Working prototype or MVP
An iPhone or iPad build of the selected workflow.
MedTech + commercial app development
JonWard Studios develops working prototypes and minimum viable products (MVPs) for MedTech and commercial teams. Current builds are delivered for iPhone and iPad. MedTech projects can include a regulatory baseline, design and development file, usability engineering file, testing, and source-code handoff.
A prototype puts the primary app workflow on a device for testing, review, demonstrations, or investor meetings. An MVP includes the essential features needed for customer or beta use.
Medical-device regulatory and quality experience
Successful FDA 510(k) submissions overseen
SaMD, regulatory baseline, and development records
Five-day prototype and fifteen-day MVP targets
Two types of work
Both start with a defined user and workflow. Both include working software, testing, a design and development file, and a usability engineering file. MedTech work also includes a regulatory baseline and follows applicable FDA guidance and relevant ISO 13485 design and development requirements.
An iPhone or iPad build of the selected workflow.
Requirements, architecture, risks, traceability, testing, and release records.
Intended users, use environment, workflow, and completed usability work.
Source repository and project files for the completed build.
Prototype and MVP work
A prototype is a simpler design and build centered on the primary app workflow. An MVP includes the essential features needed for customer or beta use. Both are tested and documented.
Every project includes a design and development file. Its contents reflect the product, intended use, and agreed build scope.
Includes a regulatory baseline, design and development file, usability engineering file, testing, and source-code handoff.
Work follows applicable FDA device-software and cybersecurity guidance and relevant ISO 13485 design and development requirements.
MedTech app developmentIncludes a design and development file, usability engineering file, testing, and source-code handoff.
Prototype and MVP developmentClient review and testing builds are provided through Apple TestFlight.
A simpler design and build centered on the primary app workflow for concept review, demonstration, or an investor meeting.
A working app with the essential features needed for customer or beta use.
Further development and premarket submission work can be scoped separately.
Selected work
Why JonWard Studios
JonWard Studios is led by Jon Ward, whose 25-year career has included work with more than 700 medical-device manufacturers and product teams and 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 main app workflow before further investment.
Explore regulatory advisory at JonWard.ioHow we work
Identify who will use the app, what they need to do, and when the working build is needed.
Map the screens, interactions, data, and requirements before development.
Develop the working prototype or MVP alongside its design, development, and usability files.
Review the working app and deliver the source code, repository, and project files.
Start with the concept
Tell us who will use the app, what they need to do, and when you need a working build.
Contact Jon