Medical Product Development Process – Clinician and Technician

Over our history we’ve developed medical products for use by a broad range of medical professionals including physicians, nurses, dentists, hygienists, physical therapists, home health professionals and others. During the research phase of most medical product development projects we rely on observation and interview with these expert users to gain insights around their likes and dislikes regarding existing products as well as their unstated desire for improved tools and processes. These users are highly skilled and highly opinionated and are as essential to the medical product development process as our internal medical research, design and engineering team members. A typical medical product development process integrates these experts throughout, often resulting in the development of formal or informal advisory teams.

Clinicians provide great sounding boards and help the medical product development team recognize opportunities for innovation while helping designers maintain familiarity and / or understandability. One of the key differences between developing products for clinicians and medical professionals versus the general population is the training factors particularly with medical / surgical devices. These users are highly trained and skilled tool users. And as a result have mastered certain techniques using existing tools. So the design team needs to understand how to create new forms and features during the medical product development process that will improve the quality of care without introducing undue change to technique.

Like clinicians, technicians are highly skilled and repetitive users. Often times the medical products and equipment they use is more complex and requires significant training and certification. We’ve developed a broad range of medical products with these users in mind including x-ray digitizers, blood analysis systems, MRI workstations, EEG monitoring devices. Many of the devices and systems technicians operate are large and complex and may include both physical and digital interface elements that need to be considered during the medical product development stages. Technicians may also be working on the equipment for long periods of time which places emphasis on ergonomist for safe operation over long periods of time.

And with large and complex products comes sighting challenges. Health facilities are loaded with large, complex and expensive equipment and space optimization is a critical element of the medical product development process. Easy and logical workflow is equally important. So our research and design team members simulate workflows and experiment with different system configurations to test and arrive at solutions that provide great ergonomics, improve workflow and reduce footprint.

The challenge becomes more acute when medical product development teams are faced with developing a new device that medical professional have never seen before.

On recent case in our product development practice is the pictured Infrascanner, a non-invasive handheld brain hematoma detector that uses near infrared (NIR) technology for the rapid detection of bleeding in the brain.

Hematomas most commonly occur as a result of head injury. An estimated two million individuals seek medical treatment for head trauma in the U.S. each year, and the worldwide incidence is estimated at around ten million (including parts of the world where CT scan technology is not readily available). While CT Scans are currently the diagnostic standard for medical hematomas, many head trauma patients do not quickly receive a CT scan due to availability and cost issues. The Infrascanner addresses this unmet medical product need for a simple, low-cost, accurate hematoma detection. This medical product is good for use in a variety of settings such as at the scene of an accident, hospital emergency rooms / ICU units, and military applications. The product data is transferred wirelessly to a PDA for storage. The intuitive design of the device makes it self explanatory to any medical personnel that could utilize this tool.

The primary challenge product development team faced was in understanding all the different environments that the product would be used in, and creating a form that was easily usable across the board. Sometimes the patient is lying down, sometimes sitting up, either conscious or unconscious, and operators have to take readings at all 8 sites on the head regardless of these variations.

Another primary product development challenge was in keeping the optics consistently aligned. Changes in the alignment between readings could produce erroneous results so tolerance analysis was important. Finally just fitting 5 PCBs and all their ribbon cables into a small medical product was a challenge.

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