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. BioT's published three-year comparison puts an in-house build at $2,288,875 against $438,100 on BioT, with certification alone accounting for $945,000 before headcount. In-house builds require separate teams for security, compliance, infrastructure maintenance, and regulatory updates. With BioT, the infrastructure is in place from day one: the platform's own certifications are already held and audited, security is medical-grade by default, and your engineering team can focus on device innovation instead of cloud plumbing. Your device's regulatory clearance remains yours to obtain; BioT reduces the infrastructure evidence you have to produce yourself.

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. Software development follows IEC 62304, and BioT maintains an IEC 62304-compliant Design History File and an SBOM for every release. The platform supports customers operating under HIPAA, GDPR, FDA 21 CFR Part 11, and MDR/IVDR: BioT provides the certified infrastructure controls, the BAA, and the DPA, while regulatory clearance of your device remains yours to obtain. The architecture includes native PHI protection, attribute-based access control (ABAC), and encryption of data in transit and at rest. BioT customers have achieved FDA clearance and CE marking on the platform.

The full certification list, and what you inherit from the platform versus what stays yours, is on the compliance page.

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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 environments 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), and can be adapted to run on other cloud providers or private cloud infrastructure.

Question 6

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

Accepted Answer

BioT publishes its medical device cloud platform pricing on AWS Marketplace, on one-month contracts, in four editions.

Start, $1,500 per month. Up to 5 devices under fair usage.
Development, $2,950 per month. Includes a single development deployment.
Study, $4,150 per month. Includes separated development and production deployments, for clinical trials and studies.
Essentials, $7,500 per month. Includes 2 development deployments and 1 high-availability production deployment.

There are no upfront license fees. Additional AWS infrastructure costs may apply on top of the subscription. Private offers are available if you need a custom quote. Beyond the platform subscription, budget for your own development resources (device firmware integration, application customization) and any third-party services you connect.

On the wider question of cost, BioT's published three-year comparison puts an in-house build at $2,288,875 against $438,100 on BioT.

Current editions and pricing are listed on AWS Marketplace.

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 connectivity, feature requirements, and regulatory needs, but typically range from 2 to 4 months.

Question 8

Who owns the device's data?

Accepted Answer

You do. BioT runs in one of two deployment models: installed into your own AWS account, or hosted on a BioT-managed account with a dedicated environment for your production system. In either case you retain ownership and control of your device data at all times. BioT provides and operates the infrastructure and, where BioT hosts it, processes your data on your behalf as a processor under a Business Associate Agreement and, where applicable, a Data Processing Agreement. BioT does not acquire ownership of your data.

Question 9

Does the BioT platform support class III devices?

Accepted Answer

Yes. BioT supports all device classifications, including Class III. We have customers who have successfully qualified regulatory compliance for Class III devices while using BioT. The platform's medical-grade architecture, HITRUST r2 certification, and IEC 62304 software development practices support the rigorous requirements of high-risk device classifications.

Question 10

How does BioT secure my solution against attack?

Accepted Answer

BioT's security architecture is HITRUST r2 certified, SOC 2 Type II attested, and ISO 27001 and ISO 27799 certified. The platform includes native PHI protection, attribute-based access control (ABAC), encryption of data in transit and at rest, and continuous monitoring. BioT undergoes routine penetration testing by independent cybersecurity auditors and releases security updates promptly as the threat landscape evolves. No platform can eliminate security risk. BioT's role is to reduce it with certified, independently audited controls and to give you the evidence your own security file requires.

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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.

Question 12

How can I run my algorithms when working with BioT?

Accepted Answer

BioT supports secure cloud-based execution of proprietary AI models and clinical algorithms. You can deploy your algorithms on BioT's HITRUST r2 certified cloud infrastructure with PHI protection, ABAC-controlled data access, and encryption of data in transit and at rest. The dedicated Plugin API enables you to execute your own algorithms and code on any of BioT's modules, including the Measurement module that processes the device data stream. BioT supports virtually any coding language or technology.

Question 13

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

Accepted Answer

BioT is a verticalized application platform purpose-built for connected medical devices. General-purpose clouds give you raw infrastructure; BioT gives you the medical device layer on top of it. BioT arrives with HITRUST r2, SOC 2 Type II, ISO 27001, ISO 27799, and ISO 13485 already certified, an IEC 62304-compliant Design History File, and a per-release SBOM. It adds pre-built medical device workflows (monitoring, adherence, notifications), patient and caregiver management, device lifecycle management, and a regulatory-aware analytics engine. On raw AWS, GCP, or Azure the cloud layer is Software of Unknown Provenance and the IEC 62304 justification is yours to write. Building equivalent capabilities typically takes 12-24 months and costs 3-5x more.

Question 14

How does BioT protect my patients’ privacy?

Accepted Answer

Privacy is built into every layer of the platform. BioT encrypts and de-identifies PHI as needed and prevents leakage to ancillary data stores such as log files. BioT executes HIPAA Business Associate Agreements and GDPR Data Processing Agreements with its customers. The platform includes consent management, audit logs, and a multi-region data-routing service. ABAC provides fine-grained access control at the data attribute level, so you control exactly who sees what.

Question 15

Which connectivity technology should I use to communicate with BioT?

Accepted Answer

BioT supports multiple connectivity options including Wi-Fi, Bluetooth Low Energy (BLE), and cellular (4G/5G). For home-use devices, most customers use BLE from the medical device to a phone gateway. Cellular provides excellent ease of use, especially for elderly patients, though coverage and global deployment need consideration. BioT's team can advise on the best option based on your device type, clinical setting, and patient population.

Question 16

How should I integrate my device to BioT?

Accepted Answer

BioT provides device SDKs for devices running an operating system. For firmware on bare-metal hardware, BioT offers REST API and MQTT documentation that is straightforward to implement. The integration process is well-documented and supported, with most device onboarding completed in less than a day.

Question 17

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

Accepted Answer

BioT provides an open-source mobile application starter app that demonstrates the BioT JavaScript SDK. Both the starter app and the SDK can be compiled for iOS and Android. They are fully documented, so you can build your patient-facing application quickly. The portal builder also provides a web-based option for patient and clinician applications.

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