Stage-Gate Process for the Development of Medical Devices

2009 ◽  
Vol 3 (2) ◽  
Author(s):  
Jan B. Pietzsch ◽  
Lauren A. Shluzas ◽  
M. Elisabeth Paté-Cornell ◽  
Paul G. Yock ◽  
John H. Linehan
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Business Processes ◽  
Development Model ◽  
Product Launch ◽  
Regulatory Requirements ◽  
Device Development ◽  
Study Results ◽  
Comprehensive Development ◽  
Device Industry

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.

Constraints of Service Development within the Medical Device Industry: A Preliminary Study

2012 ◽  
Vol 433-440 ◽  
pp. 733-739
Author(s):  
Linda Ryan ◽  
David Tormey ◽  
Perry Share
Keyword(s):  
Medical Device ◽  
Technology Leadership ◽  
Service Development ◽  
Regulatory Requirements ◽  
Medical Device Industry ◽  
Device Development ◽  
Service Creation ◽  
Complex Development ◽  
Development Processes ◽  
Device Industry

Cost, quality and technology leadership are no longer sufficient for businesses to secure critical advantage. Instead, differentiations are being provided through the supply of innovative services, which can rapidly develop into a firm’s unique selling proposition. However, although services can provide additional competitive advantage, the inherent differences between product and service can cause difficulty in the effective integration of the two processes. Services are dominated by intangible elements which can be difficult to perceive and quantify. Within the medical device industry, the growing focus on usability, patient safety and increasing regulatory requirements has further complicated the already complex development process. In order to meet regulations, development is undertaken within strict boundaries to produce tightly controlled outputs. It can be seen that there is an incongruity between the nature of medical device development and the service development processes. This paper explores the constraints and inhibitors of service creation within the context of the medical device industry. Service innovation and its application is discussed. Difficulties in the addition of a service element and their potential solution within a medical device context are explored.

The Bioengineering Design Forum

1997 ◽  
Vol 11 (2) ◽  
pp. 116-119 ◽  
Author(s):  
Patrick J. Prendergast
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Medical Device Industry ◽  
Industry Collaboration ◽  
University Industry ◽  
Device Industry

The author assesses the results of the Bioengineering Design Forum – a collaboration between university researchers, clinicians and industry in Ireland. The aim of the Forum is to initiate, develop and bring to a successful conclusion R&D collaborations that lead to new or improved medical devices. By laying down certain operating procedures for the Forum, an effective ‘meeting ground’ has been developed which serves the objectives of both university engineering departments and the medical device industry in a unique way. The purpose of this paper is to relate our experiences of the Forum; they may be useful to others who would like to attempt similar initiatives in other fields. The author also describes the results that may be expected from this kind of university–industry collaboration in practice.

Using Value Stream Mapping to Improve Medical Device Development

2013 ◽  
Vol 7 (2) ◽  
Author(s):  
Christopher Sweem ◽  
Stan Crossett ◽  
Lori Lucke
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Development Process ◽  
Value Stream Mapping ◽  
Medical Device Development ◽  
Value Stream ◽  
Device Development

In this paper a method is presented for using value stream mapping for improving the development process of medical devices. Two examples are shown to demonstrate the utility of this approach.

scholarly journals Harnessing Experience for Efficient Medical Device Product Development

2009 ◽  
Vol 3 (2) ◽  
Author(s):  
L. Lucke ◽  
D. Anderson ◽  
D. Smith
Keyword(s):  
Product Development ◽  
Medical Device ◽  
Clinical Application ◽  
Medical Devices ◽  
New Technology ◽  
Project Planning ◽  
Time To Market ◽  
Medical Device Development ◽  
Device Development ◽  
Development Times

Transitioning new research ideas into commercial products is difficult. For medical device design, the task is especially complicated because the commercialization of research ideas requires interdisciplinary teams that understand the nature of the clinical application as well as the abilities of the technology. Device development is complicated by the need to work within a regulated environment which requires well defined processes and significant testing to demonstrate the safety and efficacy of the device. An experienced development team, well versed in the design and manufacturing of medical devices, can greatly enhance the success of a commercialization program. A study of actual programs shows how experience can reduce development times. There are several factors that affect the success of new medical device development including the use of effective development tools and the innovativeness of the product concept. Successful product development may use a number of tools to assist with planning and control of the project. However it is difficult to measure the effect of experience on the success of new product development. In this work, several medical device development programs were studied to determine the role experience plays in improving the time to market for medical devices. Time to market is measured along several dimensions including complexity, technological invention, and uniqueness of clinical application. All designs were completed by the same company. As time progressed, the time to market improved even for complex designs with new technology. Over a ten year period of time, ten significant medical device development projects were executed. All required development of complex electromechanical systems with moderate to high complexity, and more than half developed products for new clinical applications or utilized new technology. After the development group had acquired at least five years of development experience, it was clear that the development times were improving by almost 50% over the predicted development times. Among the factors that contribute to this effect are the development of experts, the creation of design frameworks, and the optimization of processes which improve product development times while reducing project and regulatory risk. Experts with specific experience in systems engineering, program management, electromagnetic compatibility, manufacturability, and usability along with expertise in electronics, mechanical and software design can significantly reduce design times. Technology platforms central to medical devices such as blood and fluid pumps, sensor interfaces, real-time control systems, batteries and power systems are necessary for rapid development. Processes including project planning and tracking, requirements management, configuration management, risk analysis, and manufacturing design transfer are essential for streamlining development as well as ensuring support for regulatory submissions and audits. It has been challenging to demonstrate this effect, which has been anecdotally known for some time, in a quantitative manner. Doing so required studying an organization with not only significant experience over time, but breadth of experience in terms of program risk and complexity. The results of this study quantify the significant benefit of organizational experience in reducing time to market.

A Review of Design for X Methods for Medical Devices: The Introduction of a Design for FDA Approach

2011 ◽  
Author(s):  
Lourdes A. Medina ◽  
Richard A. Wysk ◽  
Gu¨l E. Okudan Kremer
Keyword(s):  
Medical Device ◽  
Drug Administration ◽  
Medical Devices ◽  
Development Process ◽  
Regulatory Compliance ◽  
Design For Manufacturing ◽  
Design For X ◽  
Device Development ◽  
Unites States ◽  
Fda Regulations

This paper focuses on the importance of the regulations, in particular the Food and Drug Administration (FDA), in the development of medical devices. The FDA regulates medical devices to assure that these products are safe and effective before their release into the Unites States market. We introduce the concept of Design for FDA (DfFDA) and describe DfFDA guidelines for medical device development. While many researchers describe the regulations in the form of reviews and models, the literature to date has not reported a DfFDA method. Here, DfFDA is proposed as a method to be used in parallel with other DfX methods when applicable. The DfX methods identified include: Design for Validation (DfV), Design for Reliability (DfR), Design for Quality (DfQ), Design for Manufacturing (DfM), Design for Assembly (DfA) and Design for Usability (DfU). This paper also reviews the literature addressing the FDA regulations and DfX methods, and an overview of the FDA regulations is presented. DfFDA is developed to increase awareness about regulatory compliance and promote designers to consider the regulations throughout the development process of medical devices.

scholarly journals Innovation and Design: Pollution Prevention Opportunities in Medical Device Design

2009 ◽  
Vol 3 (2) ◽  
Author(s):  
J. Becker ◽  
C. Zimmer ◽  
K. Larson
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Chlorinated Solvents ◽  
Pollution Prevention ◽  
Cost Savings ◽  
The United States ◽  
Medical Device Industry ◽  
Potential Cost ◽  
Environmental Considerations ◽  
Device Industry

A wide variety of materials and chemicals are used in the development, production, cleaning, packaging, sterilization and shipment of medical devices. Some of these materials are used in large quantities and are often a source of waste. Some materials, such as poly vinyl chloride (PVC) plastics, have toxicity concerns. Additionally, many chemicals including chlorinated solvents and ethylene oxide are carcinogenic or highly toxic and can be detrimental to the environment and public health. While the medical device industry is highly regulated in the United States by the Food and Drug Administration, new green initiatives in the European Union are modifying the regulatory oversight of chemicals, materials, and their manufacture. In addition, hospitals are working to reduce waste and pollution as part of their operations and are increasingly asking vendors to assist them. Minimizing waste and pollution associated with medical devices can improve a company's environmental performance and save money. The primary focus in medical device manufacturing is patient safety and compatibility. Environmental considerations, which can include potential cost savings, are often overlooked in the design and process development phases. Numerous pollution prevention and energy efficiency options exist for medical device manufacturers. These options can be integrated into the development, design and process protocols, and engineering change orders when designing a new product or improving an existing part. By having a process design evaluation plan that includes environmental considerations, companies can effectively manage the creation of waste streams, toxicity of material inputs, and process efficiencies as a mechanism at both the front-end and the duration of the product line. These options often cut costs and can help reduce current and prospective regulatory burdens. The Minnesota Technical Assistance Program (MnTAP) at the University of Minnesota has been assisting businesses with pollution prevention and cost savings for 25 years. MnTAP's engineers and scientists have worked with the medical device industry to reduce the quantity of packaging and waste associated with cardiac catheters, reduce the use of toxic cleaning solvents, minimize the use of PVC, and research safer disinfection and sterilization methods. This poster includes case studies of the above mentioned projects, an overview of less toxic sterilization methods, and tools for medical device manufacturing that meet FDA requirements, but reduce waste and toxicity during production and use.

scholarly journals Innovation in Pediatric Medical Devices: Proceedings From The West Coast Consortium for Technology & Innovation in Pediatrics 2019 Annual Stakeholder Summit

10.2196/17467 ◽  
2020 ◽  
Vol 5 (1) ◽  
pp. e17467
Author(s):  
Juan Espinoza ◽  
Kathryne Cooper ◽  
Nadine Afari ◽  
Payal Shah ◽  
Sriharinarayana Batchu ◽  
...  
Keyword(s):  
Los Angeles ◽  
Medical Device ◽  
Medical Devices ◽  
West Coast ◽  
Small Sample Size ◽  
Small Sample ◽  
The West ◽  
Device Development ◽  
Small Market ◽  
Broad Array

Pediatric medical devices cover a broad array of indications and risk profiles, and have helped to reduce disease burden and improve quality of life for numerous children. However, many of the devices used in pediatrics are not intended for or tested on children. Several barriers have been identified that pose difficulties in bringing pediatric medical devices to the market. These include a small market and small sample size; unique design considerations; regulatory complexities; lack of infrastructure for research, development, and evaluation; and low return on investment. In 2007, the Food and Drug Administration (FDA) created the Pediatric Device Consortia (PDC) Grants Program under the administration of the Office of Orphan Products Development. In 2018, the FDA awarded over US $30 million to five new PDCs. The West Coast Consortium for Technology & Innovation in Pediatrics (CTIP) is one of these PDCs and is centered at the Children’s Hospital Los Angeles. In February 2019, CTIP convened its primary stakeholders to discuss its priorities and activities for the new grant cycle. In this paper, we have presented a report of the summit proceedings to raise awareness and advocate for patients and pediatric medical device innovators as well as to inform the activities and priorities of other organizations and agencies engaged in pediatric medical device development.

scholarly journals Gaining Competitiveness via Procurement Transformation That Retains German Engineering Origin

2016 ◽  
Vol 5 (1) ◽  
pp. 57
Author(s):  
Daniel Feyerlein
Keyword(s):  
Medical Device ◽  
International Markets ◽  
Decision Makers ◽  
Local Production ◽  
Medical Device Industry ◽  
Study Results ◽  
German Origin ◽  
Local Sourcing ◽  
Made In ◽  
Device Industry

<p>With the evolution of globalization, multinational companies face increasing competition on national and international markets. As a result, they seek to implement proper strategies to maximize capacity and competitiveness. This article asks whether a multinational company in medical devices has the strategic potential to transform its procurement strategy to embrace a local sourcing concept to gain competitiveness while retaining engineering origin. Study results from the medical-device industry show that attributes delivered by German origin can improve competitiveness. A significant majority of customers see the importance in the “Made in Germany” label. Customers also tend to accept the conception of local production that retains German engineering. The medical-device industry represents several branches in areas such as quality and technology. The results of this paper address product marketing, product strategy, and decision-makers dealing with sourcing alternatives. The results suggest that the strategy of pairing local production with German engineering is desirable to enhance competitiveness.</p>

scholarly journals Neurologic Medical Device Overview for Pathologists

2019 ◽  
Vol 47 (3) ◽  
pp. 250-263
Author(s):  
Sarah D. Cramer ◽  
Juliana S. Lee ◽  
Mark T. Butt ◽  
Jaime Paulin ◽  
William C. Stoffregen
Keyword(s):  
Nervous System ◽  
Animal Models ◽  
Medical Device ◽  
Study Design ◽  
Medical Devices ◽  
Nervous Tissue ◽  
Time Points ◽  
Group Design ◽  
Device Development ◽  
Tissue Responses

Thorough morphologic evaluations of medical devices placed in or near the nervous system depend on many factors. Pathologists interpreting a neurologic device study must be familiar with the regulatory framework affecting device development, biocompatibility and safety determinants impacting nervous tissue responses, and appropriate study design, including the use of appropriate animal models, group design, device localization, euthanasia time points, tissue examination, sampling and processing, histochemistry and immunohistochemistry, and reporting. This overview contextualizes these features of neurologic medical devices for pathologists engaged in device evaluations.

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