Industry
Medtech Innovation Needs a Digital Upgrade
BCG overview of why medtech is shifting from one-time products toward digital platforms, closer user feedback, and new talent models.
How to use this library
Start with the section that matches the decision in front of you. These links are not a certification path or legal advice; they are selected to help non-specialists understand the language, tradeoffs, and evidence expectations behind medtech software and hardware decisions.
External links open in a new window. For each topic, read one industry piece to understand business context, one academic or public-sector piece to understand evidence and implementation, and one official source when the topic touches regulation, privacy, cybersecurity, or funding.
Medtech Strategy And Ecosystem
Industry
How the Medtech Industry Can Capture Value from Digital Health
McKinsey article on how digital health changes medtech business models, customer relationships, and ecosystem strategy.
Academic
Beyond Validation: Getting Health Apps into Clinical Practice
npj Digital Medicine review on why validated health apps still need workflow integration, payment models, support, and adoption planning.
Clinical Workflow, Users, And Equity
Public agency
How to Map Workflows in Health Care Settings
AHRQ plain-language tool for understanding workflow mapping before technology changes clinical work.
Public agency
Guide to Integrate Patient-Generated Digital Health Data into EHRs
AHRQ guide on patient-generated data, clinical burden, equity risk, usability, and workflow integration.
Academic
A Framework for Digital Health Equity
npj Digital Medicine review explaining how digital tools can widen or reduce access gaps depending on design and implementation.
Software, Interoperability, And Data Exchange
Standards community
Welcome to the HL7 FHIR Foundation
Non-technical introduction to FHIR and why interoperability matters for health data exchange.
Public agency
Health Level 7 Fast Healthcare Interoperability Resources
HealthIT.gov explainer on FHIR and the standards ecosystem behind modern health data exchange.
Industry
Digital Transformation and Interoperability
Deloitte overview of why interoperability, digital transformation, and connected care are strategic issues, not only technical integration tasks.
AI, Evidence, And Model Change
Academic
The Practical Implementation of Artificial Intelligence Technologies in Medicine
Nature Medicine perspective on workflow, privacy, transparency, interoperability, patient safety, and regulation for medical AI.
Official source
Artificial Intelligence in Software as a Medical Device
FDA landing page for AI/ML software as a medical device action plans, guiding principles, and regulatory thinking.
Official source
Transparency for Machine Learning-Enabled Medical Devices
FDA, Health Canada, and MHRA guiding principles on transparency for machine-learning-enabled medical devices.
Regulatory, Quality, And Risk
Official source
Health Canada: Software as a Medical Device Definition and Classification
Official Canadian guidance for deciding when software may be regulated as a medical device and how classification works.
Official source
How to Determine if Your Product is a Medical Device
FDA overview for founders learning how intended use and claims influence whether a product is treated as a medical device.
Official source
Overview of Device Regulation
FDA overview of device regulation, including risk classification and quality management expectations.
Privacy, Security, And Postmarket Operations
Official source
Medical Device Cybersecurity: What You Need to Know
FDA consumer-facing explanation of connected medical device cybersecurity and why software maintenance matters.
Public agency
Guide to Privacy and Security of Electronic Health Information
HealthIT.gov resource on privacy and security responsibilities around electronic health information.
Public agency
NIST Cybersecurity Framework 2.0: Small Business Quick-Start Guide
NIST guide for smaller organizations that need a practical cybersecurity framework without starting from technical jargon.
Procurement, Value, And Total Cost
Academic
Value-Based Procurement for Medical Devices: A Scoping Review
Open-access review of value-based procurement, including total cost of ownership and outcomes beyond purchase price.
Industry / public sector
Total Cost of Ownership Guide
Ontario Centre of Innovation guide to thinking beyond purchase price when evaluating healthcare technology investments.
Industry
Medtech's New Era of Collaboration and Innovation
BCG article on the pressures facing medtech, health systems, and ecosystem collaboration.
Funding And Commercialization In Canada
Official source
NRC IRAP: Support for Technology Innovation
Official overview of advisory services and funding support for Canadian SMEs developing technology innovations.
Official source
Mitacs Accelerate
Mitacs overview of research internships that connect companies, academic supervisors, and student or postdoctoral talent.
Official source
CRA SR&ED Tax Incentives
Official source for the Canadian Scientific Research and Experimental Development tax incentive program.
Official source
Alberta Innovates: Digital Health Sandbox
Alberta Innovates example of provincial support for digital health technologies, interoperability, and clinical-setting development.
Official source
Regional Defence Investment Initiative in the Prairies
PrairiesCan overview of RDII for SMEs and ecosystems with credible defence or dual-use supply-chain opportunities.
Official source
SSHRC Partnership Engage Grants
SSHRC program page for short-term partnered research between post-secondary institutions and partner organizations.
Practical next step
Pick one section and read two sources before your next planning meeting: one for business context and one for evidence, implementation, or official expectations.
- Apply it: turn one reading into a question for your stakeholder map, builder brief, risk register, or funding stack.
- Useful companion: search the workbook by the topic you just read.
- Templates: use a worksheet to convert the reading into an artifact.