MedTech app development

MedTech app development for prototypes, MVPs, and human factors studies.

Backed by 25 years of medical-device design, regulatory, and quality management experience.

Work directly with an experienced MedTech app developer.

Jon Ward works directly with the team on the app workflow, intended use, product risks, usability, testing, development records, and handoff. Builds can include iPhone, iPad, Apple Watch, desktop applications, and hosted web applications.

JonWard Studios also develops drug, device, and clinical companion application prototypes and MVPs.

Discuss a MedTech app

MedTech development framework

Regulatory, risk, usability, and development records.

The content and depth of each activity reflect the intended use, functions, risks, and agreed prototype or MVP scope.

01Preliminary Regulatory Strategy

02Preliminary PMS search

03Usability Engineering File

04Risk management + traceability

05Cybersecurity risk assessment

Preliminary PMS search

Published postmarket, literature, and clinical-study sources are reviewed for relevant risk scenarios and clinical-workflow considerations. Applicable findings are carried into the current-stage design and development records.

Prototype

Current-stage regulatory assumptions, risks, usability, traceability, and test evidence for the prototype scope.

MVP

Current-stage requirements, risk controls, traceability, verification, usability, cybersecurity risk assessment, and release evidence for the agreed MVP.

Cybersecurity scope

Known cybersecurity risks are identified and applicable design controls are addressed for the agreed prototype or MVP scope. Full infrastructure, complete threat modeling, penetration testing, and production-security work are out of scope. They are considerations for a full design project.

Standards considered

MedTech design projects consider applicable FDA guidance and the following standards: ISO 13485, ISO 14971, IEC 62304, IEC 62366-1, IEC 81001-5-1, ISO/IEC 27001, and ISO/IEC 42001 when AI applies. Other standards may be included by request.

Review the Prototype and MVP package limits, development stages, and handoff details.

View Prototype + MVP packages and the six-stage process

Drug + device companion development

Clinical User Experience

Drug and device companion applications may support in-person, remote, or hybrid programs through coordinated patient applications and professional dashboards.

Patient experience

Enrollment and onboarding

Program enrollment, account setup, treatment education, device pairing, baseline information, and preparation.

Treatment initiation

First-use support, administration or device instructions, technique guidance, treatment schedules, and initial patient-reported measures.

Ongoing treatment

Medication or device routines, reminders, education, treatment-specific activities, and information collected between interactions.

Experience and outcomes

Symptoms, events, flares, patient-reported measures, subjective assessments, device information, and longitudinal progress.

Follow-up and continuation

Remote check-ins, scheduled assessments, support requests, continued education, treatment follow-up, and preparation for remote or in-person interactions.

Professional and program experience

HCP and program dashboards.

Patient applications may be accompanied by web or desktop dashboards for HCPs, sponsors, CROs, and program teams.

Program and participant status

Enrollment, treatment stage, scheduled activities, completion status, and information awaiting review.

Review and follow-up

Role-appropriate patient information, longitudinal summaries, review queues, and follow-up activities.

Program oversight

Population-level status, assessment completion, operational reporting, configuration, and role-based access.

The intended use and Preliminary Regulatory Strategy define the proposed functions, users, data flows, review responsibilities, and regulatory path.

Discuss a companion app

MedTech portfolio

Examples of completed development work.

These MedTech examples have not been released for clinical use by JonWard Studios.

iPhone + web console

Outcomes Registry: Knee

Patient app and sponsor/CRO console.

View Outcomes Registry

iPhone + iPad

SprayRight

Camera-guided nasal-spray coaching.

View SprayRight

iPhone + Apple Watch data

Orthopedic Mobility Collection

Longitudinal mobility collection for orthopedic studies.

View Orthopedic Mobility

Common questions

Before development begins.

Can the app be prepared for a human factors study?

A build can be prepared for formative or summative usability testing when the agreed scope includes the required design work and testing.

What MedTech records are included?

The agreed project may include a Preliminary Regulatory Strategy, design and development file, usability engineering file, test records, source repository, and project files.

How are applicable standards addressed?

Applicable guidance and standards are identified from the intended use, functionality, risks, and agreed development scope.

Start the conversation

Have a MedTech app concept?

Send Jon the intended use, target users, primary workflow, target devices, and desired timeline.

Contact Jon