AC 2010-409: USING QUALITY SYSTEM REGULATIONS AND FDA DESIGNCONTROL GUIDANCE AS A BASIS FOR CAPSTONE SENIOR DESIGN

Robert Gettens, Western New England College

Michael Rust, Western New Engalnd CollegeAssistant Professor of Biomedical Engineering

Diane Testa, Western New England College

Judy Cezeaux, Western New England College

© American Society for Engineering Education, 2010

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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

these engineers for careers in biomedical device and related industries. The objective of this

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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

design course to some extent. In previous biomedical engineering education conferences hints

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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.

These updates last roughly one hour. Meetings with clinical and industrial advisors are also

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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.

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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 of Design Control

Design Reviews

The course structure outlined above was built around the FDA design control guidance.

Design controls were built into the design process using the traditional waterfall model presented

in the FDA Design Control Guidance (Fig. 1).7 For the fall course, design reviews are held at the

first three phases of the design process, that is, after “user needs” solicitation, creation of design

input and finally after the design process. The final design review constitutes a design freeze,

and is held with a large community of clinical and industrial experts outside of the institution as

well as engineering faculty members. Ideally this would be the case for all of the design

reviews, but has not been implemented due to practical considerations. In the spring semester

design reviews focus on the design output and ideally design verification and validation.

Figure 1: Traditional waterfall process reproduced from the FDA design control guidance

(a federal document).7 The fall capstone design course focuses on the first three phases

of the design process (orange oval), while the spring semester focuses on the final two

phases of the design process (green oval).

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Design History Files

In addition to focusing design reviews on the FDA design control model, the capstone program

mimics the project documentation required for the development of a biomedical device. It

should be stressed that the capstone project only mimics the documentation required for a

biomedical device. The major portion of this documentation is the maintenance of a design

history file (DHF) (Fig. 2). In an industrial setting the file would more appropriately be called a

project folder since students log additional information in the folders than would typically be

required for an FDA audited DHF. Examples of this additional information are inclusion of

project planning and financial aspects of the project. It would not be practical to include an

entire design history file here due to size limitations. An example table of contents is included

(Fig. 3) to give a feel for the types of documents included in a design history file using our

method.

Figure 2: Examples of typical student design history files. These files are maintained

by each student and assessed at the end of each term. The opened file shows a completed

change control form for one deliverable.

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Figure 3: An example table of contents from a design history file. Due to size limitations

posting an entire file is not practical. This table of contents gives an idea of the types of

documents included in a design history file using our method.

The majority of capstone projects in our program are medical device projects and most

students also move on to the medical device industry. A similar program, however, could be

tailored for pharmaceutical design history files if such projects become available.

Change Control

Students are instructed that the DHF is a living document thus changes to deliverables are

expected and welcomed. These changes are maintained using a formal change control process

which mimics that seen in industry. As aspects of deliverables change during the course of the

project the most recent version of the deliverable is placed at the top of that deliverable section

(Fig. 2). On top of the deliverable document a change control form is placed. The change

control form indicates the project, deliverable, revision number, contents, reason for the change

and approvals of the project leader (student), technical director and a quality reviewer (Fig. 4).

This process mimics the quality system practiced in the device industry. Typically, the technical

director is the project advisor and the quality reviewer is another biomedical engineering faculty

member. In the industrial setting the quality function would follow a separate hierarchy of

supervision. For the purposes of introducing students to design controls, using a second faculty

member as a reviewer was deemed an appropriate model. Note that when all signatures are

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obtained students receive an approval stamp from the department chair for that deliverable. This

does not, of course, preclude follow-on changes to the deliverable.

Figure 3: Example of a change control document for a project deliverable. The student is

the project leader while the technical director and quality reviewer are faculty members.

Student Assessment and ABET

Students are assessed by the faculty on professionalism, maintenance of the DHF and

performance on design reviews. The professionalism portion of the assessment is based on

maintenance of a laboratory notebook, project leadership and preparedness for meetings. The

DHF is assessed based on a grading matrix and rubric for each deliverable (Table 2). Page 15.1335.9

Performance on design reviews are similarly assessed using a grading rubric focusing on 1) the

aesthetics of the performance and 2) the technical content of the review.

Table 2: Grading matrix used for the DHF portion of the capstone design course.

Since the DHF is a living document a certain amount of liberty must be given in the assessment

of the deliverables. Faculty must be able to assess the grey area of design, eloquently described

by Gassert et al. in their paper concerning research vs. design in capstone courses.8 This

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freedom is particularly needed in the fall semester when certain deliverables based on individual

projects may be largely incomplete. Examples of note are the design verification and validation

plan as well as global considerations of the design. It should also be stressed that projects

evolve at different rates, and this must be taken into consideration. All of these factors are of

particular concern when incorporating a design control process such as that described in this

paper.

The incorporation of QSR and design controls into the capstone design course is only in its

second year with fourteen students having been through the program. Therefore, the data needed

for a critical assessment on the impact for graduates in the industrial setting is not yet available.

Also we did not yet receive IRB approval to use quantitative information on student performance

for research purposes so we are not able to report those data. Initial reports do indicate that the

process does indeed better prepare students for the language and requirements of design control

and QSR. Additionally, we received very positive feedback from our Industrial Advisory Board

on the incorporation of this program. John Kirwan, President of Incite Innovation, LLC gave the

following incite in response to the program, "As a biomedical industry veteran, I frequently

evaluate skill sets of potential new hires. Having a solid education in the engineering

fundamentals coupled with a firm grasp of design controls and quality systems regulation

provides recent graduates with the definite advantage of being able to join a R&D group and hit

the ground running."

While many of the ABET assessment criteria could be assessed in the capstone design courses

our program chooses to specifically assess criteria 3c, 3e and 3h. The criteria definitions are 3c:

an ability to apply to design a system, component, or process to meet desired needs within

realistic constraints such as economic, environmental, societal, political, ethical, health and

safety, manufacturability, and sustainability, 3e: an ability to identify, formulate, and solve

engineering problems and 3h: the broad education necessary to understand the impact of

engineering solutions in a global, economic, environmental, and societal context. A summary

of these criteria, the delivery strategy and assessment methods are shown in Table 3.

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Table 3: Summary of the ABET criteria assessed by the two semester senior capstone

design courses using design control as a basis for instruction.

Lessons Learned

The program described in this paper has been implemented for one and one half years

incorporating two fall semesters and one spring semester. In addition to standard student

surveys, formal after action reviews were held at the end of each fall semester. Several valuable

lessons were learned from these sessions:

≠ Students felt that the change control process should be streamlined.

≠ Students felt that the entire faculty, not just the capstone course director, should be better

educated on 21CFR820-30 and the implemented program. It should be pointed out that

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we have full buy-in on this program from our faculty. Our faculty is learning the

process along with the students and becoming more and more knowledgeable with QSR

as we move forward.

≠ The requirements needed to elicit user needs should be communicated early in the

semester so that ample time is given to complete the necessary paperwork. This

pertains specifically to institutional review board (IRB) approval to conduct user

surveys.

≠ Students felt that underclassmen, freshman-junior level should be invited to and take part

in design reviews as outside observers.

≠ Design projects stemming from research have difficulty fitting into the design model

presented. These projects should be avoided or the structure should be altered to make

allowances.

One area of difficulty for students was taking the lead as the project manager. Students are, of

course, used to a unilateral approach in the faculty-student relationship, in which information is

given by the faculty member to the student. It may be challenging for students to break this

cycle and begin generating knowledge on their own, but this effort is ultimately necessary for

their development. It was also found that Gantt charts were an underutilized resource. Students

suggested that as part of weekly project meetings they should update and bring project Gantt

charts. It was felt that this would help guide them in leading projects and more efficiently use

the Gantt chart tool.

Conclusions

Knowledge of the requirements to develop a medical device, specifically QSR and design

control is one key facet that sets biomedical engineers apart from the other engineering

disciplines. Practicing the tenets of design control, rather than simply having those tenets

dictated, better prepares biomedical engineers for the medical device workplace. The program

described here is an easy to implement system that mimics the design control process in a

medical device company. The method provides a means for students to practice being design

engineers in the “real-world”. The attainment of this skill set will be a key asset for the

biomedical engineering community, setting us apart from our engineering colleagues and making

our students employment exceedingly desirable by the medical device community.

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