Only few are familiar with the term general wellness device, or non-medical devices category. However, for most of you these three words do not mean much, although they may sound familiar. Perhaps, some relative conceptual comparisons will offer a better understanding of the term general wellness device. Furthermore, these comparisons may also help you to understand the difference between general wellness devices and medical devices. Having clarity in differentiating between medical devices and non-medical devices will help you to better assess their benefits.
For example, MD, a medical doctor accreditation, differentiates medical healthcare practitioners from those who offer non-medical or general wellness services. Acupuncturists, massage therapists, nutritionist, and other health and wellness practitioners, can provide numerous wellness related services. Although they do require certain forms of professional accreditation, they do not have to be medical doctors to practice. On the other hand, they can be limited in what they can do. For example, usually they cannot prescribe medications or do certain medical procedures, which only medical doctors can do.
It is a common practice for someone who does not feel well to seek medical help in one way or another. This search for help usually starts by seeking an advice from a healthcare or wellness practitioner. Thus, a health practitioner can assess the individual and recommend a course of action, or a treatment protocol. After that, it is up to the individual to follow the recommendations or to seek a second opinion. In some cases people prefer to do additional research or seek out alternatives like meditation or some forms of biohacking.
It all sounds pretty commonplace, logical and simple enough, at least in theory. However, reality may look a little different, at least in terms of product and category definitions.
How do you choose the right healthcare practitioner to help you?
Let’s start with a healthcare practitioner. As most things in life, they also come in different “forms” and “sizes”. These characteristics are not in reference to the physical aspects of the practitioners. Rather, they reflect on the health practitioners’ qualifications, competencies, abilities and professional accreditations.
For example, if you have a headache, you may do one of the following things. One, you can make an appointment to see your trusted physician. Two, you could also take an over-the-counter medication, which helped you in the past. Three, alternatively, you can go to a local drop-in clinic to see any licensed physician, whom you may not know. Four, you can choose to see a chiropractor or a naturopathic specialist. Five, yet, others may prefer to see an acupuncturist or a neurofeedback practitioner. There are other options as well.
The main point here is that a number of choices that any one individual can make are numerous. Personal experiences and believes usually guide you in your selection of options, alternatives and efforts to improve your health.
Healthcare and wellness related accreditation
Furthermore, not a small part of your choice in your selection of healthcare practitioners will be their professional accreditation. In simple terms, accreditation means compliance with regulatory requirements to qualify for the job. Most of you would prefer to seek advise of a healthcare or wellness practitioner who has such accreditations.
Some prefer to use services of a practitioner with a specialized accreditation and focus in a specific area of wellness. Others may choose one with more holistic approach to health and wellness. Again, it is a matter of choice. However, ultimately, these services have to lead to tangible results. In this case such results would be an improvement in your health. Specifically, you’d be eager to experience an improvement in the issue that brought you to the wellness practitioner originally. Consequently, you will likely assess the benefit of your practitioner’s choice based on the change in your wellbeing.
What are the similarities between healthcare practitioner and medical device accreditations?
The subjects of accreditation and compliance with regulatory requirements are important aspects in medical device business as well. Thus, we can draw simple parallels between the healthcare practitioners and medical devices. Similarly, we can draw a parallel between wellness practitioners and the category of general wellness devices. Both of these two, latter, categories can be referred to as non-medical.
Medical device is an accreditation given to a device that can provide a defined health benefit under specific conditions. Just like letters MD differentiate accreditation and qualification for medical doctors, the name medical device does the same for technology.
In most countries, only designated regulatory bodies can grant medical device accreditations. For example, in USA such a regulatory body is the Food and Drugs Administration, or FDA.
There is a tremendous multitude and variations of medical devices and their types. They range from very simple tools, like tongue suppressors, to very complex, like X-Ray and MRI machines, to name some of the better known. Even an app on your mobile phone or a handheld device, can be classified as a medical device.
Consequently, medical devices range widely not only in their technological complexities, but also in the benefits, which they can deliver. For example, an MRI machine, a diagnostic device, can help a neurosurgeon to better plan a complex brain surgery. However, any surgery will be hard to do without a simple surgical scalpel, which is an interventional medical device.
What are the types of medical devices according to FDA?
The FDA denotes classifications for easier definitions of complexity and risk levels associated with medical devices. Thus, the FDA designates three main classes of medical devices, although the full hierarchy is more complex. These class designations refer to the level of risk and complexity associated with a particular device and its use. For example, Class 1 medical devices fall under the lowest risk category. Those devices that are Class 2 have higher levels of risk associated with their use. Finally, Class 3 medical devices are those that have the highest level of possible risk associated with their applications.
Digging deeper into the subject of medical devices, it is important to note rigorous regulatory requirements for the device manufacturers. These requirements include highly regulated design and manufacturing practices, which have to comply with strict standards imposed by the regulators. Furthermore, all design decisions have to be supported by the data from rigorous scientific research.
Over the last two decades, technology has progressed significantly. With this progress came opportunities to use new technologies in design and development of new products. Many of such products are devices that can help to improve your wellbeing. While some of them have classifications of medical devices, others fall under general wellness device category, or non-medical device category.
What is a general wellness device?
General wellness device is a category different from the medical device categories. You may be curious to know what is a general wellness device. You may also want to know how general wellness devices are different from their well-established and better-known medical device cousins. Answers to these important questions may help to remove doubts and confusion that you may feel about general wellness devices.
In theory, one of the differences is simply defined by the benefits that the manufacturer can claim for the device. However, in reality, oftentimes, the main difference is in the regulatory definition related to the intended usage of the device.
For example, a medical device has to demonstrate a defined benefit for a specific application. Methodical and rigorous research data has to support the claimed benefit. Furthermore, compliant clinical trials have to be the source of the supporting clinical data. Thus, only medical device status offers the manufacturer the right to claim that their devices deliver a defined benefit, or benefits, for a specific medical condition. In other words, that such a device can treat a specific condition or disease. Thus, such claims can be made only for medical devices.
Non-medical or general wellness devices
On the other hand, a device, which may deliver the same, or very similar effects on the body, under the same conditions, cannot be called a medical device, if it was not subjected to all the required clinical trials. However, limited clinical data does not make a device unhelpful on unusable. It simply means that it cannot claim a medical device designation, at least not until all required trial are done. Furthermore, such devices can be categorized as non-medical or general wellness devices.
What is the difference between medical devices and general wellness devices?
Notably, a treatment for a specific condition or a disease is the territory of medical devices only. As non-medical devices, general wellness devices can provide only general health and wellbeing benefits. They can be sold to the general public as a general wellness devices that offer only general wellness benefits.
What is a general wellness benefit?
General wellness devices can deliver benefits to physical health in one form or another. For example, some devices can produce a specific from of heat helpful for muscle recovery after exercise. Another device can deliver light or electric charge to do the same. Thus, the common thread for these devices is their ability to deliver a general wellness benefit.
A general wellness benefit is as a health-related benefit that is not a treatment for any specific medical condition. Therefore, such devices get classification of general wellness devices, as noted earlier. Furthermore, the manufacturer has to make sure that device complies with safety requirements defined by the regulators. Such compliance provides assurance that the device is safe in exploitation. For example, electrical general wellness devices have to comply with specified electrical safety standards.