The design process for medical devices is highly regulated to ensure the safety of patients. This
paper will present a review of the design process for implantable orthopedic medical devices. It will cover the
main stages of feasibility, design reviews, design, design verification, manufacture, design validation, design
transfer and design changes
With new technologies come many innovative medical devices and tools to help treat patients and to improve their quality of life thru diagnosis, monitoring and therapy. New fields of study within Engineering are emerging throughout the academic community to better understand and improve these devices and tools. As a Systems Engineer what are we doing in this application that’s different from others? What are the challenges? What do we need to improve on? And Why?
This presentation provides an overview of the different types of Medical Devices and addresses the associated implications that affect the system under design. An example of a specific Medical Device will be presented along with a description of how the system integrates with Biological component. Systems Engineering Process comparison between Medical Device industry and Defense industry where Systems Engineering was conceived has been integrated throughout this presentation. You will learn more about some of the challenges that Medical Devices industry is facing and potential Systems Engineering solutions with specific approach and methodology.
Key to Successful Design to Manufacturing - Siddharth Desai, I-Flow Corporationmarcus evans Network
Siddharth Desai, I-Flow Corporation - Speaker at the marcus evans Medical Device Manufacturing Summit Spring 2012, held in Las Vegas, NV, delivered his presentation on Key to Successful Design to Manufacturing
How To Manage and Mitigate Risk in Medical Device New Product DevelopmentGreenlight Guru
A company’s ability to understand and manage risk can mean the difference between financial success and disaster.
(You can view the full webinar here: http://www.greenlight.guru/risk-in-medical-device-new-product-development-webinar)
In this webinar you'll learn:
- How to understand the true nature and impact of project and product risk
- How to effectively measure risk quantitatively
- How to use risk management as a tool to accelerate NPD
- What you need to know about the upcoming risk-based changes to ISO 13485 to ensure compliance
When created early in the product development lifecycle, a trace matrix can do more than just help you gain FDA approval for your device. Unfortunately, many companies create the matrix sporadically during a project, mainly right before regulatory submission—too late to capture the benefits a well-maintained matrix can deliver.
During this recorded webinar, guest speaker Steve Rakitin, President of Software Quality Consulting, discussed five of the benefits gained by maintaining a matrix throughout the project. A software engineer with more than 20 years of experience in the medical device industry, Steve explains how a trace matrix can help you:
- Plan and estimate testing and validation needs
- Ensure all requirements are implemented
- Verify that all requirements have been tested
- Manage change throughout product development
- Provide evidence that hazard mitigations are implemented and validated
With new technologies come many innovative medical devices and tools to help treat patients and to improve their quality of life thru diagnosis, monitoring and therapy. New fields of study within Engineering are emerging throughout the academic community to better understand and improve these devices and tools. As a Systems Engineer what are we doing in this application that’s different from others? What are the challenges? What do we need to improve on? And Why?
This presentation provides an overview of the different types of Medical Devices and addresses the associated implications that affect the system under design. An example of a specific Medical Device will be presented along with a description of how the system integrates with Biological component. Systems Engineering Process comparison between Medical Device industry and Defense industry where Systems Engineering was conceived has been integrated throughout this presentation. You will learn more about some of the challenges that Medical Devices industry is facing and potential Systems Engineering solutions with specific approach and methodology.
Key to Successful Design to Manufacturing - Siddharth Desai, I-Flow Corporationmarcus evans Network
Siddharth Desai, I-Flow Corporation - Speaker at the marcus evans Medical Device Manufacturing Summit Spring 2012, held in Las Vegas, NV, delivered his presentation on Key to Successful Design to Manufacturing
How To Manage and Mitigate Risk in Medical Device New Product DevelopmentGreenlight Guru
A company’s ability to understand and manage risk can mean the difference between financial success and disaster.
(You can view the full webinar here: http://www.greenlight.guru/risk-in-medical-device-new-product-development-webinar)
In this webinar you'll learn:
- How to understand the true nature and impact of project and product risk
- How to effectively measure risk quantitatively
- How to use risk management as a tool to accelerate NPD
- What you need to know about the upcoming risk-based changes to ISO 13485 to ensure compliance
When created early in the product development lifecycle, a trace matrix can do more than just help you gain FDA approval for your device. Unfortunately, many companies create the matrix sporadically during a project, mainly right before regulatory submission—too late to capture the benefits a well-maintained matrix can deliver.
During this recorded webinar, guest speaker Steve Rakitin, President of Software Quality Consulting, discussed five of the benefits gained by maintaining a matrix throughout the project. A software engineer with more than 20 years of experience in the medical device industry, Steve explains how a trace matrix can help you:
- Plan and estimate testing and validation needs
- Ensure all requirements are implemented
- Verify that all requirements have been tested
- Manage change throughout product development
- Provide evidence that hazard mitigations are implemented and validated
Extraordinary design considerations e bacon 2011 08-05Elizabeth Bacon
This presentation was delivered at Device Design Day 2011 by Elizabeth Bacon of Devise. The talk was recorded, so if you're interested in seeing that please contact liz(dot)devise(at)gmail(dot)com for a link.
In this presentation, we will discuss the concept and interrelation between product and process design and product life cycle. We will also talk about key decisions required in process design and evaluation of process design.
To know more about Welingkar School’s Distance Learning Program and courses offered, visit: http://www.welingkaronline.org/distance-learning/online-mba.html
Demystifying Designing for ‘X’ by ProTek Medical ProtekMedical
http://www.protek.ie/
Annette Carty-Mole B.Eng (Hons)
Design Engineer, ProTek Medical
When a company is given the task of designing a
new product or redesigning an existing product, it
is important to keep in mind the three main goals
of cost, quality and speed. These goals can be
further split into more quantitative criteria which
are relevant throughout the product’s life cycle.
Designing for manufacture and assembly are typical
examples of two criteria which will have a large
impact on the cost, quality and speed at which the
product is developed. The methodology of design
that meets an all-encompassing range of criteria is
known as designing for ‘X’.
Project Management Plan
Project Management Plan
Introduction
Project management planning involves defining, preparing, and coordinating all other subsidiary plans and integrating them to come up with one comprehensive plan. To make sure that the patient image wands being manufactured by PROVISION Healthcare Technologies is a success both from development, distribution and sales and marketing, the project management should be well consolidated .This will enable the project to be closely monitored. Project execution and controlling would be very much easier when there is a well documented management plan.
Product Development
The design and control process
During the development of the patient wands, the design and control process is very important. It is at this stage that procedures in the project plan are documented and incorporated during design and development of those patient wands.
The design team has the duties of doing the following:
· Identifying the customers’ needs
· Understanding the competitor’s product.
· Meeting essential requirements that is required to achieve a high quality product, from inception through to production.
· Identifying early inconsistencies or discrepancies by comparing what is currently made to the initial concept. This will help reduce redesigning and reworking. On the other hand, it will help improve product design and quality
· The design team should ensure that the end product will meet the customer needs.
Design and development planning process
At this stage, a plan that outlines the development activities while allocating individuals their duties and responsibilities is established and maintained .It is at this stage that the plan is reviewed, updated and approved. The software and hardware designs should be verified and be validated at this point.
Input Design
In order to come up with the best design, external ideas should be borrowed. It is during this phase that a survey of customers and other stakeholders for example nurses and clinicians should be done. Administering of questionnaires or interviewing can be conducted. The information gathered would be used to review, address and develop the specifications of the product.
Output Design
The output design procedures need to clearly refer to the input design that was earlier developed. The output design is expected to highlight the critical measures for proper functioning of the devices and software. Some of the output designs include:
· The hardware component
· user manual
· Specifications
· A risk analysis
· Study results which include validation and biocompatibility studies, storage and shipping tests
· Technical files
Design review
Design review is done to confirm the construction of the design. It is from here that deficiencies are detected and corrected .Hazard analysis review and failure mode analysis are the two common review analyses that can be done to ensure that the design is up to date. The design should be reviewe ...
Extraordinary design considerations e bacon 2011 08-05Elizabeth Bacon
This presentation was delivered at Device Design Day 2011 by Elizabeth Bacon of Devise. The talk was recorded, so if you're interested in seeing that please contact liz(dot)devise(at)gmail(dot)com for a link.
In this presentation, we will discuss the concept and interrelation between product and process design and product life cycle. We will also talk about key decisions required in process design and evaluation of process design.
To know more about Welingkar School’s Distance Learning Program and courses offered, visit: http://www.welingkaronline.org/distance-learning/online-mba.html
Demystifying Designing for ‘X’ by ProTek Medical ProtekMedical
http://www.protek.ie/
Annette Carty-Mole B.Eng (Hons)
Design Engineer, ProTek Medical
When a company is given the task of designing a
new product or redesigning an existing product, it
is important to keep in mind the three main goals
of cost, quality and speed. These goals can be
further split into more quantitative criteria which
are relevant throughout the product’s life cycle.
Designing for manufacture and assembly are typical
examples of two criteria which will have a large
impact on the cost, quality and speed at which the
product is developed. The methodology of design
that meets an all-encompassing range of criteria is
known as designing for ‘X’.
Project Management Plan
Project Management Plan
Introduction
Project management planning involves defining, preparing, and coordinating all other subsidiary plans and integrating them to come up with one comprehensive plan. To make sure that the patient image wands being manufactured by PROVISION Healthcare Technologies is a success both from development, distribution and sales and marketing, the project management should be well consolidated .This will enable the project to be closely monitored. Project execution and controlling would be very much easier when there is a well documented management plan.
Product Development
The design and control process
During the development of the patient wands, the design and control process is very important. It is at this stage that procedures in the project plan are documented and incorporated during design and development of those patient wands.
The design team has the duties of doing the following:
· Identifying the customers’ needs
· Understanding the competitor’s product.
· Meeting essential requirements that is required to achieve a high quality product, from inception through to production.
· Identifying early inconsistencies or discrepancies by comparing what is currently made to the initial concept. This will help reduce redesigning and reworking. On the other hand, it will help improve product design and quality
· The design team should ensure that the end product will meet the customer needs.
Design and development planning process
At this stage, a plan that outlines the development activities while allocating individuals their duties and responsibilities is established and maintained .It is at this stage that the plan is reviewed, updated and approved. The software and hardware designs should be verified and be validated at this point.
Input Design
In order to come up with the best design, external ideas should be borrowed. It is during this phase that a survey of customers and other stakeholders for example nurses and clinicians should be done. Administering of questionnaires or interviewing can be conducted. The information gathered would be used to review, address and develop the specifications of the product.
Output Design
The output design procedures need to clearly refer to the input design that was earlier developed. The output design is expected to highlight the critical measures for proper functioning of the devices and software. Some of the output designs include:
· The hardware component
· user manual
· Specifications
· A risk analysis
· Study results which include validation and biocompatibility studies, storage and shipping tests
· Technical files
Design review
Design review is done to confirm the construction of the design. It is from here that deficiencies are detected and corrected .Hazard analysis review and failure mode analysis are the two common review analyses that can be done to ensure that the design is up to date. The design should be reviewe ...
Engineering Design is a decision making process (often iterative or recursive) in which the sciences are applied to modify/create something to meet predefined objectives (specifications). Basic stages of the design process include establishment of objectives and criteria, analysis, synthesis, definition of actual manufacturing techniques and routes as well as the modes of usage, maintenance and disposal.
A Review on Design of a Fixture for Rear Coverijsrd.com
In fixtures which are used for machining process, minimizing work piece deformation due to clamping and cutting forces is necessary due to which machining accuracy can be maintained. The different methodologies used for clamping operation in different application by various authors are discussed in this paper. Fixtures are required in different industries according to specific application. Rear Cover is important part in agriculture tractor. The fixture set up for Rear Cover is done manually, which leads to machining defects, poor quality, increase in rejection rate, more cycle time and more hectic to operator. So, there is need to develop system which can help in achieve quality, increase productivity, elimination of human error, reduction in cycle time.
Abstract: Tolerance synthesis and machining parameter have been recognized as key issue for process design and development. Manufacture of product in desired shape with desired characteristics and properties depend not only on design of product but also on selection of appropriate manufacturing process. This paper describes process selection methodology, cycle time calculation machine selection.
This paper i.e. Process Design and Development of Engine Block is related to process design. When a company has to introduce number of products, once decision on design and product is made then, one of the crucial step that the company has to take is how to manufacture that product, comes under process design. Process design tells us thoroughly how product is made, which machines are used, cutting parameter etc.
The purpose of this process is to design process for engine block with weekly production at 3 blocks without affecting existing production of KV block with capacity of 113 blocks per week, arrange flow of part at shop floor in order to minimize the loss of time. Scheduling in production management is therefore very basic function in manufacturing and it has to be well match with process planning.
Introduction: What is software engineering? Software Development Life Cycle, Requirements Analysis, Software Design, Coding, Testing, Maintenance etc.
Software Requirements: Functional and Non-functional requirements, User Requirements, System Requirements, Documentation of the software requirements.
Software Processes:
Process and Project, Component Software Processes.
Software Development Process Models.
Waterfall Model. Prototyping.
Iterative Development.
The RAD Model
JamesSticky NoteThis is an introduction to a volume of t.docxchristiandean12115
James
Sticky Note
This is an introduction to a volume of the Journal of Education devoted to my papers. This piece is quite close to my paper "What is Literacy?".
1
Chapter 8
Design for Six Sigma
1
Design for Six Sigma
Design for Six Sigma (DFSS) represents a set of tools and methodologies used in product development for ensuring that goods and services will meet customer needs and achieve performance objectives and that the processes used to make and deliver them achieve six sigma capability.
2
2
DFSS Methodology: DMADV
Define – establish goals
Measure – identify voice of the customer and define CTQ measures
Analyze – propose and evaluate high-level design concepts
Design – design the details of the product and processes used to produce it
Verify – ensure that the product performs as expected and meets customer requirements
3
Features of DFSS
A high-level architectural view of the design
Use of CTQs with well-defined technical requirements
Application of statistical modeling and simulation approaches
Predicting defects, avoiding defects, and performance prediction using analysis methods
Examining the full range of product performance using variation analysis of subsystems and components
4
Concept Development
Concept development – the process of applying scientific, engineering, and business knowledge to produce a basic functional design that meets both customer needs and manufacturing or service delivery requirements.
5
Innovation
Innovation involves the adoption of an idea, process, technology, product, or business model that is either new or new to its proposed application.
The outcome of innovation is a discontinuous or breakthrough change that results in new and unique goods and services that delight customers and create competitive advantage.
6
Types of Innovation
1. An entirely new category of product (for example, Twitter)
2. First of its type on the market in a product category already in existence (for
example, the DVD player)
3. A significant improvement in existing technology (for example, the Blu-ray
disc technology)
4. A modest improvement to an existing product (for example, the latest iPad)
7
Creativity
Creativity is seeing things in new or novel ways.
Creativity tools, such as brainstorming and “brainwriting,” are designed to help change the context in which one views a problem or opportunity, thereby leading to fresh perspectives.
8
Understanding the Voice of the Customer
What is the product (good or service) intended to do?
Technical requirements, sometimes called design characteristics, translate the voice of the customer into technical language, specifically into measures of product performance.
9
Design Development
Design development - the process of applying scientific, engineering, and business knowledge to produce a basic functional design that meets all CTQ.
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About
Indigenized remote control interface card suitable for MAFI system CCR equipment. Compatible for IDM8000 CCR. Backplane mounted serial and TCP/Ethernet communication module for CCR remote access. IDM 8000 CCR remote control on serial and TCP protocol.
• Remote control: Parallel or serial interface.
• Compatible with MAFI CCR system.
• Compatible with IDM8000 CCR.
• Compatible with Backplane mount serial communication.
• Compatible with commercial and Defence aviation CCR system.
• Remote control system for accessing CCR and allied system over serial or TCP.
• Indigenized local Support/presence in India.
• Easy in configuration using DIP switches.
Technical Specifications
Indigenized remote control interface card suitable for MAFI system CCR equipment. Compatible for IDM8000 CCR. Backplane mounted serial and TCP/Ethernet communication module for CCR remote access. IDM 8000 CCR remote control on serial and TCP protocol.
Key Features
Indigenized remote control interface card suitable for MAFI system CCR equipment. Compatible for IDM8000 CCR. Backplane mounted serial and TCP/Ethernet communication module for CCR remote access. IDM 8000 CCR remote control on serial and TCP protocol.
• Remote control: Parallel or serial interface
• Compatible with MAFI CCR system
• Copatiable with IDM8000 CCR
• Compatible with Backplane mount serial communication.
• Compatible with commercial and Defence aviation CCR system.
• Remote control system for accessing CCR and allied system over serial or TCP.
• Indigenized local Support/presence in India.
Application
• Remote control: Parallel or serial interface.
• Compatible with MAFI CCR system.
• Compatible with IDM8000 CCR.
• Compatible with Backplane mount serial communication.
• Compatible with commercial and Defence aviation CCR system.
• Remote control system for accessing CCR and allied system over serial or TCP.
• Indigenized local Support/presence in India.
• Easy in configuration using DIP switches.
Democratizing Fuzzing at Scale by Abhishek Aryaabh.arya
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Automobile Management System Project Report.pdfKamal Acharya
The proposed project is developed to manage the automobile in the automobile dealer company. The main module in this project is login, automobile management, customer management, sales, complaints and reports. The first module is the login. The automobile showroom owner should login to the project for usage. The username and password are verified and if it is correct, next form opens. If the username and password are not correct, it shows the error message.
When a customer search for a automobile, if the automobile is available, they will be taken to a page that shows the details of the automobile including automobile name, automobile ID, quantity, price etc. “Automobile Management System” is useful for maintaining automobiles, customers effectively and hence helps for establishing good relation between customer and automobile organization. It contains various customized modules for effectively maintaining automobiles and stock information accurately and safely.
When the automobile is sold to the customer, stock will be reduced automatically. When a new purchase is made, stock will be increased automatically. While selecting automobiles for sale, the proposed software will automatically check for total number of available stock of that particular item, if the total stock of that particular item is less than 5, software will notify the user to purchase the particular item.
Also when the user tries to sale items which are not in stock, the system will prompt the user that the stock is not enough. Customers of this system can search for a automobile; can purchase a automobile easily by selecting fast. On the other hand the stock of automobiles can be maintained perfectly by the automobile shop manager overcoming the drawbacks of existing system.
Event Management System Vb Net Project Report.pdfKamal Acharya
In present era, the scopes of information technology growing with a very fast .We do not see any are untouched from this industry. The scope of information technology has become wider includes: Business and industry. Household Business, Communication, Education, Entertainment, Science, Medicine, Engineering, Distance Learning, Weather Forecasting. Carrier Searching and so on.
My project named “Event Management System” is software that store and maintained all events coordinated in college. It also helpful to print related reports. My project will help to record the events coordinated by faculties with their Name, Event subject, date & details in an efficient & effective ways.
In my system we have to make a system by which a user can record all events coordinated by a particular faculty. In our proposed system some more featured are added which differs it from the existing system such as security.
Cosmetic shop management system project report.pdfKamal Acharya
Buying new cosmetic products is difficult. It can even be scary for those who have sensitive skin and are prone to skin trouble. The information needed to alleviate this problem is on the back of each product, but it's thought to interpret those ingredient lists unless you have a background in chemistry.
Instead of buying and hoping for the best, we can use data science to help us predict which products may be good fits for us. It includes various function programs to do the above mentioned tasks.
Data file handling has been effectively used in the program.
The automated cosmetic shop management system should deal with the automation of general workflow and administration process of the shop. The main processes of the system focus on customer's request where the system is able to search the most appropriate products and deliver it to the customers. It should help the employees to quickly identify the list of cosmetic product that have reached the minimum quantity and also keep a track of expired date for each cosmetic product. It should help the employees to find the rack number in which the product is placed.It is also Faster and more efficient way.
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1. IOSR Journal of Mechanical and Civil Engineering (IOSR-JMCE)
e-ISSN: 2278-1684,p-ISSN: 2320-334X, Volume 12, Issue 6 Ver. II (Nov. - Dec. 2015), PP 76-82
www.iosrjournals.org
DOI: 10.9790/1684-12627682 www.iosrjournals.org 76 | Page
A Review on Design Process of Orthopedic Implants
Vipul V.Ruiwale1
, Dr.R.U.Sambhe2
1
(Mechanical Engineering Department, MIT College of Engineering, Pune, Maharashtra, India)
2
(Mechanical Engineering Department, JRD Institute of Engineering and Technology, Yavatmal, Maharashtra,
India)
Abstract : The design process for medical devices is highly regulated to ensure the safety of patients. This
paper will present a review of the design process for implantable orthopedic medical devices. It will cover the
main stages of feasibility, design reviews, design, design verification, manufacture, design validation, design
transfer and design changes.
Keywords:– 3D Printing, Design, Implant, Medical device, Orthopedic,
I. Introduction
The design process for medical devices is highly regulated to ensure the safety of patients and
healthcare workers. The Medical Device Directive [1] was developed to regulate medical devices in Europe. It
is a document that is legally binding, enforceable in law and with penalties for non-compliance. Regulations
outside Europe vary. For example, in the United States of America, the Food and Drug Administration (FDA) is
responsible for the safety of medical devices [2] and DST is responsible in India. In order to comply with the
regulations, companies are required to have a quality management system in place [3-5] to ensure that the whole
design process is managed and planned in a systematic and repeatable manner. To comply with the regulatory
aspects it is required to maintain a Design History File (which can also be know as a Technical File or Design
Dossier) which describes the design history of a product and is maintained after product is released to include
subsequent changes to the product and relevant post-market surveillance data. The aim of this paper is to give an
overview of the design process for implantable orthopedic medical devices.
II. Design Process
2.1. Overview
The medical implant process, as with other design processes, can be broadly divided into six areas [6-9]:
1. Market
2. Design specification
3. Concept design
4. Detail design
5. Manufacture
6. Sell
However, in this paper a more detailed structure to the design process is discussed, shown in Fig. (1). Each of
these points of the design process are discussed here.
2.2. Feasibility
2.2.1. Design Inputs
Ideas for new or improved or patient specific medical implants will come from surgeons, other
clinicians, sales teams or medical engineers, probably working together as an interdisciplinary team. A surgical
review panel may be formed to help guide the design and ensure that the implant functions correctly surgically.
2.2.2. Commercial Aspects
A feasibility study for a new idea for patient specific implants and to reduce the lead time to
manufacture implant needs to be undertaken to identify the potential market share, similar implants produced by
competitor companies. A review of the intellectual property is also required to determine whether the design can
be protected.
2. A Review on Design Process of Orthopedic Implant
DOI: 10.9790/1684-12627682 www.iosrjournals.org 77 | Page
2.2.3. Planning
It is important that each aspect of the design process is project managed with achievable task set and
defined throughout the project life cycle. The setting of task should enable the project manager to assess the
progress of the project to make sure that it is completed on time and within budget. The definition of the task
should detail the requirements for the project to achieve the objective, for example completing the market
feasibility report and the project objectives. The project plan should include regular tasks and project meetings
to assist with the identification of problems and allow early action to be taken to counteract delays to a project.
The planning process should also include a risk management plan, which should highlight the relevant strategies
that will be employed to reduce and manage the risks that are associated with a project. The planning process
should identify the human and financial resources required to successfully realize a design.
Fig.1 Design Process of Medical Implant [43]
3. A Review on Design Process of Orthopedic Implant
DOI: 10.9790/1684-12627682 www.iosrjournals.org 78 | Page
2.2.4. Regulatory Requirements
All medical devices must have regulatory approval before they can be released to market. There are a
number of internationally and nationally agreed requirements to which medical devices must conform. Currently
these standards are not harmonized, and there are differences between those that regulate India, Europe and the
United States. Medical devices must also be classified according to the level of risk associated with their use
upon a patient and to the user. The classification process of a medical device will determine the relevant
approval route to market. It is therefore essential that the regulations that will influence the design of a product
are identified early in the design process. Independent advice on this area must be sought from a Regulatory
Authority, Conformity Assessment Body or other authorised third party.
In the design of the product it is necessary to identify global standards, which apply to all medical
devices, semi-global standards which apply to a particular family of devices and specific standards that apply to
particular devices or pieces of equipment. By identifying these standards complications in the latter stages of the
design process can be avoided. Not all of the standards are mandatory, compliance will often help to accelerate
the approval process.
2.2.5. Design Requirements
The design requirements (or product design specification) are essential before a medical device can be
designed. It sets out exactly what is required of the design against which each stage of the design can be
verified. Whilst the initiation of the project will highlight some of the technical requirements for a project, it is
important to perform a thorough requirement capture process to ensure that all of the functional performance
needs are identified early in the design process. It is important to remember that the requirements are solution
independent to prevent narrowing the design options available. A general standard exists to help determine the
design requirements [10]. Many types of medical device also have particular requirements. In addition, specific
requirements can be specified for certain devices, such as joint replacement implants for the hip and knee
[11,12].
The design requirements for the implant will include:
• intended performance
• design attributes
• materials
• design evaluation
• manufacture
• testing
• instruments required
• sterilization
• packaging
• information to be supplied by the manufacturer [7,14]
For a total knee arthroplasty the important requirements would be for the implant to last for 25 years,
have the required range of motion, prevent loosening and minimize wear debris [19]. In the design of a new
wrist arthroplasty it would be important to consider the range of motion (flexion/extension, radial/ulnar
deviation or radio-carpal rotation), fixation and materials [20]. For the design of an intramedullary nail
stabilizing the bone while the fracture heals would be an important requirement [21].
2.3. Design Reviews
A design review is required, at each stage of the design process, to formally document comprehensive,
systematic examination of a design to:
• evaluate design requirements
• assess capability of the design
• identify problems [13]
2.4. Design
2.4.1. Concept Design
The concept, or conceptual, design stage is where solutions are generated to meet the design
requirements. The aim is to generate as many ideas as possible. At this stage ideas should not be judged.
Various methods exist to help with creativity in developing concept designs such as Brain storming [22-24] and
TRIZ (Theory of Inventive Problem Solving) [22]. Concept design may involve:
4. A Review on Design Process of Orthopedic Implant
DOI: 10.9790/1684-12627682 www.iosrjournals.org 79 | Page
• simple sketches of ideas;
• computer aided design models;
• analytical calculations;
• initial manufacturer consultation.
Once a range of concept designs have been developed it is worth assessing each of the concept designs
for patentable technology to ensure that the final design has been fully protected. The protection of ideas and
concepts can play an important role in the success of a product once launched to the market. It is therefore
essential to consider this as early as possible in the design phase. The range of concept designs can then be
systematically rated by the design team to determine the most suitable concept to develop, in the detail design
stage.
2.4.2. Detail Design
At the detail design stage the flesh is put onto the bones of the chosen conceptual idea [7]. A concept design is
worked through until a detail design has been produced. This will include:
• generation of solid computer aided design models
• specification of materials
• drafting of engineering drawings
• analysis of tolerance stacks within associated assemblies to ensure correct operation
• detailing with the inspection requirements to ensure that the part/assembly operates correctly
• liaison with manufacturers to ensure that the device is designed for manufacture (DFM), designed for
assembly (DFA) or designed for manufacture and assembly (DFMA)
2.5. Design Verification
2.5.1. Introduction
Design verification involves confirmation by examination that a medical implant meets the design
requirements and is essentially asking the question “are we building the thing right?” [26,27]. It is essential that
verification is considered early in the design process. Ideally, when a design requirement is decided, a method
for verifying that requirement should also be developed [27]. Design verification methods can include:
• finite element analysis
• risk analysis
• rapid prototyping
2.5.2. Finite Element Analysis
Finite element analysis is a widely used technique in medical device design and can be used to verify if
a design will have sufficient strength to withstand the loading conditions in the human body [28-47]. Finite
element analysis is a proven cost saving tool and can reduce design cycle time. In the development of a new
method for closing a median sternotomy using cannulated screws and wire, finite element analysis was used to
investigate the stresses acting between the screw and sternum [29]. In knee replacement implants, finite element
analysis can be used to optimise the bearing surfaces [30]. Finite element analysis can also be used to investigate
design changes to existing devices. For example, Mathias et al. [31] used finite element analysis to investigate
the effect of introducing holes into the femoral component of a total hip replacement implant to engage with a
stem introducer instrument and Leahy et al. [15] undertook a redesign of a flexible fixation system for the
lumbar spine based on an existing design.
2.5.3. Risk Analysis
A key part of the medical implant design process is to undertake a risk analysis [32]. Any medical
implant should be designed and manufactured so that it does not compromise the safety of patients or healthcare
workers. Manufacturers must eliminate or reduce risks as far as possible; any risks that exist must be weighed
against the benefits to the patient. The way to show risks have been eliminated or reduced is to undertake a risk
analysis. Many techniques, such as Failure Mode Effect Analysis and Fault Tree Analysis can be used in a risk
analysis; guidance for these methods can be found in standards [33] and [34], respectively. Failure Mode Effects
Analysis (FMEA) can have a number of variants which address different aspects of the product development
cycle, all of which use a bottom-up approach to evaluate risks associated with aspects of the design. Examples
of the variants are Design Failure Mode Effects Analysis (DFMEA), Process Failure Mode Effects Analysis
(PFMEA), Failure Mode Criticality Analysis (FMECA) and User Failure Mode Effects Analysis (UFMEA). The
aim of these methods is to consider all the possible risks associated with a medical device and identify ways that
5. A Review on Design Process of Orthopedic Implant
DOI: 10.9790/1684-12627682 www.iosrjournals.org 80 | Page
these risks can be eliminated or reduced. In FMEA the occurrence, severity, and detection of each failure are
rated on a scale from 1 to 10. A risk priority number is then calculated by multiplying the three ratings together.
The design team must then decide if a possible failure mode is acceptable or if ways need to be found to reduce
it. [32].
It is also important not to isolate the medical implant from the surgical instruments, packaging,
sterilization; these have many risks associated with them that could adversely affect the performance of a
medical implant. An international standard for medical device risk analysis has been published [35]. Risk
analysis helps to realize a design if it is undertaken at an early stage and should be undertaken at stages during
the design process, including a final risk analysis.
2.5.4. Rapid Prototyping
Rapid prototyping is a very effect technique for verifying the design of medical implant as it aids
communication between engineers and surgeons [33]. Models of implants can be produced within hours by a
variety of methods such as Selective Laser Sintering (SLS), Fused Deposition Modeling (FDM) or three-
dimensional printing [34]. The surgeon can then inspect the models and size them against a skeleton. Rapid
prototyping can also be used to produce models of human bones, which is particular useful if there is abnormal
anatomy into which an implant will be used [34].In fact rapid prototyping or 3D printing can also be used to
manufacture a patient specific implant.
2.6. Manufacture
Before the design is transferred to production it is essential to ensure that the chosen manufacturing
processes are repeatable and reliable. The choice of manufacturing technique depends on many factors:
• number to be produced
• surface finish required
• post machining cleaning processes
• sterilization process (if necessary)
As well as the manufacture of the implant, packaging for the implant, sterilization techniques,
operation instructions and requirements also need to be finalized.
2.7. Design Validation
Validation of the device is performed under actual or simulated conditions for use. While verification is
answering the question “are we building the thing right”, validation is asking “have we built the right thing”
[26,27]. Validation is to ensure that the medical device meets the user requirements and the intended use.
Validation can include:
• mechanical testing of prototypes
• evidence that similar medical devices are clinically safe
• a clinical investigation
• sterilization validation
Mechanical testing allows the mechanical conditions in the human body to be simulated in the
laboratory. Mechanical testing will give no indication of how the device will behave in the body from a
biological point of view, but it will ensure that devices have sufficient strength and stiffness to perform as
required. There are a large number of standards available to guide the pre-clinical mechanical testing of joint
replacement implants.
In some cases of mechanical testing it is beneficial to use human cadaveric material [39]. For example,
cadavers have been used to investigate the attachment of a hook device to the spinous process of the lumbar
spine in terms of strength and slippage [38,41]. In addition, cadavers can be used to trial surgical instruments
[41]. Once pre-clinical testing has been completed manufacturers of joint replacement implants are required to
make a decision as to whether a clinical investigation is required. This is guided by the standards.A critical
review of the literature is required to ascertain similar implants and how they have performed in patients.
2.8. Design Transfer
Before a design is transferred to production it is necessary to ensure that all documents and training
associated with the device are in place. Design transfer can include:
• generation of instructions for use
• finalization of the surgical technique
6. A Review on Design Process of Orthopedic Implant
DOI: 10.9790/1684-12627682 www.iosrjournals.org 81 | Page
• plan the training of surgeons
• finalization of the packaging
• completed vendor requirements such as audits, first article inspection or surveys
• Total cost bill of materials
• completed inspection plans and process worksheets
• creation of the master device record
2.9. Design Changes
After a medical device is on the market it is necessary for the manufacturer to have a post-market
surveillance process in place to ensure the safety of patients and healthcare workers after the device is on the
market. Feedback from surgeons may lead to design changes being made to the device or the surgical
instruments. The changes that arise from this feedback must be fully documented.
III. Conclusion
The design process for the medical implant is discussed in detail here. It is applicable to all the
orthopedic implant which are not patient specific. Certain modifications can be done to the design process based
on new manufacturing techniques developed, requirement of patient specific implants, new materials available.
IV. Future Scope
With the advancement in CAD, Computer Imaging, manufacturing it can be seen that 3D printing can
be used to manufacture the patient specific implants as each and every patient will have different body features
so patient specific implants can be manufactured having complex features. It can also be noted that the implant
manufacturing process is very generalized as it does not consider patient specific data. Also the manufacturing
lead time of implant manufacturing is matter of concern as sometimes a patient can need the implant to be done
in very less time e.g. accident trauma. So efforts can be made to create a design process for additive
manufacturing as it can manufacture complex shapes and also which will reduce the manufacturing lead time so
a patient can get an implant in very less time.
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