DEVICE PRODUCT DEVELOPMENT
Over the years I’ve worked on lots of device projects, usually of the “let’s commercialize this new technology” sort. Each project is different, but I think can be defined along the same 5 axes: urgency, team, cost, regulations, technology, volumes. In this essay I hold that, regardless of where along each axis a particular project falls, the roles needed are the same—though often one person must fill multiple roles. I’ll elaborate on each role in turn, but first I’ll describe each axis.
Axes
Urgency
Early in my career I thought everything had to be done “The Right Way”. I used to scoff when I would tear apart a device and see some nonsense; a solid piece of aluminum hollowed out save for one little fin, a mess of wires and glue, &c. A few years in I realized that sometimes something shitty that ships is better than something better that doesn’t. Of course no one, least of all designers and engineers, wants to ship something bad. Nevertheless, circumstances intervene and it can sometimes be the right, distasteful, call.
Team
Solo projects are deeply different than 2-man projects. 10-man projects are different yet again. More people means more horsepower, but it also means more communication overhead. Somewhere around 5-10 people it makes sense to have someone whose only job is to coordinate.
Experience matters too. A team of senior people tackling a familiar problem is different than that same team tackling a new problem or a bunch of new grads tackling anything. Much of a good coordinators job is checking in with the right people in the right way at the right time. Very tricfky.
Market: Cost
Market: Regulations
Technology
Volumes
But one thing is common: the devices exist to generate data. Sensors collect it, firmware processes it, algorithms interpret it, software displays it. Everything else—the enclosure, the battery, the regulatory filings—exists to support that data pipeline.
So I want to generalize what I can about these projects through the lens of data. If a role is neglected or a phase is rushed, how does the data suffer? Wrong data, bad data, less data, no data.
Functional Roles
Every product needs these roles filled. Big companies have one or more people in each. Small teams double up—your ME might also do manufacturing, your EE might write algorithms. The possibilities depend on who you’ve got.
The common thread: if any role is neglected, your data suffers.
Management
Product Management (PM)
Owns the product vision. Sits between what the tech lead says is doable and what sales wants. Makes the hard calls about what the product is.
If neglected: you’ll build the wrong thing and collect the wrong data.
Technical Lead (TL)
Owns system performance. Sits between what the PM wants and what the engineering teams say is possible. Makes the hard calls about how to build it.
If neglected: you won’t collect any data because the thing won’t work.
Technical Program Manager (TPM)
Owns schedule, budget, and logistics. Sits between what PM and TL want to do and what the resources allow. Makes the hard calls about when and how much.
If neglected: you’ll run out of money or time before you collect any data.
Device
Industrial Design (ID)
Makes the device something people want to use—easy, attractive, intuitive. Works closely with ME and PM.
If neglected: people won’t use it (no data) or they’ll use it wrong (bad data).
Mechanical Engineering (ME)
Makes sure parts fit, sensors reach what they need to reach, nothing breaks, and it’s cheap enough to build. Works closely with ID and EE.
If neglected: the device costs too much (no data), breaks (bad data), or the sensors can’t do their job (bad data).
Electrical Engineering (EE)
Picks and configures the components—processing power, sensors, power management. Works closely with ME and FW.
If neglected: the device costs too much (no data), is unreliable (bad data), or has weak sensors (bad data).
Firmware (FW)
Writes the code running on the device. Works closely with EE, SW, and Algo. May also work with ID on device UI.
If neglected: the device is unreliable (less data, bad data).
Interface
Software (SW)
Generally peripheral to device engineering. The critical device-related work is the mobile app (with ID) and data infrastructure (with FW and Algo).
If neglected: data never makes it off the device, or it’s unusable when it does.
Algorithm (Algo)
Turns raw sensor data into a digital biomarker. Works closely with FW and SW.
If neglected: you have data but it doesn’t mean anything.
Overarching
New Product Introduction (NPI)
Gets the device built at scale. Works closely with ME, EE, and FW.
If neglected: the device ships late (less data) or costs too much (no data).
Quality Engineering (QE)
Makes sure regulatory requirements are met. Works across ME, EE, FW, and Algo.
If neglected: the device can’t ship (no data) or gets recalled (no data, plus lawyers).
Disciplines: A Closer Look
To build a device you need ME, EE, and FW at minimum. Here’s how FW teams typically work—the others follow similar patterns.
Firmware Team Structure
A firmware team has developers, testers, a lead, and sometimes its own TPM if the team gets big enough.
FW Lead: Sets the architecture, high-level design, and test strategy. Breaks the system down into chunks that developers can build and testers can verify.
Developers: Build chunks of the architecture in code and unit tests. Also build tools and libraries for testing (BLE stacks, debug interfaces, etc.).
Testers: Write test strategies and protocols. Run tests against system requirements. May build automated integration tests.
Methodology
Firmware teams usually run some flavor of agile/scrum. The basics:
Tasks: The smallest tracked unit of work. Estimated in hours or points, usually a few hours to 2-3 days of effort.
Features (Stories): A user-facing capability that takes multiple tasks to build. “As a user, I can see my battery level” might break into tasks for the fuel gauge driver, the BLE characteristic, and the mobile app display.
Sprints: A fixed time window (usually 2 weeks) where the team commits to finishing a set of features. At the end, you demo what you built.
The trap with agile in hardware-adjacent firmware: sprints assume you can ship at the end of each one. But firmware often can’t ship until the hardware exists. So you end up with a backlog of “done” features you can’t actually verify until boards arrive. Plan for this.
Phases
What follows is a progression of maturity stages for a device development project. Laid out like this, it looks clean and linear. It’s not. Use it as a guide, not a script.
Each phase has inputs (what you need to start), work (what each role does), and gates (what you need to move on). I’ve added notes on what usually goes wrong.
Initiation
The goal here is to decide whether this project should exist. You’re writing the business case and defining scope—not designing the product yet.
What usually goes wrong: Teams skip this and jump into design. Then six months later, someone asks “wait, why are we building this?” and nobody has a good answer.
Work
Business Case: Write down why this project is good for the organization. Include history and context. Be honest about risks.
Scope: Describe the high-level goals. Just as important: describe what’s explicitly not in scope. Adjacent features that seem obvious will creep in later if you don’t fence them off now.
Objectives: Describe each objective in detail. Ideally this feeds into an OKR scheme—see Measure What Matters.
Team: Early on you can get away with a tech lead and a few engineers. If the pace is fast, make sure you can scale to all the roles above.
Costs/Benefits: Salaries, capital expenditure, unit costs, opportunity costs. Get real numbers, not vibes.
Gates
- Business case approved internally
- Scope documented and agreed upon
- Initial team identified
- Rough cost/benefit analysis complete
Planning & Requirements
The goal here is to define the product, staff the team, and nail down requirements. You’re also sizing the market opportunity.
What usually goes wrong: Requirements stay vague because nobody wants to commit. “We’ll figure it out as we go” is fine for some things but deadly for hardware. Changing requirements after tooling starts is expensive.
Inputs
- Product concept
- Market research
Work
PM:
- Size the total addressable market (TAM)
- Find the target audience and what they care about
- Make vs. buy analysis
- Write user needs
- Map the competitive landscape
- Set volume and cost targets
TPM:
- Set budget and schedule
- Staff the team
- Flag key demos and integration milestones
- Find NPI support
- Spot potential IP issues
TL:
- Draft product requirements
- Estimate material costs
- Estimate resources against schedule
- Flag risks
Gates
- Product definition approved internally
- First draft of marketing requirements
- Product one-pager
- Rough schedule
- Buy-in from execs and key partners on project charter
Architecture
The goal here is to find candidate end-to-end systems that could meet the requirements. You’re not picking one yet—you’re exploring options and understanding tradeoffs.
What usually goes wrong: Teams fall in love with the first architecture that seems to work. Then they discover a fatal flaw in PoC and have to start over. Explore at least two or three options here.
Inputs
- Draft concept/MRD
- Rough experience needs and use cases
- Architecture success criteria
Work
TPM:
- Draft program development plan
- Draft regulatory plan
- Create resource plan
- Create communication plan
TL:
- Draft PRD
- Start and maintain open issues list
- Flag regulatory requirements
ID:
- Define user interaction model
- Form studies
- Proof-of-concept sketches
- Volumetric renderings
ME:
- Research state of the art
- Flag mechanical risks
- Find environmental factors and operating ranges
- Spot critical features
- Volumetric study with EE
- Draft critical feature designs
EE:
- Research state of the art
- Flag electrical risks
- Preliminary BOM
- Volumetric study with ME
- System block diagram
- Eval boards or breadboards for risky items
- Component decision matrix
- Draft HW/SW interface doc
FW:
- Research state of the art
- Flag software risks and constraints
- System block diagram (FW architecture)
- Interface definition (product ecosystem)
- Draft software requirements
Gates
- Candidate design solutions documented
- Buy-in from execs on design risks
- Buy-in from execs on architecture direction
- PRD approved
- Development plan (cost, budget, schedule)
Proof-of-Concept (PoC) Builds
The goal here is to build and test enough variants of high-risk interfaces that you can pick one design concept for each. A good rule of thumb: the concepts you pick should be no more than three major iterations from mass production.
What usually goes wrong: Teams build one PoC, it works, and they declare victory. Then in Alpha they discover the PoC only worked because of a lucky sample or a benchtop power supply. Build enough PoCs to understand the variance.
Inputs
- Draft PRD
- Draft program development plan
- Updated MRD
- System architecture
- PoC success criteria
Work
TPM:
- Update PRD
- Update regulatory plan
- Manage and communicate risks
- Plan demos
ID:
- Draft A-surface CAD
- Build cosmetic models
- Update user interaction model
ME:
- Material and component trials
- Risky critical feature trials
- Test models
- Near-final-form (NFF) design/CAD package
- Initial ME BOM
- Update mechanical risks
- Draft CM criteria
- Alpha development plan
- Tolerance analysis for risky features
- Draft reliability test plan with EE
EE:
- NFF schematic, layout, EE BOM
- Functional NFF PoC system
- Key component selection
- Updated volumetric study with ME
- Full HW validation with SW
- HW/SW integration test
- Update electrical risks
- Draft CM criteria
- Alpha development plan
- Draft regulatory plan
- Create experience metric model
- Update HW/SW interface doc
- Draft reliability plan with ME
- Draft line test plan and limits
FW:
- Update and refine architecture
- EE schematic review
- Prototype (throwaway) code
- NFF hardware validation
- Update risks and constraints
- Development plan (WBS)
- Unit and integration test plan
- Update software requirements
Gates
- Critical components proven feasible
- Buy-in from execs on PoC system
Alpha Build
The Alpha (sometimes “E0” or “Proto”) is the first build in the intended form factor, or close to it. Mechanical parts are usually off-the-shelf, machined, or 3D-printed. A few might be tooled. EE boards are generally correct form factor.
Parts are built and tested in-house. The goal is enough confidence to start the RFQ process with contract manufacturers.
What usually goes wrong: The form factor introduces problems that didn’t exist on the benchtop. Thermal issues, antenna detuning, mechanical interference. Budget time to find and fix these.
Inputs
- Updated PRD
- Updated program development plan
- Draft reliability test plan
- Updated MRD
- Functional PoC
- Form factor and Alpha success criteria
Work
TPM:
- Update PRD
- Maintain open issues list
- Manage and communicate risks
- Monitor system integration
- Manage vendor relationships
- Mediate ID vs. cost vs. performance battles
- Plan demos
ID:
- Update A-surface CAD
- Draft CMF (color, material, finish)
- Validate user interaction
ME:
- Final component selection
- Update ME BOM
- Form-factor CAD package
- Functional form-factor prototypes
- Run high-risk reliability tests
- Update reliability plan with EE
ME/EE:
- Update reliability plan
- Update regulatory plan
- Flag CM criteria and risks
- Estimate costed BOM
- Develop test fixtures
EE:
- Form-factor schematic, layout, EE BOM
- Functional form-factor prototypes
- Validate form-factor hardware
- High-risk reliability and integration testing
- Validate user interaction
- Regulatory high-risk pre-scans
- Update experience metric model
- Update line test plan and limits
FW:
- Update and refine architecture
- Key product feature development (refactor from PoC)
- Bootloader
- Initial manufacturing test suite
- Regulatory test FW plan
- Develop test tools
- Development plan
- Update documentation (APIs, etc.)
- Update software requirements
- Update unit and integration test plan
Gates
- Integrated system proven
- Design ready for quoting
- Form factor approved by execs
- Regulatory plan locked
Request for Quote (RFQ)
The goal here is to take the Alpha design and refine it for volume manufacturing. You’re selecting factories and getting real cost numbers.
What usually goes wrong: Teams lowball the RFQ to hit a cost target, then discover during EV that the factory cut corners to hit that price. Be realistic about what things cost. Cheap tools make expensive problems.
Inputs
- Final PRD
- Final MRD
- CM short-list for RFQ
Work
TPM:
- Orchestrate RFQ package
- Organize test plans (reliability and line)
- Mediate cost vs. performance
- Support IP demands
- Factory selection
ME:
- EVT CAD package
- Tooling/fab strategy
- Restricted substances check
- FMEA
ME/EE:
- RFQ documentation packages
- DFx incorporation
- Updated costed BOM
- Update CM criteria and risks
- Define assembly instructions
- Finalize reliability plan
- Finalize line test plan
EE:
- Vendor schematic/design review
FW:
- Finalize manufacturing test suite
- Manufacturing test docs
NPI:
- Ramp up
- DFx input
- Review CM line process plan
- Review test plans
- Supply chain plan
- Sample allocation plan
- NPI build plan
Gates
- Factory selected
- Costs understood and accepted
- Build package complete
Engineering Validation (EV) Build
This is usually the first build at the production factory. Parts are made with production processes. Assembly includes required test stations.
What usually goes wrong: Everything. This is where you find out what the factory actually understood vs. what you thought you communicated. Expect yield problems, test escapes, and long debugging sessions. Budget for multiple trips to the factory.
Inputs
- Build package
- NPI build plan
- Line test plan
- Reliability test plan
- Functional form-factor units
- Manufacturing tests (firmware)
- Full QA coverage
- CM supply chain plan
- EV success criteria
Work
TPM:
- Mediate design transfer
- Manage and communicate risks
ID:
- Cosmetic review
ME:
- Production tooling review
- DV CAD package
- Update ME risks
ME/EE:
- Reliability results review
- Assembly process review
- Process capability review
- Enterprise BOM control
- Update risks
- Support regulatory testing
EE:
- DFx updates
- Approve proposed second-sources
- Fab and assembly docs
FW:
- Manufacturing test updates
- Line test troubleshooting
- Regulatory test support
NPI:
- Design ownership transfer
- Reliability review
- Qualification DOE
- Draft line documentation
- Draft line test coverage and limits
- Update NPI build plan
Gates
- Device is manufacturable
- Device meets regulatory requirements
- Assembly documentation complete
- Device meets assembly requirements
Design Validation (DV) Build
The goal here is to build the validated form-factor design in volume and fix any remaining design issues. Process issues come later.
What usually goes wrong: Teams assume EV fixed everything. It didn’t. DV will surface corner cases—units that passed line test but fail in the field, reliability failures that only show up at volume. Keep engineering engaged.
Inputs
- Updated NPI build plan
- Updated line documentation
- Successful EV build
- Successful regulatory testing
- EV yield and limit data
- EV reliability results
- Enterprise BOM control
- NPI team ownership
Work
TPM:
- Manage risks
ID:
- Cosmetic review
- Final CMF tweaks
ME/EE:
- Reliability results review
- Failure analysis assistance
- Design updates
- Update risks
EE:
- Review line limits and failure stats
FW:
- Manufacturing test updates
- Line test troubleshooting
NPI:
- Monitor line data
- Monitor reliability results
- Freeze test limits
- Qualification DOE
- Update line documentation
- Update line test coverage and limits
- Update NPI build plan
Gates
- Manufacturing process meets QC criteria
- CMF locked
Process Validation (PV) Build
The goal here is to build the validated DV design in high volume and fix any process and capacity issues. The design is frozen—you’re tuning the line.
What usually goes wrong: The line runs fine at 100 units/day but falls apart at 1000. Bottlenecks appear. Test stations become the constraint. Operators make mistakes the automation didn’t anticipate. This is why you do PV before MP.
Inputs
- Updated NPI build plan
- Updated line documentation
- Successful DV build
- DV yield and limit data
- DV reliability results
Work
TPM:
- Manage risks
ID:
- Cosmetic review
ME/EE:
- Reliability results review
- Failure analysis assistance
- Design updates
- Update risks
EE:
- Review line limits and failure stats
FW:
- Manufacturing test updates
- Line test troubleshooting
NPI:
- Monitor line data
- Monitor reliability results
- Qualification DOE
- Pilot units
- Update line documentation
- Update line test coverage and limits
- Update NPI build plan
Gates
- Process meets capacity and yield requirements for MP
Mass Production (MP)
You made it. The design is frozen, the process is validated, and units are shipping. Now the work shifts to monitoring, cost reduction, and field support.
What usually goes wrong: Teams declare victory and move on to the next project. Then field returns start coming in, and nobody’s watching. Keep someone on MP monitoring—line yields, reliability data, field return rates. Problems caught early are cheap to fix.
Inputs
- Successful PV build
- PV yield and limit data
- PV reliability results
Work
TPM:
- Project post-mortem
- Final documentation
ME/EE:
- Final documentation
FW:
- Field upgrade development
- Field upgrade test cases
NPI:
- Cost-down exercises (sourcing, design)
- Monitor line data
- Monitor reliability results
Gates
- Manufacturing process continues to meet QC and yield requirements
- Field return rates acceptable
- Functionality frozen (no more changes without a new project)
What’s Missing
This doc is still incomplete. I haven’t covered:
- Test engineering
- Regulatory affairs
- Quality systems
- Biostatistics
- Human factors / UX
- Clinical operations
- Clinical science
- Algorithm development in depth
- Common failure modes by phase
Maybe someday.