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, 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, 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

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, 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.

As the medical field continues to grow and develop, new custom medical devices are needed to help patients better recover from surgeries. We recognize a variety of needs in healthcare so we do not limit our designs to one specific medical area. With the vertical design and manufacturing process, we have complete control over designs and final products and can ensure every tool is up to our high-standards. The fast-paced medical world is beginning to implement disposable medical tools because of their many benefits to doctors, healthcare centers, and patients.

Benefits of Disposable Medical Supplies

  • Decontamination – Disposable medical tools ensure a contamination free instrument before each surgery. When a tool comes to the healthcare center pre-sterilized, the decontamination or lengthy sterilization process isn’t needed, therefore saving healthcare centers money.
  • Traceability – Once a tool is used, disinfected, and put into storage, it’s cleanliness isn’t traceable. Disposable, one-time-use tools ensure the ability to account for all pieces of inventory and full traceability. The lot number that each piece has is able to be traced back to the medical manufacturing plant to prevent inconsistencies and issues.
  • Supply Logistics – Inventory that is lost, broken, or stolen takes a significant amount of money out of the bottom line of a healthcare center. Single-use instruments allow for supply tracking and ensure there isn’t an abundance of one tool, which can tie up capital.
  • Risk Management – Infection and the mitigation of spreading of diseases is one of the highest priorities in a medical facility. Contaminated instruments spread infection, create health issues, and can complicate surgical recovery. When instruments are used once, there is no risk of cross-contamination between patients.
  • Cost Allocation – Accounting for each tool used in a surgery helps accurately calculate the cost of each surgery. When using reusable tools, the mix of initial cost, sterilization cost, labor cost, and utilities can make it difficult to accurately account for total cost of procedures.
  • Waste – While many argue the amount of waste single-use tools create, the energy, water, detergent, steam, and electricity used to decontaminate reusable tools is more detrimental to the environment than disposable tools.

Remington Medical doesn’t focus on specific medical specialization tools, but instead works directly with healthcare professionals to develop innovative tools specific to their needs. Our special, vertical integration ensures each step of the design and manufacturing process is accomplished effectively and efficiently. This ensures quality products as well as the ability for a quick turnaround time and complete customization. Whatever your medical specialization, see how Remington Medical can improve your disposable medical tools today.