Research Papers

Stage-Gate Process for the Development of Medical Devices

[+] Author and Article Information
Jan B. Pietzsch

Department of Management Science and Engineering, Stanford University, 380 Panama Way, Stanford, CA 94305-4026; Wing Tech Inc., 9916 Newhall Road, Potomac, MD 20854

Lauren A. Shluzas

Department of Management Science and Engineering, and Department of Mechanical Engineering, Stanford University, 380 Panama Way, Stanford, CA 94305-4026

M. Elisabeth Paté-Cornell

Department of Management Science and Engineering, Stanford University, 380 Panama Way, Stanford, CA 94305-4026

Paul G. Yock

Department of Bioengineering, Stanford University, James H. Clark Center, 318 Campus Drive, E-100, Stanford, CA 94305-5428

John H. Linehan

Department of Bioengineering, Stanford University, James H. Clark Center, 318 Campus Drive, E-100, Stanford, CA 94305-5428; Clinical and Translational Sciences Institute, Northwestern University, 750 North Lake Shore Drive, Chicago, IL 60611

In the context of this study, medical devices are defined as technologies used in the diagnosis, cure, mitigation, treatment, or prevention of diseases or conditions that do not achieve their primary treatment effect by pharmacological, immunological, or metabolic means.

Verification: Establishing conformance of design outputs to design input. Validation: Establishing conformance that final product meets user needs.

CPT®: Current Procedural Terminology

DRG: Diagnosis Related Groups

Note that recalls do not necessarily need to result in a withdrawal and redesign of a product. In many cases, recalls are handled with field corrections or notices to users.

J. Med. Devices 3(2), 021004 (Jun 17, 2009) (15 pages) doi:10.1115/1.3148836 History: Received May 12, 2008; Revised May 03, 2009; Published June 17, 2009

The medical device development process has become increasingly complex in recent years. The advent of new technology concepts, stricter regulatory requirements, and the ever increasing importance of reimbursement decisions for successful device commercialization require careful planning and strategy-setting, coordinated decisions, and consistent, rigorous business processes. The design and implementation of such processes, often captured in development models and accompanying standard operating procedures, have become a key determinant of the success of device commercialization. While various models may exist in the device industry, no comprehensive development model has been published. This paper reviews existing model representations and presents a new comprehensive development model that captures all aspects of device development and commercialization from early-concept selection to postmarket surveillance. This model was constructed based on best-practice analysis and in-depth interviews with more than 80 seasoned experts actively involved in the development, commercialization, and regulation of medical devices. The stage-gate process includes the following five phases: (1) initiation - opportunity and risk analysis, (2) formulation - concept and feasibility, (3) design and development - verification and validation, (4) final validation - product launch preparation, and (5) product launch and postlaunch assessment. The study results suggest that stage-gate processes are the predominant development model used in the medical device industry and that regulatory requirements such as the food and drug adminstration (FDA’s) Quality Systems Regulation play a substantive role in shaping activities and decisions in the process. The results also underline the significant differences between medical device innovation and drug discovery and development, and underscore current challenges associated with the successful development of the increasing number of combination products.

Copyright © 2009 by American Society of Mechanical Engineers
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Figure 1

The product definition process (based on Ref. 12)

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Figure 2

Application of design controls to waterfall design process (13)

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Figure 3

Overview of a design change life cycle (based on Ref. 14)

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Figure 4

Schematic overview of clinical research in the product development cycle (based on Ref. 15)

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Figure 5

Schematic representation of the risk management process according to ANSI/AAMI/ISO 14971:2000

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Figure 6

Integration of risk assessment with design control activities (16)

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Figure 7

Total product life cycle (18)

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Figure 8

Regulatory pathways for medical devices (representation based on Ref. 20). Legend: QS Regulation: QSR; IDE: investigational device exemption; IRB: Institutional Review Board

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Figure 9

Linear medical device development model

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Figure 10

Needs-finding funneling process and relationship to product development model

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Figure 11

Design iteration based on failed verification and validation



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