Perspectives on Device Design—Part 2
How is the movement of healthcare out of the hospital and into patients’ homes impacting device design?
Senior Manager, Medical Products Group, Microchip Technology Inc.
Compelling arguments, based on economics and outcomes, are driving more care into the homes of patients, resulting in an increasing number of medical devices becoming consumer products. A device used in the home must be different from a hospital device in a few important ways. First, a home device needs to essentially be self-operating, because the user will not be a medical professional. Sensors, actuators and microcontrollers make it possible for designers to create many medical devices smart enough to be usable by practically anyone. The second difference between hospital and home devices is cost. There are far more homes than there are hospitals, so for broad-based home care to be practical, the associated devices must be produced at much lower costs. Although this attribute is basically at odds with making devices smarter, technology will again play a part in the solution, as the same models familiar to the consumer-electronics world are applied to medical devices. Perhaps the most significant impact on medical devices, as they move into the home, will be how they enable patients to take control of their healthcare. Empowering people to be more responsible for their own care will help them to live healthier lives.
Global Market Manager, Commercial Products, FCI
Home treatment of patients is typically being done with smaller, lightweight, power-efficient, and multi-functional equipment. Therefore, the traditional medical OEMs are looking for different interconnect solutions to meet these needs. For an interconnect supplier, this opens the door to offer new connector solutions—often smaller pitch/lower profile versions of proven connector systems, like mezzanine systems. The trend is clearly moving away from 1.0 mm down to 0.8 or 0.5 mm ruggedized BTB versions. Some connector suppliers are working closer with medical companies on application specific and often creative solutions. For example, FCI's high performance mezzanine system, Conan, is being used as a high performance edgecard system. The mezzanine system met the needs for smaller, highly reliable rectangular BTB connections for the application. Additionally, FCI's flexible circuit solutions and custom FPC cables with high-end BTB connectors meet the need for flexible, reliable interconnects in equipment with space constraints. In other words, there is more discussion around the type of interconnect used because of miniaturization, which means interconnect companies are involved in solving hardware design challenges of medical OEMs more than ever.
Business Development Mgr., KMC Systems Inc.
Over the last year, usability analysis has created significant changes in the medical device industry. On March 21, 2010, compliance with MDD 2007/47/EC was enforced internationally, meaning that stricter regulations are put on usability and human factor testing in medical devices brought to market. The movement of healthcare out of the hospital and into patients’ homes makes it more important than ever for devices and instruments to be safe and intuitive from a human factors standpoint in order to provide the most effective patient care possible.
For medical device manufacturers, this means that outlining a well-defined process upfront in the product development stage is essential to creating a user-friendly product ready for manufacture. Consideration must be given to simple design decisions, such as switch location and interface layout. Delivering quality design while fitting the user’s needs ensures a smoother FDA approval process; so many medical device companies are seeking partners in the industry that have extensive experience in human factors engineering and usability. Working with a proven partner will help expedite the product design and development phase by eliminating design pitfalls that can lead to human error in the home, hospital or laboratory.
Sales Manager—Medical, Bosch Rexroth Corporation
Hospital only medical devices are administered and monitored by a trained healthcare professional. With the movement into the home, the device’s industrial design and human interface need to be carefully considered. The patient many times will set up and generally will “operate” the device. They could have dexterity, sight and other conditions which will impact their ability to perform these functions. Patient safety is of primary concern; therefore the controls need to be failsafe to eliminate any accidental change of dosage or therapy which may injure the patient.
Device settings and data needs to be collected without regular visitation to the home by a healthcare provider. Hence, a secure web based monitoring function can be used to provide needed data while insuring patient confidentiality.
The quantity produced of a home healthcare device is typically much higher than hospital-only devices. In many cases, this requires different design and manufacturing techniques. All challenge the core competencies of the device designers and typically require more automation than hospital-only devices, as patients will be tasked to control the device, not healthcare professionals.
Program Manager, Ximedica
Movement of healthcare devices out of the hospital and into the home requires very different up-front usability research. Devices now need to be designed for diverse user groups with a wide range of physical and cognitive abilities, from moms to seniors to the recent hospital discharged patients to trained clinicians. The value stream is quite different in terms of purchase, storage, usage, disposal, etc. We’ve seen tremendous growth in smaller, disposable OTC devices, such as lateral flow immunoassays (that aid in identifying specific pathogens rather than cross-checking numerous maladies), as well as in-home diagnostic products. Due to rising healthcare costs, many people are choosing to self-diagnose where they can and companies are racing to develop inexpensive diagnostic devices that are not only easy-to-use in-home, but are also very accurate in terms of sensitivity and specificity. Enabling technologies include increased assay sensitivity, low-cost readouts, and simple (manual) mechanisms.
A step up in device complexity includes lab-on-chip technology. Typically, these chips require a reader. Some of the most compelling applications of device readers are the portable ones—lightweight, robust, battery-powered, and fully functional. This allows healthcare providers to travel to remote areas of the world, bringing medical diagnostics (and subsequent treatment) to people who would otherwise never set foot in a hospital or clinic. Enabling technologies include: low power LEDs, miniaturized motion and visualization devices, high capacity batteries, very efficient electronic design, and sophisticated software algorithms.