Global Medtech Company
Medical Device Mobile Applications for Better, Faster Cardiac Diagnoses
We partnered with a leading medical technology company to develop a solution to replace outdated bedside cardiac monitors.
We partnered with our client to develop a solution to replace outdated bedside monitors with insertable cardiac monitors (ICMs) to provide a better, more secure experience for patients and clinicians when monitoring electrocardiogram (ECG) for a variety of cardiac conditions. Taking a human-centered approach, we developed two mobile applications — one for patients and one for clinicians — that communicate between the ICM and data management systems, transmitting real-time cardiac data and symptoms to clinicians in order to come to a more accurate diagnosis faster.
On an easy-to-use app, patients track their symptoms, which are then mapped to the Bluetooth-transmitted data from their ICM. A simple set-up process and intuitive daily symptom monitoring experience builds confidence in patients, even if they are otherwise unfamiliar with using a smartphone.
With the clinician-facing app, clinicians are empowered with a streamlined patient registration and tracking process, as well as more successful and regular patient data transmissions, including a dual-stage algorithm which sends an alert when it detects and then verifies potential arrhythmia in a patient.
“Implementation of this product required a skill set and integration of technology new to our team. Nerdery has been key in helping us develop and integrate these areas.”
— Medical Device Client
The multi-year effort led to a successful Class II medical device FDA submission and market rollout.
Successful Class II medical device FDA submission and market rollout
Authored numerous documents included in the FDA and IEC 62304 regulatory submission processes
Cardiac clinicians and patients have faced significant challenges with post-surgery remote patient monitoring.
Clunky hardware, inconsistent and unsuccessful data flow, and confusing or inefficient user experiences issues have led to delayed decision-making by clinicians and frustrated patients, who are already under mental and physical stress due to cardiac conditions. Our client needed a solution to pair with their new, long-term implantable cardiac monitor that would:
Provide patients with a simple, secure, easy-to-use remote monitoring experience that makes them feel safe, supported and empowered.
Enable the implant support team to quickly and reliably set up and activate the ICM device and patient monitoring.
Provide physicians with improved detection algorithms, more successful and regular patient data transmissions.
Provide physicians with a streamlined patient registration and tracking process.
Enable a clinic to effectively run a monitoring service line with an efficient, scalable infrastructure in a fast-growing segment.
Provide hardware diagnostics for insights into how the implantable cardiac monitor device is performing in the field.
Strategy & Solution
Nerdery collaborated with our client to build a next-generation mobile monitoring device from scratch.
We began with a high-level concept of the scripting engine designs and produced a rapid prototype to validate the approach.
Partnering with the client’s human factors, systems and marketing teams, we led the requirements definition process and designed the user experience.
Nerdery’s verification and validation efforts included the creation and execution of automated, manual, unit, and integration tests. Traceability matrices confirmed our tests and design covered all requirements.
Collaborating on the integration and communication across the system, we built the mobile solutions while the client’s hardware (ICM) and server (data management system) teams were also in active development.
Implementation centered around a custom Bluetooth Low Energy (BLE) communication and included a focus on robustness, security and risk mitigation.