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Recent Patents on Risk Management During Medical Device Lifecycle “Managing

the Transition From Bench to Market”

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DOI: 10.2174/1872212108666140829011303

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Recent Patents on Engineering, 2014, 8, 133-142 1

Recent Patents on Risk Management During Medical Device Lifecycle

“Managing the Transition From Bench to Market”

Ilham H. Ibrahim* and Constantin Chassapis

Department of Mechanical Engineering, Stevens Institute of Technology, 1 Castle point on Hudson, Hoboken NJ 07030,
USA

Received: April 27, 2014 Revised: August 27, 2014 Accepted: August 28, 2014

Abstract: Risk management (RM) is an ongoing systematic approach which tends to predict future problems facing any
product development process by analyzing loops of gathered or stored data and communicating their impact to enable de-
sign decision-making. It identifies problems, analyzes data, models and implements solutions and performs ongoing moni-
toring to assure that the corrective and/or preventive actions are being considered. As the majority of medical devices are
monitoring devices, data communication and analysis play a crucial role in predicting the effectiveness and safety of a de-
vice. Device related data, patient related data and device-patient related data are great sources for enhancing either new
designs or improving already existing ones. Analyzing such data can provide researchers and device development teams
with a complete justification and patterns of interest about performance, life and safety. This paper introduces a review of
the existing patents in the field of medical devices RM procedures, techniques and technologies as a mandatory require-
ment by the Food and Drug Administration (FDA) [1] regarding the device approval and marketing. The paper focuses on
the body of literature during three main stages of the device lifecycle; the design stage, the manufacturing stage and the
device-user interface stage. The aim is to highlight major practices and their similarities as well as differences and future
expectations for medical device risk assessment techniques. The authors use this study to guide the establishing of a new
technique to quantify risk at the early design stage using device performance data under the umbrella of the RM proce-
dure.
Keywords: Medical devices, regulatory system, risk assessment, risk management, verification, validation and safety.

INTRODUCTION product based or process based. Product based RM focuses

It is crucial for the manufacturers of medical devices to
produce safe and effective products to satisfy design re-
quirements and reduce future risk related to device failure or
malfunctioning during use. Therefore, manufacturers of
medical devices must follow not only a strict set of regula-
tions and controls, but also a procedural proactive plan is
required to ensure device performance and reduce the poten-
tial for future risk associated with the use of a medical de-
vice. Today’s tough economy controls practices in many
fields, not to mention the medical device industry field as
one of the most influential fields on economy where law
suits and device recalls potentially impact the industry’s
growth. “Given the large number of medical device designs
continually emerging on the market” [2], appropriate risk
management is critical to patient safety and device approval
for marketing. Therefore, to address these concerns and
achieve compliance with national and international regula-
tory requirements, companies must develop, implement and
maintain an effective risk management process to identify
potential hazards associated with the use of their medical
devices. Generally, Risk Management (RM) [3] can be either
*Address correspondence to this author at the Department of Mechanical
Engineering, Stevens Institute of Technology, 1 Castle point on Hudson,
Hoboken NJ 07030, USA; Tel:/Fax: 2012168315;
E-mails: iibrahim@stevens.edu; cchassap@stevens.edu
on potential failures of the product as it is designed while
Process based RM focuses on potential failures of the manu-
facturing process itself [1]. In both situations, “shared under-
standing and responsibility are achieved through communi-
cation and mutual education, which can be effectively
achieved by the participation of all stakeholders in establish-
ing the basis for safety and performance of medical devices”
[4].
This paper investigates the application of risk assessment
and risk management procedures introduced in recent patents
in the field of medical devices and highlights similarities and
differences shown by those practices. It also identifies the
different stages of a device lifecycle that apply the concepts
of risk management from design to manufacturing and in
field of application. It is obvious that each step during the
device development process is worth the efforts of investiga-
tion and data communication to capture the critical aspects
that inhibit the intended performance and represent a threat
to the users of a medical device (MD). This investigation can
conclude the effectiveness of those techniques and build a
foundation for a future study based on identifying the char-
acteristics of constructing more effective techniques with the
ability of using data from previous cases to design an ex-
periment capable of quantifying and assessing a risk at early
stages of the design process. This will improve a device’s
quality and safety while complying with regulations and

1872-2121/14 $100.00+.00 © 2014 Bentham Science Publishers

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Recent Patents on Engineering, 2014, Vol. 8, No. 2
Fig. (1). Risk management process.
rules to expedite the device approval process. Section 2 of
this paper introduces the stages of a common RM process
and incorporates two examples in the MD field using two
well-known techniques for assessing a risk; the Failure Mode
and Effects Analysis (FMEA) and the Fault Tree Analysis
(FTA). The common national and international MD Stan-
dards are introduced in section 3. The criteria used in con-
trolling and monitoring a risk are introduced in section 4. In
section 5, an identification of the main stages where RM can
be integrated with the MD’s lifecycle during device verifica-
tion and validation is introduced. In section 6, a patent
review research covers three main stages of the MD lifecy-
cle; design, manufacturing and while being in use by patients
is introduced to show methods and techniques used in the
field.
MEDICAL DEVICE RM PROCESS AND APPLICA-
TIONS
Fig. (1) shows the general steps of the RM process. “This
is carried out by assessing different scenarios to reduce risk,
implementing these actions and re-evaluating residual risks”
[5]. Typically, an RM procedure starts with a risk analysis.
“Risk analysis is an extremely useful quality engineering
methodology that builds quality up front in the design and
manufacturing phases rather than having a rigorous quality
inspection program” [14]. Risk analysis consists of two main
activities; Risk Identification and Risk Assessment. When
risk is evaluated, it can be categorized as acceptable or unac-
ceptable according to a preset criteria based mainly on re-
sponses from previous device reports, (e.g., false device re-
sponse or injuries during application). Risk Control and Risk
Monitoring are following steps for ongoing managing of the
Ibrahim and Chassapis


foreseen risks and adverse events that had been recognized
from the previous analysis.
Therefore, medical device firms should incorporate
analysis tools that manage and evaluate risk within their de-
sign and development cycle at the early stages of the design
process where errors are manageable and of lesser cost. To
identify a risk, multidisciplinary teams meet to brainstorm
ideas and communicate past experience gained from similar
cases or by analyzing data from databases about device per-
formance and recalls obtained by searching the FDA’s data-
base. One technique for identifying a risk is to start by its
effect or impact on user and search all contributing causes to
such effect. The appropriate weighing criteria are used to
assess each case and plan the required actions to either pre-
vent or reduce the associated risk. When risks are identified a
special technique to weigh their impact is determined based
on the severity and likelihood of occurrence. This technique
depends on the imposed regulations, level of control and
device class. Based on the hazard/risk potential for harm,
actions are being determined to manage its impact.
Evaluating the potential of a device becoming a hazard is
the approach to device safety. This evaluation is often re-
ferred to as risk assessment. It begins with risk analysis to
identify all possible hazards, followed by risk evaluation to
weigh the risk of each hazard [15]. Currently effective tools
are being used in the risk analysis and risk assessment pro-
cedures such as: Preliminary Hazard Analysis (PHA), Fault
Tree Analysis (FTA), Software Hazard Analysis (SHA) and
Failure Mode and Effects Analysis (FMEA). Those tech-
niques usually look into all possible risks within a device
including software failures, hardware component failures,
human errors and user’s usage profile. Fig. (2) shows an ex-
Risk Management in Medical Device
Fig. (2). Example of applying FMEA to assess the risk of disconnected pacemaker.
ample of applying FMEA to investigate a failure mode of
“disconnected pacemaker”. The Risk Priority Number (RPN)
used here is the product of Severity, Occurrence and De-
tectability of the hazard. Five possible causes of the failure
mode of “disconnected pacemaker” are being evaluated and
weighed based on a preset criteria. The higher the value of
the RPN, the higher the risk associated with such failure
cause which will require more resources to mitigate its im-
pact on performance.
Another application to assess the same failure mode of a
disconnected pacemaker is shown in Fig. (3). It shows an
example of applying FTA on a pacemaker to investigate a
disconnected wiring system with a risk of inadequate re-
sponse to the patient’s heartbeat variation problem.
MEDICAL DEVICE STANDARDS
The Medical Device Standardization industry is highly
regulated to ensure device safety, effectiveness and reliabil-
ity under its conditions of use [6]. Medical device standards
play an extremely vital role in the device industry because
they encourage consistency, enhance safety and improve
efficiency. Some of the most well-known worldwide estab-
lished standards include the International Organization for
Standardization (ISO), American Standards for Testing of
Materials (ASTM) and European Committee for Standardi-
zation, CEN [7]. These standards can be classified into three
categories depending on how broad they are: i) vertical stan-
dards, they are specific to a device, example: the EN 60601
series regarding electrical medical devices, ii) horizontal
standards, they address broad aspects, common to all medi-
cal devices such as: quality systems and risk management
and iii) semi-horizontal standards, they address a set of re-
quirements common to a group of devices, such as: steriliza-
tion and biocompatibility [8].
In this study, the horizontal standards are significantly
important as they establish for a quality system that consid-
Recent Patents on Engineering, 2014, Vol. 8, No. 2 3


ers the risk management application. Two common standards
that assist this context are, ISO 13485 and ISO 14971 stan-
dards. ISO 13485 is focusing on harmonizing the require-
ments of a quality system in different countries to match the
requirements of their medical device directives. The need for
this is to create a management system that can be thought of
as a framework on which to build compliance to various
regulatory and customer requirements [9]. It specifies the
requirements for a quality management system in Europe
and other countries such as Canada, Australia and Japan
[10]. In the US, the FDA has its own Quality System Regu-
lations (QSR) which follows a set of guidelines known as the
Good Manufacturing practices (GMPs). One voluntary es-
tablished organization, the Global Harmonization Task Force
(GHTF), is “endeavoring to bring international harmoniza-
tion to medical device certification through 13485 standard.
It is pushing for the use of 13485 in place of country-specific
regulatory requirements” [9]. This encourages technological
innovation and facilitates international trade between differ-
ent markets worldwide.
Although, countries have different rules and standards for
their product’s approval, it is the same risk management phi-
losophy that governs these requirements [11]. ISO 14971, as
an example, covers the risk determination and application
activities for the whole life cycle of a medical device [12]. It
is also being used to assist manufacturers who wish to sell
their products on the European market. It is a recognized
standard by the European Medical Device Directives (EU
MDD), the FDA’s quality system and other regulatory sys-
tems [13]. It is essential that, all involved in the development
and marketing process of medical devices, are aware of ap-
plicable standards and their current changes and updates.
Regulatory agencies depend on published international stan-
dards to define the detail that products must comply with in
order to satisfy their essential safety and effectiveness re-
quirements [6]. However, it is the manufacturer’s responsi-
bility to follow the procedures suitable to the product being
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Recent Patents on Engineering, 2014, Vol. 8, No. 2
Fig. (3). Example of applying FTA to investigate the cause of a disconnected pacemaker.
manufactured. This will help in establishing an effective risk
approach to product realization and facilitate the validation
process of a medical device. Compliance with regulatory
requirements ensures that only safe and effective devices are
being marketed.
MEDICAL DEVICE RISK ANALYSIS AND MONI-
TORING
In the international standards for medical device risk
analysis, risks are classified into three categories: “IN (intol-
erable), ALARP (as low as reasonably practical), and BA
(broadly acceptable)” [14], as shown in Fig. (4). Two meas-
ures are being used; the likelihood of occurrence and the
severity of the hazard. This classification is based on the
results of reliably built experimental models or prototypes
under a predefined set of design controls, (e.g., a set of dis-
ciplines, practices, and procedures incorporated into the de-
sign and development process of medical devices and their
Ibrahim and Chassapis


relevant manufacturing processes) [16]. The design and de-
velopment team usually depends on the amount and quality
of information to find the root cause(s) of the problem using
one of the previous analysis techniques. The generated
knowledge is aimed at helping the design engineers to sys-
tematically uncover hazards and adverse events. Once the
risk analysis is completed, risk control is performed to re-
duce or eliminate possible risks and to allocate needed re-
sources to resolve possible problems. The utmost goal of risk
control is to satisfy user concerns about product safety and
effectiveness and to help manufacturers comply with regula-
tory issues. The International Standards Organization, “ ISO-
14971 standard [17] does not include any specific indication
as to what risk is acceptable, but does offer some methods to
determine acceptable risks, such as relevant standards, rec-
ommendations or comparisons with risk levels of compara-
ble medical devices already in use” [16]. Mostly, acceptance
criteria are a function of the type of device and the type of
controls needed to satisfy the regulatory requirements.
Risk Management in Medical Device
Fig. (4). Medical device risk control categories.
Fig. (5). Data monitoring and evaluation .
Medical devices regulatory agencies require manufactur-
ers to have a monitoring system in place so that they con-
tinue to monitor the performance of the medical devices be-
ing marketed, and respond to any previously unrecognized
hazards [11]. Many device performance problems are not
being identified during pre-market stages as many devices
have very low failure rates. Therefore, risk monitoring is
essential for addressing safety issues and ensuring that a bal-
ance is maintained between the health benefits and the risk
posed by the medical device [18]. Gathered data can reveal
adverse events and information necessary to protect users.
Data analysis methods use statistical characteristics of the
data sets to compare attributes of a device performance and
study associated patterns of interest. Fig. (5) shows the data
distributions for multiple investigations and the effect of the
independent (explanatory variables) on the yield (response
variable) in monitoring the performance function of a device.
The variance , equation (1), and the Tylor expansion,
equation (2), are two examples on analyzing data to enable
design decision-making and study variability and deviations
from target values. Bayesian Probability Method is also
Recent Patents on Engineering, 2014, Vol. 8, No. 2 5




widely used in the same manner using probabilities and con-
ditional probabilities of associated events.
(1)
(2)
The authors’ work employs a novel technique for varia-
tion risk management of device performance based on his-
torical process data modeling and visualization. The novel
technique is a proactive systematic procedure comprises a
tool set that is being placed in the larger framework of the
risk management procedure and fully utilizing data from the
Data Bases to predict and address the risk of variations at the
early stages of the design process rather than at the end of
each major stage. The technique effectively utilizes such data
regarding a medical device’s performance, testing results,
recalls and user reports and feedback to improve new de-
6



Recent Patents on Engineering, 2014, Vol. 8, No. 2
signs and reduce future risks. The work tends to reduce de-
sign iterations and increase device safety and adopt to varia-
tions in processes and procedures. In this paper, the patents
were found using the Google patent search. The patents'
search covers the interval from 2000-2013 and focuses on
applications and methods used to capture medical risks and
their managing techniques and inventions. The search is di-
vided into three areas; the first is the design stage of the
medical device, which used the keywords “risk assessment
and MD design, MD design key characteristics and design
verification and risk evaluation”, for the second stage, which
covers manufacturing, the most used searching words were
“device testing and validation and MD risk assessment dur-
ing manufacturing”. The third stage focused on “implantable
medial device risk assessment and patients safety and risk
evaluation”.
INTEGRATING RM WITH THE MEDICAL DEVICE
DEVELOPMENT STAGES
Bringing together the design and development disciplines
needed to control the design can be accomplished by estab-
lishing and maintaining an effective RM process at all stages
of the device lifecycle. It introduces the opportunity of pro-
viding a concrete evidence of device safety and compliance
with regulatory requirements at each millstone of the device
development process. Fig. (6) shows a proposal for the inte-
Fig. (6). The integration between RM and the medical device development process [19].
Ibrahim and Chassapis
gration between the traditional RM process and the design
and manufacturing process of a medical device. The applica-
tion of RM is integrated with the design and manufacturing
process to verify that a design output conforms to the top
requirements, (e.g., performance, quality, reliability and
etc.). It also confirms that the manufactured product is satis-
fying the form, fit and function needs.
MEDICAL DEVICE VERIFICATION AND VALIDA-
TION
The goal of design verification is to confirm by examina-
tion and show objective evidence that the design output
meets the design input [15]. It is performed throughout the
entire design development process. Typically, it involves
testing, simulation, inspections, modeling, and analysis.
“Testing to failure is one technique that allows the determi-
nation of important design information, such as safety fac-
tors, design margin, potential fracture locations, and unan-
ticipated failure mechanisms” [2]. Measurement methods
and process capability data are key elements in defining es-
sential design characteristics that mainly describe perform-
ance and compliance with design requirements. Usually veri-
fication methods are being developed based the characteris-
tics of each specific requirement. “Design verification meth-
ods can include; finite element analysis, risk analysis and
rapid prototyping” [20]. All design verification activities


Risk Management in Medical Device
become Design History File (DHF) records to be submitted
to the FDA for device approval.
On the other hand, a design validation always follows
successful design verification. The objective of the design
validation requirement is to confirm by examination and
show objective evidence that the final design output consis-
tently meets the specific intended use. As “design verifica-
tion is done while the design work is being performed, the
medical device may not be complete or may not be in its
final configuration” [16]. On the contrary, design validation
needs to have the final medical device to perform such activ-
ity. Design validation is a final challenge to all the existing
Quality Systems (QS), including design control, training of
manufacturing personnel and process validation [15]. It
seeks to prove a process is repeatable or reproducible and
final results come to agree with predefined acceptance crite-
ria and process limits. Failure to establish and maintain ade-
quate procedures for validating the device design, including
a risk analysis and assessment procedure is violating the de-
vice approval requirements [1]. Many techniques can be ap-
plied to device validation such as accelerated durability test-
ing, fatigue analysis and testing to failure. The outputs of the
validation tests are being documented in the DHF to support
the process of a device approval for marketing.
PATENT REVIEW: RM DURING MEDICAL DEVICE
LIFECYCLE
To be successful in achieving corporate goals and satisfy-
ing device regulations and customer expectations, the proc-
ess of RM must be proactive at all stages of the device de-
velopment process. Reducing hazards related to the device
design or performance is crucial to all researchers and manu-
facturers working on developing new methods and tech-
niques to satisfy such goals. In this section, a review of pat-
ents related to identifying and managing a device’s risk of
being a hazard are being analyzed to capture the theme of
such procedures. Three stages are being identified as their
obvious impact on the device development process; i) The
design stage, ii) The manufacturing stage, iii) The Device-
user interface stage.
RM DURING MEDICAL DEVICE DESIGN STAGE
Managing risks starts at the top-level customer require-
ments in the early stages of the design process with the goal
of achieving those requirements by targeting the variations
initiation within the design attributes. The invention in [21]
introduces a method of assessing the risk of variations, it is
referred to as “feature based assembly”. The invention fo-
cuses on the critical key characteristics (KCs) about a device.
KCs identification is essential in determining which product
features, manufacturing processes and assembly process pa-
rameters most significantly affect the product’s performance
function and form. The invention creates a closed loop of
communication between design, manufacture and assem-
bly. The invention works by selecting KCs based on risk
assessment; and carrying out a process of part feature identi-
fication for the selected KCs. A risk assessment of varia-
tion of the one or more potential KCs is based upon four
values, namely the probability of failure or variation, the
Recent Patents on Engineering, 2014, Vol. 8, No. 2 7
severity of the variation, the detectability of the variation,
and the repairability of the variation. According to the pat-
ent, this invention has the benefits of saving on resources
and improving performance and quality. Quantifying the risk
of variations is done based a predefined criteria.
Another technique, shown by the invention in [22] intro-
duces, “a fabrication method to rapidly fabricate different
prototypes of drug delivery systems, medical devices, phar-
maceutical dosage forms, tissue scaffolds or other bioaffect-
ing agents in small batches using a computer-guided system”
to vary the composition and structure in order to optimize the
product and the manufacturing process. The information and
experience gained from experts in a particular technical area
can be used with the method to recommend different compo-
sitions and designs of the prototypes as a knowledge acquisi-
tion tool to perform reasoning. 3D printing is a one men-
tioned method to build the prototypes. It allows the fabrica-
tion of several different prototype designs in a short time
necessary for the desired tests. According to [22], “this is
significantly reduces the development time of new products
compared to conventional technologies”. In [23] the inven-
tion shown uses a unique combination of tools, data, and
processing techniques to provide a more accurate in-vitro
representation of anticipated in-vivo forces exerted on medi-
cal devices and thereby reduces cost and time in the fabrica-
tion and testing of prototypes. It uses a feature’s 3D volu-
metric data to design medical devices such as cardiovascular
stents and endovascular grafts. A geometry generator uses
data to create a mesh of the device surface. A stress analyzer
simulates and analyzes the potential in-vivo stresses of the
candidate medical device. A computer generated model of a
medical device may be virtually placed or deployed within
the anatomical model to measure the response of the device
to the environment.
According to [23], this invention can be applied to accel-
erated testing of medical devices by dramatically increase
the load imposed upon the computer generated model in a
relatively short period of time. Also, it can be used to vary
and test material and configuration properties of models of
anatomical features to select optimal designs within a given
set of design parameters and over a broad range of anatomi-
cal environments. It states that failure modes and theories of
failure experienced during in-vivo clinical testing of giving
medical device subjected to dynamic mechanical and chemi-
cal forces can be evaluated. A method for design based risk
assessment of a device is introduced in [24]. It is based on a
set of actions. It starts by recognizing a plurality of patterns
of interest (POIs) utilizing design data of the medical device.
Generating a design based classification database (DBCD)
from such data. Receiving inspection results and comparing
them to each of the plurality of POIs in order to identify an
occurrence of at least one of the POIs in the inspection re-
sults. Monitoring a frequency of occurrence of each of the
POIs in order to identify one or more process excursions of
the device. The device risk level can be determined by calcu-
lating a normalized polygon frequency for the device utiliz-
ing a frequency of occurrence for each of the critical poly-
gons. All previous methods are based on investigation and
optimizing the design attributes to reach the target perform-
ance.
8



Recent Patents on Engineering, 2014, Vol. 8, No. 2
RM DURING MEDICAL DEVICE MANUFACTUR-
ING STAGE
During such stage validating a medical device is crucial
to test its ability to perform as intended over a specified pe-
riod of time. In [25] the inventors introduce a new method
for validating a medical device and testing its quality by
monitoring the parameters of an eletrocoating process. The
quality of electrocoated medical devices is being measured
by comparing obtained value of the coating process parame-
ter with a predefined or a “target value”, (e.g., deposition of
a layer that properly adheres to the substrate and is generally
free of defects observed with conventional methods). This
mainly happens by comparing measured values of the poten-
tial difference of electric current at a time before electrocoat-
ing and after the electrocoating process. A stent was used as
an exemplary medical device to illustrate the implementation
of the present invention. The main goal of device validation
is to detect operational failure modes and prepare a strategy
to control them. An example on that is introduced in patent
[26]. A computer system receives data to be configured to
detect failure modes before a trial of a medical therapy. It
detects, based on the trial data that one or more of the alert
conditions have occurred. In response, the computer system
outputs an alert associated with a mitigation procedure de-
fined for the given failure mode before the start of the trial.
Failure modes have been determined before the trial and
given scores to determine their priorities and plan their miti-
gation such as the planning of a routine monitoring to cap-
ture failure causes. One example of targeting variations in
performance is introduced in patent [27]. The proposed in-
vention introduces an automated data management system
capable of executing a comparison of a medical device op-
erational parameter to a prespecified order data. Comparing
data from at least one of the settings sent from the medical
device to data from the order stored in the computer memory
and transmitting a comparison result signal to a remote com-
puter. This method tends to reduce variations between data
outcomes for better control of such applications. Those
methods are vital for setting protection plans for current and
new devices before reaching the patients.
RM DURING DEVICE-PATIENT INTERFACE
During this stage the device is becoming in direct contact
with a patient’s body which enables a new domain of inter-
acting variables with great variability and higher chances of
deviating from the nominal values. As an example, patent
[28] describes a method and apparatus for evaluating heart
rate variability in order to forecast a cardiac event. It intro-
duces a microprocessor-based cardiac stimulator receives
heart-beat signals from the heart. The cardiac stimulator
computes time intervals occurring between successive heart
beats and then derives measurements of heart rate variability
for predetermined time intervals. Heart rate variability had
been recognized as an indication of the cardiac health risks
such as impending cardiac anomalies. It describes the varia-
tion in the beat-to-beat fluctuations which occur around a
person's mean heart rate. As an initial step in the risk of vari-
ability evaluation, heart rate variability zones are established
to define normal and abnormal cardiac sinus rhythm. These
Ibrahim and Chassapis
zones represent the pathway that extends from a generally
normal heart rate variability condition to an abnormal heart
rate variability condition. Given that procedure, subsequent
measurements of heart rate variability risk are compared
with this pathway. Selective therapy regimes “response” are
initiated depending on the measurement of heart rate vari-
ability zones.
Furthermore, other useful information based this variabil-
ity risk management procedure can be extracted from such
study and data analysis. Enabling data communication be-
tween an Implantable Medical Device (IMD) and a host
computer is the focus of the patent [29]. The invention pro-
poses a solution for communicating data to a host computer
coupled with a patient management system to monitor non-
traumatic symptoms to provide early detection of symptoms
that may signal an increased likelihood of a traumatic medi-
cal event. The process of monitoring a medical device goes
beyond evaluating a device performance to a more compli-
cated task of placing a device at the implant site properly.
Patent [30] introduces an invention that provides an im-
proved system for monitoring and managing the risk of in-
correctly placing an IMD within the vascular system of the
body. It relates to the use of audio signals for determining
lead location and for assessing the level of tissue contact
achieved by devices carried on the lead during cardiac stimu-
lation and monitoring. To generate an indication of an IMD
status, a processing circuit is used along with means for
comparing the received electrical signal to predetermined
acoustic patterns at various locations in the body. This data
may be utilized to confirm and enhance the status data that is
generated using the acoustic signals or may be stored as
trend data that may be used by a clinician in evaluating long-
term patient condition. The success of an IMD depends on
its ability to read and communicate the current status of the
environmental parameters at the implant site. Those types of
methods and procedures provide an effective way for pre-
ventive solutions that possesses a great potential for achiev-
ing safety and reducing costs of hospitalization and exces-
sive use of therapeutic treatments.
FUTURE OF RM IN THE MEDICAL DEVICE IN-
DUSTRY
There is no doubt that neither today’s market for medical
devices, nor today’s consumers are like those 10 years ago.
Regulations are more stringent, competition is strict and
pressure on manufacturers increases. The fact that we now
live in a time characterized by a breakthrough in knowledge
acquisition and information accessibility makes it even more
challenging to keep competing in such market with great
awareness and active consumers. According to [31] consum-
ers can access information on firms, products, technologies,
prices, treatments, and consumers actions and reactions from
around the world. This means the geographical limits on
information are eroding so fast which enable other players to
strongly compete and win market share. Giving that the
medical device industry is a very promising business, it is
expected to grow to hit $228 billion by 2015, the US market
is expected to represent nearly 40% of this value [32], there-
fore new methods and techniques for managing devices po-
tential risks are essential requirements to build efficacy and
Risk Management in Medical Device
reliability in devices while cutting down high prices by reduc-
ing design trials and time to market. The protection of ideas
and concepts can play an important role in the success of a
device once launched to the market. It is therefore essential to
consider this as early as possible in the design phase. The
medical device and the health care innovation sector are
highly dependent on effective patent protection. A robust In-
tellectual Property (IP) system is especially important because
the dynamics of the medical device industry are rapidly evolv-
ing. However, IP does not guarantee market success, but it is
helpful to small innovating firms that cannot survive without
IP protection [33]. However, success and competition are
based on adopting innovative ideas and protect them, it is
mostly important besides creativity and innovation to empha-
size on safety and efficacy of new devices and procedures.
Most patents focused on dealing with risks at the third stage
when the device is in use, in the authors’ research new meth-
odology is constructed to quantify risks at early design stages
based on process data feedback to ensure more robust designs
and increase a device’s safety.
CURRENT AND FUTURE DEVELOPMENT
Due to its ability in identifying future risks and providing
opportunities for planning urgent actions to reduce their im-
pact on device users and producers, RM is mandated by all
medical device agencies all over the world. This paper ex-
plores the RM applications in the medical device field
through reviewing related recent patents at three main stages
of a device lifecycle to highlight the procedures and/or tech-
niques followed to deal with devices potential risks. The
patent review shows an essential dependency on data collec-
tion and analysis at all three stages of the device’s lifecycle
to establish for risk assessment and prevention. Although
most techniques handled risks by continuous monitoring of
device’s and patient’s variables and responding to changes to
reduce risk or prevent adverse events from happening, very
few were focused on reducing future risks at the early design
stages using the device’s key characteristics. New techniques
that focus on the effective use of data collected from device
reports and user feedback can be embedded into a robust
design model capable of predicting and quantifying risk at
the early design stages. In the authors’ future research the
focus is on establishing a new robust technique capable of
assessing risk, quantitatively, during early design stages by
fully utilizing data stored in device databases. That will en-
able design decision making and help managing future risks
while reducing time and cost by focusing on the most critical
characteristics. This will attain a common target for all
stakeholders by emphasizing on the top requirements of a
medical device such as safety and efficacy.
CONFLICT OF INTEREST
The authors confirm that this article content has no con-
flict of interests.
ACKNOWLEDGEMENTS
This work is supported by NSF Grant No. NSF DGE-
0742462. This support is gratefully acknowledged.
Recent Patents on Engineering, 2014, Vol. 8, No. 2 9
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