IDC Designs Personal ECG Heart Monitor

The development of medical products is usually characterised by long lead times and a significant amount of testing and compliance with medical regulations. However, there is an increasing overlap between medical devices and consumer products which means that medical manufacturers have to develop and launch products at the speed of a consumer market. In this case study, Industrial Design Consultancy (IDC) reveals how they developed a medical heart monitor for consumers – the project was highly successful and completed in only six months.

The Brief: Medick Healthcare wanted IDC to produce an entirely new product concept; a personal ECG (Electrocardiogram) heart monitor intended for consumers in a non-medical environment. The product was to be aimed at a broad range of consumers, primarily in the 50+ age range. Yet with some 230,000 people losing their lives to cardiovascular disease every year, the product was also to be used by a younger audience too.

The product was to act as a medical device providing important health information, whilst still

retaining consumer appeal and simplicity of use. IDC was tasked with creating a design that would be discreet, comfortable, easy to view and understand, whilst still appealing to a consumer audience of a wide age range and technical awareness. Physically the device needed to be both compact and robust. The product also required rapid development; working to a six-month timescale.

Kay Patton, managing director of Medick Healthcare explains, "In many cases, this product will be life-changing and potentially life-saving so when it came to the design stage, it was absolutely critical to get it right. We needed a robust design that would be ergonomically and aesthetically appealing to a generally computer literate audience, but with the emphasis on simplicity and ease of use."

Product Innovation: The heart monitor was to be the first device of its kind designed for personal use,. The product cleverly combined the conventional sampling techniques of ECG monitors with neural network technology, enabling patterns and trends to be identified from millions of heartbeats. Any unusual rhythms or patterns are then identified and stored in the memory for uploading for analysis via the internet. In addition if users can press the 'Event' button to log the data around a period of concern for example after running for a bus or feeling short of breath. Users could view these heart patterns on the LCD screen integrated within the product, quickly and easily. In addition to the technology, the real design challenge was in developing a product that was essentially a medical device, yet needed to be presented in a consumer package for a fast moving market and designed to fit in with people's day to day lives.

Making the Medical Device a Consumer Product: Medical devices are increasingly judged by the same standards as consumer products and are expected to fit with people's lifestyles and aspirations. This means that the desirability, positioning and time to market of new products all need to be right. In order to establish the look and feel of the potential product, the visual direction of each individual concept was mapped on a radar chart to illustrate their relative market positions and help define the overlap between the consumer and healthcare markets.

By taking this approach the team was able to easily identify the preferred market opportunity and get the practicalities and details of the product defined whilst retaining the essence and appeal of the chosen concept. The illustration shows how initial direction flowed from initial brief through to the final product.

Project Responsibilities and Resources: The project demanded IDC's skills for: industrial design, engineering, project management, rapid prototyping and model making.

Rapid development was only made possible by IDC having all the necessary resources under one roof. IDC was involved from the very first stage of the design process through to production sign off. This required definition of the product positioning within the market, creation of the design concepts from a visual and user perspective and engineering the whole product from a manufacturing point of view.

When it came to manufacturing, IDC project managed the development and tooling programme right through to initial production and quality assurance. Compliance with medical device requirements was vital and needed to be managed throughout the devlopment. IDC also has electronics design capability, but Medick's partner undertook this element as it related to their proprietary ECG sampling technology.

Rapid Design and Development: IDC is fortunate to have engineers and designers working side by side as this creates a synergy which provides designers with technical input in the early stages, whilst enabling them to remain involved in the design as the engineering plans emerge. This ensures the design intent remains key to the product as the technical challenges are overcome.

CAD has made it much easier for designers and engineers to visualise products but often there is no substitute for a physical model or prototype when it comes to assessing and finessing a design. Having rapid prototyping on site allows ideas to be made and reviewed the same day without the delay for quotation, administration and shipping. Vacuum casting allows accurate functional prototypes to be rapidly produced before the final commitment to injection moulding is made.

In this project, the prototypes produced at IDC were used for user evaluation, drop tests and photographs for marketing purposes, prior to placing the order for tooling. This was an important factor in reducing development time. IDC has an excellent track record for rapid development projects. This success is mainly due to the project management team being able to coordinate everything in-house and IDC's experience of managing manufacturing components abroad (in this case with the toolmaker in Taiwan).

Product Materials: IDC helped select the best plastics for the product. Factors to consider when selecting materials were: strength and stiffness, impact, surface finish and appearance, wear, cost and ease of moulding. The final material chosen was PC-ABS, as this had the best balance of properties and came at a reasonable price.

Product Success: Leading physician Professor Brian Glenville is just one endorser of the product, "This is a real breakthrough for the public and doctors alike... The reports and readouts produced by Medick's MHM 100 offer a similar level of depth and insight to professional devices. Anyone taking a report from this device to their GP can do so confident in the knowledge that it provides all of the key indicators a Doctor would expect to see on an ECG."

Designing, developing and taking to market a medical product in consumer timeframes demonstrates the effectiveness of the one-stop-shop approach adopted by IDC.