Two SmartPilot devices attached to YpsoMate autoinjectors, part of a digital health solution.

Combine SmartPilot with YpsoMate and begin capturing accurate, unbiased injection data while enabling intuitive, step-by-step user guidance. Transforming the proven YpsoMate autoinjector into a fully connected digital health solution facilitates your big data strategy.

SmartPilot's ergonomic, user-centered design ensures an effortless injection experience. Seamlessly integrated with Ypsomed Digital Health, it empowers patients to confidently manage their therapy.

SmartPilot is compatible with both YpsoMate 1 mL and 2.25 mL autoinjectors.

 

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Now FDA 510(k) cleared

SmartPilot has received 510(k) clearance from the US. Food and Drug Administration (FDA), securing market access. A 510(k) clearance indicates that the device has been demonstrated to be as safe and effective as, that is, substantially equivalent to, a legally marketed predicate device, in accordance with applicable FDA requirements. 510(k) clearance allows decoupling the regulatory process of the pharmaceutical combination product (drug and YpsoMate autoinjector) from those for the SmartPilot, thereby reducing risk and streamlining market access for the pharmaceutical partner.

Monitor adherence & understand user pattern

Facilitate adherence monitoring in clinical trials or real-world patient monitoring programs with SmartPilot. This add-on device captures injection events and compares them with treatment schedules in the app, delivering comprehensive insights into patient adherence and usage patterns.

Patients retain the flexibility to inject wherever they prefer, as the SmartPilot operates effectively both with and without an active app connection, ensuring no loss of any important data. After each injection, data is recorded and stored in the SmartPilot's local memory. It is then automatically transferred via Bluetooth® to the app when a connection to the app is established, providing continuity and reliability in data tracking.

Data captured by SmartPilot:

  • Date and time of injection
  • Injection success: In case of unsuccessful injection, SmartPilot provides detailed insights of handling errors such as partial injection or insufficient holding time
  • The information from the YpsoMate NFC-based label, such as drug type, expiry date, batch/lot number, production date (optional feature)
SmartPilot woken up
Injection progress
Injection error/wrong drug
Eject autoinjector

Seek to avoid handling errors

Step 1

A person adjusts a medication injector pen, the SmartPilot for YpsoMate, displayed next to a smartphone screen showing injection history and a notification bell icon.

Couple YpsoMate autoinjector with SmartPilot.

Step 2

A person using a SmartPilot injector on their arm, alongside a phone app displaying "Ready to inject" and a start button.

Perform the injection and automatically transfer data to mobile application.

Step 3

A hand uses a Smart injector on a forearm, while a smartphone displays a green checkmark indicating a successful injection.

Remove from skin after completion of injection including holding time.

Step 4

A hand inserts a pen injector into a yellow sharps container, while a smartphone displays a feedback prompt labeled "easy."

Discard YpsoMate save SmartPilot for future use, and rate perceived experience when performing self-injection.

Promote patient confidence in self-injection by delivering intuitive step-by-step user guidance during the injection process. SmartPilot detects the YpsoMate spring movements and translates them into injection steps displayed on the patient app.

Facilitate successful injections by detecting handling errors. SmartPilot delivers information about user handling errors to the app and the app delivers real-time user-specific guidance on how to avoid errors. In addition, SmartPilot delivers visual and audible feedback guiding the user through the injection process, even if the injection is performed without app connection.

These handling instructions are for demonstration purpose only. They do not replace the instructions for use of the customer product.

Effortless injection experience

Image of two SmartPilot devices with labeled features highlighting easy sampling, adjustable indicators, and ergonomic designs for use.

SmartPilot was developed and designed in close collaboration with potential users. Several human factor studies were performed to evaluate acceptance and user friendliness of the solution and the feedback has been incorporated into the design.

Sustainable solution

Icon of a power plug with a prohibition symbol, indicating that there's no need to charge or change the battery of SmartPilot during its lifetime.

No need to charge or change the battery of SmartPilot during its lifetime. SmartPilot can be re-used for up to two years (or 120 injections) and stored for three years prior to use.

White battery icon with an infinity symbol on a blue background, indicating battery status of SmartPilot.

Visual and audible feedback of the SmartPilot indicated the battery status and the app informs the user when the battery is low or empty.

 

Supporting correct drug use

Image shows a SmartPilot device for YpsoMate auto-injector, highlighting its NFC technology for identification.

The YpsoMate NFC – based label is an optional feature and works even when the patient performs an injection without connection to the app.

After inserting YpsoMate into the SmartPilot, the device provides visual and audible feedback, along with app-based messages, informing the patient about the validity of the medication.

The drug product is verified by comparing the drug type, set in the SmartPilot’s injection settings, with the YpsoMate’s NFC-based label.  

The expiry date is checked by cross-referencing the current date on SmartPilot with the expiry date from the YpsoMate's NFC-based label.

Developed and manufactured according to medical device standards

Ypsomed develops, creates, and operates digital health solutions that comply with data privacy regulations, follow cyber security standards and meet medical device quality system regulations. More details available under "Ypsomed Digital Health".

Disclaimer

SmartPilot is intended for the capture and recording of injection data from compatible autoinjectors to provide a comprehensive user feedback using visual indicators and audible signals to guide users throughout the injection process. It is not specifically indicated for the treatment, prevention, cure, or diagnosis of a disease or condition. Although SmartPilot may enhance the user experience, the therapeutic effect is provided solely through the use of the delivered drug under the supervision of a qualified healthcare provider. If you have questions about the SmartPilot, your treatment, or your medical condition, please consult a qualified healthcare professional.

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Resources & expert insights on SmartPilot for YpsoMate

SmartPilot factsheet

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