Medical device companies hire contract manufacturing organizations for the development and production of their medical devices.
Learn about the role of medical device prototyping in feasibility testing.
In the United States, there are very few businesses that still allow for smoking indoors. The negative impact on people’s health has been well documented at this point.
The term artificial intelligence might have once seemed like a part of science fiction: a dream that we would never see in the real world. We now have driverless cars and limited AI technology in things like our wrist watches. Medical researchers are now taking these AI systems into the world of healthcare.
These applications are all about shrinking the time between symptoms and diagnosis. We have always looked for ways that computer science can improve human health. Now medical device companies are working on ways to use machine intelligence to make their products more effective for patients everywhere.
Making Rare Diseases Easier to Find
ThinkGenetic is a digital health startup company. It is finding a way for AI to help patients discover if they might have a genetic disease. David Jacob, ThinkGenetic’s CEO, recently moderated a panel called: How Artificial Intelligence is Moving the Needle in Medtech. “The panel will be looking for ways to use artificial intelligence to make their devices more knowledgeable,” says Jacob, “one of the underlying things will be how do we shorten the diagnosis odyssey – whether that’s with machine learning or with a wearable device.”
ThinkGenetic believes that it can locate people with diagnosed and undiagnosed genetic diseases by using AI systems. Jacob likes to call it, “GPS for genetics.” One of the most significant challenges for drug companies is finding patients. They create drug treatments for genetic conditions then they struggle to find the patients suffering from these illnesses in the real world.
How the AI Works
“What ThinkGenetic does is finds these patients on the internet when they’re out searching for answers and walks them through the process of learning more about themselves,” says Jacob. The application will take the patient step-by-step through a process. This application will help them figure out if they might have a genetic issue and then what it might be. This computer power will step in for human intelligence. First, it will take in all the signs and symptoms, and then it will connect them to all the possible diagnoses.
- Genetic diseases are among the rarest and difficult conditions to diagnose.
There is AI research filtering the symptoms and asking questions to narrow down the prospects. The artificial neural networks will then talk about what it could be before telling the patient what they need to talk about with their doctor. ThinkGenetic has genetic counselors on their staff to guide people to the next steps.
Other Uses for Artificial Intelligence
Advanced AI has become a component of many new medical leaps forward in the field of diagnosis. San Francisco based, Freenome, has created clinical studies to make AI-Genomic blood tests for colorectal cancer more normal. These test trials would be able to learn from its own mistakes over time, making cancer screening more accurate.
AI technology is also now being used alongside programs that will monitor a woman’s health. Ava, a startup firm, is currently working on a bracelet that will be able to track and monitor a woman’s cycle using AI. This application could aid in both pregnancy prevention and those women trying to become pregnant.
One of the most ambitious reported uses for AI is the company Beta Bionic. They are trying to create a bionic pancreas that can perform two crucial services for diabetes patients.
1. Monitor the blood sugar of a patient easily.
2. Regulate a patient’s blood sugar all on its own.
Beta Bionic has recently received FDA approval to start recruitment for in-home test studies of an insulin-only version of the device. Most of these new technologies are not meant to replace or simulate human doctors. These advances will hopefully only advance human medical care.
David Jacob predicts that the amount of uses for AI is only going to get bigger over the next few years. “In healthcare, I see AI making us more proactive rather than reactive, We’re going to see things coming before they actually come… All these devices are going to be sending data that can be useful to the healthcare system. If the algorithms are written correctly then we can basically see problems [ahead of time].”
In the recent past, the practice of using genetic sequencing to treat rare diseases was beyond our capacity. However, new technology advancements are making this dream a reality. The field of genomic medicine is growing.
What Does Genomic Medicine Mean?
According to news-medical.net, genomic medicine means catering medical care to a patient by using their own genetic makeup. Every cell that exists in your body contains DNA. This DNA has a say in everything about you, from the color of your hair to the way your body functions as a whole. The genome is the entire DNA content present in one cell of a living being.
Genomic medicine is making its way into more hospitals. At first, this practice was used to build complete genetic maps of patients. Since then, researchers have built off of that work. They have created a clearer understanding of human biology and chronic diseases. It is a non-invasive technology that can target diseases like brain cancer and cholera.
Research and Technology Make Genomic Medicine a Reality
Doctor Eric Green, Director of the NHGRI in Bethesda, MD, states that “The first change is an incredible increase in our knowledge about the human genome…and how changes or differences between peoples’ genomes influence health and confer risk for disease.”
It was not just one big technological leap that made this practice possible. It was a series of small changes over time that allowed this theory to become a reality. First, healthcare technology advances vastly reduced the cost of DNA sequencing.
- The first sequencing of a genome cost nearly $1 million and today it costs about $1,000.
The lower cost made further advancements even easier. Stephen Kingsmore, President and CEO of Rady Children’s Institute for Genomic Medicine gives credit to two specific pieces of technology. “The new Illumina NovaSeq sequencer has…increased the speed and scalability of human genome sequencing. Likewise… the Edico Genome DRAGEN software/hardware have enabled genome analysis to be performed in about one hour.”
Is It Making a Difference?
Experts believe we are just seeing the beginning of the effect genomic medicine can have. Still, it is already having an impact through a handful of practices that all have a medically legitimate benefit.
- Noninvasive prenatal testing: The current biggest use of genomic medicine has been in the prenatal field. Prenatal genetic tests can give parents an early view into the future of their offspring. A basic blood sample from the mother can provide a look into the future health of a child.
- Treating and diagnosing cancer: Being able to sequence DNA will allow doctors to look into a specific patient’s cancer. Then they will able to target that particular cancer with certain treatments.
- Pharmacogenomics: People all over the world have to live with all sort of allergies. Many allergic reactions come as a surprise. Genome sequencing could allow doctors to predetermine if a patient might have a bad reaction to a drug or medication.
Building the Groundwork to Make Genomic Medicine Possible
Kingsmore says that, in order to be ready for the future of genomic medicine and its applications, healthcare facilities have to place an importance on building “a well-rounded healthcare technology ecosystem.”
This means developing premium IT departments, then fully integrating them into the functions of a hospital. This will allow the hospital to share information freely and quickly. Proper access to technology also allows for the gathering of genome information with cloud-based software. A practice like that will help genomic medicine grow even faster.
“None of this is going to happen overnight.”
Dr. Eric Green cautions everyone not to expect genomic medicine in their medical practice tomorrow. There are still regulatory and reimbursement issues that need to be resolved. Healthcare professionals are also figuring out the best applications of this groundbreaking practice.
However, Green encourages us this science is expanding, “I think it’s very clear that the train has left the station…we are going to find ourselves in a very interesting transition phase for the next 10 to 20 years as it begins to spread throughout clinical practice.”
Just like the advances that brought us genomic medicine, the use of such practices will also be a slow bit-by-bit process.
For more information on genomic medicine, look to [healthtechmagazine.net].
A small study released in 2017 has documented a possible link between brain activity and the risk of obesity in teens. The study scanned the brains of teenagers while they were exposed to tempting phrases about food and a buffet of low and high-calorie food.
The definition of a medical device is a simple textbook answer. For the sake of clarity, the exact meaning has been shaped over the years based on what a device does or is intended to do. Here, we are going to discuss the technical definition and what that means for the laymen.
Defining a Medical Device
According to ce-marking.com, a medical device, or MD, is defined as “any instrument, apparatus, appliance, material, software, or other article, whether used alone on in combination, including the software necessary for the proper application, intended by the manufacturer” to be used for patients for the function of a specific list of criteria:
- Diagnosis, prevention, monitoring, or treatment of disease
- Diagnosis, prevention, monitoring, or treatment of an injury or handicap
- Investigation, replacement, or modification of the anatomy, or of a physiological process
- Control of conception
This description also excludes devices that function by pharmacological, immunological, or metabolic means. Further complicating the matter, many devices could be considered medical devices purely depending on their intended purpose for use. This includes many toiletry and cosmetic products. This possible list of medical devices refers to items such as:
- Toothbrushes, dental sticks, dental floss, dental chewing gums
- Baby diapers, tampons, mattress protectors
- Instrument for tattooing
- Deodorants
The Class System
To try and simplify all of this, the medical devices industry has agreed to specify other criteria and classifications that can further explain what a medical device is. Once something is certified as a medical device, it is further defined by separate classes. According to the Federal Drug Administration, or FDA, “Devices are classified into one of three regulatory classes: Class I, Class II, or Class III.”
These classes also include some subclasses, such as Class Is, Class Im, Class IIa, and IIb. There are a series of factors that could alter the classification of a medical device. It is usually the intended purpose of the device, assigned by the manufacturer, that determines the class of the medical device. The factors that could alter a device’s class include:
- The amount of time the device is intended to be used continuously
- Whether the device is surgically invasive
- Whether or not the device is active or implantable
- Whether the device holds a substance that is ancillary to the primary use of the said device
Why is a Class System Needed?
Healthcare and medical devices are held to a higher standard than other regular devices. This is because of their uses in the care of human beings. The companies that invent these devices and the official organizations that regulate them have to take their definitions very seriously. This is also how the medical device market is regulated. The FDA medical device classification database has to be able to break down and explain what every device is and what it does. This also helps to avoid patent conflict and later disputes about the intended use of a device.
According to ce-marking.com, it would be impossible to try and test all new medical devices to the most “rigorous conformity assessment procedures available.” This is why the class system was created. To speed up and simplify the process for medical device companies as much as possible, they chose not to judge these devices on just their technical features.
Doing so would be too complicated because many devices have more than one use or could have a different use in the future. Instead, they chose to classify a device “based on potential hazards related to the use and possible failure of devices taking account of technology used and of health policy considerations,” meaning just judging a device by how it affects the human body.
For a complete breakdown of how medical devices are separated into their classes, visit ce-marking.com.
The top 10 medical innovations for 2018 were revealed at the [Cleveland Clinic’s Medical Innovation Summit] on October 23-25, 2017. It was the climax of the summit. This list was put together by a panel of Cleveland Clinic scientists and physicians overseen by Chief Wellness Officer Michael Roizen, MD. These are medical advances that will change healthcare across the world for 2018 and years to come. They were announced in order of expected impact.
1. Hybrid Closed-Loop Insulin Delivery System
Diabetes is one of the most common diseases in America today. According to the American Diabetes Association, roughly 1.25 Americans already have Type 1 diabetes. This new innovation has been called the world’s first artificial pancreas. The hybrid closed-loop insulin delivery system can make dealing with Type 1 diabetes easier.
- 1.5 million Americans are diagnosed with diabetes every year (American Diabetes Association).
This new invention was approved by the FDA in 2016. It allows for direct contact between the ongoing glucose monitoring device and insulin pump to maintain blood glucose at a level never before seen. The technology takes over for the old “open loop” method. That practice required patients to use data from their own ongoing glucose monitor to figure out how much insulin to inject themselves with.
2. Neuromodulation to Remedy Obstructive Sleep Apnea
The most common sleep disturbance across the board is sleep apnea. It is known to advance high blood pressure and the risk of heart disease or stroke. The CPAP device or, continuous positive airway pressure device, is the most well-known treatment for this ailment. However, over 40 percent of sleep apnea sufferers refuse to use it.
- Sleep Apnea affects over 20 million Americans every night.
This latest innovation has created something subtler. It is an implant that will provide direct stimulation to open key airway muscles during slumber. This implant is operated by remote or a wearable patch and acts as a pacemaker of sorts. It uses a breathing sensor and battery-powered stimulation lead. They help to sync air intake with the action of the tongue. In clinical testing, these neuromodulation systems have shown encouraging results. Physicians hope this will mean a better night’s sleep for patients and their partners.
3. Gene Therapy for Inherited Retinal Diseases
Inherited retinal diseases are a group of rare blinding diseases. They are caused by genes passed down from family members. They can result in degrees of vision loss or total blindness. This year, the FDA is expected to approve a new treatment for inherited retinal diseases. It is a cutting edge new gene therapy that will deposit a new gene to targeted cells by viral “vectors.” This therapy proposes to treat conditions like congenital amaurosis and retinitis pigmentosa.
- These rare genetic mutations currently have no FDA-approved treatments.
This new therapy deposits a “normal” copy of the gene that results in a functioning protein. Scientists place this gene in a custom virus and this “vector” brings it to the retinal cells. In 2017, the FDA gave this treatment orphan drug status. Then a panel of U.S. health advisors recently advised its approval. Experts believe this approval could lead to orphan drug and breakthrough status for more gene therapies.
4. A Never Before Seen Decline in LDL Cholesterol
Often called “bad” cholesterol, LDL, or low-density lipoprotein is the cause for fatty collections that can block arteries. Via a new course of medications, we have seen LDL levels drop by as much as 75 percent.
- There are 400,000 coronary deaths every year and 102 million Americans affected by high cholesterol.
Studies have shown a 20 percent drop in risk of stroke, cardiovascular death, or myocardial infarction. Those patients took statins and a new class of cholesterol-lowering drugs (PCSK9 inhibitors) to discover these drastic levels of LDL reduction.
5. Creation of Distance Health Services
Shrinking the distance between patient and doctor is always a prime concern of the medical industry. Removing hurdles means faster and more effective treatments. This helps provide the optimal outcome along with cost-effective savings.
The world has seen a huge increase in mobile devices. Hospitals are preparing to enact distance health services in 2018. More and more patients have attachable mobile devices. These are able to relate medical information to doctors monitoring their condition from a distance.
- 19 million people are expected to use remote monitoring devices in 2018.
This new innovation could be world changing for patients that are physically challenged or are weak to infection.
6. Next-Gen Vaccine Platform
With our modern outbreaks of Zika and Ebola, it has become crucial to speed up the process of vaccine development. Vaccines and their treatment course are vital to stopping an epidemic before they start. Industry experts are now working to upgrade our entire vaccine infrastructure.
- One vaccine can take $200 million and at least 10 years to develop.
They are developing practices that will allow us to produce new vaccines faster. They are also working on better delivery systems for vaccinations to huge populations. Experts are finding new ways to hone the practice of freeze-drying vaccines for shipping to remote locations.
Companies are using things like tobacco plants and insects to construct new flu vaccines. There are cutting edge oral and edible vaccines being developed. As well as, intranasal vaccines and vaccine chips. With all of these new treatments and practices, we hope to be able to fight off current and new epidemics.
7. Targeted Breast Cancer Therapies
Innovators are building a whole slew of new targeted therapies to treat breast cancer. We are seeing positive outcomes from PARP inhibitors for patients with BRCA1 and BRCA2 mutations. As well as, novel CDK 4/6 inhibitors for ER-Positive/HER-2-negative breast cancer.
- Breast cancer kills more than 40,000 American women every year.
Innovative HER-2 targeted agents are also showing good signs in a subgroup of HER-2 positive patients. Scientists hope that these results will lead to higher survival rates possibly even leading to the end of chemo treatments for many breast cancer patients.
8. Improved Surgery Recovery
We all know the rule about not eating before a surgery and long-term bed rest during recovery. Well, all of that is now changing. The nationwide opioid epidemic and rise in hospital revisits has made healthcare experts rethink the old way of doing things. Recent research shows us that an Enhanced Recovery After Surgery, or ERAS, protocol can make a big difference.
- ERAS can reduce blood clots, nausea, hospital stay, and speed up recovery.
This new protocol encourages movement post-surgery. It allows patients to eat before surgery and limits the use of opioids. Hospitals are now leaning towards alternative medications instead of the standard use of opioids. Experts have seen that these new processes can even reduce post-surgery complications.
9. Centralized Monitoring of Hospital Patients
When nurses and doctors have been on-call for long hours on end, they can often become too used to the constant noise. It’s called “alarm fatigue” and it can cause important warning signs to be missed. Studies show that nearly 45 percent of inpatient cardiac arrests are not marked properly.
- According to the American Heart Association, fewer than one in four patients will survive an in-hospital cardiac arrest.
The answer to this challenge is centralized monitoring. It means that personnel who are off-site will monitor certain patient vitals. Blood pressure, heart rate, respiration, and more could all be watched off-site. All of this data is then combined to then trigger on-site actions. These off-site experts will filter out the trivial noises.
10. Scalp Cooling for the Reduction of Chemotherapy-Related Hair Loss
Hair loss might seem like small potatoes compared to some of the other illnesses talked about here. However, the psychological well-being of a patient undergoing any treatment can have a profound impact on their outcome. Patient comfort is also a key part of treatment.
- According to pharmacytimes.com, at least 65% of chemo patients will suffer hair loss.
This new method is called “scalp cooling.” It reduces the temp of the scalp by several degrees. This is done directly before, during and after a chemo treatment. It has been shown to be very effective, specifically for female patients undergoing chemo for early stage breast cancer. This method was approved by the FDA in May of 2017.
For more information about the top 10 innovations for 2018, check out [Cleveland Clinic’s ConsultQD] page.
