Key Metrics

850

Learners Reached

98%

Completion Rate

Timeline

4/1/2024 - 9/1/2024

Tags

FDA
Medical Device
Healthcare
Sales Training
Compliance