Devices and Sensor Architecture
Connected autoinjectors represent a significant evolution in the field of self-injection therapies. These devices combine the core functionality of a traditional autoinjector-precise, user-friendly drug delivery-with embedded IoT-enabled sensors designed to capture real-time data about administration events, patient behavior, and device status.
At the heart of these systems are compact, low-power sensors that monitor variables such as:
- Injection start and end time
- Device orientation and stability
- Needle deployment and retraction
- Ambient and skin contact temperature
- Dose delivery confirmation via pressure or acoustic feedback
The integration of connectivity-typically via Bluetooth Low Energy (BLE) or NFC-enables autoinjectors to sync with companion mobile apps or cloud platforms. In more advanced setups, LoRaWAN or cellular modules are used for direct-to-cloud transmission, allowing healthcare providers to track adherence remotely.
This forms part of a broader shift toward adherence IoT: a network of smart drug delivery devices that improve visibility and control over long-term therapies. Patients receive timely reminders, real-time feedback, and coaching features, while clinicians gain access to dose-level analytics and alerts on missed or incorrect injections.
Some wearable injectors-also referred to as patch injectors-include even more complex telemetry to support slow, high-volume infusions over 5–30 minutes. These devices must not only deliver medication but also continuously monitor flow rate and patient movement to ensure proper delivery.
While cellular technologies like LoRaWAN and LTE-M are being piloted in advanced use cases (e.g., continuous patch pumps or multi-day infusion systems), Bluetooth Low Energy (BLE) remains the dominant standard for autoinjectors-especially in devices designed for monthly or biweekly use, where data volume and battery constraints are minimal.
For a deeper look at how connected delivery platforms fit into the larger landscape of smart therapeutics, visit our How Technology Is Changing Pharma: A Complete Guide.
Company Examples: SHL, YpsoMate, and Emerging Leaders
As demand for connected, patient-friendly drug delivery grows, several companies have emerged as frontrunners in the connected autoinjector space. These manufacturers are not only building reliable devices but also integrating wearable injector technologies with cloud connectivity, mobile platforms, and UX-focused design.
SHL Medical
SHL Medical is widely recognized as a global leader in autoinjector technology. Its Molly® platform is a modular, prefilled autoinjector system that now includes smart variants capable of logging injection events and syncing with digital health systems. SHL’s connected autoinjectors feature:
- Dose confirmation and injection timestamp
- Visual and haptic feedback for patient assurance
- Optional Bluetooth-enabled communication modules
- Integration APIs for third-party health platforms and clinical trials
The company has established partnerships with major pharmaceutical players to bring these devices into real-world use across multiple therapeutic areas – including neurology, endocrinology, and immunology.
Ypsomed – YpsoMate®
Ypsomed’s YpsoMate® series offers a widely adopted platform for both standard and connected autoinjectors. Their smart offerings feature:
- Integrated electronics for injection monitoring
- A mobile app ecosystem for adherence tracking
- Open system architecture, making it easier for pharma partners to customize branding and workflows
Ypsomed’s connected devices are particularly suitable for biologic therapies and have been implemented in several large-scale adherence programs in Europe and North America.
Other Innovators
Several other manufacturers are pushing the boundaries of connected, wearable injectors:
- Enable Injections: Specializes in large-volume wearable devices that deliver over several minutes.
- BD (Becton Dickinson): Offers connected versions of traditional pen-injectors, integrating with digital diabetes care.
- Phillips-Medisize: Develops custom autoinjectors with embedded sensors and AI-based adherence feedback.
These players are all contributing to a rapidly maturing segment where usability, data quality, and integration flexibility are critical.
Benefits for Patients and Providers
For Patients: Convenience, Confidence, and Control
Connected autoinjectors are designed with the patient experience in mind. Whether used at home or in a clinical setting, these devices simplify the injection process and reduce anxiety through:
- One-button activation and ergonomic form factors
- Built-in reminders and alerts for upcoming or missed doses
- Real-time feedback via LEDs, vibration, or mobile notifications
- Access to companion apps showing injection history and trends
- For wearable injectors, discreet, adhesive designs allow longer or larger-volume infusions without manual effort
This improved user experience boosts long-term adherence-particularly in chronic therapies for conditions like rheumatoid arthritis, multiple sclerosis, and ADHD, where the psychological and logistical burden of regular injections can lead to skipped doses.
Related Application: ADHD and Youth Engagement
In areas like pediatric neurology, connected autoinjectors are being explored alongside platforms like OnDosis, which combines precise dosing with behavioral tracking and coaching.
Learn more in our OnDosis: Personalized ADHD Therapy “at the Push of a Button”.
For Providers: Data-Driven Care and Reduced Risk
Healthcare professionals benefit from continuous access to injection data:
- Dose confirmation logs help ensure patients are receiving their treatment
- Alerts about missed or delayed injections can prompt timely follow-up
- Trends across populations allow clinicians to personalize care plans
- In clinical trials, autoinjector telemetry improves protocol compliance and reporting accuracy
For health systems focused on value-based care and remote patient monitoring, connected autoinjectors provide a much-needed data stream bridging the gap between prescription and actual usage.
As part of the larger adherence IoT ecosystem, these devices are helping shift chronic disease management from reactive to proactive-giving both patients and providers better tools to succeed.
Safety and Lockout Mechanisms
In the realm of connected autoinjectors, patient safety is just as important as data capture or usability. These devices are designed with multiple layers of safeguards to prevent misuse, ensure accurate dosing, and avoid accidental needle deployment. The result is a system that patients can trust and regulators can approve with confidence.
Key Safety Features
Needle Lockout Mechanism
After a dose is delivered, many devices trigger a mechanical lock that physically prevents the needle from being reused or redeployed. This reduces risks of contamination, double-dosing, and injury.
Electronic Dose Verification
Built-in sensors confirm whether a full dose has been delivered. In cases of partial injection, the system can prompt the user or notify a connected care platform for follow-up.
Pre-use Device Validation
Companion apps or indicator lights check device readiness before each injection. If a temperature threshold is exceeded or a previous error occurred, the injector will block activation.
Tamper Detection & Firmware Integrity
Some advanced systems include security chips or encryption protocols to detect tampering or unauthorized software changes—a growing concern for cloud-connected medical devices.
Bluetooth Fail-Safe Mode
Devices typically ensure that connectivity loss does not interfere with the delivery mechanism. The injection can proceed even without an active connection, while the data can sync later when reconnected.
(картинка)
Optional Visualization
Include a diagram showing a 4-layer protection model:
- Mechanical lock
- Software verification
- Connectivity safeguards
- Post-dose audit trail
These integrated security systems are increasingly essential for regulatory approval under FDA and MDR frameworks, particularly for combination products involving biologics or high-risk therapies.
Regulatory Requirements
United States – FDA Pathways and SBOM
In the U.S., connected autoinjectors are typically classified as combination products, requiring coordination between the Center for Devices and Radiological Health (CDRH) and the Center for Drug Evaluation and Research (CDER).
- 510(k) for devices substantially equivalent to cleared autoinjectors
- De Novo for novel digital-enabled devices
- Breakthrough Device Designation in certain high-impact therapeutic areas
If the device includes digital or wireless features, it falls under Software as a Medical Device (SaMD) guidelines.
As of October 1, 2023, FDA requires all “cyber devices” to include a Software Bill of Materials (SBOM) under §524B FD&C Act.
For usability and human factors validation, the standard is IEC 62366-1:2015 + A1:2020, which defines requirements for risk-informed design.
Europe – MDR and ISO Requirements
In the EU, connected autoinjectors are regulated under the Medical Device Regulation (MDR 2017/745). These rules cover classification, clinical evaluation, cybersecurity, and post-market surveillance.
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ISO 11608-1:2022 – Covers technical and functional requirements for needle-based injection systems
https://www.iso.org/standard/79130.html - ISO/IEC 27001 and IEC 80001 – Cover information security and risk management for health IT and cloud-connected platforms
Global Trends
Across jurisdictions, regulators now expect not only safe mechanics but secure and maintainable connected systems. Submission materials must demonstrate threat modeling, update protocols, patient protection, and post-market vigilance.
Early engagement with authorities and robust documentation of digital architecture-especially where cloud APIs or AI are involved-is now essential to avoid delays and enable global scaling.
Market Outlook & Forecast
“The global connected drug delivery devices market size is expected to reach USD 25.63 billion by 2030, according to a new report by Grand View Research, Inc. The market is expected to expand at a lucrative CAGR of 23.45% from 2023 to 2030.”
Several converging trends are fueling this expansion. First, the shift toward home-based care is prompting both hospitals and insurers to support remote medication administration in order to reduce costs and increase patient autonomy. Second, the growing pipeline of biologic drugs-particularly in oncology, neurology, endocrinology, and autoimmune disease-requires precise, user-friendly delivery systems that lend themselves to real-world monitoring.
Third, value-based care models now place greater emphasis on collecting real-time adherence and outcome data, pushing healthcare providers and payers to favor connected solutions over legacy devices. Fourth, manufacturers like SHL Medical and Ypsomed are forming strategic collaborations with pharmaceutical companies to co-develop integrated delivery ecosystems that combine hardware, software, and cloud-based reporting. Lastly, the convergence of connected autoinjectors with AI and digital therapeutics is enabling new levels of personalization, such as algorithm-guided dosing and patient-specific risk stratification.
From a geographic perspective, North America continues to lead in adoption due to regulatory clarity and reimbursement incentives, while Europe is close behind, supported by its robust MDR framework. Meanwhile, Asia-Pacific shows rising interest, especially for wearable injectors suited to high-volume biologics in cancer and metabolic diseases.
Connected autoinjectors are no longer optional. They are becoming foundational to how modern therapeutics are delivered, monitored, and reimbursed-especially in a future shaped by decentralized, digital-first healthcare.
