Working prototype or MVP
A mobile build of the expected workflow for testing and demonstration.
Digital tools and mobile apps
Mobile app development for MedTech.
JonWard Studios develops working prototypes and MVPs for MedTech teams. A project can include a baseline regulatory strategy, a baseline design and development file, a baseline usability engineering file, and source-code handoff.
We work quickly so teams can enter investor meetings with a working app, a documented workflow, and more confidence in the concept. We also build commercial apps using the same development process.
INPUT
01Concept + workflow
02Prototype or MVP
03Documentation + testing
04Source + handoff
OUTPUTWorking app and records
→25 years
Medical-device regulatory and quality experience
150+
Successful FDA 510(k) submissions overseen
MedTech
SaMD, regulatory strategy, and development records
Fast delivery
Five-day prototype and fifteen-day MVP targets
Two types of work
MedTech apps.
Commercial apps.
Both start with a defined user and workflow. Both end with working software and a documented build. MedTech projects add the regulatory and usability records.
Baseline design and development file
Requirements, architecture, risks, traceability, testing, and release records.
Baseline usability file
Usability documentation developed with the prototype or MVP.
Source code and handoff
Source repository, review deck, and development files.
Prototype and MVP work
Prototype and MVP are different engagements.
A prototype is a simpler design and build centered on the primary app workflow. An MVP connects the agreed core workflows and includes testing and records for that scope.
Documentation by project type
Every project includes a design and development file. Its contents reflect the product, intended use, and agreed build scope.
Design and development file with regulatory strategy
Includes the agreed requirements, design, risks, traceability, testing, and release records for the build.
MedTech work also includes a baseline regulatory strategy and baseline usability engineering file. Early-stage records are structured around applicable FDA guidance for device software and cybersecurity and relevant ISO 13485 design and development requirements.
The resulting baseline can be carried into future premarket submission work. Depending on the agreed scope, the build and records may be ready for formative or summative usability testing.
Design and development file
Includes the agreed requirements, design, risks, traceability, testing, and release records for the build.
Commercial work also includes a baseline usability file covering the workflow, use environment, and evaluation findings.
Choose the build level
Client review and testing builds are provided through Apple TestFlight.
01 / Prototype5 business days · target
Prototype Build Sprint
A simpler design and build focused on the primary app workflow for concept review, demonstration, or an investor meeting.
- The primary app workflow, built from start to finish
- Working mobile prototype
- Design and development records for the prototype scope
- Baseline usability file
- Review deck, repository, and handoff
02 / MVP15 business days · target
MVP Build Sprint
A broader working build that connects the agreed core workflows for evaluation, testing, or fundraising.
- The agreed core workflows, connected in one working app
- Working mobile MVP
- Design, development, and usability records for the agreed MVP scope
- Agreed tests, results, and release records
- Repository and handoff
Current mobile builds are delivered for iPhone and iPad. MedTech prototypes begin with synthetic or approved nonsensitive data. Further development and regulatory application support can be scoped separately if requested.
Selected work
Explore the portfolio.
Featured projectFast From
Why JonWard Studios
Medical-device experience.
Practical app development.
JonWard Studios is led by Jonathan Ward, whose 25-year career has supported more than 700 medical-device manufacturers and product teams and included oversight of more than 150 successful FDA 510(k) submissions.
The studio applies that FDA, quality, and SaMD perspective to MedTech and commercial mobile app development. The work combines a working application with the records needed to evaluate the concept and expected workflow before further investment.
Explore regulatory advisory at JonWard.ioHow we work
From concept to handoff.
Define the first build.
Identify the intended user, core workflow, milestone, and what the app needs to demonstrate.
Design the experience.
Map the screens, interactions, data, and requirements before development.
Build and document.
Develop the working prototype or MVP alongside its design, development, and usability files.
Review and hand off.
Review the working app and deliver the source code, repository, and project files.
Start with the concept
Tell us what you want the app to do.
Share the intended user, expected workflow, near-term milestone, and what the prototype or MVP needs to demonstrate.
Start a conversation