Independent portfolio work. Not commissioned by, affiliated with or endorsed by the Health Sciences Authority. Built from public pages only; no workshop, sprint or user test has taken place.
Device market-entry checker: agile BA package
A product backlog, process models and executable acceptance criteria for the redesign proposed in an independent UX review of HSA's medical-device e-services (review, prototype). Source and walkthrough: GitHub repository.
34user stories in 6 epics
107points planned in 3 releases
46Gherkin scenarios
26automated runs against the prototype
51planted defects, all caught in CI
User story map
Backbone left to right, releases top to bottom. Green cards are built in the prototype and have executable acceptance tests. Numbers are story points.
| Start | Describe my business and device | See what applies | Check I can trust it | Act on it | Keep the rules right | Report an adverse event | |
|---|---|---|---|---|---|---|---|
| R1 MVP: one-page answer for Class B market entry | S-01 Reach the checker from every HSA entry point2 | S-04 Give my device's risk class or be sent to HSA's classification tools3 S-07 Be told what to fix when I miss an answer2 S-10 Complete the checker with the keyboard alone3 S-03 Get my dealer's licences from what my company will do5 S-05 Answer only the questions that matter to my case5 S-09 Go back and change an answer3 | S-17 Learn how to get access to SHARE1 S-11 See the fastest Class B registration route I qualify for8 S-14 See fees as application plus evaluation with a first-year total3 S-15 See the document checklist for my route3 | S-19 Be warned of forfeiture before choosing an immediate route2 S-18 Be told where HSA's own pages disagree3 | S-27 Get alerted to broken links on guidance pages3 | ||
| R2 All risk classes, trust and take-away | S-02 See what the checker covers and its as-at date before I start1 | S-08 Choose "None of these" without contradicting my other answers1 S-06 See an honest progress count1 | S-16 See which quality system evidence is accepted2 S-12 See my Class C route, including the EU-Australia MRA rule5 S-21 Retailers and re-exporters see what applies to them3 S-13 See my Class D route, including drug-device and excluded categories5 | S-20 See the HSA source behind every result block2 | S-22 Print or save my answer as a PDF1 S-23 Copy my answer as text for a colleague2 | S-26 Maintain route conditions in one table8 S-28 Test rule changes before they are published5 | |
| R3 Adverse event reporting online | S-24 Save my answers and continue later5 | S-33 Answer the consent question with Yes or No, not both1 S-32 Report as a clinic or home user without picking a hospital1 S-29 File an initial mandatory report online and get a reference number8 S-30 See which reporting deadline applies from the event category3 S-34 Be sent to the right report form from the landing page2 S-31 Look up IMDRF codes inside the form5 | |||||
| Won't (this time) | S-25 Pre-fill my SHARE application from the answer13 |
Process: As-Is and To-Be (BPMN 2.0)
As-Is: persona P1's current journey, 15 tasks, two dead ends and nine interpretive decisions. To-Be: the same goal with the checker. Files: process/ (open in bpmn.io or Camunda Modeler).
UML: the checker's main flow
Ordered backlog
Order: release, then WSJF. INVEST column order I N V E S T, each claim lint-checked against the data. AC = executable / specification-only scenarios.
| ID | Story | Release | MoSCoW | Pts | WSJF | INVEST | AC |
|---|---|---|---|---|---|---|---|
| S-01 | Reach the checker from every HSA entry point As P1, I want the "Check device's route" button and every self-help result link to open a working checker, so that I am not sent to google.com or a 404 page at the moment I need the answer. | R1 | Must | 2 | 17.00 | ✓✓✓✓✓✓ | 0 / 2 |
| S-17 | Learn how to get access to SHARE As P1, I want the Corppass steps for SHARE access in the result, so that my company's Corppass set-up does not block me after I have prepared everything. | R1 | Must | 1 | 15.00 | ✓✓✓✓✓✓ | 1 / 0 |
| S-04 | Give my device's risk class or be sent to HSA's classification tools As P1, I want to pick the risk class, or say I don't know, so that I either get the route for my class or know to classify the device first. | R1 | Must | 3 | 8.00 | ✓✓✓✓✓✓ | 1 / 0 |
| S-27 | Get alerted to broken links on guidance pages As CO, I want a scheduled link check that alerts me when a link fails, so that dead ends like the 404 checker are fixed within days. | R1 | Must | 3 | 7.00 | ✓✓✓✓✓✓ | 0 / 2 |
| S-07 | Be told what to fix when I miss an answer As P1, I want an error message next to the question when I continue without choosing, so that I can correct it without guessing. | R1 | Must | 2 | 6.50 | ✓✓✓✓✓✓ | 2 / 0 |
| S-10 | Complete the checker with the keyboard alone As P1, I want focus to move to each new question and every control to work with Tab, Space and Enter, so that I can use the checker without a mouse or with a screen reader. | R1 | Must | 3 | 6.00 | ✗✓✓✓✓✓ | 1 / 1 |
| S-03 | Get my dealer's licences from what my company will do As P1, I want to tick the activities my company will carry out with the device, so that I am told which dealer's licences I need without interpreting licence prose. | R1 | Must | 5 | 5.20 | ✓✓✓✓✓✓ | 1 / 1 |
| S-05 | Answer only the questions that matter to my case As P1, I want questions about approvals, history and safety to appear only when they can change my answer, so that I finish quickly and am not asked things that do not apply. | R1 | Must | 5 | 3.20 | ✗✓✓✓✓✓ | 1 / 0 |
| S-11 | See the fastest Class B registration route I qualify for As P1, I want the checker to work out the route from my approvals, marketing history, safety record and rejections, so that I do not have to interpret the route table against my device. | R1 | Must | 8 | 5.12 | ✗✓✓✓✓✓ | 2 / 0 |
| S-19 | Be warned of forfeiture before choosing an immediate route As P1, I want the consequence of an eligibility error shown next to an immediate route, so that I check every condition before I commit. | R1 | Must | 2 | 13.00 | ✗✓✓✓✓✓ | 2 / 0 |
| S-18 | Be told where HSA's own pages disagree As P1, I want a warning when the overview and the route guide state a condition differently, with the stricter reading applied, so that I do not rely on the more permissive page and lose my fees. | R1 | Must | 3 | 8.67 | ✗✓✓✓✓✓ | 2 / 0 |
| S-14 | See fees as application plus evaluation with a first-year total As P1, I want the route's application and evaluation fees and an indicative total including licences, so that I can budget without adding figures from three tables. | R1 | Must | 3 | 5.33 | ✗✓✓✓✓✓ | 1 / 1 |
| S-15 | See the document checklist for my route As P1, I want a checklist of the documents my recommended route needs, so that I can start preparing without opening a generic guidance index. | R1 | Must | 3 | 5.33 | ✗✓✓✓✓✓ | 1 / 1 |
| S-09 | Go back and change an answer As P1, I want a Back button that keeps my earlier answers selected, so that I can correct one answer without starting again. | R1 | Must | 3 | 4.33 | ✗✓✓✓✓✓ | 2 / 0 |
| S-02 | See what the checker covers and its as-at date before I start As P1, I want a notice saying the tool is independent, what it does not cover and the date its rules were read, so that I know how far to rely on the answer. | R2 | Should | 1 | 10.00 | ✓✓✓✓✓✓ | 1 / 0 |
| S-08 | Choose "None of these" without contradicting my other answers As P2, I want the "None of these" option to clear the agencies I ticked, and an agency to clear "None of these", so that my answer cannot say both. | R2 | Should | 1 | 7.00 | ✓✓✓✓✓✓ | 1 / 0 |
| S-20 | See the HSA source behind every result block As P1, I want each block to link to the HSA page it was transcribed from, opening in a new tab, so that I can check the rule myself. | R2 | Should | 2 | 6.00 | ✓✓✓✓✓✓ | 1 / 0 |
| S-06 | See an honest progress count As P1, I want the counter to say "of up to N" when later questions depend on my answers, so that I am not told there are more questions than I will see. | R2 | Should | 1 | 5.00 | ✓✓✓✓✓✓ | 2 / 0 |
| S-16 | See which quality system evidence is accepted As P1, I want the QMS evidence for each licence as a "one of these" list, so that I know a single certificate is enough. | R2 | Should | 2 | 5.00 | ✓✓✓✓✓✓ | 1 / 0 |
| S-22 | Print or save my answer as a PDF As P1, I want a print button on the result, so that I can file the answer with the application work. | R2 | Should | 1 | 5.00 | ✓✓✓✓✓✓ | 1 / 0 |
| S-12 | See my Class C route, including the EU-Australia MRA rule As P2, I want to be asked whether my EU and TGA approvals came via the MRA only when that matters, so that my approvals are counted the way the Class C guide says. | R2 | Should | 5 | 3.80 | ✓✓✓✓✓✓ | 1 / 0 |
| S-21 | Retailers and re-exporters see what applies to them As P1, I want retail-only and re-export-only companies to get their own short answer, so that they are not shown a registration route they do not need. | R2 | Should | 3 | 3.33 | ✓✓✓✓✓✓ | 2 / 0 |
| S-13 | See my Class D route, including drug-device and excluded categories As P1, I want Class D special categories to change the route and fees, so that I get the right route for high-risk devices. | R2 | Should | 5 | 3.00 | ✓✓✓✓✓✓ | 1 / 0 |
| S-26 | Maintain route conditions in one table As CO, I want route conditions held once and rendered into the overview, the guides and the checker, so that the pages cannot disagree again. | R2 | Should | 8 | 3.00 | ✓✓✓✓✓✓ | 0 / 2 |
| S-28 | Test rule changes before they are published As CO, I want a rule change to run the checker's acceptance tests before it goes live, so that an edit cannot silently change someone's route. | R2 | Should | 5 | 3.00 | ✗✓✓✓✓✓ | 0 / 1 |
| S-23 | Copy my answer as text for a colleague As P1, I want to copy the whole answer as plain text, so that I can paste it into an email or ticket. | R2 | Could | 2 | 2.50 | ✓✓✓✓✓✓ | 1 / 0 |
| S-33 | Answer the consent question with Yes or No, not both As P4, I want the consent question to accept a single answer, so that my consent is unambiguous. | R3 | Should | 1 | 10.00 | ✓✓✓✓✓✓ | 0 / 1 |
| S-32 | Report as a clinic or home user without picking a hospital As P4, I want the institution field to accept a clinic or "not applicable", so that I can submit a report that fits my setting. | R3 | Should | 1 | 8.00 | ✓✓✓✓✓✓ | 0 / 1 |
| S-29 | File an initial mandatory report online and get a reference number As P3, I want an online form instead of emailing a Word file, so that I get an acknowledgement and a reference number at submission. | R3 | Should | 8 | 3.62 | ✓✓✓✓✓✓ | 0 / 3 |
| S-30 | See which reporting deadline applies from the event category As P3, I want the deadline (48 hours, 10 or 30 days) shown when I choose the event category, so that I file on time. | R3 | Should | 3 | 8.00 | ✗✓✓✓✓✓ | 0 / 1 |
| S-34 | Be sent to the right report form from the landing page As P3, I want the landing page to ask whether I am a dealer or a user before showing a form, so that dealers do not file mandatory reports on the users' form. | R3 | Should | 2 | 6.50 | ✗✓✓✓✓✓ | 0 / 1 |
| S-31 | Look up IMDRF codes inside the form As P3, I want to search IMDRF terms from the form, so that I do not switch to another website mid-report. | R3 | Could | 5 | 2.00 | ✗✓✓✓✓✓ | 0 / 1 |
| S-24 | Save my answers and continue later As P1, I want a link that restores my answers, so that I can check a fact with a colleague and come back. | R3 | Could | 5 | 1.20 | ✓✓✓✓✓✓ | 0 / 2 |
| S-25 | Pre-fill my SHARE application from the answer As P1, I want the result to start my SHARE licence and registration applications with the facts I gave, so that I do not re-enter them. | – | Won't | 13 | 1.38 | ✗✓✓✓✗✓ | 0 / 1 |
Release forecast
Forecast, not actuals. Velocity is assumed at 8–14 points per 2-week sprint (likely 11). No team exists and no sprint has been run.
| Release | Points | Cumulative | Sprints (best–worst) |
|---|---|---|---|
| R1 MVP: one-page answer for Class B market entry | 46 | 46 | 4–6 |
| R2 All risk classes, trust and take-away | 36 | 82 | 6–11 |
| R3 Adverse event reporting online | 25 | 107 | 8–14 |
