Bold Type: Innovating Medical Device App Development with Speed, Compliance, and Security

In the world of medical devices, where precision and regulatory adherence are non-negotiable, the software running these devices must not only be functional and beautiful but also compliant with strict standards. Bold Type, led by President and PhD holder Jose Bohorquez, has mastered this balance by offering a revolutionary approach to medical device app development. Their unique approach involves a "semi-custom app" development process, reducing time and cost while ensuring strict adherence to industry standards.

At the core of this process is the Foundation App, a platform designed to handle the complexities of medical device software, including wireless connectivity, secure data transmission, and regulatory compliance. Instead of starting from scratch, Bold Type builds on the Foundation App, offering clients a tailored solution that’s both efficient and customizable. As Bohorquez explains, “We’ve taken years of experience in developing medical device apps that interface with wireless medical devices and developed a Foundation App that can be easily customized.” This approach balances the flexibility of custom solutions with the efficiency of off-the-shelf options.

Features That Matter

Bold Type’s semi-custom apps come with a range of features that meet the core requirements of medical device companies. From Bluetooth connectivity and user authentication to cloud data transfer and over-the-air software updates, the foundational elements are already built and validated. This allows Bold Type to deploy apps across iOS, Android, web, and desktop platforms from day one.

Beyond the basics, Bold Type goes above and beyond to address clients' specific feature requests, offering a host of additional features, including:

• Data Visualization: Helping users make sense of complex data with intuitive visuals.
• Symptom Logging: Allowing patients to easily track and share symptoms with healthcare providers.
• Reminders: Ensuring users stay on top of their treatment plans with timely notifications.
• Content Delivery: Offering customizable content to engage and educate users.
• Adherence Tracking: Monitoring patient compliance with medical devices and therapies.
• Gamification: Using interactive elements to encourage user engagement and compliance.

Regulatory Expertise: More than Just Code

Creating a medical device app is about more than just writing code—it’s about ensuring that every element of the software is in compliance with stringent regulatory requirements. Bold Type understands the unique challenges medical device companies face when it comes to FDA submissions, and they are well-versed in the documentation required to meet those needs.

Bohorquez emphasizes this point: “It’s not just the app; it’s also the documentation you’ll need when submitting to the FDA.” Bold Type delivers not only a fully functional, compliant app but also a comprehensive documentation package that fits into the client’s Design History File (DHF). This documentation ensures that the product meets FDA requirements and supports a smooth regulatory submission process.

A Flexible and Transparent Pricing Model

Bold Type offers a flexible, transparent pricing model tailored to medical device startups with tight budgets. Their Starter Package includes the Foundation App, ready for deployment on both the Apple App Store and Google Play, along with BLE communications protocol documentation, source code, and an nRF52 development kit for evaluation. Offered at a fixed cost, it ensures no hidden fees. For specific needs, Bold Type provides customization services at a competitive hourly rate, allowing clients to pay only for the necessary adjustments.

Expertise That Sets Bold Type Apart

What makes Bold Type truly unique is their deep expertise in medical device software development. The leadership team, led by Bohorquez, boasts decades of experience in developing secure, compliant software for regulated markets. By focusing exclusively on medical device apps, the company has developed a level of specialization that few can match.

“We are pioneers in the development of medical device apps,” says Bohorquez. “Specializing in creating secure, compliant, and user-friendly software solutions is what we do, and when you do one thing over and over, you get very good at it.”

This singular focus has allowed Bold Type to reimagine the app development process. Instead of starting from scratch for every client, they’ve built a scalable platform that allows them to deliver apps faster and at a lower cost—without sacrificing quality or compliance.

A Vision for the Future

As the medical device industry continues to evolve, the demand for innovative software solutions will only increase. With its unique development process, regulatory expertise, and deep technical knowledge, Bold Type is well-positioned to lead the charge in medical device app development.

Bohorquez and his team are not just building apps—they’re building the future of medical technology, one semi-custom solution at a time. As they continue to refine their processes and expand their offerings, Bold Type remains committed to one goal: helping medical device companies innovate with confidence.

In an industry where security, compliance, and usability are paramount, Bold Type delivers on all fronts, making them a trusted partner for medical device companies around the world.

Jose Bohorquez PhD, President

“Specializing in creating secure, compliant, and user-friendly software solutions is what we do, and when you do one thing over and over, you get very good at it.”