A retrospective analysis of the design, patent process, and potential utility of an improvised medical device

The purpose of this product dissertation was to present an improvised medical device to healthcare administrators and clinical professionals for evaluation of its potential utility in healthcare. Described were the design, use, patent process, hypothetical cost-benefit analysis, and evaluation for usefulness by an expert group interview of a one nostril nasal cannula designed to administer oxygen and provide a means to measure exhaled carbon dioxide in the sedated surgical patient. Traditional nasal cannulas and oxygen masks often interfere with the surgical field. A device was improvised to meet the needs of the patient, anesthesia provider and surgeon. Prior to patent application the cannula was used safely and effectively for approximately one year in operating room settings during the performance of more than 100 facial surgical procedures on sedated patients. A literature review and patent search found no available identical device. The utility patent process for this device is recorded as U.S. 6,913,017 B2. Monetary costs associated with use of the device were identified as cost of the product to the facility and to the patient, product storage, and staff in-service. Quantified non-monetary costs were identified as potential patient risks, and facility reputation. Potential benefits were more arbitrary. Depending on use, some listed costs such as replacement of several traditional products used for construction of the improvised device, were classified as potential benefits.Staff in-service was redefined as a benefit as a quality improvement measure. The customer satisfaction benefit with potential for increased facility revenue outweighed all costs. The expert group interview was composed of one anesthesiologist, one facial surgeon, four Certified Registered Nurse Anesthetists (CRNA), and two Registered Nurses (RN). The anesthesiologist and one of the RNs were also healthcare administrators. The experts evaluated the improvised device for usefulness and offered advice to healthcare administrators as to value of inclusion in the facility inventory. The experts viewed a demonstration video of the construction and use of the device. The group interview session was audiotaped and transcribed. The five interview questions were: 1. After viewing the video, what initial questions or concerns do you have regarding the use or benefits of the improvised product? 2. Can you foresee any additional benefits to the improvised product? 3. Can you foresee any contraindications or limitations to the use of the improvised product? 4. Would you consider using the finished, manufactured improvised product? 5. What advice would you offer to the healthcare administrator such as the Chief Executive Officer (CEO), Chief Operating Officer (COO), or Chief Financial Officer (CFO) of an organization when considering the addition of the new product to the inventory? Thematic analysis of categorized nouns identified in responses to the five questions suggested three dominate themes. Efficiency, types of cases, and the product itself were deduced as prominent factors in determining utility of the improvised device. Thematic deduction for advice to the healthcare administrator were to consider patient safety , surgeon satisfaction, and to include the product in the facility inventory. All experts indicated a willingness to use the product. Results of a dogmatism survey administered to the experts indicated that all had strong opinions; however, they were willing to accept change when proven wrong. Observations indicated positive expert group interest in the product. In conclusion, utility was established and administrators received useful advice. Keywords: healthcare administrator, improvised medical device, utility, patent.