I need the shortest overview
Start with the one-hour talk companion, then use software and hardware basics for plain-language definitions.
How to use this map
The workbook is deeper than the one-hour talk. You do not need to read every page in one sitting. Use this map to choose the path that matches the decision you need to make now: stage, workflow, software, hardware, regulation, integration, security, funding, pricing, or launch readiness.
The strongest learning path moves from shared language to concrete decisions. First understand the system, then identify stakeholders and workflow risks, then use the specialized pages to plan evidence, architecture, security, deployment, cost, funding, and team ownership.
Choose by decision
I do not know my stage
Open the stage planner to choose ideation, prototype, pilot, production, or scale and see the next technical and business questions.
I need a build estimate
Read getting started with engineering, then prepare a builder brief before asking for time or cost estimates.
I need to sell into a health system
Start with the medtech ecosystem, then read interoperability, TCO, and the CareLink integration case.
I need a funding path
Read funding in Canada and Alberta, then use the funding stack case to compare RDII, Mitacs, IRAP, SR&ED, NSERC, SSHRC, CIHR, and Alberta Innovates.
I need a reusable artifact
Go to templates and workshop resources for Gantt schedules, logic models, SMART goals, PIA worksheets, SBOM inventory, V&V plans, and risk matrices.
Stage-to-resource route finder
If you are short on time, pick the row closest to your current stage and produce the artifact in the last column.
| Stage | Read first | Then read | Useful artifact |
|---|---|---|---|
| Ideation | Talk companion | Medtech ecosystem and clinical workflows | Stakeholder register and assumption log |
| Prototype | Engineering starter guide | Native vs PWA and architecture patterns | Builder brief and architecture review checklist |
| Pilot | Canada and Alberta context | V&V, deployment, and threat modeling | PIA inputs, V&V plan, and support runbook |
| Production | QMS essentials | IEC 62304, postmarket cybersecurity, and hosting costs | Release plan, SBOM, incident response plan, and cost model |
| Scale | Team and stack | TCO, funding, and founder cases | Capability map, funding stack, and procurement-ready business case |
Full workbook map
Fast orientation path
- One-hour talk companion
Use during the live session to keep the main concepts visible.
- Stage planner
Choose the stage, product focus, user count, pricing model, and next technical/business pathway.
- Program structure
Understand how the workbook is organized and what learners should be able to explain.
- Software and hardware basics
Build shared language for apps, APIs, servers, databases, cloud systems, sensors, firmware, and AI-assisted prototyping.
- Medtech ecosystem
Connect the technical product to clinical, operational, privacy, security, quality, regulatory, finance, and procurement stakeholders.
Building software pathway
Choose this path when the product is mainly an app, dashboard, API, cloud service, data system, AI feature, or software-enabled workflow.
1. Shape the build
Getting started with engineering explains what builders need before they can estimate or build responsibly.
2. Choose the app approach
Native vs PWA helps teams decide between mobile apps, web apps, and hybrid strategies.
3. Plan the architecture
Architecture patterns explains cloud-first, edge-heavy, and hybrid system choices.
4. Run the lifecycle
SDLC stages and IEC 62304 connect development work to controlled records and maintenance.
5. Prove it works
Verification and validation explains why demos are not enough for medtech readiness.
6. Govern data and AI
Data governance, AI/ML, and model monitoring cover data quality, oversight, drift, and controlled change.
Building hardware pathway
Choose this path when the product includes a sensor, connected device, firmware, edge processing, wireless connection, field service, or physical deployment constraint.
1. Understand signals
Sensors and signal chains explains how raw physical measurements become data your software can use.
2. Choose edge and connectivity
Edge, firmware, and connectivity covers offline behavior, BLE, Wi-Fi, cellular, firmware, and secure updates.
3. Plan reliability
Reliability, power, and thermal tradeoffs explains battery life, heat, wear, field conditions, and service economics.
4. Tie hardware to risk
ISO 14971 risk engineering connects sensor limits, device failures, usability, and postmarket feedback to safety controls.
5. Support the live system
Deployment and observability and postmarket cybersecurity cover monitoring, patching, incidents, and support.
6. Model cost
Hosting cost and TCO make the device plus cloud plus support model visible.
Regulatory and quality pathway
- Canada and Alberta context
Start with privacy, custodians, PIAs, data residency, and local deployment assumptions.
- Health Canada and ecosystem strategy
Clarify intended use, claim boundaries, evidence maps, and standalone versus integrated positioning.
- FDA pathways
Use U.S. pathway language to pressure-test claims, predicates, novelty, and evidence burden.
- Design controls
Connect user needs, requirements, outputs, verification, validation, and change impact.
- ISO 13485 QMS
Understand the operating system for controlled documents, supplier control, training, CAPA, and release discipline.
- ISO 14971 risk engineering
Make safety risk visible from concept through postmarket learning.
Operations, integration, and business pathway
Clinical workflow
Clinical workflows before code shows why care pathways, handoffs, interruptions, and overrides shape product requirements.
Interoperability
HL7, FHIR, and DICOM explains integration standards and why an integration brief matters before build.
Cybersecurity
Threat modeling and postmarket cybersecurity connect attack surfaces to operating controls.
Deployment
Deployment and observability covers release, rollback, logs, metrics, alerts, and incident response.
Hosting and cost
Hosting providers and TCO connect architecture choices to monthly cost and buyer value.
Funding
Funding in Canada and Alberta helps map milestones to grants, tax credits, partnerships, and runway planning.
Reference and workshop resources
Use these when the next step is discussion, comparison, teaching, or artifact creation rather than learning another technical concept.
Case studies
Founder case studies provide realistic Alberta and Canadian decision scenarios covering hardware/software scaling, VC versus bootstrapping, integrations, talent, AI cost, and funding stacks.
Templates
Templates and resources turn discussion into concrete artifacts: Gantt schedules, logic models, SMART goals, builder briefs, PIA worksheets, SBOMs, V&V plans, and risk registers.
Reading library
The reading library collects accessible industry, academic, and official sources for non-specialists who need stronger context before making a decision.
Glossary
The glossary is the quickest way to clarify terms such as FHIR, PIA, SBOM, PCCP, QMS, TCO, CAPA, validation, firmware, and data residency.
Search
Search the workbook when you remember a term, funding program, stakeholder group, worksheet, or acronym but not the module name.
Capstone
The integrated workshop combines software, hardware, privacy, regulatory, AI, deployment, and business-model decisions in one scenario.
Capstone readiness path
Before the integrated workshop, read enough to explain the product system, data path, risk controls, privacy assumptions, AI boundaries, monitoring plan, and cost model.
Practical next step
Pick the pathway that matches your next real decision. If you are not sure, start with the stage planner, then use this page to choose the smallest useful next reading and artifact.
- First decision: choose your current stage.
- First foundation: software and hardware basics.
- Working tools: templates and workshop resources.
- External context: reading library.
- Search: find a page by term, acronym, funding program, stakeholder group, or worksheet.