Design control guidance for medical device manufacturers fda. Product development model, medical device, healthcare. Clark center, ration, and 5 product launch and postlaunch assessment. According to several independent research studies i. Accelerating product developments via phasegate processes. Food and drug administration fda under the medical device regulation act of 1976 an ensuing revision to the federal food, drug and cosmetics act of 1938. Yet, due to the nature of medical devices and their impact on personal health and safety, the entire product life cycle of a device must be carefully documented. In an effort to increase understanding of the medical device development process and help companies execute the benchtobedside process of product development more effectively. Development and application of a stage gate process to reduce the underlying risks of it service projects 1 eunjoo jeong, 2 seungryul jeong 1kookmin university, graduate school of business it, seoul, south korea 2 kookmin university, graduate school of business it, seoul, south korea email. 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 strategysetting, coordinated decisions, and consistent, rigorous business processes.
Medical device product development 2 executive summary increased regulatory scrutiny is a reality in todays medical device industry. The stagegate discoverytolaunch process is the industry standard for managing product innovation and is used by companies of all sizes around the world. Medical devices, like all products and software, are constantly evolving. The outcomes of each stage have a direct effect on subsequent ones. Between stages, a gate is used to determine whether the team should move to the next stage or an iteration should be applied in the current stage before moving tot he next one. The medical device development process has become increasingly complex in recent years. With the updated version of the model, nexgen stage gate system, the process becomes more scalable, iterative, and engaging with the consumers through the spiral, which allows consumer feedback to be taken and. Small medical device companies are engaged primarily in developing new medical technologies, and typically their work is narrowly focused on a specific therapeutic.
Stage gate process for the development of medical devices the medical device development process has become increasingly complex in recent years. The general flow of the typical or generic stagegate process is shown pictorially in exhibit 1. Our adherence to this roadmap helps us to minimize risks and avoid shifting those risks to the final stage of fullscale product manufacture, which is undesirable. It is intended to be a reference text that will be on your desk, right next to your ipad and cellphone. Stanford researchers publish comprehensive model for. The stagegate model together with its front end innovation process help lego develop innovative new products to achieve business goals while incorporating user feedback at all stages. Implementation of risk management in the medical device industry. T1 stage gate process for the development of medical devices. Ghtf sg4 guidelines for regulatory auditing of quality. They must be implemented by manufacturers of class ii or iii medical devices and some class i devices. The stage gate model includes i general vision and investment strategy definition. Medical device development academicindustry challenges for. Our company has developed a strict classification of main development stages of a new electronic product. Stagegate and the critical success factors for new product.
Food and drug administration s fda center for devices. A stagegate sometimes referred to as phasegate process is a framework for tracking product development from an idea to the distribution of finished product by dividing the development process into distinct stages separated by decision points know as gates. Plm best practices for medical device manufacturers to ensure. Venture search, screening, and rapid preevaluation. Stages are the areas where work is done based on a. There are a number of factors to consider, including a devices classification, premarket preparation and submission to the fda. The institute for health technology studies is a nonprofit research and educational organization supporting independent analyses of the. Complete guide to bringing a medical device to market. Medical device software is used across a broad range of technology platforms medical device platforms custombuilt commercial off the shelf cots platforms e. Some companies use a stagegate or linear sequential process these refer to the same waterfalltype process.
But with all the standards and regulations imposed for the assurance of a medical device s effectiveness and safety, the amount of risk involved. It is a project management technique, in which an initiative or project takes place, divided over several stages. Medical device product development lifecycle four phases. From the early stages of device components design, factors such as practical manufacturing limitations, ease of components assembly, and costefficient processing, should be taken into account. Jun 01, 2016 3 basic pathways to medical device approval. Stage gate process download easy to edit powerslides. Pdf stagegate process for the development of medical. The outcome of one phase acts as an input for the next phase, in sequential order. Here is a complete stepbystep guide for fda medical device approval process.
Ultimate guide to medical device design and development pannam. Risk management for manufacturers of in tgs 07 vitro. The study results suggest that 318 campus drive, stagegate processes are the predominant development model used in the medical device e100, industry. The stagegate model includes i general vision and investment strategy definition. The risk management qms software for medical devices. The stagegate process, also known as the phasegate process, tends to guide the new product development process through five main stages. This new wave of products spans multiple domains, crossing both mechanical and electrical. In different jurisdictions different terms are used.
A stage gate system is a conceptual and operational road map for moving a newproduct or project from idea to launch. It can be said that they are a vital part of healthcare. Ii venture search, screening and rapid preevaluation. The stagegate process is comprised of a series of stages and gates, as shown in figure 2. Companies developing medical devices the use of which exposes patients to potential safety concerns will also be required to carry out a clinical riskbenefit analysis. Future trends in medical device technologies 2 abstract from 2007 through 2008, the u. New product development is a crucial process for innovation in dynamic and competitive business environment. However, literature on them is scarce and dispersed making any optimization process burdensome. Five steps to medical device commercialization medtech. The stagegate process includes the following five phases. Intimate knowledge of this tool is key in the translation of a brilliant concept to a successful product. It ensures all individuals involved in product development are included in the process. Well they are are both stage gate models, because they both have gates and stages. Purchasing costs cover only a minor part of the total cost of ownership.
This guidance document describes different study design principles relevant to the development of medical device clinical studies that can be used to fulfill premarket clinical data requirements. Barriers and best practices will be recounted after discussing germane characteristics of medical devices. The stage gate process model focuses on the innovation process and is also referred to as the waterfall process. Stagegate your roadmap for new product development. Stage gate divides the effort into distinct stages separated by management decision gates gate. For example, later on we will see the stage gate model of the design agencies park that consists of six phases.
Risk management in medical product development process using. Wf models have a sequential design process in which progress is seen as flowing steadily downwards like a waterfall through the phases of conception. It is a functionneutral business process that coordinates all of the disciplines and their respective practices while bringing visibility and oversight to the innovation pipeline. Medical devices, from ideation to postlaunch assessment, are directed in the united states by the u. Stagegate is an essential tool used by top industrial companies to successfully manage complex development process es for products like medical devices and drugs. These factors have a major impact on the medical device development cycle, which can be broken down into five major stages. There are several reasons for launching a new product into the market. Medical devices are intended to save and improve quality of life. By default this would be the cpic critical partner unless otherwise stated. Some stage gate models have just two stages, while others maybe have 14 or 20 stages. Each tollgate marks a decision point whether to carry on the project.
It may be due to a healthcare practitioner wanting life to be easier for them during a medical procedure which. Managing the risks during mpd process is very crucial. Ultimate guide to the phase gate process smartsheet. The stages technique breaks new product development projects into five phases scoping, business case creation, development, testing continue reading stage gate.
Development process stage gate stage 1 initiation feasibility stage 2 concept definition. Linehan, stage gate process for the development of medical devices, j. Here the five key and overlapping stages are as follows. All these factors have major impact on development cycle of medical device. The data, along with the devices themselves, are creating the internet of medical things iomt a connected infrastructure of medical. Pdf stagegate process for the development of medical devices. Pdf the medical device development process has become increasingly complex in recent years the advent of new technology nu ems. Fivephase stagegate model captures process complexity from product ideation through postmarket surveillance. The medical device development process before discussing the workshop content, it is important to explicate medical device characteristics. This model is determined as a sequential process chain with precise milestones for the innovation process marked by socalled gates 22.
From wearable health devices to complex medical implants consumers are demanding increasingly advanced and personalized products. A stagegate system is a conceptual and operational road map for moving a newproduct or project from idea to launch. Apr 01, 2017 the stage gate model includes i general vision and investment strategy definition. The medical device development cycle, on a broad scope, is not well defined. In this phase, gather available data and conduct initial research about the idea. Perform a swot strengths, weaknesses, opportunities, threats analysis to help you narrow down the pool of projects and quantify the opportunities for your product. Unlike product development, the ultimate outcomes of technology development efforts are unpredictable. Ah, that reminds me, i must apologize to those in the uk. Design and development for medical devices has to deal with relevant regulations, product safety, and risk controls on product defects in addition to the usual application requirements, specification requirements, and end customer needs.
All companies examined have a defined new product development process structure in place and have implemented some form of phase gate or toll gate. Any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings. In stage gate methodology, these phases are called stages each stage is designed to collect specific information or meet specific goals, and crossfunctional teams collaborate and various functional capabilities are integrated into the development process. This phase concludes with the documentation of such strategy and the formation of a life sciences advisory network to assist in the venture evaluation process. Nothing is accomplished in the real world unless it is adopted by industry. Typically, this stage is undertaken by a very small core team of technical and marketing people. Amendments to the federal food drug and cosmetics act in 1976 expanded the agencys role to oversee safety in the development of medical devices. The journal of medical devices presents papers on medical devices that improve diagnostic, interventional and therapeutic treatments focusing on applied research and the development of new medical devices or instrumentation. The stage gate model has long been used in product development. Medical devices are used in every stage of healthcare from diagnosis to treatment. Unstructured interviews were the primary source of information used throughout this investigation. The stage gate process includes the following five phases. Device manufacturers need solutions that not only archive and manage data, but also facilitate the sharing.
Stagegate project management medical devices siemens. A model for the development of sustainable innovations for. Stagegate process for life sciences and medical innovation. Each stage stage 1 gate stage is defined by a set of specific research activities. Plm best practices for medical device manufacturers to ensure quality 2 ebook using arena plm arena offers a simple and affordable product that allows medical device companies to manage their development process including dmr, dhf, docs, procedures in fda and ce standards. The hippo model is an alternative way of depicting the iceberg, which can be found on p. Food and drug administration fda was given the responsibility for ensuring both the safety and efficacy of drugs prior to marketing. Plm best practices for medical device manufacturers to. The set of processes, activities, and tasks described in this standard establishes a common framework for medical device software life cycle processes outlines requirements for the following steps in the software life cycle process. The launch plan was developed based on the stage gate process, which is a reliable and successful method used in different successful launch cases.
Complexity stage model of the medical device development. Scorecards and the use of tailored success criteria are used to rate. Whereas new drug approval takes an average of 12 years, moving. How to manage design and development of medical devices. The objective of this research is to explore risks during mpd in a dental product manufacturing company and propose a model for risk mitigation during mpd process to minimize failure events. Implanted medical devices capable of undergoing dynamic changes in function and safety are continuously analysed. The interview process was conducted in agreement with a previously reported methodology pietzsch et al. There are 3 basic processes to obtain fda marketing approval for medical devices, depending on the nature of the device and the circumstances under which approval is sought. Basic medical instruments and equipment have given way to multifaceted, smart products. Prematurely introducing a technology into the product development process, when there is high uncertainty that the technology will ever meet the desired specifications, often leads to project delays, project uncertainty and project cancellation.
This process consists of three stages and four gates, and feeds the front end of the typical new product process. New process development npd medical device product design should be carried out with manufacturing in mind. Here is presented a study on the distinctive features of medical devices and their development process. The stage gate process includes the following five. Use of this document does not assure compliance with any regulation and is intended only to provide education to individuals involved in standard operating procedure creation. Linehan, stagegate process for the development of medical devices, j. Stage substage 90 decision 00 registration 20 start of main action 60 completion of main action 92 repeat an earlier phase 93 repeat current phase 98 abandon 99 proceed 00 preliminary stage 00. Understanding the 5 phases of medical device development. Itp stage gate innovation management guidelines are based on stage gate principles a registered. Development and application of a stagegate process to reduce the underlying risks of it service projects 1 eunjoo jeong, 2 seungryul jeong 1kookmin university, graduate school of business it, seoul, south korea 2 kookmin university, graduate school of business it, seoul, south korea email. The stagegate model has long been used in product development. The disease or condition is defined by criteria independent of the ivd medical device under consideration. Stagegate is the core development process used at lego to sustain commercial and operational momentum.
Stanford researchers publish comprehensive model for medical device development. Stagegate divides the effort into distinct stages separated by management decision gates gate keeping. In contrast, implanted medical devices may undergo dynamic changes in function and safety over years or even decades. Many of these steps overlap with each other as scientists invent, refine, and test the devices. In this approach, the whole process of medical device development requires linear and logical separation of phases. Fda design control guidance for medical devices perforce. Cooper describes the innovation process with his commonly used stage gate model covering five stages. The medical device milestone map saul ewing arnstein. The study results suggest that 318 campus drive, stage gate processes are the predominant development model used in the medical device e100, industry. May 27, 2015 medical product development mpd process is highly multidisciplinary in nature, which increases the complexity and the associated risks.
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