Medical Device Engineering

From records to diagnostic tools, technology is revolutionizing health care.


Technology advances continue to revolutionize health care, which is helping lead to better outcomes, diagnosis and prevention. Devices of all types now incorporate powerful processors, proprietary software and depend on DSP algorithms and network connectivity to perform their functions. But with health and lives at stake, the health care sector demands products with the highest possible accuracy at every step.

In recent years, digital security has also come to the forefront as health care records are some of the most valuable stolen data available. Further, a data breach in health care can result in HIPPA violations and other ramifications.

Cardinal Peak team members bring years of experience to this critical and demanding market, ensuring your product will be accurate and secure. From healthcare product design to HIPAA compliant software development, our team is committed to providing clients with premium medical device consulting and engineering.


Our Case Studies: Healthcare Product Design

As a top medical device software development firm, Cardinal Peak provides medical device consulting and medical device engineering including the projects below. From HIPAA compliant video to healthcare product design, if you’re looking for an engineering partner, contact us.

FAQs About Our Medical Product Development

What kind of medical device engineering does Cardinal Peak specialize in?

The medical device industry adopts new technologies to improve healthcare and enhance the patient experience. We offer medical device consulting to help healthcare companies connect their products into the evolving IoT universe. Providing a smartphone-based application for use with a medical device opens up new options for patients to take charge of their care. Cloud-based services analyze the collected data giving the caretaker the history they need to provide personalized treatment plans. Cardinal Peak provides medical device engineering services to take medical devices to the next level of connectivity.

In addition to IoT, application, and cloud development, we design complex circuit boards and specialized FPGA and DSP code for critical medical products. We offer full medical device software development that is compliant with HIPPA regulations. Our engineers and developers have made significant contributions to healthcare product designs including in vitro diagnostics, veterinary ultrasound, HIPPA compliant video recording, anti-counterfeiting, patient survey apps, and more.

What does the medical product development process entail?

We help clients through every step of the medical product development process, from Phase 0 product imagining to transfer-to-manufacturing. As your medical product contract engineering partner, we work with you at every point in the development process. We train on your design control procedures and follow the processes in your Quality Management System, becoming true members of your development team. Our experience in medical software and hardware design helps your team hit prototype milestones, create pre-production devices for clinical trials, and transfer the final design to manufacturing. We provide the appropriate documentation to support your FDA and CE Mark regulatory submission packages. Let Cardinal Peak do what we do best, medical product contract engineering, while you focus on the science and patient outcomes.

What does a medical device consulting partnership look like?

Cardinal Peak offers several engagement models when partnering with large medical device companies or small medical start-ups. We understand the skills you need on your project and offer our experienced developers as a staff augmentation solution. You direct the Cardinal Peak developers, and they work in your systems and use your tools. For our project-based model, we take responsibility for a portion of the project and assign, direct, and manage our engineers toward completion of mutually agreed upon goals.

We create proposals and estimates based on a time and materials approach. This approach allows for the most flexibility as the scope of the project adjusts to the demands of the overall product cycle. We manage our projects using a modified Agile development process and encourage interaction with your team at every step. Our experienced team is here to help you develop leading-edge medical devices bringing unique solutions to your patient cohort.

Healthcare Product Development Resources

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Donating Engineering Services for Columbia University’s CovidWatcher App

In times like these, we asked ourselves, “what can we do to help?” Enter Cardinal Peak’s engineering expertise. This post highlights our efforts to help Columbia University develop CovidWatcher, an application that surveys users about their exposure, symptoms, access to medical care, and how the coronavirus and restrictions are impacting their daily life.

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IoT in the Medical Device Industry

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