AC 2010-409: USING QUALITY SYSTEM REGULATIONS AND FDA DESIGN CONTROL GUIDANCE AS A BASIS FOR CAPSTONE SENIOR DESIGN Robert Gettens, Western New England College Michael Rust, Western New Engalnd College Assistant Professor of Biomedical Engineering Diane Testa, Western New England College Judy Cezeaux, Western New England College Page 15.1335.1 Page © American Society for Engineering Education, 2010 Using Quality System Regulations and FDA Design Control Guidance as a Basis for Capstone Senior Design Abstract Medical device development in the industrial setting follows the tenets of Quality System Regulations (QSR) and the design control guidance of the U.S. Food and Drug Administration (FDA). Many biomedical engineers learn the language and practices of QSR and design controls on the job. Experiential learning in these areas gives biomedical engineering graduates a valuable skill set coveted by medical device companies. This skill set will position biomedical engineers apart from other engineering disciplines and will help more completely define the biomedical engineer. The Biomedical Engineering Department at Western New England College has developed an approach to the capstone senior design course which integrates QSR and design controls into the curriculum. This integration uses an experiential method in which students follow the guidelines for design control and QSR, closely mimicking best practices seen in the medical device industry. The idea to incorporate QSR and FDA design control guidance was generated largely through the Department’s industrial advisory board. Members of our board from the medical device industry see a knowledge gap in QSR and design control in recent hires from the general pool of engineering graduates. The incorporation of these elements into our capstone design course, not just in theory, but in practice, seeks to alleviate this gap. Introduction According to the 2009 AIMBE biomedical engineering placement survey, 49% of bachelor-level graduates obtained employment in industry. 1 The U.S. Department of Labor projects an employment growth rate of 72% for biomedical engineers in the decade 2008-2018. This growth rate is much faster than for other engineering disciplines. 2 Reasons for this projected rapid increase include the demand for more technically sophisticated medical devices due to an aging population, and concern for the development of more cost effective medical procedures. 2 This increased demand coupled with an existing trend of engineers going to the medical device industry necessitates a change in the academic setting to better prepare and train 15.1335.2 Page these engineers for careers in biomedical device and related industries. The objective of this paper is to present an experientially-based pedagogical method using the senior capstone design course to train engineers directly in the procedures of the Quality System Regulation (QSR), thus better preparing graduates for careers in the biomedical device workplace. A pilot survey of faculty, students and industry sources concerning engineering design courses across disciplines demonstrated an emerging theme of learning and development of professional skills in these courses. 3 Indeed in recent years the importance of preparing biomedical engineers professionally through the use of the capstone design course has been stressed by a number of programs. 4-6 Pedagogical techniques being used in biomedical engineering curricula to introduce students to “real-world problem-solving”, which was presented by Ropella, Kelso and Enderle, include the use of computer simulation, internships and cooperative education, guest speakers, guest instructors, field trips, bioethics instruction and problem-centered instruction. 5 At Bucknell, a four course sequence over the Junior and Senior Years was implemented in order to introduce students to such skills as regulatory issues, teamwork, environmental impacts, formal decision making, computer-aided design, machining, rapid prototyping, cell culture and statistical analysis. 4 Importantly these skills are taught and practiced prior to embarking on the senior capstone design project. 4 At the University of Virginia professional skills such as job searching, interviewing, written and oral communication, ethics, negotiation skills, leadership, intellectual property and entrepreneurship have been integrated into the senior capstone design course. 6 Our capstone design course offers an experiential method that builds upon these professional skills. For engineers to be effective in the medical device industry they must be familiar with and be able to adhere to Food and Drug Administration (FDA) regulations as outlined in Title 21 of the U.S. Code of Federal Regulations. Section 820 of Title 21 governs QSR. The design controls put forth in Subsection 820.30 of the QSR are of particular importance to engineers involved in the design process. A summary of 21CFR820.30 from a user perspective is outlined in the FDA design control guidance document. 7 The importance of design over research projects is firmly established for senior capstone design courses, particularly as directed by guidelines of the ABET, Inc.8 Therefore, since accredited biomedical engineering programs must offer design-based projects and design in the biomedical device industry must follow the design controls put forth by 21CFR820.30, it is logical that academic programs should attempt to incorporate these regulations into the capstone 15.1335.3 Page design course to some extent. In previous biomedical engineering education conferences hints of merging these two concepts were presented. At the 2009 BME-IDEA Biennial meeting the incorporation of 21CFR820.30 in the Case Western Summer Design Experience was presented. 9 A discussion of the need for and current resistance to incorporating design controls into the capstone design course was discussed by Jay Goldberg in the IEEE Engineering in Medicine and Biology Magazine. 10 Prior to employing this method of delivering the capstone project we followed a more traditional academic structure. At that time, the course structure was a two semester sequence of senior capstone design. A fall written and oral proposal was followed by spring project execution and final oral defense and written report. The emphasis of the projects was engineering design even though an academic structure was in place. The impetus behind our endeavor to integrate 21CFR820.30 into our senior capstone course came from our industrial advisory board. Members of the board, and specifically those from the biomedical industry, indicated to our department that the new hire engineers they were employing had only a cursory knowledge of FDA regulations, the quality function and design control. We were advised to better incorporate 21CFR820.30 into our senior capstone course. It was pointed out that knowledge of the FDA design control process could be one of the major skill sets separating biomedical engineers from other engineers. This would make the undergraduate biomedical engineer an attractive asset for a medical device employer. This paper outlines a method to incorporate 21CFR820.30 into a capstone design course. It should be noted that the method attempts only to simulate working in the biomedical device industry. The method does not and could not replace the massive workforce and procedural documentation required to obtain FDA approval for a biomedical device. General Course Structure The general course structure used in this work incorporates many of the tenets put forth in Jay Goldberg’s book on biomedical engineering capstone design courses. 11 Similar to many programs, the senior capstone design project is delivered in a series of two courses. A 3-credit fall course covers the initial phases of the design process. A 4-credit spring course builds on the fall course and incorporates the majority of the prototype fabrication process and device testing. During both semesters students meet with faculty advisors for weekly status update reports. Page 15.1335.4 Page These updates last roughly one hour. Meetings with clinical and industrial advisors are also encouraged. The fall course includes a weekly lecture followed by a working laboratory section later in the week. The lecture typically introduces the topic to be covered in the working section. Lecture topics cover areas of professionalism focused around the FDA design control guidance. Written deliverable documents based on working sessions are scheduled to document the design process as well as guide the students toward successful completion of their project. A summary of the presented lectures, working sessions and project deliverables (due dates are for the draft forms) is shown (Table 1). Table 1: General course design for the fall section of the capstone design course. Lecture is for 1 hour. Lab activities range from 3-4 hours. All deliverable due dates are for draft documents to guide student project planning. Page 15.1335.5 Page Ideas from several other programs were incorporated in this work. An example is the two week introductory design experience used at Bucknell University and presented at the 2009 BME- IDEA Biennial conference. 12 Rather than offer the activity at the start of the semester, as Bucknell did, we offered it midway through the course (Table 1: week 7). Initial feedback from students indicated that this timing was ideal, since at that point in the course they were familiar enough with the design process to effectively engage the exercise. Incorporation