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Making the Case for Industrial Design and Human Factors
Posted in Surgeon as Entrepreneur | Jan 2011 | Comments (0)
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An all too familiar dilemma: a physician has a great idea, but can only take it so far. A new device, a change to a procedure, a way to save time in the OR; medical technology is driven by physicians on the front lines of medical practice. How can ideas be harnessed for the benefit of patients and physicians?
Medical device development firms exist to partner with surgeon inventors and bridge the gap between a great idea and an effective product. Device development agencies collect individuals with diverse competencies to navigate the currents of the medical device design and manufacturing industry. To move an idea through the development process, a multitude of concerns must be addressed:
- Mechanical functionality
- Clinical efficacy
- Device/user interaction
- Manufacturability
- Reliability
- Regulatory compliance
Some agencies will be able to deliver on all of these interests. The best development teams balance design and engineering, with groups focusing on each concern.
However, it is not enough to create a device that works. A new device must be intuitively usable. Distractions abound in the OR. A device that is self-evident in its use will increase the surgeon’s confidence and contribute to its correct operation, and thus its clinical efficacy. Industrial design and human factors are disciplines focused on a device’s usability. Excluding these capabilities from the process will imperil the success of the device.
Fuzzy Boundaries
Engineering is typically concerned with accuracy and efficacy: How will the device work mechanically? How does the device interact with tissue? What are the processes necessary for manufacturing? Strong engineering competencies can be the backbone for a successful design project.
The design disciplines ought to be user-focused: Does the device fit users of various size? Is the sequence of actions clearly indicated? Does the device promote adequate visibility at the surgical site?
Engineering, manufacturing, regulatory and the design disciplines each have differing goals for the project. As each group champions those goals, conflict arises from which refinement ensues, resulting in a more robust product. In the best development firms, each discipline challenges the other to move beyond its historical boundaries and question the capabilities of the team. Designers might get involved in the search for pertinent technology, and engineers may take human factors to task to ensure the best user experience possible.