ACAP, 3/25/2021 2.o NEW PROGRAM PROPOSAL FORM

Name of Institution: Clemson University

Name of Program (include degree designation and all concentrations, options, or tracks): MS Medical Device Reprocessing

Program Designation: Associate’s Degree Master’s Degree Bachelor’s Degree: 4 Year Specialist Bachelor’s Degree: 5 Year Doctoral Degree: Research/Scholarship (e.g., Ph.D. and DMA) Doctoral Degree: Professional Practice (e.g., Ed.D., D.N.P., J.D., Pharm.D., and M.D.)

Consider the program for supplemental Palmetto Fellows and LIFE Scholarship awards? Yes No

Proposed Date of Implementation: August 2021

CIP Code: 51.0722 (Healthcare Innovation)

Delivery Site(s): 85750 (Online Degree Programs)

Delivery Mode: Traditional/face-to-face Distance Education *select if less than 25% online 100% online Blended/hybrid (50% or more online) Blended/hybrid (25-49% online) Other distance education (explain if selected)

Program Contact Information (name, title, telephone number, and email address): Dr. Martine LaBerge, Professor and Chair of Bioengineering; 864-656-5557; [email protected] Dr. Melinda Harman, Associate Professor of Bioengineering; 864-656-4140; [email protected] Dr. Jeremy King; Assoc. Provost for Institutional Effectiveness; 864-934-3554; [email protected]

Institutional Approvals and Dates of Approval (include department through Provost/Chief Academic Officer, President, and Board of Trustees approval):

University Graduate Curriculum Committee: 8 January 2021 Provost: 12 January 2021 Clemson University Board of Trustees: 5 February 2021 (anticipated; will confirm with CHE staff prior to ACAP)

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ACAP, 3/25/2021 2.o Background Information State the nature and purpose of the proposed program, including target audience, centrality to institutional mission, and relation to the strategic plan.

Clemson’s Department of Bioengineering, in collaboration with its Department of Industrial Engineering, proposes a new professionally-oriented non-thesis-based MS degree in Medical Device Reprocessing to prepare students for advanced careers in the fast-growing global medical device industry. Medical device “reprocessing” involves the cleaning, disinfection, and sterilization of medical devices after each use. Reprocessing is an essential practice in healthcare delivery, and plays a key role in the more than 100 million surgical procedures in the U.S. each year. The mission of the proposed MS degree is to educate students from across the STEM disciplines to optimize reprocessing technology supporting safe and routine reuse of medical devices. We accomplish this mission by integrating and applying knowledge of fundamental principles of bioengineering, medical device design, quality education and regulatory science in an industry immersion/training program.

The Food and Drug Administration (FDA) recognizes medical device reprocessing among its top 10 regulatory science priorities. The FDA and industry advocacy groups continue to call for training in effective engineering design and validation studies to ensure that reprocessed medical devices are safe. Given that device reprocessing and reuse is ubiquitous in global healthcare delivery, technical solutions to mitigate reprocessing risk must address both design constraints in high-resource settings (e.g. U.S. healthcare system) and the unique needs/opportunities in global emerging markets. Medical device reprocessing has a significant impact on healthcare costs by reducing medical waste and producing significant cost savings. According to the Association of Medical Device Reprocessors (AMDR), in 2018 alone, reprocessing companies in the U.S., Canada and Europe reduced hospital solid-waste generation by almost 7,100 tons and generated cost savings of more than $470 million for healthcare institutions.

The COVID-19 pandemic has challenged reprocessing of single use medical devices given constraints on availability of medical supplies and renewed attention to the role of infectious diseases. It is of the utmost importance that the medical device reprocessing workforce be well-educated. As there is no comprehensive advanced degree program targeting medical device reprocessing in the United States, this proposal strategically fills large public health and workforce development gaps.

The knowledge and skills gained through this MS degree program will prepare globally-engaged STEM students to be innovative leaders in sustainable biomedical technology for solving global health issues and addresses the shortage of workers trained in reprocessing technology. This program supports workforce development in this sector, heeding calls for training and innovation in modern reprocessing technologies used to ensure medical device safety.

This program leverages existing resources in the departments of Bioengineering and Industrial Engineering. Sustained interest in the field of medical device reprocessing is manifest to us by graduate student enrollment of 1707 total student credit hours in three existing medical device recycling and reprocessing graduate courses in bioengineering taught since 2012. The MS degree in Medical Device Reprocessing builds on this demand via fully on-line course delivery, enabling enrollment by working industry professionals and international students. This MS degree in Medical Device Reprocessing fosters global learning in a professional and disciplinary context aligned with the University’s global competency outcomes: • Describe reprocessing technology in a global context and the role of healthcare professionals. (K1, K3) • Critically examine and address global challenges affecting healthcare sustainability and hindering the safe and routine reuse of medical technology. (S1, B2)

This MS degree in Medical Device Reprocessing builds on historic academic and research strengths in the Bioengineering Department and is aligned with the with the ClemsonFORWARD strategic plan: • Research: The MS degree in Medical Device Reprocessing is aligned with two innovation clusters through its emphasis on health innovation and sustainable environments.

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ACAP, 3/25/2021 2.o • Engagement: The MS degree in Medical Device Reprocessing will educate graduate students engaged in critical thinking, global awareness, and scientific and technical knowledge centered on reprocessing technology and healthcare sustainability. It will foster partnerships with global academic institutions and private medical device industries. • Academic Core: The MS degree in Medical Device Reprocessing at Clemson University is the first U.S. graduate engineering degree focused on medical device reprocessing. It supports interdisciplinary education by enrolling graduate students having undergraduate degrees from diverse academic backgrounds/departments.

Assessment of Need Provide an assessment of the need for the program for the institution, the state, the region, and beyond, if applicable.

Medical device reprocessing (MDR) is a process of making used single-use devices (SUD) fit for reuse by cleaning and sterilizing them. This process begins with the 1) design of those devices, 2) failure prediction, 3) development and assessment of processes for effective reprocessing and 4) their sterilization following Food and Drug Administration (FDA) regulations. Traditional undergraduate education programs in bioengineering provide the needed skills to develop needed technology to ensure continuous improvement in healthcare. However, the combination of needed skills to realize robust MDR can only be attained through a focused advanced degree program. In addition to an understanding of the design process, advanced skills are needed for assuring the safe and effective reprocessing, project management, regulatory science, quality science, supply chain, and performance assessment. These skills are needed by both the original equipment manufacturers (OEMs) and the reprocessing industry.

The global medical device reprocessing market has grown rapidly and steadily in the last few years mainly due to the growing need to reduce medical waste. Medical waste constitutes a major part of the overall waste production in various countries, and is a particularly bothersome part of the waste due to its biologically active nature. SUDs are the largest group of devices used for surgeries, procedures, and life- support: blades, catheters, scopes, respirators, cauterizers, etc. The COVID-19 pandemic and shortage of personal protective equipment (PPE) such as masks, shields, etc has delivered a new opportunity for the reprocessing market. Reprocessed single-use medical devices are as safe and effective as original medical equipment, assure availability, and have greater affordability.

The use of re-processed SUDs also results in reduction of costs associated with special handling and waste management of devices. Healthcare facilities not only save 50% for every reprocessed device they purchase and spend less on medical disposal, but they also save money when original equipment manufacturers (OEMs) lower their prices to compete with third-party re-processors, thus lowering the overall cost of healthcare. An additional benefit is that environmental sustainability is enhanced.

Increasing numbers of technologies and applications to medical equipment and devices, along with the medical needs of a growing and aging population, will require the services of biomedical engineers with advanced skills. According to the US Bureau of Labor Statistics, employment of biomedical engineers is projected to grow 5 percent from 2019 to 2029, faster than the average for all occupations. In 2019, the number of jobs for this field was 21,200 (Biomedical Engineers : Occupational Outlook Handbook: : U.S. Bureau of Labor Statistics (bls.gov)). The advanced skills provided to the graduates of the Medical Device Reprocessing MS program will increase their competitiveness in the labor market, and provide the workforce needed to serve the biomedical device industry (OEM), the bioscience market, and the medical device reprocessing industry. In South Carolina alone, the biomedical sciences industry has already reached critical mass and is poised for further rapid growth. According to SC BIO (scbio.org), the industry reports more than $11 Billion in annual economic impact, a steady 1.7% growth annually for the past 15 years, and more than 670 dedicated live science firms. With hundreds of new patents and licensed technologies since 2012, the SC life science industry in blooming with large OEMs relocating to SC (e.g. Arthrex, Abott, Boston Scientific) and numerous start-ups and mid-size companies operating on the foundation of medical device innovation and development. The proposed program will provide them the needed competitive workforce.

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Transfer and Articulation Identify any special articulation agreements for the proposed program. Provide the articulation agreement or Memorandum of Agreement/Understanding. N/A

Employment Opportunities

State National Expected Expected Number of Employment Number of Employment Data Type and Occupation Jobs Projection Jobs Projection Source Bioengineers/ Biomedical Engineers including regulatory science specialist, quality assurance engineers, and process- manufacturing specialists 1,612 1.5% 21,200 5% ccbio.org/bls.gov

*Data above for 2019-2029 (current BLS projection range)

Supporting Evidence of Anticipated Employment Opportunities Provide supporting evidence of anticipated employment opportunities for graduates.

Evidence supporting employment opportunities is based on the number of available positions posted on the scbio.org website. Additionally, a survey conducted with the bioengineering undergraduate majors in fall 2020 indicated that at least 15 students (out of 372) would enroll in this program if available in addition to 11 who would consider strongly. Clemson Bioengineering in collaboration with Industrial engineering currently offer a course-based creative inquiry sequence on reprocessing and human factors led by Drs. Melinda Harman and David Neyens that enrollms more than 12 students from STEM majors each semester. These students are candidates for enrollment in the MS program. We also expect that our collaboration partnerships with Arusha Technical College in Tanzania and IIT Delhi on reprocessing research and design will serve as an immediate feeder for the program. Clemson Bioengineering has secured several research grants from the medical device industry to conduct design evaluation for medical device reprocessing including Arthrex (Sandy Springs, SC), Steris (Spartanburg, SC) and Stryker Sustainability (Phoenix, AZ) to name a few. Those employers have hired graduate students who have enrolled in the three courses sequence in medical device reprocessing. The skills set acquired through the MS program will enhance the marketability and competitiveness of any bioengineer/biomedical engineer for employment in the industry at large.

Description of the Program

The proposed MS degree is a 1-year, 30 credit hour program with entry in the fall semester, and graduation the following summer semester. The program curriculum avails itself of 12 already-existing and offered courses, and has only required the development of one new course (see below).

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Projected Enrollment—Detailed Model Year Fall Headcount Spring Headcount Summer Headcount New Continuing Lost Graduate New Continuing Lost Graduate New Continuing Lost Graduate 2021- 13 0 0 0 0 13 0 0 0 13 0 13 22 2022- 18 0 0 0 0 18 0 0 0 18 0 18 23 2023- 23 0 0 0 0 23 0 0 0 23 0 23 24 2024- 28 0 0 0 0 28 0 0 0 28 0 28 25 2025- 33 0 0 0 0 33 0 0 0 33 0 33 26

Projected Enrollment Fall Spring Summer Year Headcount Headcount Headcount 2021-22 13 13 13 2022-23 18 18 18 2023-24 23 23 23 2024-25 28 28 28 2025-26 33 33 33

Explain how the enrollment projections were calculated. The projected enrollment is based on the following evidence: 1) The annual growth in student enrollment for the core lecture courses in the existing Medical Device Recycling and Reprocessing Certificate increased 18% to 31% over the past 3 years. 2) Student enrollment in the Bioengineering MEng program increased 36% from AY2015-16 to AY2019-20.

There are three additional sources of evidence that demonstrate the possibility of high interest in a MS in Medical Device Reprocessing degree program: 1) Student enrollment in core lecture courses offered in the existing Medical Device Recycling & Reprocessing certificate program has been increasing. Average student enrollment for those four core lecture courses has increased 136%, from 11 students in AY2012-13 (1st year) to 26 students in AY2019-20 (8th year). 2) Enrollment in existing core lecture courses offered in the Medical Device Recycling & Reprocessing certificate program by graduate students from a broad range of engineering and science disciplines has been increasing as well. Over the 5 year period from 2014-2019, 14% of students enrolled in those core lecture courses were in non-bioengineering disciplines. 3) Finally, there are existing pathways for students to enroll in this program via current programs and institutional partnerships. Current programs include the BS/MS degree in Bioengineering, the BS/MS degree in Biological Sciences/Bioengineering, and the BS/MS Bioengineering degree programs at academic institutions across South Carolina (The Citadel in Charleston, SC) and planned combined education plan between Clemson Bioengineering and Claflin University School of Natural Sciences and Mathematics. There are also a number of established relationships via memoranda of understanding with international academic institutions (Arusha Technical College in Tanzania; the Indian Institute of Technology in India).

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ACAP, 3/25/2021 2.o Besides the general institutional admission requirements, are there any separate or additional admission requirements for the proposed program? If yes, explain. Yes No

Curriculum

New Courses List and provide course descriptions for new courses.

BIOE 6380 Engineering Controls & Validation for Microbiological Systems This course provides a detailed overview of cleaning, disinfection/sterilization, and packaging requirements for reprocessing medical devices. It emphasizes biocompatibility, process controls, and cleaning/disinfection/sterilization systems in manufacturing and healthcare sectors. It addresses compliance with global regulations and standards, including instructions for use, methods for cleaning and sterilization validation, equipment design, and packaging processes.

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Total Credit Hours Required: 30

Curriculum by Year Credit Credit Credit Course Name Course Name Course Name Hours Hours Hours Year 1 Fall Spring Summer BIOE 8150 Design, Manufacturing & BIOE 8140 Medical Device BIOE 6380 Engineering Controls for Validation Methods Commercialization Microbiological Systems 3 for Reusable Medical Devices 3 3 IE 6300 HF Eng. in Healthcare 3 IE 8000 Human Factors IE 6620 Six Sigma Quality 3 (systems engineering) 3 BIOE 8660 Global Regulatory & BIOE 8670 Product Development, Legal Framework of Quality 3 Specifications, Process & Validation 3 BIOE 8630 Regulatory and Clinical Affairs for Medical Devices OR BIOE 8620 Pre-Clinical Assessment and BIOE 8680 Risk & Failure Analysis Regulatory Affairs for Medical Devices 3 2 BIOE 8510 Mentoring Undergraduates Research Teams OR BIOE 8900 Bioengineering Internship 1

Total Semester Hours 12 Total Semester Hours 12 Total Semester Hours 6

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ACAP, 3/25/2021 2.o Similar Programs in South Carolina offered by Public and Independent Institutions Identify the similar programs offered and describe the similarities and differences for each program.

There is no similar program at a public or private university in South Carolina.

Program Name and Total Credit Designation Hours Institution Similarities Differences

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ACAP, 3/25/2021 2.o Faculty

Other Qualifications and Academic Degrees and Relevant Professional Rank and Full- or Coursework Relevant to Courses Taught for the Program Experience Part-time Courses Taught, Including (e.g., licensures, certifications, Institution and Major years in industry, etc.) Lecturer #1 BIOE 8140 - Medical Device PhD Bioengineering, Part Time Commercialization Clemson University 4 years industry experience Associate PhD Industrial Professor #1 IE 8000 - Human Factors Engineering, University Full Time of Iowa Associate BIOE 8660 - Global Regulatory Professor #2 PhD Bioengineering, & Legal Framework of Quality Full Time Clemson University 6 years industry experience Associate BIOE 8150 - Design, Professor #3 Manufacturing & Validation Full Time Methods PhD Bioengineering, for Reusable Medical Devices Clemson University Professor #1 IE 6300 – Human Factor Eng. in PhD Industrial Full Time Healthcare (systems Engineering, University engineering) of Florida BIOE 8670- Product Associate Development, Specifications, Professor #2 PhD Bioengineering, Process & Validation Full Time Clemson University 6 years industry experience Associate BIOE 8680 - Risk & Failure Professor #2 PhD Bioengineering, Analysis Full Time Clemson University 6 years industry experience Lecturer #2 BIOE 6380- Engineering Full Time Controls for Microbiological PhD Bioengineering, Systems Clemson University BIOE 8630 - Regulatory and Lecturer #3 Clinical Affairs for Medical PhD Bioengineering, Regulatory affairs for med Part Time Devices Clemson University device industry >10 years BIOE 8620 - Pre-Clinical Lecturer #3 Assessment and Regulatory PhD Bioengineering, Regulatory affairs for med Part Time Affairs for Medical Devices Clemson University device industry >10 years BIOE 8510 Mentoring Professor #2 Undergraduates Research PhD Electrical Full Time Teams Engineering, MIT PhD Biomedical Professor #3 BIOE 8900 - Industry Practicum Engineering, University Full Time of Montreal Associate PhD Industrial Professor #1 IE 6620 - Six Sigma Quality Engineering, University Full Time of Iowa

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Total FTE (full-time equivalent) needed to support the proposed program: 1.5 Faculty – part-time lecturer: 0.5 Staff: 1.0 Administration: 0 (These program values are modest because extant faculty, whose costs are sunk, already teach the extant courses as part of other extant Clemson biomedical engineering programs; the values here represent a fair apportionment, in an accounting sense, of faculty effort/load to the MS program proposed here.)

Faculty, Staff, and Administrative Personnel Given the Bioengineering department’s robust portfolio of extant graduate programs, an additional graduate student services coordinator will be hired to provide student services including recruitment and placement for the program. Additionally, a part-time lecturer will be specifically assigned to the program to provide expertise in sterilization and microbiology of medical devices. The curriculum will be delivered by a total of six current full time faculty members from bioengineering and industrial engineering who have expertise in the field and are offering these courses as part of other program curricula.

Resources

Library and Learning Resources Explain how current library/learning collections, databases, resources, and services specific to the discipline, including those provided by PASCAL, can support the proposed program. Identify additional library resources needed.

The Clemson University Libraries’ resources required for the proposed program are already in place and available online; therefore, there is no need for additional library resources. All major journals in the discipline are available online or through open access. The Clemson University Libraries hold more than 1.8 million items including books, periodicals, electronic resources, digital media collections, government publications and patents, musical recordings, maps and microforms. Over 4,000 print journal titles, 49,000 e-journals, 170,000 e-books, and 480 online databases are available. Cooper Library is linked electronically to the On-line Computer Library Center Inc. and WorldCat database providing access to more 71,000 libraries worldwide for interlibrary loan services. The PASCAL and Kudzu Consortium(s) provide access to 12 million volumes held by academic libraries in SC and 30 million volumes by 17 southeastern universities.

Students request journal articles through interlibrary loan and are emailed in 2-3 days. Reference librarians assist students by telephone, text, instant message and in-person consultation 79 hours per week and the College of Engineering, Computing and Applied Science and the fields of biomedical engineering and industrial engineering have dedicated research librarians. In addition to annual expenditures, current Library policy allocates additional funds for the exclusive purchase of materials for newly approved programs, if needed. Prioritizing funds for electronic resources, CU demonstrates a commitment to online educational programs and no new funding is required to support the library and learning resources.

My Library Account: Students enrolled in off-campus, distance education, and online programs can log in to their My Library Account to search the Clemson Libraries catalog and request the delivery of print books. In addition to print books, Clemson affiliates have access to 458,239 electronic books via individual subscriptions, aggregator databases, and consortial agreements.

Books and Articles not owned by Clemson University Libraries: Students may use the PASCAL Delivers service to borrow books from any college or university in South Carolina. Requests are made through the Clemson University Libraries home page and delivered to a participating library. Students can borrow up to 25 books for six weeks, with an additional three-week renewal period. 10

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If a book is not owned by the Clemson University Library and is not available via PASCAL Delivers, students may directly request the item from the Reference Librarian. Approved books will be rush ordered/cataloged and sent to the requesting patron, who will be responsible for returning them to Cooper Library (via either mail or return to a PASCAL Delivers library.)

Articles owned by Clemson University Libraries: Students requiring articles from print journals owned by the Library may request a scanned copy via http://www.clemson.edu/culib/forms/secure/ill/emp/dd-rp.php. Articles not available from Clemson University Libraries: Students also have free access to interlibrary loan to request copies of articles from journals not available at Clemson. Students must create an account prior to borrowing via the following website: http://libguides.clemson.edu/ill.

Reference Assistance: Students encountering difficulties finding resource materials may contact the Reference Librarian, who will respond to requests often immediately or within 24 hours. Students also have access to the Ask a Librarian service to request immediate assistance via phone/chat /text/ or email during normal Reference Desk hours.

Student Support Services Explain how current academic support services will support the proposed program. Identify new services needed and provide any estimated costs associated with these services.

The MS in Medical Device Reprocessing will be offered online. All Clemson student support services are available online with virtual meeting and access as needed. In addition to library and learning resources, a number of academic and student support services are available online to all graduate students at Clemson University:

• Clemson Online - Clemson Online staff ensure that all online students have access to the same resources and support that a Clemson education comprises for students enrolled in programs having in-person modalities. Clemson University is devoted to ensuring an innovative and substantive educational experience for all students.

• Clemson Computing and Information Technology (CCIT) - Provides a leading-edge integrated information environment integral to learning and research. Graduate students may (but are not limited to) take advantage of services such as Clemson email account, emergency text messages, mobile guidebooks, video conferencing, web development, and data storage. Help services are available via phone, email, or online chat.

• Student Accessibility Services – Graduate Students may register with Student Accessibility Services to use services such as academic access letters, assistive technology, communication services, test proctoring center and electronic textbooks.

• Center for Career and Professional Development – Clemson University is dedicated to engaging students in career development that will empower them to successfully pursue their educational and professional goals. Services provided by the career center include career workshops, resume writing, career development, job search assistance, and networking.

• Legal Assistance - All Clemson students are eligible to receive one legal aid voucher per semester. Each voucher entitles the student to one-half hour consultation with a lawyer off campus.

• GRAD 360°- A professional development program affiliated with The Graduate School that provides students with a structured way to develop and track their proficiency in the academic, personal, and professional focus areas known as “The Tiger 9”: career development; personal health, wellness and financial literacy; research and innovation; professionalism and ethics; leadership and management; teamwork and collaboration; teaching and learning; oral, written and intercultural communication; and social and global responsibility. Each student’s development program can be tailored to meet their unique needs and interests. Students can 11

ACAP, 3/25/2021 2.o identify their skills, interests, and values throughout their Clemson experience; engage their advisors in holistic advising and mentoring; acquire and develop specific skills necessary for postgraduate professional practice; and track their transformation by recording their experience in an online portfolio.

• International Services – The Office of Global Engagement’s International Services area works with incoming international students to provide valuable information, service and advice to meet their unique needs. International Services is a valuable resource for international students’ immigration, employment, and support needs, and works to create a welcoming, positive environment for Clemson’s international student population to help them meet their academic and research goals while making sure their personal goals are taken into consideration.

• Counseling and Psychological Services (CAPS) - Counseling and Psychological Services (CAPS), the mental health unit of Student Health Services, offers a wide array of services along a continuum of intensity for various psychological issues.

• Graduate Student Life – Operating under the Division of Student Affairs, this is a central body that collaborates with the Graduate School and Graduate Student Government to enhance the overall graduate student life experience.

• Clemson University Writing Center – The goal of the writing center is to help all members of the Clemson community become more confident and effective writers.

• The Harvey and Lucinda Gantt Multicultural Center - The Harvey and Lucinda Gantt Multicultural Center is committed to creating diverse learning environments that enhance the intercultural competence of our students. The center supports and advocates for the needs of all students, challenges students to think critically about themselves and their communities, provides engaging experiential learning opportunities and empowers students to be positive change agents.

Physical Resources/Facilities Identify the physical facilities needed to support the program and the institution’s plan for meeting the requirements.

The resources needed to support this online program are available. Those resources include computers equipped with camera for instructors, cloud-based video communication platforms for video and audio conferencing/lecturing (e.g., Zoom and Webex), high-speed internet, Wi-Fi, and specialized software for computer modeling. Those software resources are freely available to College of Engineering, Computing and Applied Science faculty and students. Laboratories are available for performing/recording experiment demonstrations as needed.

Our online infrastructure, which supports numerous programs, is tested and includes dedicated support from our integrated Clemson Online and CCIT units that steward a portfolio of teaching and learning tools that go far beyond simply a premier learning management system (LMS). Furthermore, with the support of our Director of Online Education, numerous professional development options are available to support faculty growth.

In August 2016, the National Council for State Authorization Reciprocity Agreements (NC-SARA) approved Clemson University as a NC-SARA institution. We remain an NC-SARA institution in good standing. Clemson’s Institutional Effectiveness unit has a dedicated professional that manages state authorization on behalf of the University. Details related to authorization by individual state (or program or any number of attributes in which a user may be interested) are provided to current and potential students in interactive, user-selected formats on the following website: https://www.clemson.edu/institutional-effectiveness/academics/state-details2.html.

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Equipment Identify new instructional equipment needed for the proposed program.

None-- Current teaching laboratories include all needed equipment that would be needed performing and recording experiments or methods to be included in online courses as needed.

Impact on Existing Programs Will the proposed program impact existing degree programs or services at the institution (e.g., course offerings or enrollment)? If yes, explain. Yes No

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ACAP, 3/25/2021 2.o Financial Support

Sources of Financing for the Program by Year 1st 2nd 3rd 4th 5th Grand Total Category New Total New Total New Total New Total New Total New Total Tuition Funding $337,740 $337,740 $481,669 $481,669 $633,930 $633,930 $794,893 $794,893 $964,944 $964,944 $3,213,176 $3,213,176 Program-Specific Fees $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 Special State Appropriation $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 Reallocation of Existing Funds $171,000 $171,000 $177,002 $177,002 $183,242 $183,242 $189,730 $189,730 $196,477 $196,477 $917,452 $917,452 Federal, Grant, or Other Funding $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 Total $508,740 $508,740 $658,671 $658,671 $817,172 $817,172 $984,623 $984,623 $1,161,421 $1,161,421 $4,130,628 $4,130,628 Estimated Costs Associated with Implementing the Program by Year 1st 2nd 3rd 4th 5th Grand Total Category New Total New Total New Total New Total New Total New Total Program Administration and Faculty/Staff Salaries $215,720 $215,720 $232,127 $232,127 $310,986 $310,986 $321,997 $321,997 $333,447 $333,447 $1,414,277 $1,414,277 Facilities, Equipment, Supplies, and Materials $13,125 $13,125 $13,138 $13,138 $13,150 $13,150 $13,413 $13,413 $13,682 $13,682 $66,508 $66,508 Library Resources $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 Other (specify) $67,548 $67,548 $96,334 $96,334 $126,786 $126,786 $158,979 $158,979 $192,989 $192,989 $642,635 $642,635 Total $296,393 $296,393 $341,598 $341,598 $450,922 $450,922 $494,389 $494,389 $540,118 $540,118 $2,123,420 $2,123,420 Net Total (Sources of Financing Minus Estimated Costs) $212,347 $212,347 $317,073 $317,073 $366,250 $366,250 $490,235 $490,235 $621,303 $621,303 $2,007,208 $2,007,208

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ACAP, 3/25/2021 2.o Note: New costs - costs incurred solely as a result of implementing this program. Total costs - new costs; program’s share of costs of existing resources used to support the program; and any other costs redirected to the program.

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Budget Justification Provide an explanation for all costs and sources of financing identified in the Financial Support table. Include an analysis of cost-effectiveness and return on investment and address any impacts to tuition, other programs, services, facilities, and the institution overall.

Sources: Tuition funding is calculated using Online Tier 2 Graduate tuition at $866 per credit hour in year 1, and increasing 3% per annum thereafter. Reallocation of Existing Funds represents extant sunk faculty workload associated with delivering program courses already taught as part of other programs at $12.5K per course. Tuition Funding and Reallocation of Existing Funds are the only two resources necessary to support the program and its expenses.

Costs: Program Administration and Faculty and Staff Salary is supported by the Reallocation of Existing Funds and includes the only real net incremental costs or the program: a) the development for three new courses at $10K per course, b) one part-time lecturer position at $40K (plus fringe) per year, c) one student services coordinator at $52K (plus fringer) per year.

Facilities, Equipment, Supplies, and Materials is comprised of two annual expenses: marketing and travel. The Marketing Expense is $5K per year and Travel Expense is approximately $8K per year. Administrative Overhead is calculated as 20% of Tuition Funding. Revenue from the net contribution will be reinvested back into the program to support any additional expenses that are not foreseen. In addition to utilizing extant faculty workload to deliver courses currently taught, the program will utilize existing facilities and services at the University.

Evaluation and Assessment

Student Learning Outcomes Program Objectives Aligned to Program Objectives Methods of Assessment Students will develop regulatory Develop student’s knowledge of pathway plan for targeted Performance in core regulatory regulatory cycle for medical medical devices and their science courses; Employer devices and their reprocessing. reprocessing. survey. Students will determine design Performance in core courses Develop student’s ability to criteria for facilitating focused on sterilization, design, design SUD for reprocessing reprocessing for safety and and manufacturing; Employer purposes. effectiveness. Survey. Students will use computer system and software validation to ensure the quality of data generation, data storage, and digital processes used in manufacturing and products with digital components using Performance in core courses technical and practical aspects addressing risk and failure Develop student’s ability to apply expected in the regulated analysis of medical devices as theory and application of quality medical device and well as product development and science for medical devices. reprocessing industries. validation; Employer survey. Students will use industrial engineering tools, specifically those grounded in human Develop Student’s ability to factors, to solve healthcare Performance in core courses involve supply chain, human supply chain problems addressing six sigma tools and factors and process improvement associated with medical device techniques, and human factor for medical device industry. use and reprocessing. engineering; Employer survey.

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Students will discuss up-to-date knowledge of issues related to regulation, compliance, and quality control in the medical Performance in core courses Develop student’s awareness device recycling and focused on reprocessing of and responsibility for sustainable reprocessing industry to foster a medical devices; employer environment. sustainable environment. survey. Employer survey; performance of students for oral and Develop student’s ability to Students will clearly and presentations in core curriculum effectively communicate to effectively advocate for medical courses and medical device professional audiences. device reprocessing. commercialization pitch.

Explain how the proposed program, including all program objectives, will be evaluated, along with plans to track employment. Describe how assessment data will be used.

The program assessment process in the Department of Bioengineering is faculty-driven, and involves all BIOE faculty members as well as a standing Assessment Committee. We will assess student outcomes in the MS Medical Device Reprocessing program at multiple levels using both direct and indirect measures as currently conducted for our B.S., M.S., and Ph.D. degrees in Bioengineering.

Our Assessment Committee, which is composed of at least four assigned members organizes assessment of both undergraduate and graduate programs for the entire department. A sub-committee for the MS Medical Device Reprocessing program will be formed with responsibility to oversee the academic curriculum and coordinate the presentation of all curriculum changes to the faculty at-large for approval. The chair of the MS Medical Device Reprocessing Assessment Sub-Committee will sit on the Departmental Curriculum Committee and the Graduate Affairs Committee. This structure allows for fluid communication between the Committees such that the formal assessment milestones are obtained. The assessment process assigns responsibility for all assessment activities, ties the assessment instruments (measures) to the program education objectives and student outcomes, and determines an assessment cycle for each instrument.

Assessment of this new degree program will include a program assessment plan and reporting in the University’s cloud-based SaaS Anthology® (formerly CampusLabs®) platform. All degree program graduates will demonstrate the following student learning outcomes (SLO): • An ability in proficiently designing and validating experiments, systems, components, or processes to meet desired needs. (SLO1) • An ability for proficiently identifying, formulating, and solving advanced problems. (SLO2) • An ability for proficient contemporary technical and scientific comprehension and lifelong learning. (SLO3) • An ability for proficient technical communication. (SLO4) • An ability to use advanced techniques, skills, and modern engineering/science tools necessary for professional practice. (SLO5)

At our annual spring Bioengineering Faculty Retreat, both the Course Notebooks and Outcomes Portfolio are evaluated as scheduled for review. All Course Notebooks are reviewed by at least one faculty member in addition to the instructor. The reviewing faculty member writes a formal report outlining the student learning. Minor and major deficiencies are reported to the faculty as a whole for discussion. The Outcome Portfolios are evaluated as a whole by at least one faculty member who also provides a formal report to the faculty at the first fall semester faculty meeting. Additionally, instructors are encouraged to bring to the discussion of the Outcomes Portfolio any concerns they have observed. These discussions will result in three possible actions: continue to assess student learning via the same or new SLOs, change a particular course’s content, or change the pre-requisite course or content. The goal of any change is to strengthen the program and improve the education provided to our students.

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Finally, we actively engage and utilize a Bioengineering Department External/ Industrial Advisory Board whose members consisting of 16 individuals affiliated with the medical device industry (including, e.g., premier entities such as J&J) who review our program students’ accomplishments, make recommendations for faculty and program objectives, and perform their own assessment of student outcomes. Faculty provide necessary corrective actions if outcomes are not met. An employer survey is also included in our assessment cycle. The Department will administer a survey through the University’s cloud-based enterprise Qualtrics® platform to employers and industry partners to assess the effectiveness of the MS program for developing a professional and effective workforce.

Accreditation and Licensure/Certification

Will the institution seek program-specific accreditation (e.g., CAEP, ABET, NASM, etc.)? If yes, describe the institution’s plans to seek accreditation, including the expected timeline. Yes No

Will the proposed program lead to licensure or certification? If yes, identify the licensure or certification. Yes No

Explain how the program will prepare students for this licensure or certification.

If the program is an Educator Preparation Program, does the proposed certification area require national recognition from a Specialized Professional Association (SPA)? If yes, describe the institution’s plans to seek national recognition, including the expected timeline. Yes No N/A

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