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User, regulatory needs drive medical design

User, regulatory needs drive medical design

Mark Pingel is director of R&D for Welch Allyn Inc., a worldwide manufacturer of medical instruments. He earned his BS-EE at Lafayette College, and MS-EE and MBA degrees from Syracuse University. Mark joined Welch Allyn in 1992, after a career in aerospace, which included engineering design, program, and functional management assignments.

As elsewhere, the drive toward smaller, interconnected, and higher-performance products is impacting medical equipment design. And with the requirement to meet not just customer and patient needs but also satisfy the requisite governing bodies, increasingly the ability to launch successful medical products hinges on astute design practices.

Design News: What are the most important technology trends today in medical equipment design?

Pingel: Welch Allyn is actively supporting research in micro-machining. We believe that nanotechnology will first yield mechanical sensors that have higher accuracy and are smaller in size. The technology will eventually lead to systems that integrate electronics and mechanics on a single chip, enabling the development of wearable and implantable devices.

We are very interested in the implications of emerging high-bandwidth communications technologies. The ability to easily transfer instrument data to databases will generate enormous improvement in effectiveness of care and reduction in cost over the next 10 years.

Q: How will these trends impact tomorrow's medical devices?

A: We are already prototyping devices using the micro-machined sensors. Integrated device systems are still several years off and we are following progress at our partner universities. Low cost RF chip sets, such as Bluetooth, will be available within a few years. We believe that as such short-range communication technologies are combined with cellular technologies, our customers will expect that every device, not just medical devices, will communicate seamlessly.

Q: How does the regulatory environment affect the design of medical equipment?

A: Welch Allyn views the regulatory environment as an opportunity, not a burden. A well designed, compliant development process leads to high-quality, reliable, and maintainable designs that are safe and effective.

Q: What considerations must be taken into account when designing medical products for global markets?

A: The U.S. market is fairly homogeneous compared to the international market. While harmonization carries the promise of a simpler regulatory requirement environment, that promise has not yet occurred. So any device manufacturer wanting to play in the global marketplace must invest in knowing the specific market safety and regulatory requirements that its devices must meet.

Secondly, end-user customer product requirements will vary widely from country to country. Use cases (flow charting the actual use of the device in the customer context) and customer preferences must be carefully researched and understood by the entire design team before detailed design begins. Design differences extend to user interfaces (user operation, units of measure, display methods, etc.) and appearance, as well as function and performance.

Q: What are the keys to medical product innovation?

A: Our most important innovations have occurred in the context of a defined customer need. Engineers get excited when they know their designs will be used and make a difference. This year we are introducing the first truly new ophthalmoscope in 85 years. This device grew from a development team getting excited and responding to a stated need. The PanOptic(TM) Ophthalmoscope provides a five times larger view of the fundus (back of the eye) and doesn't require drops to dilate the pupil.

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