This paper focuses on the challenges of meeting agency requirements as it pertains to the application of human factors in the medical device development (MDD) process. Individual case studies of the design and development process for 18 medical device manufacturers located in the US and EU were analyzed and compared using a multiple case study design. The results indicate that there are four main challenges in implementing international standards. These include a lack of direct access to users for the purposes of device development; a lack of understanding by users with regards to the impact of their feedback on the development process; contract formalities limiting user exchanges; and the attitude of clinical users directly impacting on the device developer's invitation to participate in the development processes. The barriers presented in this research have the potential to be resolved but only with greater commitment by both medical device users and developers.

This paper describes methodology for determining user needs within the design process currently being used by the University of Cincinnati's Medical Device Innovation and Entrepreneurship Program. Topics such as ethnography (user observation and interviews), task analysis, and human factors for product embodiment are discussed. Specific tools for data gathering, analysis and synthesis towards determining design considerations, requirements and specifications are defined.

Introduction: Previous simulation and porcine experiments aboard the reduced gravity program KC-135 turbojet have demonstrated that microgravity surgery is feasible. Ideally, surgical care in spaceflight will incorporate recent advances in care while remaining easy enough for a crew medical officer (CMO) lacking surgical proficiency or extensive surgical experience to perform. As a minimally invasive surgical technique, hand-assisted laparoscopic surgery (HALS) benefits the patient via smaller incisions, less pain, and faster recovery than traditional open surgery. HALS also helps less experienced laparoscopic surgeons perform laparoscopic surgery. Methods: An inexpensive inanimate surgical simulator was constructed to evaluate the usefulness of HALS in microgravity. This simulator was utilized during brief periods of microgravity provided by parabolic flight on the KC-135. The simulator was successfully used by both a physician-astronaut and an experienced laparoscopic surgeon. Task completion included simulated surgery with exploration of the intestines and ligation of the appendix. Results: Simulated HALS was successfully performed in microgravity. HALS effectively contained operative equipment and small amounts of introduced fluids within the simulated abdominal cavity. Astronaut and surgeon experience suggest that HALS could facilitate minimally invasive surgery (MIS) in microgravity. Discussion: HALS holds promise as a surgical approach in microgravity, particularly as space travel extends beyond low earth orbit. HALS provides the benefits of MIS, facilitates MIS surgery by less surgically proficient or experienced CMOs, and contains equipment and fluid within the operative field. Simulation provides an easy, cost-effective platform to evaluate medical technology for space flight as well as a method to train CMOs on-orbit.

The relationship between basic science research and product design/development are intertwined. This paper explores the definition of basic science and design as it relates to medical device development. It is intended to serve as a reference for both researchers and device developers to assist in trans-disciplinary collaborative efforts in improving patient care as each are of equal importance. The definition of a medical device is broad and varied. This paper is aimed towards those devices which interact with tissue and are rooted in the tenets of science. Both the scientific method and the design process are compared with similarities and opposites identified. The paper concludes identifying fundamental principles of medical device development and highlights the importance of both entities.