The Need
A leading Respiratory Devices company in the US was looking for an engineering partner to conceive, design and develop a Product for Smart Nebulization along with Hardware, Firmware, and Mobile and cloud apps with the required certifications.
Impacts Delivered
- 50 proto units were manufactured and supported field trials.
- Supported to obtain FDA approval
- Consistent and complete data of dosage, frequency of use, correctness of inhalations etc. are made available that improved the efficiency of treatment plans.
- Ensured the security of personal health data as per HIPAA guidelines with separate login for patient and doctors.
- Seamless integration with third party healthcare apps
- Treatment plans are configured and executed using the mobile apps
Our Solution
- Gadgeon took the complete ownership of the Product life Cycle phases:
- Concept and specification phase
- System design
- Prototyping and verification
- Pilot production
- Mass production
- After market support
- Requirement gathering from the concept at the system and product level.
- The architectural design of the system, product, and supporting apps
- Proof of concept design and development using off-the-shelf components and enabled funding for the next phase.
- Mechanical and industrial designs based on a study of handheld design best practices - weight, usage pattern, etc.
- Design and development of Mobile apps (iOS & Android), Cloud Applications along with Hardware & Firmware for the Nebulizer communicating over the BLE interface.
- Security standards as per HIPAA guidelines were applied,
- 50 proto units were manufactured and supported field trials.
- Executed product revisions based on the on-field study findings.
- BLE firmware interfaces the nebulizer with IOS app, to send therapy start & stop notifications along with battery level indication
- Therapy download option allows the data to be analyzed for effectiveness treatment
- Supported FDA certifications process to successful completion.
- Supporting inventory management.
- After-sale user support for the hardware, firmware, mobile app, and cloud application, and newer feature additions.
- Implemented seamless integration with third-party applications.
- Obsolescence management support.
Tools & Technologies
- The cloud application and web UI was developed using Amazon Web service, Node JS , Bootstrap UI, Postgresql database
- iOS App interfaced with Cloud over ReST APIs
- Nordic nRF52 BLE SoC for BLE implementation.
- Ensured security design as per HIPAA guidelines.
- Zoho Inventory for global inventory management
Sample Mobile App Screenshots
ODM Life Cycles Supported
