MedTech app development
JonWard Studios develops working prototypes and minimum viable products (MVPs) for MedTech teams. A project can pair the working app with a regulatory strategy, design and development file, usability engineering file, testing, and source-code handoff.
The expected workflow moves onto a device quickly for review, testing, demonstrations, and the next development or investment decision.
Discuss a MedTech appMedical-device regulatory and quality experience
Successful FDA 510(k) submissions overseen
Two build levels
The right build depends on the workflow, intended users, near-term milestone, and what the app needs to demonstrate.
A simpler design and build for concept review, workflow testing, demonstrations, or an investor meeting.
A broader working build for evaluation, testing, demonstrations, or fundraising.
Client review and testing builds are provided through Apple TestFlight. Both build levels include the agreed tests and project records. Delivery targets begin after the scope and required project inputs are agreed.
MedTech project records
The file contents reflect the product, intended use, agreed build, and stage of development.
Developed from the concept inputs and intended use.
Agreed requirements, design, risks, traceability, testing, cybersecurity, and release records.
Usability records developed with the build.
Applicable FDA device-software and cybersecurity guidance and relevant ISO 13485 design and development requirements.
The resulting records can be carried into future development and premarket submission work.
Depending on the agreed scope, the completed build and records may be ready for formative or summative usability testing.
Development path
Confirm the intended user, expected workflow, milestone, and required project inputs.
Map the screens, interactions, requirements, and data for the agreed workflow.
Develop the working app alongside its design, development, regulatory, usability, and test records.
Complete the final review and receive the source repository and project files.
Further development and regulatory application work can be scoped separately if requested.
Start with the concept
Share the intended user, expected workflow, near-term milestone, and what the prototype or MVP needs to demonstrate.
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