The system · v0.1
The lifecycle map
Seven phases of medical device development, and the work each one produces across six disciplines. Every MOS skill is placed somewhere on this map, which is how the map doubles as the skill catalog.
01
What each phase produces
Select a phase. Post-market evidence feeds back into design, so the last phase is not the end — it is where the next round of design inputs comes from. And you do not start at 00: you start wherever your project already is.
Feasibility and technology options
Unmet need and standard of care
Preliminary classification and pathway
Market size and competitive landscape
Initial hazard identification
Freedom to operate and IP landscape
Manufacturing feasibility and process options
Product requirements and architecture
Target population and endpoints
Intended use, indications for use, risk plan
Value proposition, pricing hypothesis, reimbursement path
Design and development plan
Applicable standards and guidance list
Make-versus-buy and supplier strategy
Design inputs and outputs, design reviews
Early human factors and clinician input
Risk file, design controls, supplier controls
Cost of goods and business case
Verification and validation planning
Prototype builds and design iterations
Usability engineering file opened
Verification testing, biocompatibility, software validation
Usability validation, pilot or pivotal study
Test plans and reports, traceability
Launch readiness and KOL engagement
Sterilization and packaging validation
Design review and design freeze
Clinical evaluation report
Technical file assembly
Clinical evidence summary
510(k), De Novo, PMA, CE mark; submission strategy
Payer strategy and coding
Labeling and instructions for use
Quality system readiness for audit
Responses to agency questions
Design transfer and manufacturing readiness
Training materials
Labeling, registration, QMS readiness
Sales model, pricing, distribution
Process validation — IQ, OQ, PQ
Post-market surveillance plan
Complaint handling and field service setup
Design changes and CAPA inputs
Post-market clinical follow-up
Complaints, vigilance, surveillance
Adoption, expansion, next indication
Periodic safety and performance reporting
Change control and re-validation
Yield improvement and cost reduction
Open for debate
The phase names, whether concept and definition should merge, and whether these are the right discipline cuts. None of it is settled, and arguing with it is a contribution.
02
The six disciplines
Every row on the map carries one or more of these tags. Most real work carries more than one, which is the point.
Technical
Does the device work?
Requirements and architecture, design inputs and outputs, prototypes, verification testing.
Clinical
Does it work for real patients?
Unmet need, target population and endpoints, human factors, studies, post-market follow-up.
Regulatory
Are you allowed to sell it?
Classification, intended use and indications, the submission file, labeling, reporting.
Quality
Can you prove any of it?
Design controls, the risk file, traceability, supplier controls, CAPA, audit readiness.
Manufacturing
Can you build it repeatably?
Process design, suppliers, design transfer, sterilization and packaging, validation, yield.
Commercial
Will anyone pay for it?
Value proposition, reimbursement and coding, pricing, distribution, adoption.
Nobody teaches you this
There is no degree in medtech. Most people learn one domain on the job and meet the other five by getting something wrong — an intended use written without a reimbursement path, a design frozen before manufacturing was consulted.
So MOS is not only skills. The Medtech Mindset Classroom covers each domain on screen: what the work involves, why it is done that way, and how to run the skills that turn it into focused outputs. A skill produces the draft. Knowing the domain is what lets you judge it.
The education layer is being built alongside the skills. Current status is on the home page.