Advancing healthcare with a new patient monitoring device

A successful partnership in MedTech R&D

In a collaborative effort to enhance patient care, AFRY has partnered with a leading medical device developer in Sweden to create an innovative patient monitoring device. The client, known for its commitment to innovation in healthcare, envisioned a patient monitoring device that enables real-time tracking and storage of vital signs.

There is a critical need in hospitals for real-time access to patient vitals, securely stored for future reference. Current solutions are inconvenient, inaccurate, and lack real-time capabilities, posing challenges for healthcare professionals.

Recognising these deficiencies, this project aimed to develop a sterile, user-friendly device that addresses these shortcomings. Specific user requirements, such as size and interface, have been carefully considered to seamlessly integrate the device into existing workflows. Ultimately, the goal is to empower healthcare professionals with a reliable and efficient patient monitoring solution, enhancing the quality of patient care.

AFRY’s contribution

AFRY's involvement has spanned various stages of the project, from concept development to large-scale production. Leveraging a multidisciplinary approach, our team has provided expertise in:

Concept development: Collaborating closely with the client, we have refined the product concept, ensuring alignment with user needs and market demands.
Design and usability: Our CAD specialists and hardware and software engineers have crafted an intuitive and ergonomic device interface, optimising user interaction, functionality and regulatory restrictions.
Prototyping and testing: Rigorous prototyping and testing processes have been conducted to validate product performance, reliability, and safety, adhering to regulatory requirements.
Regulatory compliance: AFRY has conducted a comprehensive risk analysis and planned for regulatory compliance from concept and design. We have provided documentation for every step of the process, ensuring adherence to EU MDR and FDA standards, thus facilitating smooth regulatory approvals

Sustainability integration

We have thoroughly evaluated the materials for sustainability, considering their entire lifecycle from production to end-of-life. Together with the customer, we have created a clear plan for recycling and reusing materials. Additionally, while planning the product's production, we have taken careful measures to minimise materials and packaging, significantly reducing the total amount of plastics and the overall carbon footprint compared to current solutions.

By integrating sustainability considerations into product design, AFRY and the client have demonstrated a shared vision for a more sustainable future in healthcare.

Challenges and solutions

One challenge has been balancing the diverse needs of end-users with strict regulatory requirements. While users sought intuitive and user-friendly features, regulatory standards demand adherence to strict guidelines for safety and effectiveness. To address this, we have fostered a close collaboration between design teams, regulatory experts, and end-users, facilitating ongoing communication and feedback to ensure the final product has met user expectations and regulatory mandates.

Another challenge has been selecting materials that can maintain sterility while meeting functional requirements. The device needs to be robust enough for regular use in healthcare settings while ensuring patient safety through sterile design and materials. Overcoming this challenge has involved material testing, supplier collaboration, and iterative prototyping to identify materials that effectively balance sterility and functionality.

The project has also required swift execution to meet market demands while not sacrificing adherence to quality standards and regulatory compliance. To address this, we have adopted agile project management methodologies, emphasising iterative development, frequent testing, and continuous improvement. This approach has allowed us to streamline workflows, identify and address issues promptly, and deliver a high-quality product within the specified timeframe.

The result:

A smart monitoring device to optimise patient vitals tracking

The project has led to the development of a robust handheld monitoring device, tailored to meet the needs of healthcare professionals (HCPs). This innovative device allows for easy access to patient vitals in real-time, including body temperature, blood pressure, pulse or heart rate, and respiratory rate, thereby enhancing the efficiency of clinical decision-making. The device features a user-friendly interface and securely stores data in a central database within the hospital's internal system, streamlining patient care processes.

Moreover, the project has resulted in a new range of products engineered to be sterile, reliable, and robust, characterised by enhanced usability, accuracy, and cost-effectiveness. These advancements have notably reduced production costs while improving product performance. Additionally, the new products require fewer adaptations for different geographical markets, facilitating widespread adoption and scalability.

A sketch of the new patient monitoring device.

It has been a challenging project where we have had to use both our breadth and depth in MedTech R&D. Being able to contribute to increased patient safety is extra motivating.

– Johan Rössner, Business Segment Manager in MedTech R&D at AFRY.

Project overview

Project: Development of an innovative patient monitoring device.

Client: A mid to large-size company that develops medical devices and equipment for hospitals and other healthcare settings.

Status: Finished.

Location: Sweden.

AFRY’s role in the project: Concept development, design and usability by CAD-specialists and hardware and software engineers, prototyping and testing, regulatory compliance, and sustainability integration.