boldtype

Semi-Custom Medical Device App Development

Medical device software development requires deep regulatory, technical, and cybersecurity expertise. You can trust Bold Type to develop usable, beautiful, and functional software that is secure and meets FDA’s requirements.

 

Companies underestimate the necessary balance across the three factors of development

Regulatory

Tremendous knowledge and skill are needed to develop software that meets FDA's cybersecurity requirements.

REGULATORY

Patients deserve safe and efficacious medical devices. That’s why the FDA takes their mission very seriously and demands a lot from medical device manufacturers. If your medical device incorporates an app, you are responsible for developing, testing, and documenting your app in compliance with dozens of FDA regulations and recognized standards. You need a partner who knows these regulations inside out and has a quality management system in place that is compliant and practical.

Usability

Poor usability can delay FDA clearance and limit market adoption.

USABILITY

Advances in consumer product usability have created a high bar for medical device companies. Patients and healthcare providers want products that are intuitive, easy to use, and even delightful. And FDA demands that you take usability into account, test for it, and document your studies. The last thing you want is to fail a summative usability study late in the game because your app development partner does not know the best practices in usability. Trust Bold Type to deliver apps with proven features that meet regulatory requirements and delight users.

Cybersecurity

Tremendous knowledge and skill are needed to develop software that meets FDA's cybersecurity requirements.

CYBERSECURITY

The FDA has cared about cybersecurity for a long time. In 2024, however, the bar was raised dramatically with the release of the draft guidance: Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act. If your medical device is a “cyber device” (and there is a 99% chance it is if it incorporates an app), your documentation must include architecture security views, threat modeling, threat analysis, management plans, testing results (penetration, fuzz, etc.), a software bill of materials (SBOM), monitoring and incident reporting, and more. With Bold Type, this all comes standard.

Our Services

To address this inefficiency, we created a robust Foundation App that includes all the essential features most medical device apps require:

BLE connectivity

Reliable Bluetooth Low Energy connections for seamless device integration.

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User Authentication

Ensuring only authorized users can access the app.

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Onboarding

Smooth user onboarding processes for a better user experience

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Data Transfer to the Cloud

Securely sending data to the cloud for storage and analysis

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Over-the-Air Software Updates

Update your device’s embedded software and implement security patches directly from the cloud.

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Multi-Platform

Single code base capable of deployment as an  iOS, Android, Windows, MacOS, or Linux application.

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Additional features

commonly found in medical device apps include the following.

Data Visualization

Clear and insightful data presentation for easy interpretation.

 

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Symptom Logging​

Allowing users to log symptoms for better health monitoring.

 

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Reminders

Timely notifications and reminders to enhance user compliance.

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Content Delivery

Efficiently delivering relevant content to users.

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Gamification to Drive Greater Adherence

Patients will use your device more often if it’s fun to use, so let’s turn therapy time into game time.

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Daily Tasks Lists

 Clear and insightful data presentation for easy interpretation.

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Adherence Tracking

Why burden patients with tracking device use when your app can do it automatically?

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Contact us today

We create these efficiently at a very competitive price leveraging years of experience developing similar apps

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