Biomedical Engineering Pros And Cons

The Pros And Cons Of Biomedical Engineering
Imagine what our world would be like without x–rays, without heart monitors, and without
advanced surgical tools; how would doctors diagnose, treat, or cure any patient? How would we
survive as a society if we did not have this medical technology readily available to us? This is the
reality of a world without Biomedical Engineering. The Imperial College of London defines
Biomedical Engineering as "a discipline that advances knowledge in engineering, biology and
medicine, and improves human health through cross–disciplinary activities that integrate the
engineering sciences with biomedical sciences and clinical practice" (Reyes–Guerra). In today's
society, there are new advancements being made in technology every second, especially in the
medical field. What many people do not usually realize is that the research and products are being
done and produced by biomedical engineers. As this technology continues to progress, biomedical
engineers have begun to change the way medical professionals approach a situation due to their
research and production of artificial organs and limbs, however, these advancements lead people to
question the necessity and ethics behind the topic. The research being done by biomedical engineers
is beginning to open up new doors in the medical field, giving doctors and patients more options of
treatment, new ways of diagnosis, and possibilities of artificial organs and limbs.
The idea of artificial organs, although very impactful on the medical
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Company Background Of Abc Medical Devices
Company Background ABC Medical Devices is currently the #2 supplier of artificial joints in the
Northwest. They have been in business 76 years, and have seen product development and sales
plateau in the last 10 years. Six months ago, they purchased XYZ, a much smaller competitor in the
same field. XYZ has only been in business for 5 years, but has earned a reputation for innovation
and rapid product development. They have had trouble breaking into the market, though, because
physicians are reluctant to work with such a young company. At the urging of their Board of
Directors, senior leaders at ABC approached XYZ. The conditions of the acquisition have resulted
in some restructuring. ABC's senior leadership has retained their positions; the CEO of XYZ has
been named the Head of Product Development, a cabinet level position. The rest of the XYZ
leadership team has been retained to complete the Product Development Division. ABC's former
Product Development leadership team accepted an early retirement package. ABC and XYZ
employees have been blended into their respective departments. The leaders have pledged not to lay
off any employees, but to gradually reduce staffing levels through attrition. The employees have not
easily merged. Changes brought about by the merger have resulted in 10% of the workforce
choosing to leave the company. Unfortunately, some of the most reliable and productive workers
have left, and others are expressing their dissatisfaction with the new working

Technology Advances And Medical Devices For Consumer Use
Introduction
As technology advances, medical devices are able to record increasing amounts of information.
These devices are also becoming much more assessable to consumers than in the past. In Adam
Tanner's article "Health Entrepreneur Debates Going To Data's Dark Side," he discusses the
company Safe Heart. Safe Heart is developing medical devices for consumer use. These devices are
able to measure values like blood oxygen saturation, heart rate, and perfusion index. Being able to
collect these massive amounts of data, places these devices in the realm of big data. Although the
topic of big data imposes its own issues, the medical nature of the data creates an additional set of
important issues. Safe Heart is not the first organization to develop devices that collect "big"
quantities of data. In recent years, many organizations have begun to capture and use large quantities
of medical data. Hospitals, credit agencies and researchers have all started to use medical data to the
advantage of either the patient or their own corporation. With all the data being captured, there are
legal and ethical issues that become apparent.
Main Issues
The most prominent issue related to big healthcare technology data is a legal one. The Health
Insurance Portability and Accountability Act (HIPAA), protects health data that is transmitted by a
certain groups and organizations [1]. It states that consent must be obtained from the patient to
distribute any information to a third party. The

Review Of Cybersecurity Risks Of Medical Device Software
REVIEW OF CYBERSECURITY RISKS OF MEDICAL DEVICE SOFTWARE
SURESH K. VELUPULA
FRANKLIN UNIVERSITY
COMP 650–R1WW, FALL 2014 Abstract
Nowadays, more and more medical devices are increasingly being converted or replaced from
electro–mechanical devices to software–controlled networked devices. Software for these medical
devices would need to be kept to update to keep up with the security (worms and viruses) concerns
and governing regulations while not risking the health of the patient. In this paper the author
analyzes the viewpoints and presents a review of the paper: "Inside Risks: Controlling for
Cybersecurity Risks of Medical Device Software" (Fu and Blum, 2013). Fu and Blum (2013) give
their views on the cybersecurity risks associated with the medical devices. Some of their key points
are: a) medical devices depend on software for providing care and services. b) Security risks could
cause harm to the patient. c) Post–market surveillance of the medical device is required. d) Health
data integrity and availability of patient care are crucial as compared to hacking of medical devices.
e) Provide incentives to user facilities to report security vulnerabilities and security incidents. f)
Manufacturers should consider cybersecurity during design phase of the medical device. g) Match
the underlying software life cycles with the lifecycle of the medical device. h) Standards and
regulations to protect cybersecurity would need to be created and enforced thoroughly. i) Provide

Medical Devices And Medical Applications
2.1. Percutaneous medical devices Percutaneous medical devices are increasingly used in several
medical applications and are indispensable in the medical field [1]. Percutaneous devices are defined
as foreign bodies crossing the epithelial barrier connecting external systems to the internal structure
of the body(fig). Table 1 summarizes the list of percutaneous medical devices. These percutaneous
medical devices breach the epithelial barrier in a temporarily or permanent manner; therefore,
breaking the seal that protects the body from the outer environment. Pucket Modes and causes of
Percutaneous Devices Failures Several factors determine whether a percutaneous device might get
infected. These include improper surgical technique, an existing infection at the implantation site,
the introduction of microorganism during the surgical procedure, patients with conditions that
compromise healing, improper cleaning of the device after implantation, or misuse of the device.
Table from reference of all the devices With the current advances in medical treatment and increased
patients need, there is a steady growth in the number of patients where an epithelial–implant
interface will be present. Transcutaneous devices can be categorized into two classes: (1) non–
implanted devices including catheters and drains and (2) implanted devices including soft–tissue
anchored implants such as ventricular assist devices, transcutaneous port systems (e.g., small bowel
stomas) and catheters

The Medical Device And Pharmaceutical Industries
The medical device and pharmaceutical industries exert enormous global impact. Frost and Sullivan
estimated the 2011 medical device industry revenue at $102.1 billion for the U. S. market . The
European medical technology market has been estimated at €100 billion . According to a recent U.S.
Patent and Trademark Office Patent Technology Monitoring Team Report, 16,538 patents were
issued for medical devices or pharmaceuticals in 2012 . In the same year in Europe, more than
10,000 patent applications were filed with the European Patent Office in the field of medical
technology and/or pharmaceuticals. Innovations in the health technology fields surpassed all other
European patent applications . Additionally, the European medical technology industry employs
more than 575,000 people . Moreover, the European pharmaceutical industry employs 675,000
people . Comparatively, the US medical technology industry employs 520,000 people . Thus, the
medical technology industry is an important player in the European and US economies. It is not
surprising then, that when economies compete with ethical responsibilities, there will be
controversial observations. Notwithstanding the economic impact, medical devices and
pharmaceuticals are an integral part of the global social framework. Our modern society considers
health care as a right. Citizens of all nations desire health care treatments that reflect the latest
medical technologies. Thus, there is a complex triangular

Desert Dogs Medical Surplus Is An Up
Introduction
Desert Dogs Medical Surplus is an up and coming medical surplus company based out of central
Texas whose mission is to deliver the best medical supplies and equipment to the best medi–cal
facilities around the world. Having a location in central Texas gives Desert Dogs easy access to
many major highways and international airports providing the means to transport our customer's
requests in a timely manner. Not only is Desert Dogs equipped to provide products to any hospital or
medical retail store around the world we are also able to provide a single source of supply for all
Class VIII medical supplies and equipment to all Department of Defense medical treatment facili–
ties within the United States and abroad. Desert Dogs is a minority owned, veteran owned small
business that can handle any job big or small. We are dedicated to providing our customers with a
customer service that is unmatched by any in the industry. Our 8A certification allows us to easily
obtain federal government contracts to provide supplies and equipment to Department of Defense
healthcare facilities at a fraction of the cost occurred by using larger medical surplus vendors.
Started by three former Air Force medical logisticians with a dream and a desire to continue sup–
porting no only the Air Force but the entire world we to our combined 64 years of experience and
grew a company set to rival the leading competitors in the industry. Desert Dogs has grown into a
very diverse company

Global Label Management Solution For Medical Devices...
Background The FDA introduced a new regulation that affects all FDA regulated medical device
companies. This new regulation requires that the medical devices companies become compliant with
the Unique Device Identifier (UDI) requirement within the next one to three years. Most of these
medical device companies are not yet compliant and require a suitable solution to maintain their
FDA certification. Description of the Product PRISYM ID has developed global label management
solution (PRISYM 360) that meets the FDA's UDI requirements. When a company purchases the
PRISYM 360 solution, their learners do not have the knowledge or skills necessary to perform their
job. This one–day workshop provides a condensed high level instruction covering the creation,
approval, and printing of a production label to fulfill orders for hospitals, pharmacies, and other
medical organizations. Some of the benefits of this workshop will be to provide the learners with an
introduction and overview of the new terminology, how the software functions, order of operations
related to the creation, approval, and printing of a production label, and how to create a label. The
intent is to provide the learners with a level of comfort in the application before delving into the
intense five to eight day formal instruction. Learning Objectives The application introduces a
number of new application–specific terms, essential for the learners to understand to be successful
in implementing the

Proposed Medical Design Requires The Certification And...
As part of Class I sterile, the proposed medical design requires the certification and approval by a
Notified Body (NB) for manufacturing and sterility standards [14]. At the same time the Council
Directive 93/42/EEC recommends to conform to the EN ISO 13485 and EN ISO 14971 European
standards, although it is not require [14][26][27]. Furthermore, for basic class I devices, only the
declaration of conformity is required before receiving the CE marking, making market entrance
more accessible for small companies [13]. iii. Standards Standards are published documents by
several international and national organisations that establish the basic specifications and procedures
that manufactures and product have to meet to ensure the safety and ... Show more content on
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These include different requirements such as the heat treatment, the material hardness (40HRC to 48
HRC) or the steel grade (ISO 7153–1) of the surgical device [29]. Engineers should asses what
standards are relevant for their device and how these affect the design specification. iv. FMEA
Failure Modes and Effects Analysis (FMEA) is a proactive technique that allows the identification
and prevention of errors before they occur [17]. This is especially relevant in the medical sector,
where human life is constantly at risk. The FMEA aims to prevent failure by prioritizing which of
the companies' tasks needs greater control and improvement. This is done by using a weighting
system that accounts for occurrence and the severity of the hazard [18]. For medical devices the
main regulatory framework for risk management can be found in ISO 14971 [27]. This voluntary
standard for medical devices, focuses on how companies can make safer devices by preventing and
mitigating the possible risk factors involve during the life–cycle of the product. Other important
factor of the FMEA is the development of an optimal testing methodology to ensure that the product
is suitable for its application [17]. Some of the these test are standardize by notified bodies, such as
the test for wear in knee prosthesis (ISO 14243) or the standard guide for evaluating modular hip
and knee joint components (ASTM F1814–15)

Medical Device Manufacturers And Healthcare Delivery...
Abstract
Medical device security is a growing concern for medical device manufacturers, healthcare delivery
organizations and regulators in the industry. Increasingly, researchers are demonstrating exactly how
vulnerable these devices are. In many cases, networked medical devices are regarded as a potential
weak link within a healthcare IT network that could provide a means to expose the entire network to
a malware attack. At present there is no formal method for implementing security risk management
practices in the medical device industry. However, with new regulatory guidance being developed
by the Food and Drug Administration (FDA), medical devices manufacturers will need to prove that
their devices are secure.
This paper presents a ... Show more content on Helpwriting.net ...
These medical devices have functionality to communicate via healthcare IT networks in a variety of
different ways i.e. wirelessly, across the internet, and from device to device. With this increase in
adoption and availability of interconnected medical devices, patients can now receive around–the–
clock care, outside the healthcare environment, and even in the comfort of their own home.
Consequently, resource demands to administer this patient care is significantly reduced. Healthcare
delivery organisations utilize a wide range of networked medical devices from hard–wired
monitoring devices such as diagnostic equipment (CT scanners) to implanted medical devices such
as defibrillators. The benefits of networking these devices are significant but in using such
technology, a new set of risks arise which can impact the safety of a patient. These are security risks,
threats and vulnerabilities.
Until now medical device manufacturers have only been required to demonstrate that their device is
safe and effective. With the upcoming FDA cybersecurity regulatory guidance, manufacturers will
now have to demonstrate that a medical device is also secure prior to placing it on the market [1]. In
order to satisfy this requirement, it is recommended that manufacturers supply documentation
detailing (1) the security risks identified during the design stage, (2) the security controls and
justification of these controls to

Medical Devices Are Needed For Modern Medicine
I. Introduction: Medical devices used generally in hospitals, are the articles used in treating health
related issues e.g., a disease in humans or in animals with the purpose of curing them from the
health problem. These medical devices are needed for modern medicine as they perform many
patient monitoring and management functions. Such medical device is called implantable if it is
partially or totally introduced into the human body or placed on the surface of the body. In recent
years, implantable medical devices have been advanced through developments in science and
engineering, as well as in microelectronics, and biotechnology. Implantable Medical Devices
(IMDs) are mostly used to monitor and help treat medical conditions. These include pacemakers,
implantable cardiac deﬁbrillators (ICDs), neuro stimulators and drug delivery systems, which help
in managing many diseases [1] and thus provide substantial improvement in healthcare by saving
innumerable lives. They help to achieve the vision of pervasive healthcare that is used for
identiﬁcation, monitoring, and treatment of patients. Therefore, these devices have already been
deployed in the body of many patients. The use of IMDs for monitoring is expected to be grown
further in the future. In 2005, the number of insulin pump users was nearly 245,000 and the growing
rate that is expected for the insulin pump market is 9% from 2009 to 2016 [15]. In [16], as reported
by Hanna et al., there are 25 million patients using

Defective Medical Devices And Drugs In The United States
Defective Medical Devices And Drugs In The United States Every year, millions of people in
America are prescribed a drug or medical device. These devices and medications are designed to
help us live longer and improve our quality of life. That is exactly what they do for the majority of
people who take them. However, many people are injured by defective drugs and medications.
Surgical tools, medications and medical devices are supposed to be thoroughly inspected before they
are put on the market. However, that is not always the case. In some cases, even when the
medication, medical device or surgical tool is inspected, it still causes harm to patients. The dangers
are often unknown until thousands of people are injured by the device or medication.

A Brief Note On Technology And Technology For Future Patients
It is 1975. Pacemaker technology is fairly new. One company produces the pacemakers and doctors
are only beginning to grasp the knowledge on how to implant the devices. Adding on to the
difficulty of implanting them, pacemakers are very delicate; there has been a case in which a
patient's pacemaker wires detached from the heart after a yawn. Because of cases like this, every
transistor supplier has cut off business with the pacemaker company in fear of inevitable lawsuits,
except us. As the last suppliers of a vital component to the pacemakers, we must consider all who is
at stake. Caught in a risky situation, the board of directors of our company and I must decide on
whether or not we should continue selling transistors for the purpose of producing pacemakers by
considering various approaches to the issue. In a utilitarian approach, our company would resume to
offer transistors to the pacemaker company. This would allow patients to continue have access to the
life–saving device. Also, it would allow for advancement in pacemaker technology for future
patients. As for the risk of lawsuit, our company will require the pacemaker company to spend some
profits in enhancing training programs for doctors implanting their devices. They will profit less in
the short term, but these conditions will give the pacemaker company and doctors time to further
improve on the implementation of such devices. Reducing the chances of erroneous pacemaker
implants lessens the risk for

Evaluation Of A Medical Device Company
The topic of interest was the INVO procedure, which was first introduced in a fertility clinic in
Toronto during the year of 2015 (Kirkey, 2015). The very first in Canada to do this procedure
(Kirkey, 2015). The concept behind this particular procedure is to allow women to undergo an in–
vitro fertilization with the opportunity to "incubate" the embryos inside their own body which
replaces the complex in vitro fertilization (IVF) laboratory (Kirkey, 2015). The essence of this
methodology to assisting individuals with such issues with infertility was conducted through the
INVO Bioscience, Inc. a medical device company who is focused on giving infertile patients a
treatment option (INVO Bioscience Inc., 2013). The mission statement of this company is "INVO
Bioscience offers novel solutions in assisted reproductive technologies, expanding geographic and
affordable access to the global reproductive health care community. INVO Bioscience delivers
outstanding quality products and services in compliance with worldwide regulatory requirements,
providing value to our shareholders while recognizing the contributions of our employees"(2013).
The INVO procedure is as they claim an simple and effective treatment that uses a new device, the
INVOcell (Frydman & Ranoux, 2008). "INVO is a proven procedure that has demonstrated
comparable results to conventional IVF when comparative studies were performed. Over 800 cycles
have been published worldwide that showed a clinical pregnancy rate of

Starion Entrepreneurship Case Analysis
M3786 NEW VENTURE PLANNING SAMPLE CASE ANALYSIS REPORT
STARION ENTREPRENEURSHIP SAMPLE CASE ANALYSIS REPORT
Starion Instruments, headquartered in Sunnyvale, CA is a private company with core IP assets based
on the exclusive license of groundbreaking medical research in the field of laser tissue welding.
Starion hopes to revolutionize the electrosurgical field with the introduction of products like its
cautery forceps used for cutting and sealing (cauterizing) tissue. The overall annual market for these
types of medical devices is in excess of $1 billion. Furthermore, Starion's promising IP and
continued research goals will enable it to gain a significant foothold in the worldwide medical
technology industry with sales reaching ... Show more content on Helpwriting.net ...
However, it is only with repeated use that they gain skill with a given device. Therefore, it is critical
that they see not only a cost advantage, but a significant increase in product performance in order for
considerable adoption to take place. Starion's choice to focus on the core buyer requirements
magnifies their intimate knowledge of the space and contributed greatly to the company's overall
success. The decision was made to concentrate on an open surgery strategy. Early adoption,
particularly for a small fish in a big pond, is critical to any start up. This direction, spearheaded by
management, was a deft decision for several reasons. The customer base in this field consists of an
end user with a complex hierarchy and buyer process. However, it is ultimately the end user's
decision which makes or breaks a product in this field. Therefore, the decision to launch the product
for use in open surgeries as opposed to laparoscopic procedures vastly increased the attractiveness to
the early adopter base. The open surgery tool strategy enabled doctors to rely on backwards
compatibility (the ability to simply fall back on the tried and true cut and suture method), another
key point with "experimental" tools and methods.
Prior to Starion's laser tissue welding breakthrough, the most common electrosurgical tool was the
monopolar device, also known as the Bovie device. With

Marketing Strategy of Medical Disposable Devices
Prepared by,Kundan KumarASB, Noida4608F34A3906408101 | | marketing strategy of medical
disposable devices | Acknowledgement I owe a great many thanks to a great many people who
helped and supported me during the preparation of this project. My deepest thanks to Lecturer, Ms
Rashmi Rai, the Guide of the project for guiding and correcting various documents of mine with
attention and care. She has taken pain to go through the project and make necessary correction as
and when needed. I express my thanks to the director of Amity School of Business for extending her
support. My deep sense of gratitude to Mr Vikash Khanna (Director) and Mr Yashpal, H R Manager,
Romsons group of industries, for their support and guidance. Thanks and ... Show more content on
Helpwriting.net ...
A product for every need? Well, almost They have the largest product portfolio in the industry (100
products in over 400 sizes), which caters to almost the entire spectrum of a patient's need. Designed
and manufactured to deliver maximum performance and safety, Romsons is the last word in quality.
This has earned them the recognition of their peers in the industry. Be it an award from The
Chamber of Commerce in India for outstanding export performance or the special recognition
instituted by Ministry of MSME, Government of India, their pioneering work has been universally
appreciated. Winning the trust of the best in the world What has earned them the loyalty of the most
demanding customers in the world? What gives them an edge to deliver greater value to customers?
Firstly, their experience (over 57 years) in understanding a patient's needs and a doctor's
requirements. Secondly, their firsthand knowledge of designing and developing products. Thirdly,
the unquestioned integrity of their products. But most importantly, their ability to serve the emerging
needs of our customers with speed and agility. Little surprise then, that Romsons products are being
exported to developed and emerging markets in over 67 countries. They also regularly participate in
international medical trade fairs like Medica (Germany), Hospimedia (Singapore), Arab Health
(UAE),

Legal And Regulatory Environment Of The Medical Device...
The purpose of this memo is to describe the legal and regulatory environment in the medical device
industry. The first section describes the industry while the second section describes the legal and
regulatory environment in the medical device industry, with a focus on the agencies that regulate the
industry and association that lobbies on the industry's behalf. The third section highlights the issue
whether government actors should regulate more or less within this industry. This issue is of
paramount to both industry and consumers right now because of product liability.
The medical device industry is one of the biggest industries in healthcare, driven by R & D and new
technologies. The last decade has seen an extraordinary growth in innovative and enhanced
technologies, leading to the development of life–saving products. According to the World Health
Organization, a medical device is defined as "an article, instrument, apparatus or machine that is
used in the prevention, diagnosis or treatment of illness or disease, or for detecting, measuring,
restoring, correcting or modifying the structure or function of the body for some health purpose."
Medical devices range from simple latex gloves to complex implantable pacemakers.
The US medical device industry is the global leader with sales of around $136 billion, which
represents approximately 45% of the global market, according to the US Government
Accountability Office 2014 statistics. According to Espicom's 2014 report, the

The Development and Expansion of Medtronic, Inc.
It all started with a man named Earl Bakken who loved electronics. As a self–confessed "nerd",
Bakken designed an electroshock weapon; similar to the taser's of today, and used it to protect
himself from bullies. He earned a Bachelor of Science in Electrical Engineering in 1948, and a
Master's in Electrical Engineering with a minor in Mathematics at the University of Minnesota
Graduate School. The use of electronic equipment in hospitals started to become popular after World
War II, but the hospitals did not have staff to repair them. Bakken and his brother–in–law, Palmer
Hermundslie, formed Medtronic (the combination of "medical" and "electronic") in 1949, in a small
garage, primarily working with the University of Minnesota hospital (Medtronic–history).
Even though it wasn't much more than a repair shop for medical equipment in 1949 but Bakken and
Hermundslie had a vision, and the drive to see their vision to fruition. Their first invention was in
1957 where they developed the first external, battery operated, wearable artificial pacemaker, first
used on "blue babies" who had heart rhythm problems. It was also in 1957 that Medtronic
incorporated. Although Medtronic at this point in time was earning a half million dollars in sales,
and had a reputation for being a great company, they invested a lot of time and money into research
and development, hiring additional staff, expanding its product lines, getting established in foreign
markets and building a new

The Importance Of Medical Devices In Patients And Hospital...
Cybersecurity
With the increasing connectivity of medical devices to a huge array of sensors, monitors and
electronic databases, there is an increasing vulnerability of patients and hospital systems to
malicious intrusions. Medical devices with wireless connectivity, remote monitoring, and near–field
communication technologies allow health professionals to adjust and fine–tune implanted devices
without invasive procedures. However, these conveniences also create potential points of exposure.
In January of 2017, the FDA issued a warning that implantable cardiac devices are vulnerable to
cybersecurity attacks. If exploited, an unauthorized user could remotely access a patient's radio
frequency–enabled, implanted cardiac device and rapidly ... Show more content on Helpwriting.net
...
Science is always ahead of public policy, and makes it difficult to foresee the need for new
regulatory policies. One of the principal challenges from a regulatory perspective is that even five
years ago we did not foresee any of these products being a possibility. Moreover, it is crucial that the
FDA remains thorough in their evaluations, as they are setting precedent in products in the market to
promote and protect public health.
Current changes in legislation and future
The rapidly advancing field of combination products will provide a plethora of new therapeutics
designed to personalize medicine while improving usability, safety, and patient compliance. The
regulatory challenges have become apparent, but the FDA has identified these challenges and is
preparing to address them.
The Prescription Drug User Fee Act agreements (PDUFA VI) highlights recurring themes of
importance for combination products, including patient input to the regulatory process, use of real–
world evidence, biomarker qualification, and increased pharmacovigilance. The FDA will develop
staff capacity across the medical product centers and the Office of Combination Products to more
efficiently, effectively and consistently review and respond to submissions that include combination
products. The additional capacity will include staff who focus on reviewing cGMP, human factors
tests, labeling, and most importantly aid

Medical Device Industry Overview
INDUSTRY & MARKET SEGMENT OVERVIEW
The Medical Device ("MD") industry is one of the largest and most stable industries in healthcare
with a global market exceeding $140B in revenue. The US represents approximately 60% of that
revenue, or $85B in revenue, with historical growth rates unimpacted by recessions of ~ 8%*. While
significant, only 4 % of US healthcare costs can be attributed to devices (source: King &
Donahoe, "Estimates of Medical Spending in the US). The US market produces half of the world's
medical devices and consumes 40% of the world's output. Nine of the top ten medical device
companies in the world are US–based, and 6,000 US manufacturers employ over 400,000 people in
the US. It is also a concentrated industry; ... Show more content on Helpwriting.net ...
These resources include state of the art equipment, didactic lecture, detailed product review,
competitive assessment, simulation training to perfect technique, hands on placement in models,
animals and cadavers, observation of actual cases in human catheterization labs performed by the
trainers. Training programs are fully customizable to the client's specifications. The customer value
proposition will be refined and validated with customer market research in phase II.
JI Training Vision
The vision for JI Training is that it is modular, and can be expanded to other medical disciplines,
such as cardiology, radiology, vascular surgery, and vascular medicine. World leading physicians in
these disciplines will be recruited to the JI to make the vision a reality.
Training Market Overview
The training market consists of Continuing Medical Education (CME), industry sponsored training
courses and consulting fees paid to independent physicians. CME is training for professionals to
maintain licenses and knowledge around critical issues and is put on by accredited organizations.
Approximately $2.4B was spent on CME in 2010, including both ACCME and state accredited
providers. Physician participation in CME in 2011 was $11.4M, up from 3.7M in 1998.
Approximately 36% was supported by industry through monetary and in–kind donations
(equipment, supplies, etc.) while 64% was provided by

Pharmaceutical And Medical Device Development Cycle
Abstract
Today, the major predicament faced by pharmaceutical and medical device companies is the need
for expediting the drug or device development cycle in order to place their product in the market at
the prime time to attain market success. The process for such realization requires streamlining of
efficiency at every stage of the process right from research and development, clinical research,
regulatory compliance, production, sales, and marketing. Incorporation of Lean Six Sigma without
prior streamlining and optimization of the process will limit the opportunity to benefit from the
speed and robustness that the technology proposes. The dearth of theoretical and empirical evidence
on the applicability of Lean Six Sigma technology in research conducted by medical device and
pharmaceutical companies led to this position paper to present the proficiency of this technology
with real–time illustrations.
The excerpts on application of Lean Six Sigma DMAIC technology in real world imply the
propitiousness of this model, which bolsters clinical and translational research association between
preclinical discovery, clinical trials, and adoption of innovative and effectual treatments into
practice. The merits of applying these approaches for ultimately improving the health and welfare of
the patient population is a testimony for its productivity and provides substantial evidence that these
techniques can be applied to research conducted by the medical device and pharmaceutical

Financial Benefits Of Biomedical Engineering
Behind every great doctor is an array or tools, equipment, and devices all created by biomedical
engineers. When thinking about the field of medicine, often times people do not think about who
created such common technologies like X–Ray machines, MRI machines, prosthetics, artificial
organs, and even crutches. Biomedical Engineering is an extremely important medical profession
that focuses on the creation and improvement of medical devices. This field provides many benefits
in the area of finances and education as well as a secure and rapidly growing field and a very
customizable work experience. One of the many reasons being a biomedical engineer is such a great
occupation is that it has very good financial benefits. Biomedical engineers ... Show more content
on Helpwriting.net ...
Typically biomedical engineers only require bachelors degree. The State of California Employment
Development Department says "A bachelor's degree in engineering is the basic requirement to work
as a Biomedical Engineer, generally with a concentration in biomedical engineering or a related
field," (Summary Occupational Guide 1). Considering that biomedical engineering only requires a
four year degree, and that the starting pay is much higher than the national average, biomedical
engineering has a lot of bang for its buck. However, biomedical engineers can go back and get
masters as well as doctorate degrees in biomedical engineering. This also has many benefits.
"Biomedical engineers typically receive greater responsibility through experience and more
education. To lead a research team, a biomedical engineer generally needs a graduate degree,"
(Summary 1). That is just one example of the new opportunities opened up by getting a graduate
degree, but there are others such as getting a law degree or a degree in medicine that each have new
positions and work inside the field. In addition to the new opportunities, getting a graduate degree
will increase the salary and the higher the degree, the bigger the salary. Finally, almost every singe
biomedical engineering student has to go through a co–op or an internship. While this just sounds
like more work and it is an enormous benefit. Usually students are paid a small amount, get course
credit, or both while doing a co op or internship. This is huge because often times college students
are low on money and earning money while completing degree requirements is a nice benefit. In
addition the biomedical engineering students receive valuable work experience before going into the
field. "Many programs include co–ops or internships, often with hospitals and medical device and
pharmaceutical manufacturing companies, to provide students with

Case Study Savonix
Dr. Mylea Charvat founded Savonix following her fellowship at Stanford School of Medicine. A
veteran of the tech industry, Mylea served as director of staff development in operations for
Travelocity.com in the 1990s; helping to grow the company from 100 to over 1,000 employees in 2
years. Drawing on her years of community involvement from philanthropy to technology and
academia, Mylea has leveraged decades of good will in San Francisco to create a management and
investment team of industry leaders for Savonix that is deeply committed to the success of the
company. Dr. Charvat grew up in an entrpreprenurial household. Her mother successfully launched
and sold three companies in her lifetime; the first of which was started in 1958 when Mrs.

The Ieee Code Of Ethics First Rule Essay
The IEEE Code of Ethics first rule is that engineers must make decisions consistent with the safety,
health, and welfare of the public. The definition of safety or health can be unclear, especially for
engineers when it comes to the medical device industry. In the medical device industry, the rapid
increase of technology decreases the ability for regulations to keep up. When looking at job
requirements for medical device engineers, one of the major requirements is to know the FDA
guidelines on medical devices. The FDA guidelines are what engineers follow when it comes to
designing. The FDA has its own goal to put products on the market that are safe and effective. The
FDA, though, must also satisfy congressional goals which is for the public to get quick access to
better medical devices. There are some faults found in the FDA guidelines, such as loopholes that
industries take advantage of. The FDA has allowed "innovative but potentially defective devices"
[1] to enter the market which may make the engineer who decided to pass the product question their
decisions. This brings up a dilemma for engineers. Engineers in this industry face a moral issue on
whether a design they produce balances safety and innovation. Engineers themselves must decide
whether it is morally permissible to pass a design knowing the consequences and benefits it can
bring to a patient. For an engineer to know if their design is morally permissible, the FDA
guidelines, faulty medical device cases that

The Glue For Successful Medical Device Companies
There will always be situations were some employees, managers, and even entire departments do
not equally pull their weight equally as other departments. Fair workload distribution goes a long
way, but if team members are slacking and not taking their job seriously, it trickles down throughout
the company in a negative manner. However, in a high demand industry the work never really stops,
so someone has complete the job.
Individuals that do their best to exceed expectations and goals are the glue for successful medical
device companies. They make sure everything is process oriented and all functions of distribution
are utilized at maximum potential. It may be unfair, yet the more efficient employees become over
worked and less enthused ... Show more content on Helpwriting.net ...
Rules should apply to everyone equally or the drive and will of a good team will begin to diminish
exponentially.
Consistent contribution and consistent accountability are generally needed from all employees at all
places of occupation, especially with surgery equipment. When one's morale decreases or ethical
standards are not as strong, everyone suffers, not only from a working stand point, but from a mental
stand point as well. When this gets to a certain level the turnover rate at most jobs eventually
increases. Estlund explains how "recent estimates suggest that American businesses lose
approximately $300 billion per year as a result of the loss of productivity, absenteeism, turnover, and
increased medical costs due to the increased stress at work"(Estlund, 2003).
In our society, being held accountable might make one think twice about being negligent in certain
situations. Rules are created to protect and to regulate, nevertheless, when they are not followed
correctly or at all, negative effects eventually occur. If there is no consequence to rebellious acts
towards the rules for some individuals, but extreme consequences for others illustrates that the
transparency of accountability is cloudy.
Management needs to set up checks and balances amongst themselves, as well as for the workers.
Working around medical parts used for surgery further complicates the situation. A very high
standard must be

Mobile Phones Have Effect On Medical Devices
Hospital critical medical devices immunity to EM by mobile phones
Concerns on the effect of mobile phones on medical devices.
Recent studies has shown that, using mobile phones have effect on medical devices. Many
organizations around the world are very concern about the EMI and majority of them are working
hard to ensure that EMC on medical devices is improved. But to improve the level of EMC is a
length process and require tough regulation, therefore many health organization has been promoting
EMC through "continuing development of regulations, standards, guidelines and publications that
are intended to help prevent EM1 and promote EMC and that can be applied to the safe use of RF
sources and medical devices in hospitals" [1]. The most important aspect os solving EMI is to
identifying the mode of electromagnetic inference and the following are example of EMI in the
hospitals wireless telephone services, digital television (DTV), wireless local area networks (LAN),
"Bluetooth" equipment, and security systems. All the above mention have EMI on equipment being
use in the hospitals for diagnostics, therapeutic and non–medical devices which are not directly
medical devices but are important for the functionality of the hospital.
The most concerning reasons when coming to adapt improved EMC is that most of the health
facilities has constraints when coming finances therefore it is hard for them to purchase the modern
equipment which the manufacturers

Injection Eye Drug Research Paper
CPT 67028 – Injection eye drug (Intravitreal injection of a pharmacological agent (separate
procedure) – injection on one antibiotic. CPT 67028 – Injection eye drug (Intravitreal injection of a
pharmacological agent (separate procedure) – injection of a different antibiotic. The payment was
denied because the provider of service (Dr. V. C., MD) did not sign the medical record. The
procedure billed was included as part of an evaluation and management encounter signed by a
different physician (Dr. R.T.D.). Per the QIC's letter, "Medicare requires that services
provided/ordered be authenticated by the author to indicate the service has been reviewed and
authenticated by the provider. The method used shall be a handwritten or electronic signature.
Stamped ... Show more content on Helpwriting.net ...
She was evaluated for the vision loss and changes in the appearance of her right eye; she was treated
with injections of 2 different antibiotic medications in the right

Perspective Analysis Sample
Retrospective Analysis Introduction Section: This retrospective analysis is on a class III medical
device called the Micra Transcatheter Pacing System (TPS). The device is created by Medtronic
Incorporated which is a company that focuses primarily on devices for cardio and vascular,
restorative therapies, diabetes, and minimally invasive therapies. The target customers are those who
have slow or irregular heartbeats that need to be monitored. This pacemaker is useful for patients
who could have difficulties with the placement of traditional pacemakers, or would be better off
with a single chamber pacemaker. The underlying technology used is a 1in long pacemaker that is
placed directly into the right ventricle through the femoral artery using ... Show more content on
Helpwriting.net ...
The response letter highlighted some of the restrictions placed on the device which include the
following: 21 CFR 801.109 and 515(d)(1)(B)(ii) (sale and distribution), 515(d)(1)(B)(ii) (label
devices for experience needed to operate), and 502(q) and (r) (requirements for a restricted device.
The letter also informed that an Annual Report was necessary within section 21 CFR 814.84 for the
PMA approval to stay in place. This Annual Report should have the following parts: number of
devices distributed during the regulation period, the number of the devices implanted in people, the
amount of deaths and explants, and a survival table. It is important to note that the deaths should be
broken down into related to the pacemaker and not related. The explants should be broken down into
those that no longer had battery, complications that could not be solved with programming, and
other safety and efficacy problems. Other than the Annual Report the company should also perform
a post approval study (PAS). The ending of the letter warns against the repercussions if some of
these requirements are not met. It also informs the company of what steps need to be taken if the
product was changed or if any safety and efficacy problems arose that made the product necessary
for

Proof Essays
Forum Discussion Activities
Forum Discussion Week 3 – Question #1
Please post your response to ONE of the following questions in the Forum by Wednesday, midnight,
of Week 3. Then please post at least three responses to other student's postings by Saturday,
midnight, of Week 3. * You are the Vice President of a US based software company. You have been
tasked with exploring the possibility of setting up a software development operation in India. You
have heard that the rigid caste systems can affect business operations. Do you think it is possible to
use a typical US management style in India or should you adjust to the local Indian managerial style
and employment practices? Explain.
Forum Discussion Week 3 – Question #2
Businesses ... Show more content on Helpwriting.net ...
. ." The statute itself provided a list of examples of facilitation payments in the definition of routine
governmental actions. It included the following: * Obtaining permits, licenses, or other official
documents; * Processing governmental papers such as visas and work orders; * Providing police
protection, mail services, scheduling inspections; * Providing utilities, cargo handling; or * Actions
of a similar nature. http://tfoxlaw.wordpress.com/tag/facilitation–payments/ You are the Vice
President of a US based software company. You have been tasked with exploring the possibility of
setting up a software development operation in India. You have heard that the rigid caste systems
can affect business operations. Do you think it is possible to use a typical US management style in
India or should you adjust to the local Indian managerial style and employment practices? Explain.
I would say yes I would use a typical US management style in India. I agree that adapting to India's
culture, managerial style and employment practices are great and would probably be best. But for
the very same reason we are expanding aboard and going to India is because our business model has
already been accepted by the culture. You only expand to markets if

The Effects Of Lithium Batteries On Medical Devices
Introduction
With the rise in the aging population, there has been an increase in demand for implanted medical
devices, such as pacemakers. Approximately, 70% to 80% of all pacemakers are implanted in people
65 years old or over (Bradshaw, Stobie, knuiman, & Briffa, 2014). Lithium batteries have dominated
as the main source of energy for implantable medical devices. The limitations of lithium batteries
have become apparent. The batteries have a limited energy capacity; therefore, this limits its use in
smaller devices, which in terms reduces its lifetime. Due to the short lifetime of these batteries, they
must be replaced every–so–often (Rasouli & Phee, 2010). The need to replace and recharge batteries
leads to surgeries and discomfort for ... Show more content on Helpwriting.net ...
In 1998, Paradiso implemented this into the creation of a prototype shoe. The heel of the shoe had a
spring magnetic generator. Each time the person walked approximately 1 watt was produced. The
disadvantages were that the person had to have the ability to walk and it caused discomfort.
Additional adjustments were made to the idea as the years progressed. In 2001, Paradiso placed the
piezoelectric elements on the heel and under the toes. Kornbluh placed them on the heel of both
shoes (Hannan et al., 2014). But, each one faced the issue of the patient needing the ability to walk.
Electrostatic Energy
Electrostatic generators use electrostatic induction to produce electricity. It converts mechanical
vibrations into electricity by moving the transducer in against the electrical field. The conversion
occurs with either fixed charge or fixed voltage. This method is adequate for micro–implanted
devices that use low power (Hannan et al., 2014).
Magnetic Induction Generator
There are two types of magnetic induction generators. One based on relative motion where the
generator is fixed. Another, that uses body motion. In the second case, the generator is installed with
the inertia force of the weight. Hoska conducted an investigation comparing the two types (Hnnan et
al., 2014). He found that the second less vulnerable to constant movements and more vulnerable to
vibratory movements, which can be explained due to the fact that the second type uses inertia.

Theoretical Bases And Organization Of Medical Devices
Theoretical Bases and Organization
Serious adverse event reports (encompass death, life–threatening events, hospitalization, disability,
congenital anomalies, and/or required interventions, and disabilities) and recalls related to medical
device are due to failures in the quality systems during the pre–market activities. The number of
adverse event reports has increased dramatically; these post–market issues uncovered the failures in
the quality systems such as design controls and production and process controls that could be a
strong predictor for recall root cause. The number of complexity of medical devices has grown
rapidly. In parallel, the medical device supply chain has become increasingly cost competitive and
globalized. The quality systems that manage the evolving complexity of medical devices together
with multiple layers of thousands of raw material, component, and sub–component suppliers, all of
whom potentially impact final product quality and performance.
There are opportunities for improving quality in medical device industry without increasing quality
cost by identifying the quality barriers. Quality improvements are hindered by challenges within the
industry as well as with regulatory bodies. Medical devices are subject to a high degree of
regulation, quality systems can become a principal of auditing and policing. If product quality is
managed through inspection rather than design, the quality will become reactive. According to
Deming 100%

Marketing Operations Within The Restorative Therapies...
James Byers is the Senior Manager of Marketing Operations within the Restorative Therapies
division at Medtronic. Although James is stationed at the Medtronic Fort Worth, Texas facility,
James oversees Medtronic medical bio–skills lab operations, sourcing efforts for hotel and facility
agreements, and product samples for Medical Education and third party events. Bio–Skills lab
operations are events held for surgeons and medical professionals to showcase the safe and effective
use of Medtronic products. Lab operations also include the development and improvement of new or
existing products and support of sales teams. Sourcing efforts include the sourcing for third party
events such as third party meetings and events. Sourcing for third ... Show more content on
Helpwriting.net ...
James has also managed and owned several businesses throughout his professional life. James Byers
extensive backgrounds in multiple management roles have shaped his approach to managing and
supervising effective teams and projects. James extensive time within Medical Education and the
Samples Department allowed him to develop, evolve, and progress in his current role at Medtronic.
(D1). There are many challenges that James Byers believes are currently facing him as a manager
and supervisor in his professional role. The biggest challenge facing James on a day to day basis is
convincing everyone in the organization to go in one singular direction and bring uniformity and
consistency to existing processes and guidelines. Having to manage up and across various group
dynamics to bring cohesion and cohesiveness to processes that he currently oversees is challenging
in his role as a supervisor. James could not go into much detail on his current challenges due to a
recent reorganization of several departments at Medtronic. James continually stressed that the
biggest challenge facing him and many managers and supervisors on his level have to do with
uniformity. The challenge of unifying and streamlining processes across multiple departments and
therapies within a large corporation will always be a challenge. Process uniformity challenges will
always be a factor because everyone works and thinks

The Use Of Biologics And Medical Devices Should Be Strict
The level of regulation governed by the FDA over drugs, biologics & medical devices is a widely
debated topic. In my point of view, the level of regulation on drugs, biologics and medical devices
should be strict. The current regulations governed by the FDA are very strict and should remain that
way because the base of these regulations are underlined by various tragedies which we don't want
to be repeated. For instance, the thalidomide incident in which many children were born with
Phocomelia (shortening or absence of limbs). Thalidomide, which started as an OTC drug in 1957 as
a remedy for sleeplessness was later found to have off–label effects such as mitigation of morning
sickness in pregnant women. Hence was then prescribed worldwide to pregnant women. However,
in 1962 Frances Kelsey prevented the approval of this drug in the USA. This resulted in Harris–
Kefauver Amendment in 1962 which tightened the investigation and approval of drugs requiring the
manufacturers to prove their safety and efficacy. Many incidents could be avoided in the past if the
regulations were firm and so there is an utter necessity of governing bodies for oversight of clinical
trials, new drug development and manufacturing of drugs, biologics and medical devices. Many of
these unfortunate events were mishaps, but there are many such incidents which are the result of
greed and corruption leading to adulteration of drugs, cosmetics and food products. Until the 19th
century the slaughter,

Medical Diagnostic Devices
Healthcare, and all that it provides, is considered one of the most precious resources in the United
States today. Everyone has been there. After days of feeling crummy you break down and go the
doctor. After all, there is so much you need to do. From your child's soccer game your little one has
been talking about for days, your cousin's wedding with the perfect dress hanging in the closet and
of course, you cannot afford to miss work. So there you are, in the doctor's office with the all
important question. What is wrong with me? Thankfully, with modern day science, there is
technology available to peer inside and discover what stands between you, the soccer field sideline,
and embarrassing your family by dancing the "Macarena." With each passing year, the
sophistication of medical diagnostic devices increases with disruption to the traditional and
centralized diagnostic delivery model. A review of five medical diagnostic devices available today,
or coming soon to a healthcare facility near you, will be reviewed along with how it will disrupt the
current model.
Capsule Endoscopy According to Christensen, Grossman, and Hwang (2009), medical device and
diagnostic equipment (MDDE) is progressively decentralized with each pass year in a predictable
and consistent fashion. This pattern of change may be seen in every discipline of medicine including
the arena of endoscopy, which involves a visual examination of the gastrointestinal tract. The
capsule endoscopy is one such

Graduate Level
Morgan STATE UNIVERSITY | Newland Medical Technologies | ENTR 664 Case 2 | | Olushola
Ogundele I.D: 00147829 | 1/15/2016 |
This assignment is being submitted January 15, 2016 for Dr. Leyland Lucas's ENTR.664
Entrepreneurship course being offered in Winter 2016 |
1. Discuss the process that Sarah Foster and her partners have gone through to bring to market their
medical device. How might they have avoided some of the pitfalls they have encountered?
Even though Sarah Foster and her partner have done an awesome job in coming up with a great
product it is however important to get advice and guidance from a professionals in that field in the
case we find Sarah and her partner virtually stumbled upon the idea from testing ... Show more
content on Helpwriting.net ...
Further the target market that was eventually established as patients that received kidney stones and
primary ureteroscopy and extracorporeal shock–wave lithotripsy therapy as well as stents to ease
urine discharge. The customers are indicated as both urologists and medical centers. Plus foster
failed to create a salable product because the product was more difficult to place than the standard
stent.
But generally speaking with professionals would have helped avoid wasting time, resources and
future setbacks for Sarah foster and her partners. 2. Examine Newland's strategy in light of the
special circumstances in the industry. What is your recommendation for moving the company
forward?
Fosters strategy for Newland was to find a make a demand for the Stone Removal Stent available.
Fosters team realized that there product could do more than just ease urine passage but rather could
provide a new solution for removing stones from the ureter providing them a competitive product
that companies would need in the stent market. With their initial strategy being to have a product
that is more successful at removing kidney stones and have it acquired by investors, In my view I
recommend that

The Essure Medical Device Analysis
Originally, the company Conceptus manufactured the Essure Permanent Birth Control System,
which was first approved for use by the U.S. Food and Drug Administration (FDA) on Nov. 4, 2002.
In 2013, Bayer purchased Conceptus and the companies merged. According to Bayer, more than
750,000 women use this birth control system to prevent pregnancy, with approximately 70 percent
of these women residing within the U.S.
The Essure Medical Device
The Essure Medical Device consists of flexible coils that are non–surgically placed within the
Fallopian tubes. This device is a permanent form of birth control.
Essure's flexible coils are inserted through the vagina, past the cervix and into the Fallopian tubes.
Once inserted, the device causes a build–up of the tissue within the Fallopian tubes. Over a period of
approximately three months, this tissue blocks the Fallopian tubes; thus, preventing the sperm from
traveling through them to fertilize an egg.
Three months following insertion, a radiologist checks to make sure that the Fallopian tubes are
blocked. Directly before the x–ray is taken, a contrast dye is injected through the patient's cervix to
ensure that there is no leakage of dye past the Essure Medical Device.
According to ... Show more content on Helpwriting.net ...
Art Sedrakyan is a professor at Weill Cornell Medicine in New York. He is also leading the Science
and Infrastructure Center of the FDA's Medical Device Epidemiology Network ((MDEpiNet).
Sedrakyan and a group of colleagues evaluated data from more than 8,000 women who received
Essure implants. This data was compared to data from 44,278 women who underwent the standard
surgery to block (tie) their Fallopian tubes. According to the Safety and efficacy of hysteroscopic
sterilization compared with laparoscopic sterilization: an observational cohort study, women who
opted for Essure frequently had to have surgery regardless and their risk of needing a second
procedure was substantially higher than it was for women who underwent

The Implantable Medical Device Industry
In the implantable medical devices industry, substitute products exist for some types but not all.
According to Michael Porter's "Competitive Strategy: Techniques for Analyzing Industries and
Competitors", in order for a product to be a viable substitute, it must achieve similar function as the
product that it is replacing by a different means. Porter considers four categories for analyzing a
substitute: "performance, cost of change, buyer inclination to substitute and price–performance
trade–off" (Porter, 1998). When comparing medical therapies for coronary artery disease,
musculoskeletal disorders, degenerative disc disease, spinal tumors and fractures, the present day
implantable medical devices are a minimally invasive form of treatment than former ones. They are
the new products and services and there are not many direct substitutes besides generic products. In
fact, many doctors argue that "medical therapy should be viewed as complementary rather than as an
opposing strategy" (Blumenthal et al., 2000). In many cases, substitute products can be drugs
prescribed to a patient in lieu of an operation to implant a medical device. For example, with
coronary artery disease, two therapies are commonly used: stents (implantable devices) and
coronary artery bypass graft (CABG) surgery. Differences between outcomes with stenting and with
CABG are a point of controversy (Hannan et al., 2008; Ryan et al., 2006). However, a recent study
comparing the treatment outcomes of all

Medical Device Immillation Process In The UK
This will be a description of the medical device approval process in the US and the UK, followed by
an analysis on the benefits and deficiencies involved with each system. A final opinion on the
superior system will then be given, with supporting statements.
In the US, a branch of the Food and Drug Administration (FDA) called the Center for Devices and
Radiological Health (CDRH) is responsible for regulating medical device approval, as well as
monitoring the manufacturing, performance, and safety of devices. The CDRH regulates firms who
manufacture, repackage, relabel, and/or import medical devices sold in the US [1]. All medical
devices are categorized into one of three separate classes, Class I, II, and III. Based on classification,
the ... Show more content on Helpwriting.net ...
Class III devices include surgical implants and other high risk devices. In addition to the general
controls, this class must undergo the most rigorous review process, premarket authorization (PMA).
PMA requires clinical trials with evidence of safety and device effectiveness [1]. The path to market
becomes more robust and lengthy with each increase in device class level. Furthermore, once out on
the market, there are requirements regarding product surveillance, adverse effect reporting, and
effectiveness evaluation [2]. These post market approval requirements are implemented to help
safeguard public health.
The UK belongs to the European Union, so it must adhere to their policy regarding medical device
approval. In the EU, there is not one single agency in charge of medical device regulation, instead
the regulations state that devices must meet "essential requirements," as determined by each
country's "competent authority," as well as receive a CE mark from an authorized "notified body"
[2]. In the UK, the designated competent authority is the Medicines and Healthcare Products
Regulatory Agency (MHRA); all competent authorities are government agencies [3]. Additionally,
approximately 80 for–profit, private notified bodies exist in the EU, all of which can give out CE
marks based on evaluation of safety and the device functioning as intended [3]. Due to the fact the
EU set the core requirements, if a device receives a CE mark from any

Biomedical Engineering Pros And Cons

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