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Our bodies are in constant need of replenishing our cells with oxygen, nutrients, and ATP energy to stay on top of our day to day activities. Also, the optimal function of our cells boils down to maintaining the balance that our body needs. This is also known as homeostasis.
The scientific definition of homeostasis is in a state of equilibrium, wherein the body’s chemical and physical processes are stable. The balance of the body is dependent on a plethora of factors, such as body temperature, calorie intake, level of blood sugar, the balance of fluid, and pH levels.
These factors are constantly changing and require regulation. They also adapt to changing environments like temperature, light, and activities. Reaching homeostasis requires balance for the body to reach its optimal state. This is present in humans' biology and animals' biology because it determines physical and mental performance, even stress response.
The mitochondria break down food and oxygen to produce ATP energy for the body during the cellular respiration process. Healthy light intake is important in cellular energy to stimulate the mitochondria and efficiently produce ATP energy without inflammation and oxidative stress that may disrupt the cellular respiration process. Red and NIR light therapy enhances cellular and mitochondrial function to ensure that the cellular respiration process works efficiently.
Our bodies respond to changes in external temperature through sweating and shivering. These internal temperature processes regulate the body to maintain a temperature balance. The normal body temperature is about 98.6 degrees Fahrenheit. When the body is at a normal temperature, it’s easier to perform well. It can also indicate homeostasis and balance in the body, which we naturally try to achieve. On the other hand, experiencing a fever or being exposed to the cold can make it hard to function well for a long time.
The body’s calcium is usually found in the bones and teeth, but the calcium in the blood requires constant maintenance at about 10 mg/dL. Calcium is essential for blood circulation, coagulation, and bone mineralization. When calcium is low, you may suffer from an irregular heartbeat and other health risks. Meanwhile, when calcium is high, the body may feel exhausted and sluggish because of the nervous system's inactivity. Skeletal, endocrine, and digestive systems in the bodywork hand in hand to maintain basic calcium homeostasis and balance.
The natural and continuous goal of the body in homeostasis, but many factors are at play. When we use our digestive, respiratory systems, and all the other organs, we need the necessary energy to process nutrients from food, oxygen, and light. The bodily systems are interdependent with one another and need each other to maintain balance.
When one system is lacking, the body naturally compensates by getting from another system to maintain balance. An example is a homeostasis in calcium levels in the bloodstream, which relies on food intake. If the diet lacks calcium, the body gets calcium from the bones, which technically regulates the calcium needed in the bloodstream, but eventually, it will make the bones weak and brittle.
The resourcefulness of the body to shift functions is a great deal. Still, in the long run, it may lead to serious health problems, possibly building up deficiencies and difficulties over time. It is imperative to be aware of the body’s balance and how diet, exercise, and light exposure are interconnected.
Light empowers the cells and enhances the cellular respiration process, creating ATP energy more efficiently. Aside from being essential for our life on earth, having enough light intake is an indication of biological balance. In fact, not getting your regular dose of sunlight may result in inflammation, sluggishness, off circadian rhythms, and poor sleeping habits. Most of the time, people don’t get enough light from their environment since they stay indoors and are surrounded by artificial light.
Being indoors is not how bodies are designed. We are programmed to thrive when our cells intake a good amount of healthy light. Not enough sunlight exposure can make the body imbalanced and lead to decreased energy production and Vitamin D.
You must be intentional in spending time outdoors to ensure that your body gets the amount of healthy light it requires. However, given the circumstances and limitations that we have, most people really do not get enough natural light, which red light therapy can solve.
Red light therapy is a non-invasive treatment that delivers red and NIR light wavelengths to the skin and cells and helps the mitochondria in cells produce enough ATP energy. Red light therapy helps keep the body and cells balanced, giving enough energy and power to the body even if there’s not enough light in the environment.
Our bodies function better when we reach biological balance or homeostasis. A balanced cellular environment indicates good health, and getting healthy light is an important variable to biological balance, on top of exercise, diet, and sleep. Red light therapy helps promote homeostasis and improve overall health by supporting a more efficient cellular environment. Red and NIR light wavelengths stimulate the mitochondria, producing more ATP energy that empowers the body.
If you want to read more about red light therapy and its benefits, you may go to our red light therapy blog. On the other hand, if you want to see our red light therapy devices breakdown, please don’t hesitate to browse through our catalog.
The International Medical Device Regulators Forum (IMDRF) recognizes that a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale. At its inaugural meeting in Singapore in 2012, the IMDRF identified a workgroup to develop specific documents for advancing a Medical Device Single Audit Program (MDSAP).
What is MDSAP?
The Medical Device Single Audit Program (MDSAP) is a program that conducts a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions.
Why was the MDSAP developed?
The MDSAP was developed to enable appropriate regulatory oversight of medical device manufacturers’ quality management systems. The idea is to promote more efficient and flexible use of regulatory resources through work-sharing and mutual acceptance among regulators while respecting the sovereignty of each authority. Also, in the longer term, promote greater alignment of regulatory approaches and technical requirements based on international standards and best practices
Which Regulatory Authorities are part of the MDSAP?
The MDSAP was developed by representatives of the Australian Therapeutic Goods Administration (TGA), Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, MHLW/PMDA, and the U.S. Food and Drug Administration (FDA). All regulatory authorities participating in the MDSAP are equal partners in the program.
Which manufacturers are eligible for an MDSAP audit?
Any manufacturer of medical devices is eligible. However, each regulatory authority may establish exclusion criteria for some manufacturers. It is important to note that manufacturers that participate in the MDSAP program are responsible for securing and maintaining a contract with an MDSAP recognized auditing organization. In other words, medical device manufacturers are responsible for paying for MDSAP audits conducted by an auditing organization.
Does the MDSAP add requirements for the manufacturer?
No. The MDSAP audit model was developed to cover existing requirements from the Regulatory Authorities participating in the MDSAP. The program does not add any new requirements to existing requirements from ISO 13485.
What are the potential benefits?
What are the costs associated with MDSAP audits
The cost of conducting an MDSAP audit is dictated by the commercial arrangement between the medical device manufacturer and the authorized MDSAP auditing organization.
COVID-19 Remote Audits
The spread of Covid-19 globally has resulted in the imposition of quarantine orders and travel restrictions that are affecting the ability of auditing organizations to perform MDSAP audits.
On-site audits can only be substituted with remote audits where travel restrictions or social/physical distancing as a result of the pandemic prevent on-site audits from occurring.
In Kaiyan medical, we believe in the benefits of light. We believe in healing without chemicals. With our lights, we want you to have the best version of yourself. More at kaiyanmedical.com
For more detailed information about MDSAP please take a look at their documentation.
Useful links:
We’ve all been in the search to help us achieve perfect skin. But is it just a dream, or can it really be achieved? It looks like having light shined on your face may be the most important part of your skin routine.
Red light’s anti-inflammatory and collagen-building effects on the skin have been documented for years, showing its healing abilities. However, light therapy is branching out, including other light spectrums such as green, blue, purple, and amber, for different healing abilities.
Ellen Marmur, a New York dermatologist, said, It has just enough variety that people stay excited to use it.” While many at-home devices are small and require multiple treatments to cover the entire face, masks help solve this issue.
“It makes people feel good, like they’re taking care of themselves,” Dr. Marmur said. “You can treat your skin while doing other things, so it’s easier to form the habit of doing it every day.”
LED therapy, known as photobiomodulation, can alter biological matter using varying wavelengths of light.
Jared Jagdeo, associate professor of dermatology and director of the Center for Phototherapy, SUNY Downstate Health Science University, studies LED therapy. “You can alter the skin through photo-damaging with lasers, or photobiomodulation, which is a much more gentle way of changing the way the skin functions,” he said.
When asked why red light works particularly well with skin, he said, “There’s a specific receptor in the mitochondria of the skin cells that red light specifically acts upon. And that’s why red light is an ideal wavelength for changing the way the skin functions.”
Red light can pass through the skin, deeply entering tissue and stimulating the cell’s mitochondria, which results in anti-inflammation and the skin’s rejuvenation. Collagen is also produced in the dermis, smoothing out wrinkles and plumping the skin.
While blue light doesn’t penetrate deeply into the skin, it kills acne-causing bacteria on the skin’s surface. Green light, on the other hand, focuses on melanocytes, reducing excess melanin production.
Eye safety is a valid concern, particularly because earlier this year Neutrogena recalled its LED mask over fears that it could cause eye injuries.
Brain S. Biesman, assistant clinical professor of ophthalmology, dermatology, and ENT at Vanderbilt University Medical Center in Nashville, states that most red light therapy devices aren’t powerful enough to cause eye damage. “Just normal blinking and eye movements should be sufficient to protect the eyes,” he said. “But never stare at a bright light source.”
More Thoughts
“As far as the F.D.A. is concerned, if I use CO2 laser resurfacing, it better work because of the amount of risk involved,” said Suzanne Kilmer, a clinical professor of dermatology at the UC Davis School of Medicine in Sacramento and director of the Laser and Skin Surgery Medical Group.
“Compare that to a home device,” Dr. Kilmer said. “If it doesn’t kill you, blind you or make things much worse, it’s probably going to get approved. So it’s actually more incumbent upon the people selling home devices to show efficacy. You have to trust the people who are selling them.”
“LED is real, but it’s probably not optimized yet,” Dr. Kilmer said.
With light therapy, various factors help determine the amount of light your skin needs: the light’s strength, the distance from the skin, the length of time the device is used on the skin, and the natural color of your skin.
“Some of these lights on the market are very weak, and they may not have enough energy output to actually have a biological effect,” Dr. Jagdeo said. “Imagine a glow stick. It produces a color. But you could shine it on your face all day, and it’s not going to change the way your skin works.”
Moreover, the medical community hasn’t determined the standardized dose for treating skin conditions such as hyperpigmentation and acne at home. Dr. Marmur chose her MMSphere dosing on Blu-U, an in-office blue light typically used as an alternative therapy for precancerous lesions.
“Consistent Sphere treatment for seven weeks will equal the energy given in the office with the Blu-U,” she said.
Another device, the Dr. Dennis Gross DRx SpectraLite FaceWare Pro, $435, releases red and blue light in a mask format, with each session lasting only three minutes. The mask’s LEDs are in contact with the skin, which may be a more effective treatment.
Dr. Jagdeo said, “This is a tremendously undertapped area in medicine. But LED light therapy is going to revolutionize the way home medical treatment is delivered for skin care over the next 10 to 15 years.”
If you’re considering developing your own LED facial mask, at Kayian Medical, our team of experts knows what they’re doing. We developed the Aduro mask, the top facial mask in the beauty industry with celebrities such as Julia Robert fans of the Aduro Mask. For more information, visit https://www.aduroled.com/.
COVID-19 has created challenges for nearly every market, and the medical device manufacturing industry is no exception. As the virus sweeps the globe, it’s becoming increasingly difficult for leaders to overcome the arising challenges and prepare for the future.
While I firmly believe the key to navigating this evolving landscape is putting quality at the forefront of all activities, a function made seamless through best of breed quality management tools, I was curious what other industry leaders had to say.
The following are some of their best tips for effectively leading and managing teams during the COVID-19 pandemic and preparing your organization for what’s to come.
Keep in touch. Let your people know where things stand with the business. At home or in the office practicing social distancing, each of your workers will be dealing with different issues, both private and professional. The distributed workforce requires even more channels to help people stay connected.
“Leadership needs to provide regular communication, be transparent about the impact of the pandemic on your company, and set expectations with your team, investors, partners, and customers. There is a great deal of uncertainty in the world, and clarity from management is one of the keys to a healthy organization.” — Paul Grand, CEO, MedTech Innovator
Be sensitive to employees’ personal situations. Every member has their own worries and family needs during this crisis. Review goals and when needed realign expectations to match current circumstances.
Balance the content. Focus on efficiency in meetings to ensure your team still has time to do their work and manage their personal situation. The recommended time for meetings should be 15 minutes with no more than 4 people per meeting
Office time should be reduced. To avoid conflicts, make sure yo manage expectations. Be clear about your expectations and the expectation from your team during these challenging times. The last thing you want to do is have misunderstandings or conflicts with a good working team.
The key purpose of a leader is to continuously motivate and support the team. Talk about work-life structures, supporting flexible working arrangements, and vocalizing empathy towards your workmates. As a leader, you must empower them to deliver their best work while being absolutely empathetic towards challenges in their life.
Focus on the fact that COVID-19 is temporary. The natural instinct may be to slow down and withdraw resources. Instead, this is an excellent time to strategically plan and dedicate time, staff, and resources to ensuring that the post-pandemic time capitalizes on key changes.
Just because you can’t conduct research the way you always have doesn’t mean you can’t conduct research at all. It is important to stay flexible with the research methods you use. Understanding the pros and cons of each method and their overall ability to contribute to your research goal is critical to conducting meaningful and useful research.
All companies are working to lead their teams through today’s challenges with confidence. By taking care of your team and keeping quality you will improve the teamwork collaboration, communication, and transparency.
Having acne-prone skin can be incredibly frustrating, especially when your oral and topical treatments don’t seem to work well enough. Skincare ingredient junkies know actives that target acne problems such as salicylic acid and benzoyl peroxide can be a few of the most irritating ingredients that you can put on your skin- especially when used in hefty amounts.
If you’ve been wallowing into these-but to no avail, you might ease your frustrations by learning about what Blue Light Therapy can do to acne problems.
Blue Light therapy is a form of phototherapy that uses a visible light device that has been used by dermatologists for decades as a clinically proven treatment for acne.
The treatment is considered a generally safe, non-invasive, and pain-free procedure with no downtime. Besides being a popular anti-acne treatment, Blue Light therapy has also been shown to remove stubborn acne marks and sunspots. It eliminates free radicals caused by exposure to harsh environments that may oxidize and age your skin.
One significant impact of Blue light therapy is that it has been used to treat skin cancer in patients with actinic keratoses at University of Iowa Hospitals & Clinics. The American Academy of Dermatology considers Blue light therapy a promising treatment for numerous skin issues like acne.
Blue light has been shown to have an antimicrobial effect that penetrates deep into the skin’s pores to eliminate the acne-causing bacteria, otherwise known as Propionibacterium acnes, or P. acnes. Blue Light has been proven to have an antimicrobial effect, making it an ideal treatment to effectively kill several types of bacteria in your pores and oil glands responsible for causing breakouts.
A clinical study shows that 77% of people with acne-prone skin treated with blue light therapy for five weeks have seen significant changes in their skin. Another research suggests that at-home blue light therapy has reduced acne lesions on people who have used the therapy for 28 days.
Unlike other topical treatments that address inflammation, blue light therapy targets breakout-causing bacteria in your pores and by healing the skin from within. Blue Light Therapy is a form of defensive treatment to acne by eradicating bacteria that causes redness and inflammation and a proactive solution to preexisting acne.
Who is a good candidate for Blue Light Therapy?
Experts at the American Academy of Dermatologists agree that blue light therapy works best for people who have mild to moderate acne problems. It is also a great treatment to eliminate acne scars. Blue light therapy works by addressing the acne issue from its core. It works by removing preexisting mild to moderate acne while preventing sebum build-up that causes the inflammation. Severely too deep abdominal cystic acne may benefit from other prescriptive medications that target more serious skin problems. People who incorporate Retinols in their skincare routine may also want to avoid getting Blue Light treatments as such ingredients make the skin very sensitive.
Although many dermatologists use current clinical studies, there are available at-home blue light therapy devices that effectively treat acne problems.
The best Blue Light Devices should be FDA- cleared, just like our Blue Lights Therapy Beauty Skin Complexion Handheld Device and Aduro Mask, that is made with medical-grade quality. FDA-cleared at-home devices have innovated into using the same technology that delivers satisfactory results for acne-related problems.
Blue Light therapy works best as a treatment for acne when used consistently. A weekly maintenance appointment to your dermatologist’s clinic for a blue light treatment may cost you $100, which makes it a much more expensive endeavor than investing in at-home devices.
Portable blue light therapy devices can be more beneficial for you as they can be used more frequently as an addition to your skincare routine at a lower price point.
The best blue light therapy devices in the market provide a safer alternative to other harsh treatments for acne that may require risks such as scarring and irritation. If you want to know more about effective light therapy treatments, check this out.
Now you can add a cool, avant-garde addition to your skincare that can be a very convenient and effective treatment for your stubborn acne problems.
https://www.medicalnewstoday.com/articles/319254
https://uihc.org/health-topics/blue-light-therapy-warding-skin-cancer
https://www.healthline.com/health/blue-light-therapy
Corrective and preventive action (CAPA or simply corrective action) consists of improvements to an organization's processes taken to eliminate causes of non-conformities or other undesirable situations.
The key thing about the CAPA process is that there are a lot of different processes that feed into it. You need to be diligent, but also apply scrutiny to what does and doesn’t require CAPA. Remember, it should be reserved for those systemic issues - every issue is not a CAPA!
Once you have something that’s worthy of a CAPA, here are the steps:
Today's customers expect nothing less than products of the highest quality, and it is incumbent on all manufacturers to assure this expectation is met. A proven technique for checking whether a manufacturing process is in control is a manufacturing audit.
A manufacturing audit is a comprehensive inspection of a process to determine whether it is performing satisfactorily. A manufacturing audit is usually limited to a small portion of units produced, but the manufacturing processes involved are reviewed thoroughly. An audit does not replace normal quality control efforts, but supplements them.
Medical audit is a systematic approach to peer review of medical care in order to identify opportunities for improvement and provide a mechanism for realizing them. Medical audit and clinical audit are often used interchangeably, but clinical audit might be considered to cover all aspects of clinical care-for example, nursing and the role of paramedical staff-whereas medical audit relates to practices initiated directly by doctors. It complements and may partly overlap financial audit, utilization review, and management of resources, but is primarily clinical, not managerial; its focus is the process and results of medical care rather than the use of resources and it is the responsibility of doctors rather than managers.
There are many reasons for conducting a manufacturing audit:
Kaiyan Medical got another audit supplier recognition by Made-in-China. We like to keep our audits and quality standards to the top in order to assure the best experience for our customers and clients
https://www.bmj.com/content/bmj/299/6697/498.full.pdf
You might have heard about hyperpigmentation from your dermatologist or a skincare company. But if you didn’t completely understand this skin condition — and you want to know how it develops, how to remove it, etc. — or if you have questions about this skin condition, this article can be of help.
Hyperpigmentation can be one or multiple skin patches or spots that appear much darker than your skin color. It is a cell mutation caused by changes in hormones, an injury like sunburn, acne, peeling from chemicals or any treatments, or inflammation. The darker areas of hyperpigmentation are excess deposits of melanin. And although it is harmless and common, having hyperpigmentation can make people more conscious about their looks. In fact, some people try to conceal it with cosmetic products, while some try to deal with it with professional help.
Age spots: As we age, brown, black or tan skin spots may develop on our hands, face, and/or head. These mostly affect light-skinned individuals and are caused by too much exposure from the sun.
Melasma: Usually caused by hormonal changes, melasma is common in women, especially those who are pregnant. It is composed of large patches of darkened skin that can appear on the face or stomach. Those with darker skin are more likely to have melasma.
Inflammation: This is caused by autoimmune reactions from skin conditions like acne and eczema or a skin injury. Post-inflammatory hyperpigmentation appears on the face and neck, and its appearance may vary depending on the skin tone. Inflammation can happen to anyone, regardless of skin color and origin.
There are different treatment options for hyperpigmentation, depending on your skin tone. Fair skin can be treated by most hyperpigmentation procedures, such as laser treatments and micro peeling. Medium skin usually reacts better with chemical peels and microdermabrasion therapy. Darker skin can benefit from using glycolic acid, kojic acid, microdermabrasion in a low setting, lower-strength chemical peels, and low-intensity laser treatments.
Some important things to watch out for when treating hyperpigmentation include:
Photobiomodulation is another name for red light therapy. It may help the body produce more energy and regenerate the skin by using natural light. This can also be used on hyperpigmentation and other skin injuries like acne, inflammation, burns, and scars. When used consistently, light therapy is highly effective in reducing and healing hyperpigmentation patches and helping them return to normal pigment levels.
Red light therapy is a powerful, advanced relief for skin inflammation. Skin cells heal and rejuvenate better when exposed to healthy wavelengths of light, which can help treat hyperpigmentation.
There’s a study that shows near-infrared light can help produce tyrosinase enzyme, which prevents melanin production. This helps patients with vitiligo stimulate melanocytes, the same compound in vitamin C that helps lighten hyperpigmentation. But the truth is, there is no clear clinical consensus among photomedicine researches about using near-infrared light for hyperpigmentation.
Red light wavelengths are considered to be safe as it does not stimulate the production of pigment. It creates healthy wavelengths of light to help the skin cells heal and rejuvenate naturally.
Results can be seen after several treatments done per week. The level of skin improvement depends on how consistently you use red light therapy. Also, the more consistent and the more careful you are in the process, the better the results you can see. Be sure not to pick or touch the treated areas to avoid infection or irritation.
Light therapy, especially when combined with other treatment options, can greatly help remove hyperpigmentation. To learn more benefits of red light therapy, you may reach out to us. We offer safe and easy-to-use light therapy devices that physicians use both for aesthetic and medical purposes. Meanwhile, if you have more questions about hyperpigmentation, please reach out to your dermatologist.
https://www.aocd.org/page/Hyperpigmentation#
https://www.healthline.com/health/hyperpigmentation
As the most accessible element in the globe, hydrogen plays a huge role in our biological processes. However, you may not know that hydrogen usually brings an uninvited guest in your body, and we call it deuterium. Having high deuterium levels may change the chemical reactions in your cells and affect your bodily functions and metabolism, leading to unwanted health consequences.
Deuterium is also known as a “heavy hydrogen” and is one of the two stable hydrogen isotopes. We commonly have it in our bodies — in fact, it helps children grow. However, adults may have too much deuterium because of dietary and environmental factors. As mentioned above, this may lead to chemical reactions at a cellular level and lead to health risks.
Hydrogen is necessary for our day-to-day bodily functions. Our biological processes require it, and we usually get it from what we eat or drink. Upon intake, hydrogen goes to the mitochondria, also known as the powerhouse of the cells.
Our mitochondria can be compared to thousands of engines that continually run to produce the ATP energy we need to survive daily. The majority of people eat only three to five pounds of food each day, but we usually make more than 170 pounds of ATP energy at the same time.
On the other hand, deuterium is like hydrogen’s “evil” sibling. And we repeat, excess deuterium is harmful to our bodies. Because it is twice as heavy and large as hydrogen, it may damage the nanomotors in your mitochondria and slow down ATP energy production. As time goes by, the wear and tear on your nanomotors caused by the heavy hydrogen atoms may completely break your nanomotors. This damage may cause muscle pain, dehydration, impaired memory, poor sleep, headaches, and lymph nodes.
Two “D-terminator” diagnostic tests can help measure the deuterium levels in your body. Advanced technology, such as magnetic resonance imaging (MRI), can also be used to visualize and track deuterium patterns in your body, whether it’s in your bodily fluids, DNA, or even your hair and nails. Based on these tests, your doctor will be able to determine your deuterium levels. And when it shows to be excessive, he/she may come up with a plan to deplete deuterium in your body.
We experience high deuterium levels because of what we eat or drink and some other environmental factors. For instance, carbohydrates, processed foods, and synthetic supplements contain high levels of deuterium. Tap, ocean, and river water also have high deuterium levels, so when you’re exposed to these things regularly, you may experience an overload of this hydrogen isotope.
Nutrition is the baseline of depleting deuterium. Based on your test results, your doctor may recommend consuming food groups that contain lower levels of deuterium, such as proteins, green vegetables, and healthy fats. You may also be advised to drink deuterium-depleted water to lower your deuterium levels.
Health experts say that a body that functions properly can naturally regulate deuterium levels and produce healthy amounts of ATP energy.
Red and near-infrared light can affect our body’s hydrogen bonds in a process quite similar to photosynthesis. The water inside our cells usually becomes less harmful when our bodies absorb wavelengths of red and near-infrared light between 600–950 nanometers. This helps with proper cellular respiration and helps increase ATP energy production in your body.
Changing the water's resistance in your body, red, and near-infrared light can help reduce the amount of friction at the cellular level, promote cellular longevity, and lead to higher outputs of good energy.
To learn more about the benefits of red light therapy or to see what kind of red and near light therapy devices you can use to lower your deuterium levels, click here.
If you are in the medical device industry in the U.S is likely that you heard of the 510(k) process. Those working on high-risk devices may be familiar with the PMA and De Novo pathways. These are the three options that are most commonly used by device companies.
However, there are seven major pathways that can be used to bring a medical device to market
So many people assume the 510(k) route is right for them because it is what everyone else does. Not always the case, and one of the other pathways might actually be better for your company.
Don’t look at the regulatory process as a series of hoops to jump through. Instead, focus on creating a regulatory strategy for your specific device that sets you apart from your competition.
The 7 major pathways to market in the U.S. include:
Are you developing a custom device for a specific patient? If so, your device falls under the Custom Device Exemption (CDE) pathway.
The product should be specifically designed to treat a unique pathology or physiological condition that no other device is domestically available to treat. It must be assembled from components or manufactured and finished on a case-by-case basis to accommodate the unique needs of the patient.
The device must be created or modified in order to comply with the order of an individual physician or dentist, typically in the form of a prescription. Not only must the clinician order the device, but it must also be used in the normal course of the professional practice of that physician or dentist.
The FDA even states that companies are limited to no more than 5 units per year of a particular device type.
CDE devices are exempt from PMA or 510(k) submission process but the company still needs to comply with the following regulations:
The Expanded Access program, often referred to as the compassionate use or emergency use provision. It allows an investigational device to be used, outside of a clinical trial, in situations where a seriously ill patient has few if any alternatives.
Although there are often ethical considerations, it may be appropriate to evaluate this option as a way to get early feasibility data for high-risk devices, especially when suitable animal models are unavailable. Like the HDE, this data could then be used to expand the label in the future.
Expanded access may be an appropriate pathway for you to choose when all the following apply:
The Product Development Protocol (PDP) is a subset of the PMA process that allows for another pathway for companies with devices in which the technology is well established in the industry.
This pathway allows the company to come to an early agreement with the FDA about how the safety and effectiveness of the device will be shown. The two parties are essentially creating a contract that describes design and development activities, including the outputs of these activities, and acceptance criteria for these outputs.
The company can follow the plan on their own time and report back to the FDA on the agreed-upon milestones. At the end of the process, the company is considered to have “completed” a PDP, which gives them an “approved” PMA.
The Premarket Notification 510(k) pathway is the most common route taken when launching a medical device. Almost all Class II devices and certain Class I devices will require a 510(k).
The purpose of a 510(k) submission is to provide the FDA with documented evidence showing that your medical device is substantially equivalent in terms of safety and effectiveness to a predicate device.
A predicate device is one that is already legally marketed and shares the same intended use and technological characteristics as your device. You are required to compare and contrast your device with the predicate by summarizing information from your design controls process, such as design features and verification testing.
The FDA typically processes 510(k) applications in 30–90 days. Depending on the robustness of your initial application, there may be a period of back and forth discussions, which can delay the process. It is important to plan ahead and provide all appropriate documentation at the time of initial submission.
Class III devices, and any device that cannot provide substantial equivalence to a Class I or Class II device through the 510(k) process, must use the Premarket Approval (PMA) pathway.
The PMA process is the most involved as scientific evidence, typically in the form of a clinical trial, is needed to prove the safety and effectiveness of your device.
The FDA will either approve or reject the application within 180 days. The different steps of the review process include:
If you are developing a lower risk, “novel” device, and struggling to find a predicate, the De Novo pathway might be the best option for you.
The De Novo pathway has actually been around since 1997 but many people do not know about it since it is not very commonly used. Companies that do not qualify for 510(k) clearance, due to the fact that they cannot provide substantial equivalence to a device on the market, should learn more about the De Novo pathway.
Since comparison to a predicate is not needed, companies have a “blank canvas” when it comes to labeling and can set a standard that may give them a competitive advantage over others. One of the key things to remember about the De Novo pathway is you must show your device presents low to moderate risk through a robust risk mitigation strategy.
The Humanitarian Device Exemption (HDE) pathway is for devices that are intended to treat or diagnose conditions or diseases that affect small or rare populations.
This pathway involves a two-step process. The FDA must grant a Humanitarian Use Device (HUD) exemption and the device company must then submit an HDE application to the appropriate review center.
Another important requirement is that there cannot be another comparable device on the market that shares the same intended use. The FDA will consider the following when determining if there are comparable devices on the market:
Part of the rationale for providing this pathway is there may not be a large enough patient population with clinical data to satisfy regular FDA requirements of safety and efficacy. Since these devices may be very crucial to patients with rare conditions, the FDA put it in place to do a proper review to determine if the device can be sold.
We live in a 24-hour environment, in which light and darkness follow a diurnal pattern. Our circadian pacemaker, the suprachiasmatic nuclei (SCN) in the hypothalamus, is entrained to the 24-hour solar day via a pathway from the retina and synchronizes our internal biological rhythms. Once we come to this world, one of the first things we need, is food. Naturally, as mammals(from Latin mamma “breast”), we feed ourselves from the breast. But, Human breast milk is more than a meal — it’s also a clock, providing time-of-day information to infants. The composition of breast milk changes across the day, giving energizing morning milk a different cocktail of ingredients than soothing evening milk. Researchers believe this “chrononutrition” may help program infants’ emerging circadian biology, the internal timekeeper that allows babies to distinguish day from night.
What happens, though, when babies drink milk that does not come directly from the breast but is pumped at different times of the day and stored in advance of feeding? Scientists have rarely considered the potential effects of “mistimed” milk on infants’ development, but the implications are potentially far-reaching.
In the same way, rhythmic variations in ambient illumination impact behaviors such as rest during sleep and activity during wakefulness as well as their underlying biological processes. The availability of artificial light has substantially changed the light environment, especially during the evening and night hours. Phones, laptops, ipads, and more around the babies. This may increase the risk of developing circadian rhythm sleep-wake disorders (CRSWD), which are often caused by a misalignment of endogenous circadian rhythms and external light-dark cycles. On the other hand, light can also be used as an effective and non-invasive therapeutic option with little to no side effects, to improve sleep, mood, and general well-being.
The central master-clock in mammalian species is a paired structure in the hypothalamus with a volume of just about 0.25 mm3 per nucleus. Within the mammalian SCN, a molecular oscillator keeps the clock oscillating at its normal pace. The basis of this oscillator is two interconnected molecular feedback loops of clock gene expression, a detailed description of which is beyond the scope of this review though.
Successful interaction between body and environment however needs more than just a central clock; it also requires input pathways relaying information about the environment and the body to the SCN to achieve adequate entrainment as well as output pathways communicating timing information to the body to synchronize bodily processes with the circadian phase
Sleep, eating, and energy levels all show circadian rhythms, which means they follow a daily cycle. As any parent who has sleepwalked through a 3 a.m. feeding knows, infants are not born with these rhythms fully set. Instead, their sense of day and night develops over the first weeks and months of life, thanks to cues like sunlight and darkness.
Babies vary: Some show predictable circadian fluctuations in hormones linked with alertness, sleep, and appetite, and can sleep for long stretches shortly after birth, whereas others seem to have their daily rhythms upside-down for months. Delays in the development of circadian biology can increase the risk of colic and lead to growth and feeding problems.
Breast milk may help program infant circadian rhythms, helping to explain why some parents of newborns enjoy long full nights of sleep, whereas others struggle to get their infants on a schedule.
Breast milk changes dramatically over the course of the day. For example, levels of cortisol — a hormone that promotes alertness — are three times higher in morning milk than in evening milk. Melatonin, which promotes sleep and digestion, can barely be detected in daytime milk, but rises in the evening and peaks around midnight.
Night milk also contains higher levels of certain DNA building blocks which help promote healthy sleep. Day milk, by contrast, has more activity-promoting amino acids than night milk. Iron in milk peaks at around noon; vitamin E peaks in the evening. Minerals like magnesium, zinc, potassium, and sodium are all highest in the morning.
Daytime milk may pack a special immune punch. Among mothers who provided researchers with milk samples across the first month postpartum, immune components — including key antibodies and white blood cells — looked higher in day milk compared to night milk. Another study found higher levels of a component important for immune system communication in day milk compared to night milk.
While it’s clear that milk changes over the course of the day, scientists know little about what this means for infant health. Researchers do know that the hormones and immune components in breast milk are passed along to infants and that infants are starting to develop and refine their own circadian rhythms during the first months of life. It’s plausible that the chronosignals in breast milk would help to shape infants’ own circadian biology. Differences in infant feeding patterns might help explain why there’s such variability in the development of these daily rhythms from one infant to another.
To understand the effects of light on human physiology, it is important to understand light. Briefly, light is radiation in a specific range of the electromagnetic spectrum.
The spectrum of daylight, which is light from the sun filtered by the atmosphere is relatively broadband in its distribution. The availability of daylight depends on geographical location and season. In the timeframe of human evolution, it is a rather recent development that light can be available during all times of day through artificial light. Artificial light allows for illuminating indoor and outdoor spaces. It comes in many forms, e.g. incandescent, fluorescent, or light-emitting diode (LED) lighting.
While light generated by these technologies may all appear “white”, the underlying spectra are rather different.
The reason why many different types of spectra might have the same appearance lies in the retina. Critically, different spectra, even if they create the same visual impression, may vary in their chronobiological effects on the circadian clock.
Recently, the Commission International de l’Eclairage (CIE), the international standard body for quantities related to light, issued a new standard containing a reference framework for quantifying the effects of light on non-visual functions.
Two effects of light have been interrogated extensively in human circadian and sleep research: (1) the acute suppression of melatonin in response to light exposure and (2) the ability of light exposure to shift circadian phase.
The system mediating melatonin suppression has a spectral sensitivity that is broadly consistent with the spectral sensitivity of melanopsin. Similarly, the spectral sensitivity of circadian phase-shifting shows its maximal effect near the peak spectral sensitivity of melanopsin.
The effects of light on the phase of the circadian clock depend on the timing of light exposure. This is formally summarised in the phase response curve (PRC), which describes the amount of phase shift (in minutes and hours) achieved by exposure of light at a given circadian phase. Roughly speaking, the effect of morning light is that it advances the clock, while evening and night light delays the clock.
Both melatonin suppression and circadian phase shifts are modulated by the “photic history”, i.e. the amount of light seen during the day. The long-term adaptive influences of the “spectral diet” in the real world remain an important area of investigation.
The human sleep-wake cycle, which is periods of sleep during the night and wakefulness during the day, is one of the most prominent examples of a circadian behavioral pattern, especially for babies. It results from the interaction between two factors: the circadian drive for wakefulness and the homeostatic sleep pressure. The activity of the circadian pacemaker is aligned to counteract the increasing sleep pressure resulting from sustained wakefulness during the daytime. Likewise, the nocturnal increase in circadian sleep tendency counteracts the decrease in sleep propensity resulting from accumulated sleep thereby supporting a consolidated phase of nocturnal sleep.
In addition to natural daylight, babies are nowadays also exposed to a considerable amount of artificial light. This is particularly the case in the evening hours, i.e. when the circadian system is most sensitive to light-induced phase delays. Thereby, light therapy is more efficient to delay the timing of the circadian clock and thus sleep.
Even thou, mothers can label their milk with the time it was pumped and coordinate infant feedings to offer morning milk in the morning, afternoon milk in the afternoon, and night milk at night, they keep the constant use of visual units around the baby. The use for the babies is not different, entertainment as well
Is always about finding the balance. Rather than only use one of the methods, the responsible practice of light therapy and adequate alimentation of your newborn should be combined to get on track the circadian system
