Design of

Biomedical
Devices
Module 2-Class-5 Design Phase
HARDWARE DESIGN
Design input provides the foundation for product development. The objective of the design input process is to
establish and document the design input requirements for the device. The design input document is as comprehensive
and precise as possible. It contains the information necessary to direct the remainder of the design process. It includes
design constraints but does not impose design solutions.
Once the documentation describing the design and the organized approach to the design is complete, the actual
design work begins. As the design activity proceeds, there are several failure-free or failure tolerant principles that
must be considered to make the design more reliable. Each is important and has its own place in the design process

1.BLOCK DIAGRAM .
The first step in an organized design is the development of a block diagram of the device (see Figure 1). The block
diagram is basically a flow chart of the signal movement within the device and is an aid to organizing the design.
Individual blocks within the block diagram can be approached for component design, making the task more
organized and less tedious. Once all blocks have been designed, their connections are all that remain.
FIG 1 - ECG MONITOR BLOCK DIAGRAM.
2.Redundancy
One method of addressing the high failure rate of certain components is the use of redundancy, that is, the use of more than one
component for the same purpose in the circuit. The philosophy behind redundancy is if one component fails, another will take its place
and the operation will continue. An example would be the inclusion of two reed switches in parallel where if one fails because the
reeds have stuck together, the other is available to continue the operation.
Redundancy may be of two types:
• Active
• Standby.
Active Redundancy
Active redundancy occurs when two or more components are placed in parallel, with all components being operational. Satisfactory
operation occurs if at least one of the components functions. If one component fails, the remaining parts will function to sustain the
operation. Active redundancy is important in improving the reliability of a device.Placing components redundantly increases the
MTBF of the circuit, thus improving reliability. Consider the following example of Figure 2. This shows a circuit for an amplifier.
Let's use the component U1 for redundancy. The failure rate for the component in use is 0.320 failures/million hours. The failure rate
assumption is that the component was in its useful life period. Therefore, the reciprocal of the failure rate is the Mean Time Between
Failure (MTBF).
When calculating the MTBF, the failure rate must be specified
in failures per hour. Therefore, the failure rate,as listed in the handbook
or in vendor literature must be divided by one million.

MTBF =
= 1/0.00000032
= 3,125,000 hours
 FIG 2 ACTIVE REDUNDANCY
Let's assume for our particular application, this MTBF value is not acceptable. Therefore, we decide to put two components
in parallel (Figure 2). Again, we assume the useful life period of the component. For this case:
MTBF=

= 3/2(0.00000032)
= 3/0.000O0064
= 4,687,500 hours
By putting two components in active redundancy, the MTBF of the circuit has increased by 50%.
Standby Redundancy
Standby redundancy occurs when two or more components are placed in parallel, but only one component is, active.
The remaining components are in standby mode.
Returning to our previous example, we have decided to use standby redundancy to increase our reliability (Figure 13-
4). Again assuming the useful life period and ignoring the failure rate of the switch,
• MTBF = 2/h
• = 2/0.00000032
• = 6,250,000 hours
• By using standby redundancy, the MTBF has increased by 100%over the use of the single component and by 33%
over active redundancy.Obviously, the use of redundancy is dependent upon the circuit and the failure rates of the
individual components in the circuit.However, the use of redundancy definitely increases the reliability of the circuit.
What type of redundancy is used again depends on the individual circuit and its intended application.
Component Selection

As certain portions of the design become firm,the job of selecting the proper components becomes a primary concern,
especially where there are long lead times for orders. How are the vendors for these components chosen? If one is honest
in looking back at previous design developments and honest in listing the three main criteria for choosing a component
vendor, they would be:
• Quality,
• Delivery
• Lowest cost.
The parameters of choice include:
• Fitness for use
• Criticality vs non-criticality
• Reliability
• History
• Safety
Component Fitness for Use
Fitness for use includes analyzing a component for the purpose to which it was designed. Many vendors list common
applications for their components and tolerances for those applications. Where the desired application is different than
that listed the component must be analyzed and verified in that application. This includes specifying parameters
particular to its intended use, specifying tolerances, inclusion of safety margin and a review of the history of that part in
other applications.
For components being used for the first time in a particular application and for which no history or vendor data is
available, testing in the desired application should be conducted.
Component Reliability.
• The process of assuring the reliability of a component is a multi-step procedure, including:
• Initial vendor assessment
• Vendor audit
• Vendor evaluation
• Vendor qualification.
• The initial vendor assessment should be a review of any past history of parts delivery, including on time deliveries,
incoming rejection rate, willingness of the vendor to work with the company and handling of rejected components.
The vendor should also be questioned as to the nature of his acceptance criteria, what type of reliability tests were
performed and what the results of the tests were. It is also important to determine whether the nature of the test
performed was similar to the environment the component will experience in your device. Once the initial vendor
assessment is satisfactorily completed, an audit of the vendor's facility is in order. The vendor’s processes should be
reviewed, the production capabilities assessed, rejection rates and failure analysis discussed. Sometimes the
appearance of the facility provides a clue as to what type of vendor you are dealing with. A facility that is
unorganized or dirty may tell you about the quality of the work performed.
Once components are shipped, you need to ensure that the quality of the incoming product is what you expect. A
typical approach to the evaluation would be to do 100% inspection on the first several lots to check for consistent
quality. Once you have an idea of the incoming quality and you are satisfied with it, components can be randomly
inspected or inspected on a skip-lot basis.
• Many companies have established a system of qualified vendors to determine what components will be used and the
extent of incoming inspection. Some vendors qualify through a rigorous testing scheme that determines the incoming
components meet the specification. Other companies have based qualification on a certain number of deliveries with
no failures at incoming. Only components from qualified vendors should be used in any medical device.This is
especially important when dealing with critical components.
Component History.
Component history is an important tool in deciding, what components to use in a design. It is important to review the
use of the component in previous products, whether similar or not. When looking at previous products, the incoming
rejection history, performance of the component in field use and failure rate history need to be analyze
A helpful tool in, looking at component history is the use of available data bank of component information.
Component Safety
The safety of each component in your application must be analyzed. Do this by performing a fault tree analysis, where
possible failures are traced back to the components causing them.
A failure mode analysis can be performed that looks at the results of single point failures of components. Unlike the
fault tree, which works from the failure back to the component, failure mode analysis works from the component to the
resultant failure.
Component Derating
• Component failure in a given application is determined by the interaction between the strength and the stress level.
When the operational stress levels of a component exceed the rated strength of the component, the failure rate
increases. When the operational stress level falls below the rated strength, the failure rate decreases. With the various
ways for improving the reliability of products,derating of components is an often-used method to guarantee the good
performance as well as the extended life of a product. Derating is the practice of limiting the stresses, which may be
applied to a component, to levels below the specified maximum.
Derating enhances reliability by:
• reducing the likelihood that marginal components will fail during the life of the system.
• reducing the effects of parameter variations
• reducing the long-term drift in parameter values
• providing allowance for uncertainty in stress calculations
• providing some protection against transient stresses, such as voltage spikes.
An example of component derating is the use of a 2 watt resistor in a 1 watt application. It has been shown that derating
a component to 50% of its operating value generally decreases its failure rate by a factor greater than 30%. As the
failure rate is decreased, the reliability is increased.
• Components are derated with respect to those stresses to which the component is most sensitive. These stresses fall into
two categories, operational stresses and application stresses.
• Operational stresses include:
• Temperature, humidity, atmospheric pressure.
• Application stresses include:
• Voltage,current,friction,vibration
• These latter stresses are particularly applicable to mechanical components.
• Electrical-stress usage rating values are expressed as ratios of Maximum Applied Stress to the Component's Stress
Rating. The equation for table guidelines is:
• Usage Ratio = Maximum Applied Stress/Component Stress Rating.
For most electronic components, the usage ratio varies between 0.5 and 0.9.
Thermal derating is expressed as a maximum temperature value allowed or as a ratio of "actual junction temperature" to
“maximum allowed junction temperature" of the device. The standard expression for temperature measurement is the
Celsius scale.
• Derating guidelines should be considered to minimize the degradation effect on reliability. In examining the results
from a derating analysis, one often finds that a design needs less than 25 components aggressively derated to greatly
improve its reliability. And, depending on the design of the product, these components often relate to an increase in
capacitance voltage rating, a change of propagation speed, an increase in the wattage capacity of a selected few power
resistors, etc
Safety Margin
• Components or assemblies will fail when the applied load exceeds the strength at the time of application. The consideration of
the load should take into account combined loads, such as voltage and temperature or humidity and friction. Combined loads
can have effects that are out of proportion to their separate contributions, both in terms of instantaneous effects and strength
degradation effects.
• Establishing tolerances is an essential element of assuring adequate safety margins. Establishing tolerances, with appropriate
controls on manufacturing provides control over the resulting strength distributions. Analysis should be based on worst case
strength or distributional analysis, rather than on an anticipated strength distribution.
• Safety margin is calculated as follows:
• Safety Margin = (Mean safety factor)- 1
• = (Mean strength/mean stress) - 1
• An example illustrates the concept:
• A structure is required to withstand a pressure of 20,000 psi. A safety margin of 0.5 is to be designed into the device. What is
the strength that must be designed in?
• Safety Margin = (strength/stress) - 1
• 0.5 = (strength/20,OOO) - l
• 1.5 = strength/20,OOO
• (20,000 x 1.5) = strength
• 30,000 psi = strength
• Most handbooks list a safety margin of 2.0 as the minimum required for high reliability devices. In some cases, this may result
in an over-design. The safety margin must be evaluated according to device function, the importance of its application and the
safety requirements. For most medical applications, a minimum safety margin of 0.5 is adequate.
Load Protection
Protection against extreme loads should be considered whenever practicable. In many cases, extreme loading situations
can occur and must be protected against. When overload protection is provided, the reliability analysis should be
performed worst-case the maximum load which can be anticipated, bearing in mind the tolerances of the protection
system.
Environmental Protection
Medical devices should be designed to withstand the worst-case environmental conditions in the product specification,
with a safety of margin included. Some typical environmental ranges that the device may experience include:
operating temperature 0 to +55 degrees centigrade
storage temperature ~ -40 to +65 degrees centigrade
humidity 95% RH at 40 degrees centigrade
mechanical vibration 5 to 300 Hz at 2 Gs
mechanical shock 24" to 48" drop
mechanical impact 10 Gs at a 50 msec pulse width
electrostatic discharge up to 50,000 volts
Electromagnetic compatibility becomes an issue in an environment, like an operating room. Each medical device should
be protected from interference from other equipment, such as electrocautery and should be designed to eliminate radiation
to other equipment.
Product Misuse
• An area of design concern that was briefly addressed earlier in this chapter is the subject of product misuse. Whether
through failure to properly read the operation manual or through improper training, medical devices are going to be
misused and even abused. There are many stories of product misuse, such as the handheld monitor that was dropped
into the toilet bowl, the user who used a hammer to pound a 9-volt battery into a monitor backwards or the user who
spilled a can of soda on and into a device. Practically, it is impossible to make a device completely misuse-proof. But
it is highly desirable to design around the ones that can be anticipated.
Some common examples of product misuse include:
• excess application of cleaning solutions
• physical abuse
• spills
• excess weight applied to certain parts
• excess torque applied to controls or screws
• improper voltages, frequencies or pressures
• improper or interchangeable electrical or pneumatic connections.
• Product misuse should be discussed with Marketing to define as many possible misuse situations as can be
anticipated. The designer must then design around these situations, including a safety margin, which will serve to
increase the reliability of the device. Where design restrictions limit the degree of protection against misuse and
abuse, the device should alarm or should malfunction in a manner that is obvious to the user.
Design for Variation

During design, one may need to deal with problem of assessing the combined effects of multiple
variables on a measurable output or other characteristic of a product, by means of experiments. This is
not a problem that is important in all designs, particularly when there are fairly large margins between
capability and required performance, or for design involving negligible risk or uncertainty, or when only
one or a few items are to be manufactured. However, when designs have to be optimized in relation to
variations in parameter values, processes, and environmental conditions, particularly if these variations
can have combined effects, it is necessary to use methods that can evaluate the effects of the
simultaneous variations.
Design for variation (DFV) produce a probability distributions of component or system performance
characteristics by explicitly taking into account all sources of uncertainty and variability, including those
associated with engineering model uncertainty.
Statistical methods of experimentation have been developed which enable the effects of variation
to be evaluated in these types of situation. They are applicable whenever the effects can not be
theoretically evaluated, particularly when there is a large component of random variation or
interactions between variables. For multivariable problems, the methods are much more economical
than traditional experiments, in which the effect of one variable is evaluated at a time. The traditional
approach also does not enable interactions to be analyzed, when these are not known empirically.
Design of Experiments
• The statistical approach to design of experiments is a very elegant, economical, and powerful method for
determining the significant effects and interactions in multivariable situations.
• The Taguchi Method
Genichi Taguchi developed a framework for statistical design of experiments adapted to the particular requirement of
of engineering design.Taguchi suggested that the design process consists of three phases: system design, parameter
design, and tolerance design.
• In the system design phase, the basic concept is decided, using theoretical knowledge and experience to calculate
the basic parameter values to provide the performance required.
• Parameter design involves refining the values so that the performance is optimized in relation to factors and
variation which are not under the effective control of the designers, so that the design is robust in relation to these.
• Tolerance design is the final stage, in which the effects of random variation of manufacturing processes and
environments are evaluated, to determine whether the design of the product and the production processes can be
further optimized, particularly in relation to cost of the product and the production processes.
• Taguchi separates variables into two types. Control factors are those variables which can be practically and
economically controlled, such as a controllable dimensional or electrical parameter. Noise factors are the variables
which are difficult or expensive to control in practice, though they can be controlled in an experiment, e.g., ambient
temperature, or parameter variation with a tolerance range. The objective is then to determine the combination of
control factor settings (design and process variables) which will make the product have the maximum robustness to
the expected variation in the noise factors.
Design Changes
• Design changes occur throughout the design process. Often, assessing the impact of changes of all aspects of the project
can be very difficult. This is particularly true for large projects involving multifunctional design teams. It is important to
have the design under revision controls ,that the history of changes may be tracked. To accomplish this, a design change
methodology should be employed. Each change to the design should be reviewed, documented and approved before it is
implemented. A simple change form, such as that indicated in .Figure 3 can be used. This type of form limits the number of
reviewers but assures the appropriate personnel on the development team are informed of the change.
The basic question for design change is when is a design put under revision control. For example, the product specification
changes frequently in the beginning of the process, as will other documentation. To institute a change process too early will
cause an excessive amount of documentation to become part of the project file. It is far better for all design activity that
revision control be instituted after the initial flurry of changes has occurred. The activity, whether a specification, drawing,
program, etc., should be fairly stable and have been reviewed at least once. This will allow for an orderly control of the
design without excessive documentation.
Fig. 3
Design Reviews
Despite disciple, training, and care, it is inevitable that occasional oversights or errors will occur in new designs. Design
reviews are held to highlight critical aspects of the design and to focus attention on possible shortfalls.
Design review are held to:
• review the progress of a design
• Monitor reliability growth
• assure all specifications are being addressed
• peer review the design approach.
The primary purpose of the design review is to make a choice among alternative design approaches. The output of the
review should include an understanding of the weak areas in the design and the areas of the design in need of special
attention. Topics to be covered in a design review include:
• redundancy versus derating
• redesign of weak areas versus high reliability parts
• review of Failure Mode and Effects Analysis
• review of potential product misuse
• review overstressed areas.
• The design review should follow a structured order and be well documented with topics discussed, decisions reached,
and resulting action items.
There are three overall types of design reviews:
• Informal Design Reviews: To address detailed technical design and performance issues, usually for an isolated part
of the product.
• Formal Design Review: To address technical performance issues for the entire product and correlate activities with
the project objectives and the product specifications.
• Program Review: To examine the project relative to budget and schedule performance, technical discoveries or
limitations. Program reviews, also known as progress (or project) reviews, are generally conducted by senior
managers and do not concern themselves with technical reviews of design.
• Informal design reviews are generally not scheduled per the project plan and are convened when the need arises to
address specific concerns. Generally,only local reviewers are invited. The informal reviews are used to brainstorm a
particularly tough problem or to analyze alternate design approaches. These reviews are generally extremely detailed
and focus on a particular sub-system,module or component. Informal review results are usually documented in lab
notebooks or supporting memos.
• Formal design reviews are generally held according to the project plan and are convened to support major project
milestones. Plenty of time should be allowed for the review meeting. People should be invited who will challenge the
design, including experts. The purpose is to review theory, technical design specs, implementation, and performance
to specification. The design review should be held to challenge the design, not familiarize people with it. If
familiarization is needed, a separate session should be held prior to the actual review. People should be allowed to talk
freely. Criticism should be expected and accepted.. A dedicated person not expected to participate in the review
should be asked to take the minutes.
For all design reviews, it is optimal to assure the design review personnel have not taken part in the actual design
activity. This gives a fresh and unbiased look at the design. Some of the guidelines for design reviewers include:
• design reviewers have a serious responsibility to comment on the potential outcome of the project
• when notice of review meetings are announced, reviewers should plan ahead and take time to prepare for the
reviews
• the reviewers should assure they understand project objectives and the product specification
• reviewers should attend all formally planned learning sessions
• if possible, reviewers should submit concerns and questions to the review chair in advance of the design review
meeting. The issues and concerns can be discussed in depth at the meeting.
• reviewers should help the design review leader during the meeting by questioning the design's performance relative
to the product specification, design specification, project objectives, safety, effectiveness, and reliability of the
product's functioning.
Questions.
1.What are the factors to be considered in hardware design of medical device and explain
briefly each aspect.

2.What is meant by active and stand by redundancy?

3.What are the factors to be considered in selecting a component for a medical device
design?

4.What is component derating?

5.What is meant by safety margin? Explain with an example.

6.What is design for variation and briefly explain design of experiments with reference to the
Taguchi method.

7.What are the different types of design reviews and why design review is necessary?

8.What are factors to be considered in selecting a vendor?

9.What is product misuse and list out some examples of product misuse.