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.

1.
Booz Allen Hamilton
, 1982,
New Product Management for the 1980s
,
Booz, Allen & Hamilton
,
New York
.
2.
Cooper
,
R. G.
, and
Kleinschmidt
,
E. J.
, 1986, “
An Investigation Into the New Product Process: Steps, Deficiencies, and Impact
,”
J. Prod. Innovation Manage.
0737-6782,
3
(
2
), pp.
71
85
.
3.
Tzokas
,
N.
,
Hultink
,
E. J.
, and
Hart
,
S.
, 2004, “
Navigating the New Product Development Process
,”
Ind. Mark. Manage.
0019-8501,
33
, pp.
619
626
.
4.
Killen
,
C. P.
,
Hunt
,
R. A.
, and
Kleinschmidt
,
E. J.
, 2007, “
Managing the New Product Development Project Portfolio: A Review of the Literature and Empirical Evidence
,”
Management of Converging Technologies
,
PICMET ‘07
, Portland, OR, Sept. 2007,
T. A.
Anderson
, ed.,
Portland International Center for Management of Engineering and Technology
,
Portland, OR
, pp.
1864
1874
.
5.
Cooper
,
R. G.
, 1990, “
Stage-Gate Systems: A New Tool for Managing New Products
,”
Bus. Horiz.
0007-6813,
33
(
3
), pp.
44
54
.
6.
Rochford
,
L.
, and
Rudelius
,
W.
, 1997, “
New Product Development Process—Stages and Successes in the Medical Products Industry
,”
Ind. Mark. Manage.
0019-8501,
26
, pp.
67
84
.
7.
Kaplan
,
A. V.
,
Baim
,
D. S.
,
Smith
,
J. J.
,
Feigal
,
D. A.
,
Simons
,
M.
,
Jefferys
,
D.
,
Fogarty
,
T. J.
,
Kuntz
,
R. E.
, and
Leon
,
M. B.
, 2004, “
Medical Device Development—From Prototype to Regulatory Approval
,”
Circulation
0009-7322,
109
, pp.
3068
3072
.
8.
Fries
,
R. C.
, ed., 2000,
Handbook of Medical Device Design
,
CRC
,
Boca Raton, FL
.
9.
King
,
P. H.
, and
Fries
,
R. C.
, 2003,
Design of Biomedical Devices and Systems
,
CRC
,
Boca Raton, FL
.
10.
Whitmore
,
E.
, 2004,
Development of FDA-Regulated Medical Products: Prescription Drugs, Biologics, and Medical Devices
,
ASQ Quality
,
Milwaukee, WI
.
11.
Kucklick
,
T. R.
, 2005,
The Medical Device R&D Handbook
,
CRC
,
Boca Raton, FL
.
12.
Fries
,
R. C.
, 2006,
Reliable Design of Medical Devices
,
2nd ed.
,
CRC
,
Boca Raton. FL
.
13.
1997, FDA CDRH 1997, Design Control Guidance for Medical Device Manufacturers.
14.
Worona
,
T.
, 2006, “
A Product Design Approach to Developing Design Controls
,” MDDI, Nov.
15.
Stark
,
N.
, 2001, “
Integrating Clinical Research Into the Product Development Cycle
,” MDDI, May.
16.
FDA
, 1996, FDA ODE Guidance for the Content of Premarket Submission for Medical Devices Containing Software (Draft Version 1.3), Rockville, MD, Aug., pp.
12
.
17.
Dhillon
,
D. S.
, 2000,
Medical Device Reliability and Associated Areas
,
CRC
,
Boca Raton, FL
.
18.
FDA
, 2005, Total Product Lifecycle, FDA-CDRH Presentation by CDRH Director Dr. David Feigal, http://www.fda.gov/cdrh/strategic/presentations/tplc.htmlhttp://www.fda.gov/cdrh/strategic/presentations/tplc.html.
19.
Califf
,
R. M.
,
Peterson
,
E. D.
,
Gibbons
,
R. J.
,
Garson
,
A.
, Jr.
,
Brindis
,
R. G.
,
Beller
,
G. A.
, and
Smith
,
S. C.
, Jr.
, 2002, “
Integrating Quality Into the Cycle of Therapeutic Development
,”
J. Am. Coll. Cardiol.
0735-1097,
40
, pp.
1895
1901
.
20.
Helmus
,
M. N.
, 2003,
Biomaterials in the Design and Reliability of Medical Devices
,
Plenum
,
New York
.
21.
Pietzsch
,
J. B.
,
Aquino
,
L. M.
,
Yock
,
P. G.
,
Paté-Cornell
,
M. E.
, and
Linehan
,
J. H.
, 2007, “
Review of U.S. Medical Device Regulation
,”
ASME J. Med. Devices
1932-6181,
1
(
4
), pp.
283
292
.
22.
Chai
,
J. Y.
, 2000, “
Medical Device Regulation in the United States and the European Union: A Comparative Study
,”
Food Drug Law J.
,
55
, pp.
57
80
.
23.
Strauss
,
R. L.
, and
Corbin
,
J.
, 1998,
Basics of Qualitative Research: Techniques and Procedures for Developing Grounded Theory
,
Sage Publications Inc.
,
Thousand Oaks, CA
.
24.
Stanford Biodesign
, 2007, Biodesign Innovation Sourcebook, Case: OIT-60.
26.
Teixeira
,
M. B.
, and
Bradley
,
R.
, 2003,
Design Controls for the Medical Device Industry
,
Marcel Dekker
,
New York
.
27.
Centers for Medicare and Medicaid Servies (CMS)
, 2008, Innovator's Guide to Navigating CMS, Version 1.0, August 25, 2008, Centers for Medicare and Medicaid Services, Baltimore, MD.
28.
FDA
, 2006, Premarket Notification 510(k), FDA CDRH Web Publication, http://www.fda.gov/cdrh/devadvice/314.htmlhttp://www.fda.gov/cdrh/devadvice/314.html.
29.
Meinert
,
C. L.
, and
Tonascia
,
S.
, 1986,
Clinical Trials: Design, Conduct, and Analysis
,
Oxford University
,
New York
.
30.
Chow
,
S. -C.
, and
Liu
,
J.
, 2003,
Design and Analysis of Clinical Trials: Concepts and Methodologies
,
Wiley-IEEE
,
New York
.
31.
Abdel-aleem
,
S.
, 2009,
Design, Execution, and Management of Medical Device Clinical Trials
,
Wiley
,
New York
.
33.
FDA
, 2006b, Process Validation, FDA CDRH Web Publication,: http://www.fda.gov/cdrh/qsr/04valid.htmlhttp://www.fda.gov/cdrh/qsr/04valid.html.
34.
Justiniano
,
J. M.
, and
Gopalaswamy
,
V.
, 2004,
Six Sigma for Medical Device Design
,
CRC
,
Boca Raton, FL
.
36.
37.
Pietzsch
,
J. B.
,
Paté-Cornell
,
M. E.
, 2008, “
Early Technology Assessment of New Medical Devices
,”
Int. J. Technol. Assess Health Care
0266-4623,
24
(
1
), pp.
37
45
.
38.
Gelijns
,
A. C.
, 1989, “
Technological Innovation: Comparing Development of Drugs, Devices, and Procedures in Medicine
,” Background Paper, Institute of Medicine (IOM).
39.
Ehreth
,
J. E.
, 2005, “
Industry Challenges for Outcomes Research
,”
Italian Journal of Public Health
,
2
(
2
), pp.
74
75
.
40.
Foote
,
S.
, and
Berlin
,
R.
, 2005, “
Can Regulation Be as Innovative as Science and Technology? The FDA’s Regulation of Combination Products
,”
Minnesota Journal of Law, Science & Technology (MJLST)
,
6
(
2
), pp.
619
644
.
41.
Lavender
,
M.
, 2005,
Regulating Innovative Medicine: Fitting Square Pegs in Round Holes
,
Duke Law & Technology Review
,
Durham, NC
, Vol.
1
.
42.
Robinson
,
R.
, 2004, “
Nonclinical Development Activities for Medical Devices
,” Regulatory Affairs Focus Magazine, http://www.raps.orghttp://www.raps.org.
43.
Boam
,
A.
, 2003, “
Drug-Eluting Stents: An FDA Case Study
,”
Regulatory Affairs Focus Magazine
, pp.
18
23
.
44.
Muni
,
N.
, and
Gross
,
T.
, 2004, “
Problems With Drug-Eluting Coronary Stents—The FDA Perspective
,”
N. Engl. J. Med.
0028-4793,
351
(
16
), pp.
1593
1595
.
45.
Portnoy
,
S.
, and
Koepke
,
S.
, 2005, “
Regulatory Strategy: Preclinical Testing of Combination Products
,” Medical Device & Diagnostic Industry, pp.
152
163
.
46.
Cramer
,
C.
, and
Rastogi
,
S.
, 2007, “
Combination Medical Products: Capitalizing on Convergence
,” MDDI, http://www.devicelink.com/mddi/archive/07/01/009.htmlhttp://www.devicelink.com/mddi/archive/07/01/009.html.
47.
Bauer
,
H. H.
, and
Fischer
,
M.
, 2000, “
Product Life Cycle Patterns for Pharmaceuticals and Their Impact on R&D Profitability of Late Mover Products
,”
Int. Bus. Rev.
0969-5931,
9
(
6
), pp.
703
725
.
You do not currently have access to this content.