MedTech + commercial app development

Mobile app development with 25 years of MedTech experience.

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.

25 years

Medical-device regulatory and quality experience

150+

Successful FDA 510(k) submissions overseen

MedTech

SaMD, regulatory baseline, 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 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.

01

Working prototype or MVP

An iPhone or iPad build of the selected workflow.

02

Design and development file

Requirements, architecture, risks, traceability, testing, and release records.

03

Usability engineering file

Intended users, use environment, workflow, and completed usability work.

04

Source code and handoff

Source repository and project files for the completed build.

Prototype and MVP work

Choose the build.

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.

Records by project type

Every project includes a design and development file. Its contents reflect the product, intended use, and agreed build scope.

MedTech applications

App and MedTech records

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 development
Commercial applications

App and development records

Includes a design and development file, usability engineering file, testing, and source-code handoff.

Prototype and MVP development
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 centered 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
  • Tests, design and development file, usability engineering file, and source repository
Discuss a prototype
02 / MVP15 business days · target

MVP Build Sprint

A working app with the essential features needed for customer or beta use.

  • The essential tasks users need to complete
  • Working mobile MVP
  • Tests, design and development file, usability engineering file, and source repository
Discuss an MVP

Further development and premarket submission work can be scoped separately.

Selected work

Explore the portfolio.

Featured projectFast From

Why JonWard Studios

Medical-device experience.
Practical app development.

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.io

How we work

From concept to handoff.

01

Define the first build.

Identify who will use the app, what they need to do, and when the working build is needed.

02

Design the experience.

Map the screens, interactions, data, and requirements before development.

03

Build and document.

Develop the working prototype or MVP alongside its design, development, and usability files.

04

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.

Tell us who will use the app, what they need to do, and when you need a working build.

Contact Jon