Question 1

What is BioT?

Accepted Answer

BioT is the infrastructure for medical device clouds. It is a cloud-native Platform-as-a-Service (PaaS) that provides medical device manufacturers with the flexible, open, and secure foundation needed to connect devices, manage real-time data, run analytics, execute algorithms securely, and deliver connected care applications. BioT is hosted on AWS and available in the US, EU,and Asia.

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Question 2

How does BioT compare to building a custom cloud in-house?

Accepted Answer

Building a medical device cloud in-house typically takes 12-24 months and costs 3-5x more than using BioT. In-house builds require separate teams for security, compliance, infrastructure maintenance, and regulatory updates. With BioT, the infrastructure is built right from day one: compliance is pre-validated, security is medical-grade by default, and your engineering team can focus on device innovation instead of cloud plumbing.

Question 3

What compliance certifications does BioT hold?

Accepted Answer

BioT holds HITRUST r2 certification, SOC 2 Type II attestation, and is ISO 13485, ISO 27001, and ISO 27799 certified. BioT is compliant with HIPAA, GDPR, FDA 21 CFR Part11, and MDR/IVDR. Software development follows IEC 62304. The architecture includes native PHI protection, attribute-based access control (ABAC), and encryption of data in transit and at rest.

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Question 4

Can BioT be deployed on-prem?

Accepted Answer

Yes. The BioT platform was designed to work on the most common cloud environment including on-prem private clouds. The platform uses a cloud-abstraction architecture that allows it to run on different infrastructure configurations while maintaining the same compliance and security posture.

Question 5

Can BioT be deployed on any cloud?

Accepted Answer

Yes. BioT incorporates a cloud-abstraction architecture that enables deployment across different cloud environments. The platform is currently hosted on AWS with multi-region availability (US, EU, and Asia). The architecture is designed to be infrastructure-agnostic, supporting deployment on other cloud providers or on-premises environments as required by customer data residency or operational needs.

Question 6

How much does BioT cost? What other costs do I need to take into account?

Accepted Answer

BioT operates on a SaaS subscription model with predictable, transparent pricing. Development environments start at approximately $3,000/month. Production environments start at approximately $4,500/month. There are no upfront license fees. Pricing scales with usage, so costs grow proportionally with your device fleet. Beyond the platform subscription, budget for your own development resources (device firmware integration, application customization) and any third-party services you connect.

Question 7

What is the typical timeframe to launch a BioT-powered device?

Accepted Answer

Most manufacturers go from signup to a working pilot in weeks, not months. BioT's no-code configuration system lets you define your device data model, set up workflows, and configure access controls without writing code. Device onboarding can be completed in less than a day. Full production deployment timelines depend on your device complexity and regulatory pathway, but BioT removes the cloud infrastructure bottleneck from the equation.

Question 8

Who owns the device's data?

Accepted Answer

You do. BioT is the infrastructure provider, not the data owner. All device data, patient data, and application data belong to the device manufacturer. BioT's architecture enforces strict data isolation between tenants. You retain full control over data access, export, retention policies, and deletion. BioT provides APIs and tools for data export at any time.

Question 9

Does the BioT platform support class III devices?

Accepted Answer

Yes. BioT supports Class I, II, and III devices under both FDA and MDR/IVDR classifications. The platform's compliance framework (HITRUST r2, SOC 2 Type II, ISO 13485, FDA 21 CFR Part 11) meets the requirements for the most stringent device classifications. Multiple BioT customers operate Class III devices on the platform in production today.

Question 10

How can BioT guarantee that my solution is secured and will not be hacked?

Accepted Answer

BioT's medical-grade security architecture is HITRUST r2 certified, SOC 2 Type II attested, ISO 27001 and ISO 27799 certified, and compliant with HIPAA, GDPR, FDA21 CFR Part 11, and MDR/IVDR. The platform includes native PHI protection, attribute-based access control (ABAC), encryption of data in transit and atrest, and continuous monitoring. BioT undergoes routine penetration testing byindependent cybersecurity auditors and releases security updates promptly asthe threat landscape evolves.

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Question 11

Can I customize the BioT platform on my own?

Accepted Answer

Yes. BioT's Developer Studio supports three levels of customization: no-code (templates and visual configuration), low-code (SQL queries and rule builders), and pro-code (full API access in any programming language). You can define custom entities, relations, workflows, and rules through the BioT Console. All customizable modules are documented with code samples and SDKs available for Python, JavaScript, and other languages.

Question 12

How can I run my algorithms when working with BioT?

Accepted Answer

BioT's Plugin Framework lets you deploy proprietary algorithms as containerized microservices that run securely inside the BioT environment. Your algorithms can subscribe to real-time device data streams, process data, and write results back to the platform. The framework supports any language or runtime packaged as a Docker container. Algorithm execution is isolated, auditable, and compliant with regulatory requirements for software as a medical device (SaMD).

Question 13

What benefits does BioT provide over standard cloud platforms like AWS, GCP or Azure?

Accepted Answer

Standard cloud platforms provide general infrastructure (compute, storage, networking) but no medical device domain logic. With AWS, GCP, or Azure alone you must build device management, compliance controls, patient data models, FHIR integration, OTA firmware updates, and regulatory audit trails from scratch. BioT delivers all of these as pre-built, validated modules on top of cloud infrastructure. The result: faster time to market, lower total cost of ownership, and a compliance posture that is maintained by BioT's team rather than yours.

Question 14

How does BioT protect my patients' privacy?

Accepted Answer

BioT's privacy architecture is built around the principle of data minimization and strict access controls. Patient data is protected by HIPAA and GDPR-compliant safeguards including encryption at rest and in transit, attribute-based access control (ABAC), audit logging of every data access event, and configurable data retention and deletion policies. BioT is HITRUST r2 certified, which is the most rigorous healthcare data security framework available.

Question 15

Which connectivity technology should I use to communicate with BioT?

Accepted Answer

BioT supports multiple connectivity protocols to match your device requirements. For real-time telemetry, MQTT is recommended for low-power devices and high-frequency data streams. HTTPS REST APIs are available for request-response patterns and less frequent data uploads. BioT also supports WebSocket connections for bidirectional real-time communication. The platform handles protocol translation, so your application layer works with a unified API regardless of how devices connect.

Question 16

How should I integrate my device to BioT?

Accepted Answer

BioT provides device SDKs and comprehensive integration documentation. The typical integration path involves: (1) defining your device data model in the BioT Console using the no-code entity builder, (2) implementing the BioT Device SDK in your firmware to handle authentication, data reporting, and command reception, and (3) testing the integration in your BioT development environment. SDKs are available for common embedded platforms. For devices that cannot run an SDK, BioT supports gateway-based integration patterns.

Question 17

How should I build a patient mobile app that integrates with BioT?

Accepted Answer

BioT provides a complete set of REST APIs and WebSocket endpoints for mobile app development. You can build native (iOS/Android) or cross-platform apps using any framework. BioT handles user authentication (including patient self-registration), device pairing, real-time data streaming, and push notifications. The API documentation includes mobile-specific guides, authentication flows, and sample code. BioT does not impose restrictions on your app's UI/UX design or technology stack.

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