CARDIAC MONITORING AND THERAPY DEVICES:
Let’s get to the heart of the matter.

Developing a cardiac device is a complex and challenging undertaking, demanding a unique blend of specialized skills.

Our expertise in electrical engineering, embedded software engineering, and electrophysiology has been instrumental in designing and developing a diverse range of cardiac therapy and monitoring devices:

Implantable Cardioverter Defibrillators (ICDs): Monitoring heart rhythm and delivering therapy to manage abnormal rhythms and prevent sudden cardiac arrest when life-threatening arrhythmias are detected.

Pacemakers: Regulating abnormal heart rhythms by delivering electrical impulses when the natural rhythm is too slow, too fast, or irregular.

Cardiac Resynchronization Therapy (CRT) Devices: Coordinating ventricular contractions to improve the heart’s pumping ability and alleviate heart failure symptoms.

Cardiac Monitoring Devices: Wearable and implantable devices that continuously track heart activity for early detection of arrhythmias and other cardiac anomalies, and acquisition of other proprietary physiologic parameters.

Optimizing Device Performance

While specific performance requirements may vary, many common requirements are shared across most implantable and wearable cardiac devices.

The device must accurately detect cardiac rhythm state, capture the electrogram for a physician to review, and when appropriate, deliver therapy to treat a detected arrhythmia.

The device must operate reliably over its expected lifetime with an extremely low failure rate.

Implantable cardiac devices must have a long battery life to minimize the frequency of device replacements or maximize time between patient recharging cycles.

The majority of implantable and wearable devices today support wirelessly enabled cloud-based patient monitoring and data collection.

The device must be easy to implant, adjust, and manage, with user-friendly interfaces for both the healthcare provider and the patient.

Safety by Design

Safety isn’t a given — it happens by design. And that’s built into everything we do, including:

Devices that make an electrical connection to the heart require an extra level of design rigor to ensure that they can’t harm the patient. We develop devices from the ground up with patient risk in mind.

Cardiac devices must be designed to deliver electrical energy to the patient’s heart every time it’s needed, but must also discriminate tricky cardiac rhythms that do not require therapy.

Only a select group of electronic components are suitable for use in implantable devices, and an even smaller subset meet the requirement for life-saving use. Only parts with increased reliability testing and supplier permissions can find their way into cardiac devices, and we know where to find them.

The device must be immune to electromagnetic interference that might compromise device functionality and threaten patient health.

The device must be protected from cyberattacks that could affect device functionality or compromise patient data.

Result-based business model

Cash efficiency is a “do or die” proposition for any early stage company, and hourly-priced projects can quickly lead to cost and time overruns.

Our pricing is based on results, giving you the predictability you need to plan your budget and meet your funding milestones with confidence.

And with direct access to our project management system, you have real-time visibility into our progress so you always know where you are.

You pay for: Milestones completed

You don’t pay for: Our time

design for success

From napkin sketch to commercially-viable product, we take a holistic approach to product development, addressing all the required aspects for your device to be successful:

Technical
Ensuring the device can perform as required to deliver the intended clinical results

Usability
Ensuring the device can be operated in the intended clinical setting

Standards
Ensuring the design and development process is documented in compliance with ISO 13485:2016 and that the design meets the requirements imposed by relevant regulatory standards

Manufacturability
Ensuring manufacturing is feasible within your business case assumptions and identifying qualified suppliers and manufacturing partners

Financial
Optimizing device cost of goods sold (COGS)

IDEA

Research

Design & Development

Pre-clinical studies

Verification & Validation

Transfer to Manufacturing

CE & FDA Submissions

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“Working with Nocturnal has dramatically accelerated our time-to-market. In just one year, Nocturnal took our implantable cardiac monitor from a concept to a fully functional device with a mobile application and secure cloud connectivity.”
Jaeson Bang, Founder & CEO, Future Cardia

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