Medical.device Quotes

It’s clear where the world is going. We’re entering a world where every thermostat, every electrical heater, every air conditioner, every power plant, every medical device, every hospital, every traffic light, every automobile will be connected to the Internet. Think about what it will mean for the world when those devices are the subject of attack.” Then he made his pitch. “The world needs a new, digital Geneva Convention.

I primarily use poetry as a purge, a self-medication device when I’m in the depths of loneliness, anxiety or in the throes of depression. When I’m lost in the darkness of mental illness, I spill forth a deluge of words and prose that are oftentimes grim, dark and depressive. And when my poems are spilled forth into one of my poetry journals, I feel a weight has been indeed been lifted from me, and my mind can rest just a bit easier.

Yes, we live in a free-market democracy, but the drug and medical device industries operate more like kleptocracies. Though most of it is legal, it is not ethical and is, in effect, a form of legal extortion. Likewise,

And in the case of fecal transplants, there’s no drug or medical device involved, and thus no pharmaceutical company or device maker with diverticula deep enough to fund the multiple rounds of controlled clinical trials. If anything, drug companies might be inclined to fight the procedure’s approval. Pharmaceutical companies make money by treating diseases, not by curing them. “There’s billions of dollars at stake,” says Khoruts. “I told Katerina, if this works, don’t be surprised to find me at the bottom of the river.

And where was the support for that kind of preparation? There are all kinds of medicines and medical devices and clinics and even hospice care to prolong life and make it as easeful as possible—but who helps you to really prepare for it, philosophically? Who teaches you how to embrace it? Is there anyone out there who really does that?

The way I describe this when talking with businesspeople is that the domain of technology is no longer in the IT department; the whole company is technology. I’m talking about all companies. If you’re trying to make cars or medical devices or any kind of product at all, and you want to have new customers, technology is the fulcrum of progress in everything you’re doing.

With the Pure Food and Drug Act of 1906, the United States cracked down on false and misleading labels, unsafe ingredients in food, and the adulteration of medical and food products. In 1930, the watchdog bureau became known as the Food and Drug Administration (FDA). Later laws in 1938 covered medical devices and cosmetics, and a 1962 law added scientific rigor to the drug industry.

The Clone Wars were yet another thing to be upset about. Everything about that conflict had been a lie. The Separatists had been this big enemy, and yet when the Empire was declared they’d melted away as if at the push of a button. The big corporations had staged the whole thing, Skelly was sure. Wars sold more ships, more weapons, and more medical devices. And in the Clone Wars, even the soldiers on both sides were manufactured goods.

Aside from its cartridge, pipette, and temperature issues, many of the other technical snafus that plagued the miniLab could be chalked up to the fact that it remained at a very early prototype stage. Less than three years was not a lot of time to design and perfect a complex medical device. These problems ranged from the robots’ arms landing in the wrong places, causing pipettes to break, to the spectrophotometers being badly misaligned. At one point, the blood-spinning centrifuge in one of the miniLabs blew up. These were all things that could be fixed, but it would take time. The company was still several years away from having a viable product that could be used on patients.

It’s clear where the world is going. We’re entering a world where every thermostat, every electrical heater, every air conditioner, every power plant, every medical device, every hospital, every traffic light, every automobile will be connected to the Internet. Think about what it will mean for the world when those devices are the subject of attack.” Then he made his pitch. “The world needs a new, digital Geneva Convention. It needs new rules of the road,” Smith said, intoning the words slowly for emphasis. “What we need is an approach that governments will adopt that says they will not attack civilians in times of peace, they will not attack hospitals, they will not attack the electrical grid, they will not attack the political processes of other countries.

R.J. Reynolds owns a subsidiary called RJR Packaging, which produces packaging used on many food products for both human and pet consumption.[276] They also produce packaging for many medical devices and over-the-counter medications, as well as personal care, coffee, and confectionary products.[277] In order to remain in business, a company must be profitable. In order to remain profitable in the face of extensive, long-term compulsory levies by state governments via the tobacco settlement, the costs of products must go up so that income remains higher than expenses. Thus, Altria can raise prices on their Kraft food products you buy in order to pay off their tobacco settlement. R.J. Reynolds can pass along the cost by raising packaging costs for manufacturers of many different types of consumer products, who pass the increased production costs along to you.

Another common practice, the reps told us, was to take fancy meals to the entire doctor’s office (one of the perks of being a nurse or receptionist, I suppose). One doctor’s office even required alternating days of steak and lobster for lunch if the reps wanted access to the doctors. Even more shocking, we found out that physicians sometimes called the reps into the examination room (as an “expert”) to directly inform patients about the way certain drugs work. Hearing stories from the reps who sold medical devices was even more disturbing. We learned that it’s common practice for device reps to peddle their medical devices in the operating room in real time and while a surgery is under way. Janet and I were surprised at how well the pharmaceutical reps understood classic psychological persuasion strategies and how they employed them in a sophisticated and intuitive manner.

It’s clear where the world is going. We’re entering a world where every thermostat, every electrical heater, every air conditioner, every power plant, every medical device, every hospital, every traffic light, every automobile will be connected to the Internet. Think about what it will mean for the world when those devices are the subject of attack.

Global medical device contract manufacturing market is expected to grow at 12.3% CAGR from 2019 to 2028

At some point, the rehab geniuses decided that to help my stomach “pain,” they’d put some kind of weird medical device in my back, but they’d need to do surgery to insert it. So I stayed up all night, taking 1,800 milligrams of hydrocodone ahead of the next day’s surgery.

Given these benefits, it might be surprising to hear that the National Association of the Deaf did not see this medical device as a miracle. In 1991, the organization wrote an official statement that derided the research and the device. The statement raised a number of concerns, but most relevant for us is this: There is now abundant scientific evidence that, as the deaf community has long contended, it comprises a linguistic and cultural minority. Many Americans, perhaps most, would agree that as a society we should not seek the scientific tools nor use them, if available, to change a child biologically so he or she will belong to the majority rather than the minority—even if we believe that this biological engineering might reduce the burdens the child will bear as a member of a minority.45

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We will continue to concentrate our energies entirely on prescription medicines and in vitro diagnostics, rather than diversify into other sectors like generics and biosimilars, over-the-counter medicines and medical devices.” ■ “With our in-house combination of pharmaceuticals and diagnostics, we are uniquely positioned to deliver personalized healthcare.” ■ “Our distinctiveness rests on four key elements: an exceptionally broad and deep understanding of molecular biology, the seamless integration of our pharmaceuticals and diagnostics capabilities, a diversity of approaches to maximise innovation, and a long-term orientation.” ■ “Our structure is built for innovation. Our autonomous research and development centres and alliances with over 200 external partners foster diversity and agility. Our global geographical scale and reach enables us to bring our diagnostics and medicines quickly to people who need them.

Wilson Asfora, MD is a dedicated neurosurgeon who has contributed to the advancement of the field through research, medical device creation, and ground-breaking surgical procedures.

Ceek Women’s Health Senior Territory Manager, Cathleen Zilner, leverages her comprehensive knowledge of business and marketing to excel in medical device sales.

In America, drug companies and medical device makers argue that they have to charge high prices to fund their research and development. But Japanese experience shows that tough cost controls tend to drive innovation, not stifle it.

Then in March 1993, everything changed. My one-year-old son, Charlie, had his first seizure. There’s absolutely nothing funny about being the parent of a child with uncontrolled epilepsy. Nothing. After a year of daily seizures, drugs, and a brain surgery, I learned that the cure for Charlie’s epilepsy, the ketogenic diet—a high fat, no sugar, limited protein diet—had been hiding in plain sight for, by then, over seventy years. And despite the diet’s being well documented in medical texts, none of the half-dozen pediatric neurologists we had taken Charlie to see had mentioned a word about it. I found out on my own at a medical library. It was life altering—not just for Charlie and my family, but for tens of thousands like us. Turns out there are powerful forces at work within our health care system that don’t necessarily prioritize good health. For decades, physicians have barely been taught diet therapy or even nutrition in medical school. The pharmaceutical, medical device, and sugar industries make hundreds of billions every year on anti-epileptic drugs and processed foods—but not a nickel if we change what we eat. The cardiology community and American Heart Association demonize fat based on flawed science. Hospitals profit from tests and procedures, but again no money from diet therapy. There is a world epilepsy population of over sixty million people. Most of those people begin having their seizures as children, and only a minuscule percentage ever find out about ketogenic diet therapies. When I realized that 99 percent of what had happened to Charlie and my family was unnecessary, and that there were millions of families worldwide in the same situation, I needed to try to do something. Nancy and I began the Charlie Foundation (charliefoundation.org) in 1994 in order to facilitate research and get the word directly to those who would benefit. Among the high points were countless articles, a couple appearances of Charlie’s story on Dateline NBC, and a movie I produced and directed about another family whose child’s epilepsy had been cured by the ketogenic diet starring Meryl Streep titled First Do No Harm (1997). Today, of course, the diet permeates social media. When we started, there was one hospital in the world offering ketogenic diet therapy. Today, there are 250. Equally important, word about the efficacy of the ketogenic diet for epilepsy spread within the scientific community. In 1995, we hosted the first of many scientific global symposia focused on the diet. As research into its mechanisms and applications has spiked, incredibly the professional communities have found the same metabolic pathway that is triggered by the ketogenic diet to reduce seizures has also been found to benefit Alzheimer’s disease, ALS, severe psychiatric disorders, traumatic brain injury, and even some cancers. I

Drug and medical device companies offered invitations to free dinners around town nightly. And there were over five thousand three hundred salespeople from some twelve hundred companies registered in attendance here—more than one for every two surgeons. The

If that hurdle could be overcome, Orszag added, the best ways to cut costs would be to use information technology to judge and act on the comparative effectiveness of drugs, medical devices, and other treatments. Moreover, the system had to be overhauled to pay doctors and hospitals based on their results, not on the fee-for-service basis of how many times a doctor saw a patient or how many tests the doctor ordered.

The health sector is in desperate need of a cyber hygiene injection

HCCIC by the C suite at HHS is a profound statement of having the moral courage to do what's right for the health sector

A CISO's job is to streamline, harmonize and propagate cybersecurity and cyber hygiene throughout the organizational IoT microcosm and staff

Medical devices and EHR systems are notoriously vulnerable to remote compromise

Don't spend a dime on medical device marketing until you have solid customer insights.

FDA classifies devices according to the risk they pose to consumers. Premarket review is required for moderate- and high-risk devices. There are two paths that manufacturers can use to bring such devices to market. One path consists of conducting clinical studies, submitting a premarket approval (PMA) application and requires evidence providing reasonable assurance that the device is safe and effective. The other path involves submitting a 510(k) notification demonstrating that the device is substantially equivalent to a device already on the market (a predicate device) that does not require a PMA. The 510(k) process results in FDA clearance and tends to be much less expensive and less time-consuming than seeking FDA approval via PMA.

Marc Goodman is a cyber crime specialist with an impressive résumé. He has worked with the Los Angeles Police Department, Interpol, NATO, and the State Department. He is the chief cyber criminologist at the Cybercrime Research Institute, founder of the Future Crime Institute, and now head of the policy, law, and ethics track at SU. When breaking down this threat, Goodman sees four main categories of concern. The first issue is personal. “In many nations,” he says, “humanity is fully dependent on the Internet. Attacks against banks could destroy all records. Someone’s life savings could vanish in an instant. Hacking into hospitals could cost hundreds of lives if blood types were changed. And there are already 60,000 implantable medical devices connected to the Internet. As the integration of biology and information technology proceeds, pacemakers, cochlear implants, diabetic pumps, and so on, will all become the target of cyber attacks.” Equally alarming are threats against physical infrastructures that are now hooked up to the net and vulnerable to hackers (as was recently demonstrated with Iran’s Stuxnet incident), among them bridges, tunnels, air traffic control, and energy pipelines. We are heavily dependent on these systems, but Goodman feels that the technology being employed to manage them is no longer up to date, and the entire network is riddled with security threats. Robots are the next issue. In the not-too-distant future, these machines will be both commonplace and connected to the Internet. They will have superior strength and speed and may even be armed (as is the case with today’s military robots). But their Internet connection makes them vulnerable to attack, and very few security procedures have been implemented to prevent such incidents. Goodman’s last area of concern is that technology is constantly coming between us and reality. “We believe what the computer tells us,” says Goodman. “We read our email through computer screens; we speak to friends and family on Facebook; doctors administer medicines based upon what a computer tells them the medical lab results are; traffic tickets are issued based upon what cameras tell us a license plate says; we pay for items at stores based upon a total provided by a computer; we elect governments as a result of electronic voting systems. But the problem with all this intermediated life is that it can be spoofed. It’s really easy to falsify what is seen on our computer screens. The more we disconnect from the physical and drive toward the digital, the more we lose the ability to tell the real from the fake. Ultimately, bad actors (whether criminals, terrorists, or rogue governments) will have the ability to exploit this trust.

and stop using your Kindle if it becomes a distraction. Personal medical devices, such as pacemakers, may be sensitive to magnetic and electromagnetic fields. Since Kindle and certain Kindle accessories contain magnets and emit electromagnetic fields, they should be kept at least 6 inches (approximately 15 cm) from any personal medical device. If any interference is observed, consult with your physician before

The medical implant industry needs to decide if wireless radio frequency (RF) radiation is more important than life saving medical devices, as it is clear that the two are incompatible.

Many sickly people that were dependent on electrical medical devices may have died in hurricane Ian.

Use Error is defined as a “user action or lack of user action while using the medical device that leads to a different result than that intended by the manufacturer or expected by the user

There simply are no truly independent sources of research in the US. Industry funding has extended its reach into every sector, from medical journals that present and interpret the research to universities and contract research entities that conduct the research to patient advocacy organizations that promote various treatments to medical education for doctors to the agencies that are supposed to protect the public interest—including the Centers for Disease Control and Prevention, the National Institutes of Health, and, of course, the FDA.

As society grew more complex, corporations grew more powerful, and citizens demanded more from the government, elected officials simply did not have time to regulate so many diverse industries. Nor did they have the specialized knowledge required to set rules for fair dealing across financial markets, evaluate the safety of the latest medical device, make sense of new pollution data, or anticipate all the ways employers might discriminate against their employees on account of race or gender.

A comfortable adjustable bed, television, radio, magazines, prescription drugs, radiation exposures, wireless exposures, magnetic exposures, light exposures, air exposures, medical gasses, medical devices, swimming, gym and physiotherapy massages are all available at the hospital resort for sick people.

Blood Sugar Monitors Blood sugar monitors are integral tools that hold immense significance in the lives of individuals effectively managing diabetes. These indispensable devices, exemplified by renowned brands such as Med Supply US, offer a seamless, convenient, and precise approach to monitoring blood glucose levels. With a straightforward and painless finger prick, users gain access to real-time readings that serve as pivotal guides in shaping their dietary choices, medication adjustments, and day-to-day activities. Med Supply US has carved a reputation for itself with its line of blood sugar monitors, each meticulously designed to encompass user-friendliness, reliability, and portability. These monitors are not just medical devices; they are empowering companions that enable individuals to take control of their health with confidence. What truly sets Med Supply US's blood sugar monitors apart is their commitment to simplicity and accuracy. The process of obtaining blood glucose readings has been streamlined to require minimal effort, ensuring that users can seamlessly incorporate this crucial routine into their daily lives. The accuracy of these monitors is paramount, as it directly impacts the decisions individuals make regarding their health. Med Supply US has spared no effort in ensuring that the readings provided are both reliable and trustworthy. The portability of Med Supply US's blood sugar monitors is a game-changer. No longer confined to a specific location or time, individuals can monitor their blood glucose levels wherever they go, whenever they need. This level of convenience eradicates the notion that diabetes management should be restrictive; instead, it empowers individuals to embrace an active and dynamic lifestyle while effectively managing their condition. In conclusion, blood sugar monitors are not just devices; they are lifelines for individuals with diabetes. Med Supply US's commitment to excellence shines through in their range of blood sugar monitors, offering individuals the tools they need to navigate their diabetes journey with confidence, accuracy, and unwavering support. With Med Supply US's blood sugar monitors in hand, individuals gain not only insights into their health but also a sense of empowerment that transcends the realm of medical devices.

Thieme offers affordable reaction injection molding tooling solutions for companies everywhere. Whether you’re looking for cost-efficient medical device cover production, heavy equipment console manufacturing, or recreational vehicle part production, Thieme is here to help. Our team of qualified engineers is here to guide you through any questions you may have.

As society grew more complex, corporations grew more powerful, and citizens demanded more from the government, elected officials simply did not have time to regulate so many diverse industries. Nor did they have the specialized knowledge required to set rules for fair dealing across financial markets, evaluate the safety of the latest medical device, make sense of new pollution data, or anticipate all the ways employers might discriminate against their employees on account of race or gender. In other words, if you wanted good government, then expertise mattered.

Indeed, one of design’s most potent economic effects is this very capacity to create new markets—whether for ring tones, cutensils, photovoltaic cells, or medical devices.

General Abdulatty Kofta (Al Araby, 2021). [quoter’s note: a “kofta” is an Egyptian meatball basically] In February 2014, the general announced that the military had invented a device that could cure both Hepatitis C and H.I.V. The proposed cure was a medical device that could detect and destroy the virus, almost instantly. General Abdulatty stated that he would extract the virus from the patient, and give it back to him as a piece of Kofta, which the patient could eat. Even though there was no scientific evidence to support these claims, the pro-regime media pushed the narrative to new heights (El Dashan, 2014), even after the scientific advisor to the interim President Adly Mansour, Essam Hegy, was extremely critical of the announcement due to its lack of scientific merit (Abdelaziz and Abedine, 2014). The military even announced that the miracle cure would be available in military hospitals and clinics starting from July 2014, only to backtrack a month before that date (Loveluck, 2014). It was later established that General Abdulatty was not a medical professional nor a scientist, and that he was previously sentenced to one month in jail in 2007 for impersonating a doctor and practising without a license (Al Araby, 2021). His connection to the military was also questionable. Abdulatty was granted the rank of honorary general after after the head of the engineering authority became attracted to the general’s ideas, in spite of having no formal affiliation with the military establishment (Armbrust, 2019, p. 229). How Abdulatty was able to convince the military brass to support his bizarre claim to have found a miracle cure remain so a mystery, but it is indicative of the level of prevalent polarisation that a charlatan was able to spin such a ridiculous state-sponsored lie that a large number of Egyptians believed.” Chapter “Genesis”, Page 37

Similar to IBM’s transition from manufacturing hardware to providing high-value consulting services, medical device manufacturers may use the rich harvest of data that comes from their machines to become health data service providers.

I liked to point out that Medtronic, which makes all varieties of medical devices—from surgical tools to pacemakers—is so able to charge sky-high prices that it enjoys nearly double the gross profit margin of Apple, considered to be the jewel of American high-tech companies.

Emerging opportunities in new areas such as green energy and life sciences-related medical device technologies should not be missed out.

THERMOGRAPHY Misinformation abounds as to the true nature of breast cancer and what causes it. With so much public focus on breast cancer awareness, very little attention is given to breast health, which we know is governed by things like clean eating, routine detoxification, energy balance, and stress reduction, among other things. These other things include not blasting radiation at the breasts in the form of mammograms, which only exacerbate breast cancer risk. Dr. Martin Bales, L.Ac., D.A.O.M., a licensed acupuncturist and certified thermologist at the Center for New Medicine in Irvine, California, has for years been administering one of the best-known alternatives to mammograms: thermograms. As its name suggests, thermography utilizes the power of infrared heat—hence the root word “therm”—to detect physiological abnormalities indicative of a possible breast cancer diagnosis. Dr. Bales’s father first pioneered the technology in the late 1970s with the development of the world’s first all-digital infrared camera, which was used for missile detection purposes during wartime. Its capacity to track the heat signature of missiles was applied to the field of medicine in the 1980s, which eventually gave way to thermographic medical devices. Dr. Bales opined during a recent interview: “In the early eighties, a group of doctors approached my father and said, ‘You know, we’ve heard the body—obviously with its (blood) circulation—we can diagnose a lot of diseases by seeing where there’s hot spots and where there’s cold.’ He said, ‘Okay, I’ll make a medical version for you.’” And the rest is history: thermography machines that identify hot spots in the breasts later hit the market, and select doctors and clinics offer it as a safe, side effect–free alternative to mammograms. “The most promising aspect of thermography is its ability to spot anomalies years before mammography,” says women’s health expert Christiane Northrup, M.D., about the merits of thermography. “With thermography as your regular screening tool, it’s likely that you would have the opportunity to make adjustments to your diet, beliefs, and lifestyle to transform your cells before they became cancerous. Talk about true prevention.

In 2010 and 2015, the FDA released a pair of draft “guidance” documents on “Adaptive Design” clinical trials for drugs and medical devices, which suggests—despite a long history of sticking to an option they trust—that they might at last be willing to explore alternatives.

primarily in the field of medical devices. Intriguingly, while at Dow Corning in the 1960s, he helped to invent the first generation of silicone breast implants. Today, he owned two companies: MediCor and Southwest Exchange. MediCor’s breast implant business had looked promising for a while. But the success enjoyed there was short-lived, and McGhan turned desperate. To keep MediCor solvent, McGhan began siphoning money from Southwest Exchange. Southwest Exchange, which McGhan bought in

He shrugs and moves away. Suddenly he’s a sly punk running his hand along my desk, touching things that don’t belong to him. “Yeah, but we hit it off. There was this instant connection. You get it. You probably feel the same way when you get a new medical device, this sort of excitement down in your loins.

ALMEXUS is a Mexico based Legal and Life Sciences Consulting Firm. Our Legal Practice includes Licensed Experts in Forensic Document Examination, including handwriting and signatures. We are appointed by the Tribunal of Quintana Roo and are the only Licensed Examiners recognized by the Tribunal in all of Quintana Roo. Our Life Sciences Practice is composed of International Experts in Pharmaceutical, Medical Device, and Biotechnology. Our practice is focused on 483 and Warning Letter responses, Data Integrity Quality Systems and Quality Control Remediation.

he appeared not at all auctorial in the insufferable sense of the word (I think of writers who pose with their dogs, or hold questionable medical devices, or mousse their hair until its specific gravity resembles that of pound cake).

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