Course 310 - Design and Fabrication of Biomedical Devices

Book: Manufacturing Engineering and Technology, 8 th Edition

Biomedical Engineering Department, College of Engineering
Princess Nora bint Abdulrahman University

Design and Fabrication of

Biomedical Devices

Lecture 1
BY: DR. YAHYA ALMUALLEM
 Chapter 1

General Introduction
What is Manufacturing

 Manufacturing is making products.

 A manufactured product may, in turn, itself be used to make other products:
 (a) a large press, to shape flat sheet metal into appliances
 (b) a drill, for producing holes
 (c) machinery, to produce a countless variety of individual items.
 Types of Products

 Discrete Products which are individual items by itself:

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 Nails, bolts, screws, nuts, paper clips, and tires.

 Continuous Products which are then cut into individual pieces of various lengths for specific
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purposes:
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 a spool of wire
 metal or plastic tubing
 a roll of aluminium foil.
History of Manufacturing

 Manufacturing dates back to the period 5000 to 4000 B.C.

 France and Egypt are the oldest in sketching and manufacturing (1600)
 Materials first used: wood, stone, or metal, gold, copper, iron, silver, lead, tin, bronze, and brass.
 Ironmaking began in about 1100 B.C. in the Middle East
 Production of steel, in Asia, during the period 600 to 800 A.D.
 Today, countless metallic and non-metallic materials with unique properties are available.
 Advanced materials: ceramics, composite materials, nanomaterials
 an extensive variety of products, ranging from prosthetic devices and computers to supersonic
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aircraft
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 Industrial Revolutions -

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 Industrial Revolution, which began in England in the 1750s (also called the First Industrial
Revolution).
 Second Industrial Revolution begun in the mid-1900s, with the development of solid-state electronic
devices and computers.
 Mechanization began in England and other countries of Europe, then US developing textile
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machinery and machine tools for cutting metal.
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 A major advance in manufacturing began in the early 1800s, with the design, production, and use
of interchangeable parts.
 Digital manufacturing era began around 1990
 The term digital manufacturing reflect the notion that manufacturing parts and components can
take place through computer-driven CAD and production machinery.
Industry 4.0

 Recent innovations are the proliferation of communications protocols, sensors and controls throughout the
manufacturing enterprise referred to as Industry 4.0 or Digital Manufacturing, some of the key developments are the
following:
1. Sensors and smart device designs can be printed from conductive and insulate inks, or use very thin silicon
integrated circuits in flexible hybrid designs (Fig. I.3). These low-cost devices include communication ability and
are central to the Internet of Things
2. Machines can be monitored at all times, using Internet-based communications protocols such as MTConnect, so
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that precise information is available at all times for every machine in an organization.
3. The wide application of sensors to all aspects of manufacturing has led to the development of Big Data, where
trends and conditions of manufacturing systems can be accurately measured at all times.
4. Machine learning algorithms, and the incorporation of physics-based mathematical models of manufacturing
processes and systems, has led to the ability to apply advanced controls to the manufacturing enterprise.
5. Advanced models of manufacturing processes, combined with the detailed measurement of the manufacturing and
service environment of a product (Big Data), lead to the computer-based representation of the product, referred to
as a digital twin. The digital twin represents a virtual model of the part, and accurate performance models applied
to the virtual twin can predict failure or required service of the actual part.
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Product Design and Concurrent Engineering

 Product design involves the creative and systematic prescription of the shape and
characteristics of a product to achieve specified objectives
 Design is a critical activity, because it has been estimated that as much as 80% of the cost of
product development and manufacturing is determined by the decisions made in the initial
stages of design.
 Innovative approaches are essential in successful product design, as are clearly specified
functions and a clear statement of the performance expected of the product.
Technology Readiness Level and Manufacturing Readiness Level
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MRL

 Product development generally

follows the flow outlined in
Table I.3. Technology readiness
level (TRL) and Manufacturing
readiness level (MRL) are
measures of a products ability to
be produced, marketed, and
sold
 traditional design
↓

The Design
Process
Concurrent
engineering
 Design and manufacturing ↓
activities took place sequentially, as
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shown in Fig. I.4a.

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 Concurrent Engineering. Driven
the stages primarily by the consumer
run
electronics industry, a continuing
Simultaneously
trend to bring products to the
marketplace as rapidly as possible,
to gain a higher percentage share
of the market and thus higher
profits.
 An important methodology aimed
at achieving this end is concurrent
engineering, which involves the
product-development approach
shown in Fig. I.4b
Role of Computers in Product Design

 Product design first requires the preparation of analytical and physical models of the product, for the purposes
of visualization and engineering analysis.
 The need for such models depends on product complexity, constructing and studying these models are now
done using computer-aided design (CAD) and computer-aided engineering (CAE) techniques.
 Computer-aided manufacturing (CAM) involves all phases of manufacturing, by utilizing and processing
large amounts of information on materials and processes gathered and stored in the organization’s database.
 Computers greatly assist in such tasks as
 (a) programming for numerical-control machines and for robots for material-handling and assembly
operations
 (b) designing tools, dies, molds, fixtures, and work-holding devices
 (c) maintaining quality control throughout the total operation
Prototypes

 A prototype is a physical model of an individual component or product.

 The prototypes developed are carefully reviewed for possible modifications to the original design,
materials, or production methods.
 An important and continuously evolving technology is additive manufacturing
 Using CAD/CAM and various specialized technologies, designers make prototypes rapidly and at
low cost, from a variety of metallic or non-metallic materials.
 Additive manufacturing significantly reduces costs and associated product-development times.
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 Virtual Prototyping

 Virtual Prototyping is a software-based

method that uses advanced graphics and
virtual-reality environments to allow
designers to view and examine a part in
detail.
 Also known as simulation-based design,
uses CAD packages to render a part such
that, in a 3-D interactive virtual
environment.
 Designers can observe and evaluate the
part as it is being developed.
 Virtual prototyping has been gaining
importance, especially because of the
availability of low-cost computers and
simulation and analysis tools.
Design for
Manufacture,
Assembly,
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Disassembly,
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and Service
Design for Manufacture, Assembly, Disassembly, and Service

 Design for manufacture (DFM) is a comprehensive approach to integrating the design process
with production methods, materials, process planning, assembly, testing, and quality
assurance.
 DFM requires a fundamental understanding of
 (a) the characteristics and capabilities of materials, manufacturing processes, machinery, equipment,
and tooling.
 (b) variability in machine performance, dimensional accuracy and surface finish of the workpiece,
processing time, and the effect of processing methods employed on product quality
 The concepts of design for assembly (DFA), design for manufacture and assembly (DFMA),
and design for disassembly (DFD) are all important considerations in manufacturing.
Assembly & Disassembly

 Assembly is an important phase of manufacturing, requiring considerations of the ease, speed,

and cost of putting together the numerous individual components of a product (Fig. I.6).
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 Assembly costs in manufacturing can be substantial, typically ranging from 20% to 60% of the
total product cost.
 Disassembly of a product, for such activities as maintenance, servicing, and eventual recycling
of its individual components, is an equally important consideration.
 There are several methods of assembly of components, including the use of a wide variety of
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fasteners, adhesives, or joining techniques, such as welding, brazing, or soldering.

 Each of these assembly operations has its own specific characteristics, times, advantages,
limitations, associated costs, and design considerations.
 Individual parts may be assembled by hand or by a variety of automatic equipment and
industrial robots.
Design for Service

 Design for service is an important aspect of product design.

 Products often have to be disassembled, to varying degrees, in order to service them and,
repair them.
 The design should take into account the concept that, for ease of access, components that are
most likely to be in need of servicing be placed at the outer layers of the product.
 This methodology can be appreciated by anyone who has had the experience of servicing
machinery.
Environmentally Conscious Design, Sustainable
Manufacturing, and Product Life Cycle

 In the United States alone, more than 30 billion kg of plastic products are discarded each year,
and 62 billion kg of paper products.
 Every three months, U.S. industries and consumers discard enough aluminium to rebuild the
country’s commercial air fleet.
 Globally, countless metric tons of automobiles, televisions, appliances, and computers are
discarded each year.
 Metalworking fluids, such as lubricants and coolants, and fluids and solvents, such as those
used in cleaning manufactured products, can pollute the air and waters, unless they are
recycled or disposed of properly.
Byproducts

 There are numerous byproducts from manufacturing plants:

 (a) sand with additives from foundries;
 (b) water, oil, and various other fluids from heat-treating and facilities;
 (c) slag from foundries and welding operations
 (d) a wide variety of metallic and non-metallic scrap produced in such
operations as sheet forming, casting, and molding.
 Consider also the various effects of water and air pollution, acid rain, ozone
depletion, hazardous wastes, landfill seepage, and global warming.
Discarding

 The term discarding suggests that the product has reached the end of its useful life.
 The particular manufacturing process and the operation of machinery can each have a significant environmental
impact. Manufacturing operations generally produce some waste, such as:
1. Chips from machining and trimmed materials from sheet forming, casting, and molding operations
2. Slag from foundries and welding operations
3. Additives in sand used in sand-casting operations
4. Hazardous waste and toxic materials used in various products
5. Lubricants and coolants in metalworking and machining operations
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6. Liquids from such processes as heat treating and plating
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7. Solvents from cleaning operations

8. Smoke and pollutants from furnaces and gases from burning fossil fuels.
Design for the environment (DFE)

 The term sustainable design and manufacturing has become in common usage in all
industrial activities, with major emphasis on design for the environment (DFE).
 Also called environmentally conscious design and manufacturing and green design.
 These goals also have led to the concept of design for recycling (DFR).
 Biological cycle: Organic materials degrade naturally, and in the simplest version of a biological
cycle, they lead to new soil that can sustain life.
 Industrial cycle: The materials in the product are recycled and reused continuously.
 A basic principle of design for recycling is the use of materials and product design features that
facilitate biological or industrial recycling
Cradle-to-cradle Production

 Also called cradle-to-cradle (C2C),  Cradle-to-cradle production emphasizes:

manufacturing considers the impact of each 1. Sustainable and efficient manufacturing activities,
stage of a product’s life cycle, from the time using clean technologies
natural resources are mined and processed into
raw materials, through each stage of 2. Waste-free production
manufacturing products, their use and, finally, 3. Using recyclable and non-hazardous materials
recycling. 4. Reducing energy consumption
 Cradle-to-grave production, also called womb-to- 5. Using renewable energy, such as wind, solar, and
tomb production, has a similar approach, but it ocean waves
S gol
does not necessarily consider or take on the 6. Maintaining ecosystems by minimizing the
responsibility of recycling. -

environmental impact of all manufacturing activities

7. Using materials and energy sources that are
available locally, so as to reduce energy use
associated with their transport which, by and large,
has an inherently high carbon footprint.
Guidelines for Sustainable Design and Manufacturing

 there are overarching relationships among the basic concepts of DFMA, DFD, DFE, and DFR.
1. Reduce waste of materials, by refining product design, reducing the amount of materials in products, and select
manufacturing processes that minimize scrap (such as forming instead of machining).
2. Reduce the use of hazardous materials in products and processes.
3. Investigate manufacturing technologies that make environmentally friendly and safe products and by-products.
4. Make improvements in methods of recycling, waste treatment, and reuse of materials.
5. Minimize energy use; whenever possible, encourage the use of renewable sources of energy. Select materials can
have a major impact on the latent energy in products, as described in Section 40.5.
6. Encourage recycling by using materials that are a part of either industrial or biological cycling, but not both in the
same product. Ensure proper handling and disposal of all waste of materials that are used in products, but
are not appropriate for industrial or biological cycling.
Selection of Materials

 The selection of materials for products (consumer or industrial) and their components is typically made
in consultation with materials engineers.
 The general types of materials used, either individually or in combination with other materials, are the
following:
 Ferrous metals: Carbon, alloy, stainless, and tool and die steels.
 Nonferrous metals: Aluminum, magnesium, copper, nickel, titanium, superalloys, refractory metals,
beryllium, zirconium, low-melting-point alloys, and precious metal
 Plastics (polymers): Thermoplastics, thermosets, and elastomers
 Ceramics, glasses, glass ceramics, graphite, diamond, and diamond-like materials
 Composite materials: Reinforced plastics and metal-matrix and ceramic-matrix composites
 Nanomaterials
 Shape-memory alloys (smart materials), amorphous alloys, semiconductors, and superconductors
Properties of Materials

 Mechanical properties of interest in manufacturing generally include strength, ductility,

hardness, toughness, elasticity, fatigue, and creep resistance.
 Physical properties are density, specific heat, thermal expansion and conductivity, melting
point, and electrical and magnetic properties.
 Optimum designs often require a consideration of a combination of mechanical and physical
properties.
 A typical example is the strength-to-weight and stiffness-to-weight ratios of materials for
minimizing the weight of structural members.
 Weight minimization is particularly important for aerospace and automotive applications, in
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order to improve performance and fuel economy

Properties of Materials… Cont.

 Chemical properties include

oxidation, corrosion,
degradation, toxicity, and
flammability.
 Manufacturing properties indicate
whether a particular material
can be cast, formed, shaped,
machined, joined, and heat
treated with relative ease.
Other Selection Criteria

 Availability of materials is a major concern in manufacturing.

 Reliability of supply is important in order to meet production schedules.
 Service Life - a shortened service life of a product:
 (a) improper selection of materials
 (b) improper selection of production methods
 (c) insufficient control of processing variables
 (d) defective raw materials or parts, or manufacturing-induced defects
 (e) poor maintenance of machinery and equipment
 (f) improper use of the product.
Material Substitution in Products

 As a measure of the challenges faced in material substitution, consider the following

examples:
 (a) metal vs. wooden handle for a hammer
 (b) aluminium vs. cast-iron lawn chair,
 (c) copper vs. aluminium electrical wire
 (d) alloy steel vs. titanium submarine hull.
Selection of Manufacturing Processes

 There is often more than one method that can be employed to produce a part from a
given material.
 The following broad categories of manufacturing methods are all applicable for metallic
and non-metallic materials:
1. Casting
2. Forming and shaping
3. Machining
4. Joining
5. Finishing
6. Microfabrication and Nanofabfrication
Process Selection

 The selection of a particular manufacturing process

depends on the geometric features of the parts to be made,
including the:
 Dimensional tolerances
 Surface texture required
 Numerous factors pertaining to the particular workpiece
material
 Its manufacturing properties.
Computer-integrated Manufacturing

 Computer-integrated manufacturing (CIM) integrates the software and the hardware needed for
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computer graphics, computer-aided modeling, and computer-aided design and
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manufacturing activities
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 CIM go through all processes from initial product concept through its production and
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distribution in the marketplace.

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 CIM has capability of making possible the following tasks:

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 Responsiveness to rapid changes in product design modifications and to varying market demands
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 Better use of materials, machinery, and personnel

 Reduction in inventory
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 Better control of production and management of the total manufacturing operation.

CIM Elements

 Computer numerical control (CNC). First implemented in the early 1950s, this is a method of
controlling the movements of machine components by direct insertion of coded instructions in the
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form of numerical data.

 Adaptive control (AC). The processing parameters in an operation are automatically adjusted to
optimize the production rate and product quality and to minimize manufacturing costs.
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 Industrial robots. Introduced in the early 1960s, industrial robots have rapidly been replacing
humans, especially in operations that are repetitive, dangerous, and boring.
 Intelligent robots have been developed with sensory perception
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 Cobots designed to work and interact with humans.

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 Automated materials handling. Computers have made possible highly efficient handling of
materials and parts in various stages of completion (work in progress), as in moving a part from one
machine to another, and then to points of inspection, to inventory, and, finally, to shipment.
CIM Elements… Cont.

 Automated assembly systems. These systems have been developed to replace assembly by human
operators, although humans still have to perform some of the operations. Depending on the type of
product, assembly costs can be high; thus, products must be designed such that they can be
assembled more easily and faster by automated machinery.
 Computer-aided process planning (CAPP). By optimizing process planning, this system is capable
of improving productivity, product quality, and consistency, thus reducing costs. Functions such as
cost estimating and monitoring work standards (time required to perform a certain operation) are
also incorporated into the system.
 Group technology (GT). The concept behind group technology is that numerous parts can be
grouped and produced by classifying them into families according to similarities in:
 (a) design
 (b) the manufacturing processes employed to produce them.
 CIM Elements… Cont.

 Just-in-time production (JIT). Inventory carrying costs

are minimal, defects in components are detected right
away, productivity is increased, and high-quality
products are made and at low cost. The principle behind
JIT is that:
 (a) supplies of raw materials and parts are delivered
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to the manufacturer just in time to be used

 (b) parts and components are produced just in time
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to be made into subassemblies

 (c) products are assembled and finished just in time
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to be delivered to the customer.

 Cellular manufacturing (CM). This system utilizes
workstations that consist of a number of manufacturing
cells, each containing various production machines, all
controlled by a central robot, with each machine
performing a specific operation on the part, including
inspection (Fig. I.10).
CIM Elements… Cont.

 Flexible manufacturing systems (FMS). These systems integrate manufacturing cells into a large production
facility, in which all cells are interfaced with a central computer.
 very costly flexible manufacturing systems are capable of producing parts efficiently and of quickly changing
manufacturing sequences required for making different types of parts.
 Flexibility enables these systems to meet rapid changes in market demand for all types of products.
 Expert systems (ES). Consisting basically of complex computer programs, these systems have the capability of
performing a variety of tasks and solving difficult real-life problems (much as human experts would), including
expediting the traditional iterative process.
 Artificial intelligence (AI). Computer-controlled systems are capable of learning from experience and of making
decisions that optimize operations and minimize costs, ultimately replacing human intelligence.
 Artificial neural networks (ANN). These networks are designed to simulate the thought processes of the human
brain, with such capabilities as modeling and simulating production facilities, monitoring and controlling
manufacturing operations, diagnosing problems in machine performance, and conducting financial planning
and managing a company’s manufacturing strategy.
Quality Assurance and Total Quality Management

 Product quality is one of the most critical considerations in manufacturing, because it directly
influences customer satisfaction, thus playing a crucial role in determining a product’s success in
the marketplace
 Quality must be built into the product, from its initial design through all subsequent steps of
manufacturing and assembly operations.
 Consequently, continuous control of processes online monitoring is a critical factor in maintaining
product quality (the objective is to control processes, not products).
 Quality assurance and total quality management (TQM) are widely recognized as being the
responsibility of everyone involved in the design and manufacturing of products and their
components.
 integrity
 is a term generally used to define the degree to which a product
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Product integrity

 Product integrity is a term generally used to define

the degree to which a product:
 Functions reliably during its life expectancy (Table I.5)
 Is suitable for its intended purposes
 Can be maintained with relative ease.
 Important developments in quality assurance include
the implementation of experimental design
Quality Standards

 Global manufacturing and competitiveness have led to an obvious need for international
conformity and consensus in establishing quality control methods.
 Establishment of the ISO 9000 standards series on quality management and quality assurance
standards, as well as of the QS 9000 standards (Section 36.6), introduced in 1994.
 A company’s registration for these standards, which is a quality process certification and not a
product certification.
 ISO 9000 and QS 9000 have permanently influenced the manner in which companies conduct
business in world trade.
Human-factors Engineering

 This topic deals with human–machine interactions.

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 It is an important aspect of manufacturing operations in a plant and of products expected use.

 The human factors approach is essential in the design and manufacture of safe products.
 The need for proper ergonomic considerations are the following:
 (a) a mechanism that is difficult to operate manually, causing injury to the employee
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 (b) a poorly designed keyboard that causes pain to the user’s hands and arms during its normal use
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(repetitive stress syndrome)

 (c) a control panel on a machine which is difficult to reach or use safely and comfortably.
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Product Liability
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 Designing and manufacturing safe products is an essential responsibility of the manufacturer.

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 involved with product design, manufacture, and marketing must fully recognize the consequences of a product’s
failure, including failure due to foreseeable misuse of the product.
 A product’s malfunction or failure can cause bodily injury or even death, as well as financial loss to an
individual, a bystander, or an organization known as product liability.
 Examples of products that could involve liability are the following:
 A grinding wheel that shatters and causes injury to a worker.
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 A cable supporting a platform snaps, allowing the platform to drop, causing bodily harm or death.
 Automotive brakes that suddenly become inoperative, because of the failure of a particular component of the
braking system. J

 Production machinery that lacks appropriate safety guards.

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 Electric and pneumatic tools that lack appropriate warnings and instructions for their safe use.
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Lean Production and Agile Manufacturing

 Lean production is a methodology that involves thorough assessment of each activity of a

company.
 Its basic purpose is to minimize waste at all levels, and calling for the elimination of
unnecessary operations that do not provide any added value to the product being made.
 This approach, also called lean manufacturing, identifies all of a manufacturer’s activities and
optimizes the processes used in order to maximize added value.
 Lean production focuses on
 (a) the efficiency and effectiveness of each and every manufacturing step
 (b) the efficiency of the machinery and equipment used
 (c) the activities of the personnel involved in each operation.
 Manufacturing Costs and Global Competition

 Always critically important, economics of

manufacturing has become even more so
with:
 (a) ever-increasing global competition
 (b) the demand for high-quality
products, generally referred to as
world-class manufacturing, and at low
prices.

the manufacturing cost of a product
represents about 40% of its selling price,
which often is the overriding
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9consideration
4 in a product’s marketability
and general customer satisfaction.
 Cost of Manufacturing >
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 The total cost of manufacturing a product generally ③  Fixed. Fixed costs include costs for energy, rent for
consists of the following components: facilities, insurance, and real-estate taxes.

Q Materials. Raw-material costs depend on the ⑭  Capital. Production machinery, equipment, buildings,
material itself and on supply and demand for that and land are typical capital costs. Machinery costs can
material. Low cost may not be the deciding factor range from a few hundred to millions of dollars.
if the cost of processing a particular material is Although the cost of computer-controlled machinery can
be very high, such an expenditure may well be warranted
higher than that for a more expensive material.
if it reduces labour costs.
②  Tooling. Tooling costs include those for cutting ⑤  Labor. Labor costs consist of direct and indirect costs.
tools, dies, molds, work holding devices, and
fixtures. Some cutting tools cost as little as $2,  Direct labor, also called productive labor, concerns the
others as much as $100 for cubic boron nitride and labor that is directly involved in manufacturing
diamond. products.
 Indirect labor, also called nonproductive labor or
overhead, pertains to servicing of the total
manufacturing operation.
Trends in Manufacturing
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 Product variety and complexity continue to increase.

 Product life cycles are becoming shorter.
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 Markets continue to become multinational and global competition has increased rapidly.
 Customers are consistently demanding high-quality, reliability, and low-cost products.
 Developments continue in the quality of materials and their selection, especially for improved
recyclability.
 Machining is faster and more able to achieve better tolerances, because of innovative control
strategies and suppression of chatter.
 The most economical and environmentally friendly manufacturing methods are being increasingly
pursued, and energy management has become increasingly important.
Trends in Manufacturing… Cont.

 Titanium, magnesium, aluminium and fiber-reinforced polymers are increasingly seen as

essential technologies for meeting fuel energy efficiency goals in transportation applications.
 Improvements are being made in predictive models of the effects of material-processing
parameters on product integrity, applied during a product’s design stage.
 Developments in ultraprecision manufacturing, micromanufacturing, and nanomanufacturing
continue, so that manufacturing ability is approaching the level of atomic dimensions.
 Computer simulation, modeling, and control strategies are being applied to all areas of
manufacturing, design, performance and maintenance prediction.

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 More Trends in pages 59 – 60 in the book