Biomedical Engineering Design Biomedical Engineering Design and the Promotion of High and the Promotion of High Value Relationships with Value Relationships with

Clinical MedicineClinical Medicine

Robert HitchcockRobert Hitchcock

BackgroundBackground

A highly regulated industry

Collaborative development environment

University resources and vision

Utah BioDesign

Course HighlightsCourse Highlights

Projects are initiated by cliniciansProjects are initiated by clinicians

Students interact with cliniciansStudents interact with clinicians

Focus on FDA Quality System Focus on FDA Quality System Regulation – Design ControlsRegulation – Design Controls

Projects required to follow Standard Projects required to follow Standard Operating ProceduresOperating Procedures

Regulatory EnvironmentRegulatory Environment

CSA

ECIEC

JCAHO

ISO

FDAUSPTO

ISTA

ASTM

GHTF

SystematicSystematic• Allows organizations to develop design processes that Allows organizations to develop design processes that meet their needs.meet their needs.

Team basedTeam based• Multidisciplinary teams are empowered to make decisions.Multidisciplinary teams are empowered to make decisions.

Customer focusedCustomer focused• Requirements play a key role in driving specifications Requirements play a key role in driving specifications and validation.and validation.

RobustRobust• Verification and validation ensure a higher quality Verification and validation ensure a higher quality design.design.

Required by lawRequired by law

Why Design Control?Why Design Control?

Design Control SOPsDesign Control SOPs

Approach used by all medical device and Approach used by all medical device and pharmaceutical companiespharmaceutical companies

Interprets FDA QSR for design courseInterprets FDA QSR for design course Creates common ground for studentsCreates common ground for students Provides consistent guidelines for Provides consistent guidelines for assessmentassessment

““Audit" students as part of their Audit" students as part of their assessmentassessment

Design Control SOPsDesign Control SOPsDocument Name Doc. # Description Regulatory

Fulfillment

Design Control Policy DC 04 01 Outline the procedures to follow to develop new, or modify existing products.

21 CFR 820.30 (a)

Design Input – Marketing Brief, Product Specification Considerations

DC 04 04 Provides a procedure to develop the items that must be considered and documented in the design input phase of device development.

21 CFR 820.30 (c)

Design and Development Planning DC 04 12 To indicate the factors that may be considered in the generation of a design and development plan (the Plan) for a new product, product improvement, or product modification, or components of products

21 CFR 820.30 (b)

Design Changes DC 04 20 To indicate the process to be followed when changing, or making additions to, approved documents that are included as part of Design History Files.

21 CFR 820.30 (i)

Design Review DC 04 16 to indicate the process to be followed to conduct Design Reviews.

21 CFR 820.30 (i)

Design Validation DC 04 28 To indicate the general process to follow and the documentation required to establish a Design Validation Plan and perform Design Validations of new and revised designs (products).

21 CFR 820.30 (g)

Design Verification DC 04 24 To indicate the general process to follow and the documentation required to establish a Design Verification Plan and perform Design Verifications of new and revised designs (products).

21 CFR 820.30 (f)

Device Master Record DC 04 16 to indicate the contents of a Device Master Record (DMR).

21 CFR 820.121

Course Timeline – Spring / FallCourse Timeline – Spring / FallTask Name Duration

Spring Semester 2007 - BIOEN 3801 75 daysPrepare and present ideas, assign teams 15 days

Develop project plan 10 days

Research background & start user needs 15 days

Project review 0 days

Complete user needs 5 days

Develop marketing requirements 15 days

Design review I - Requirements 0 days

Developing specifications 18 days

Design review II - Specifications 0 days

Oral presentations - individual 0 days

2/27

3/27

4/204/20

1/7 1/14 1/21 1/28 2/4 2/11 2/18 2/25 3/4 3/11 3/18 3/25 4/1 4/8 4/15 4/22 4/29January February March April

Task Name Duration

Fall Semester 2007 - BIOEN 4801 72 daysPrototype development 40 days

Design review 0 days

Verification test plan 15 days

Project review 0 days

Verification testing 17 days

Design review 0 days

10/19

11/9

12/4

8/26 9/2 9/9 9/16 9/23 9/30 10/7 10/14 10/21 10/28 11/4 11/11 11/18 11/25 12/2 12/9 12/16August September October November December

ProjectsProjects Bone marrow Bone marrow

aspiration deviceaspiration device

Heart patch for Heart patch for stem cell stem cell deliverydelivery

Third heart sound Third heart sound monitormonitor

Optically guided Optically guided feeding tubefeeding tube

Fiber optic Fiber optic respirometerrespirometer