The steps to FDA approval for a medical device

Medical devices play a huge role in the health-care industry. They are there to resuscitate patients, monitor vital signs, diagnose disease and give medical support when needed. Because they are responsible for maintaining, preserving and improving the lives of patients, it is vital that these medical devices perform properly. The U.S. Food and Drug Administration (FDA) is responsible for ensuring that medical devices are safe and effective for use. It is no surprise that such a large government agency with such an important job has a strict set of rules and guidelines to follow when it comes to approving effective devices for medical use.

When working to approve a new medical device, many steps need to be followed precisely. The FDA’s Center for Devices and Radiological Health (CDRH) is responsible for regulating the firms that manufacture, repackage, re-label and import medical devices that are sold in the United States. The device requirements follow a rigid set of guidelines in order to ensure quality and safety. While the class of a device will determine how strenuous the process is, gaining the FDA’s approval is not an easy task at any level. Be extra cautious when purchasing medical equipment from China that is not FDA Approved. Items that are sold on eBay and other websites could cause more trouble than the bargain is worth.

According to the FDA’s Device Regulation and Guidance Overview, the basic regulatory requirements for manufacturers of medical devices include:

  • Establishment registration
  • Medical Device Listing
  • Premarket Notification 510(k) or Premarket Approval (PMA)
  • When FDA review is needed prior to marketing a medical device, the FDA will either:
    1. “clear” the device after reviewing a premarket notification, otherwise known as a 510(k) (named for a section in the Food, Drug, and Cosmetic Act), that has been filed with FDA or,
    2. “approve” the device after reviewing a premarket approval (PMA) application that has been submitted to FDA.
  • Investigational Device Exemption (IDE) for clinical studies
  • Quality System (QS) regulation
  • Labeling requirements
  • Medical Device Reporting (MDR)

Once a device has the approval of the FDA, then they can move forward with putting the device into practice. Medical Device Depot only sells FDA Approved medical equipment, so you can rest assured that you will have the best quality when your browse our selection of devices.

How 3D printing could make for inexpensive medical devices

A layering process builds objects from the base up until the job is complete. From clothing to mechanics, nearly anything can be created using a 3D printer. 3D printing has made the production of numerous objects far more accessible than they may have been in the past. Many items that you may have never guessed are being printed with this technology, such as medical implants, jewelry, shoes designed for individual feet, lampshades, racing-car parts and cell phones. Even the biotech industry is involved now, and it has a promising future building organs and tissues.

With a quick, automated way to build products from the ground up, the production process costs far less, resulting in a much more affordable end product. While 3D printing has been around for quite some time, it was formerly used mainly in industrial settings. Like all technology though, as hardware gets smaller, more affordable and easier to use, the tech spreads to other industries.

The medical device industry has quickly jumped aboard, looking to maximize the benefits of 3D printers. There is still a long road ahead for the industry, but the beginning of the adventure looks very promising. Using this type of technology, customizing a medical device or implant has become much more accessible for manufacturers. Certainly mass production has its benefits, but the real win is in being able to fit a product to an individual flawlessly. No more adjusting an uncomfortable hearing aid, for example. The patient will have a perfect fit that slides right in and stays put.

Because printing enable companies to produce this type of customization on a more scalable level, it makes the end result more economically viable. If a company needs a specialized part, it would be cheaper and quicker to have the part printed locally or in-house instead of ordering one from a supplier.

Buying tips for Ultrasound Machines

Much faster than x-rays and without the use of radiation, ultrasounds are the preferred form of radiographic techniques. Ultrasou­nds have been used successfully in obstetrics and gynecology, cardiology and in cancer detection for many years. Because they are a staple in many medical offices, it is important to understand how to find the best quality for each application. As a medical professional you don’t want to pour too much money into a piece of equipment that you won’t use enough, but you definitely don’t want to skimp when it comes to quality either. When looking for an ultrasound to add to your office, there are a few guidelines to follow to ensure you get the best for your practice.

When buying ultrasound machines consider:

  • Size – Do you need portable or stationary?
  • What will it be used for? Obstetrics and Gynecology, Cardiology or Urology?
  • Check the certifications to ensure that the machine is held to its strict safety standards. Look for USA/FDA/GMP, CE Mark/MDD and ISO 9001 certifications.
  • The technical specifications – Thigns like power output, imaging required, color Doppler and whether a DICOM or a DIGITAL system is required.
  • Check for a warranty or return policy.

Ultrasound machines can cost a pretty penny. If you are trying to stick to a budget, consider a used machine if you want a top brand such as ATL. Many offices choose to buy used machines or lease machines as well. If you are going to trade in an old machine, that can help make it more affordable, too.

Will the iWatch be the next big medical device?

With the constant evolution of technology, there is always the possibility that a new device or technology will be the next best thing in the medical device world. While consumers were elated to hear that Apple would be joining the wearable technology ranks with the iWatch, the health-care industry is equally excited to learn that Apple may have medical uses in mind for the anticipated iWatch.

Over the past year, Apple has acquired at least six prominent biomedicine experts, mostly from the sensor technology field, according to Reuters. This expertise could allow the iWatch to monitor everything from blood-sugar levels to nutrition, which goes beyond what the fitness-oriented devices can currently offer. Some of these notable hires include Dr. Michael O’Reilly, the former chief medical officer of Masimo. He was integral to the company’s research into pulse oximetry, which measures the amount of oxygen in the blood. Another hire is Ravi Narasimhan, former vice president of Vital Connect, a Silicon Valley–based maker of wearable biosensors. Additionally, Roy J.E.M. Raymann led research into how devices can more accurately monitor temperature, hormone production, and circadian rhythms to boost sleep quality at Philips’ sleep laboratory. Hardware developer Nancy Dougherty, of San Francisco start-up Sano Intelligence, helped create one of the most sophisticated sensors yet, capable of tracking kidney and liver function, measuring electrolytes, and determining, in real time, the amount of sugar in the blood.

While much of the talk about what the iWatch may offer is mere speculation, Apple does have a reputation of revolutionizing current markets. A mobile health executive told Reuters that Apple has aspirations beyond wearable devices and is considering a full health and fitness services platform modeled on its apps store. While Apple will not comment on such claims, a medical iWatch could be a boon to the medical device community. This could go far beyond the rudimentary offerings of current wearable devices and provide medical professionals real insight into their patients’ vitals and much more.

 

MDD Employees attend the TAPS charity

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On Tuesday, February 24, 2015, employees John Gladstein and Matt Berens hit the ice rink with the Washington Capitals players for a good cause. The skating party that was hosted by the washington capitals benefited Tragedy Assistance Program for Survivors.

TAPS is a non-profit organization which offers compassionate care to all those grieving the death of a loved one serving in our Armed Forces.

 

 

 

 

 

 

 

 

 

How do apps affect the medical device industry?

There’s an app for everything these days, so it should come as no surprise that there are health-related apps as well – a lot of them. In fact, as far back as 2013 there were already more than 43,000 medical apps; researchers prognosticate that the health app market will reach $58.8 billion by 2020.

But is the health app explosion a good thing for the medical device industry and the general population?

It depends, namely on the information or services each individual app is providing. Apps have the potential to be helpful to the medical device industry by partnering with current devices to transmit data more efficiently, as well as provide supplemental information about a patient that the person may not know or be able to convey themselves. However, apps that provide their users with poor information can have a negative influence on the user’s health and health choices.

As the mobile health industry has evolved, the FDA has kept pace, treating health apps as it would any other medical device. “The FDA encourages the development of mobile medical apps that improve health care and provide consumers and health-care professionals with valuable health information. The FDA also has a public health responsibility to oversee the safety and effectiveness of medical devices – including mobile medical apps,” it said in a statement. The FDA already works to determine which apps classify as medical devices and which do not merit FDA registration.

Effective health apps have the potential to be an important partner to the medical device industry, and that benefit figures only to grow as apps develop and the medical device industry itself works to create the apps it needs. But no matter the new tech, there will always be a place for apps that share accurate information in a safe, effective and healthy manner.

Vaccinations: 5 reasons you can’t afford to forgo them

Vaccinations have become a hot-button issue with strong opinions on both sides of the debate. Medical Device Depot supports vaccinations and believes vaccinating children offers numerous benefits, five of which are included below.

* Vaccinations can save a life. Many diseases that once killed thousands of children years ago are now all but extinct thanks to the application of vaccines. Polio, for example, was once the most feared disease in the nation; today there are no reports of polio in the United States. Vaccinating a child protects him from these harmful diseases and can even save his life.

* Vaccinations are safe. The application of a vaccination may cause some discomfort, but more severe reactions – such as allergic reactions – are very rare. Each vaccine is the product of a thorough medical review, and the risks of not vaccinating your child far outweigh the pain or discomfort of the vaccination itself.

* Protect others as well. Vaccinations protect not only the vaccinated but those who come into contact with the vaccinated as well. Some children are too young for a complete vaccination and others may have severe allergies or weakened immune systems that cannot handle a vaccination. Vaccinating your children prevents their spreading of disease to these higher-risk groups.

* Protection for future generations. Children today don’t have to worry about diseases such as small pox or polio thanks to the vaccination practices of previous generations. What diseases will tomorrow’s children be able to safely avoid thanks to the vaccinations of today?

* Cost and time effective. Children who haven’t been vaccinated can be denied entrance to schools or daycare facilities, causing you to miss work. And if they do become sick with a debilitating disease, the related problems could lead to increased bills and even long-term disability care. Vaccinating children eliminates these risks.

These are just five benefits of vaccinating your children. There are hundreds of others. Vaccinate your children as soon as possible, as it’s the best way to keep them healthy now and in the months and years ahead.  

The perfect spirometer for anyone prescribing Afreeza®

The new diabetes drug Afreeza® is finally available! This is great news for diabetics everywhere. And for endocrinologists, the need for basic spirometers is higher than ever.

One option no medical office can afford to pass up is the Astra100. This device is the perfect resource for any endocrinologist looking to perform an FVC and an FEV1. The Astra100 also measures FEV6, FEV1/FVC, FEV1/FEV6 and PEF.

This spirometer is easy to use and cost efficient. It allows you to test right in your own office and can be used to test lung function for asthma and COPD, or in a pre-screening and patient-monitoring capacity.

The kit includes the Astra100 spirometer, a padded carrying case, USB external printer cable, 10 AstraGuard bacteria/viral filters, 10 noseclips, a quick reference card, 2 AA 1.5-volt alkaline batteries and a turbine transducer. You’ll also have the benefit of a 2-year warranty, giving you the dependability you deserve.

Afreeza® is here and the Astra100 is the prefect spirometer to help you provide your patients with the care they need. Contact Medical Device Depot today to learn more about bringing the Astra100 into your office.

WARNING: Risk of Acute Bronchospasm in Patients with Chronic Lung Disease.

* Acute bronchospasm has been observed in patients with asthma and COPD using Afrezza®.

* Afrezza® is contraindicated in patients with chronic lung disease such as asthma and COPD.

* Before initiating Afrezza®, perform a detailed medical history, physical examination, and spirometry to identify potential lung disease in all patients. 

What to look for when buying an exam table

The medical exam table is the focal point of any healthcare facility. It’s the first thing patients notice and the only tool they will use themselves, so finding the right table is important.

Which exam table is right for a given practice varies depending on the medical office, but offices in the market for new exam tables should keep the following things in mind:

* Size matters. Adjustable tables will better meet the needs of patients of varying heights and weights. Tables that recline also allow for seated and prone examinations, and tables with a lower treatment height can negate the need for a step stool. Lastly, consider tables that offer accessible transfer height, making it easier to accommodate patients in wheelchairs.

* Store a little more. Exam tables with storage capabilities offer medical offices an easy way to store extra gowns and gloves while maintaining a clean, obstruction-free space. Push-through drawers give doctors access to the materials they need from either side of the table.

* Keep it clean. Cleanliness is paramount in a medical office and an exam table that can be properly cleaned quickly ensures that new patients can be brought into a sterile environment without delays. Tables with a laminate base offer easy cleanup, and some tables offer bacteria-fighting paint or even a microbial guard.

* The right options for the right office. An exam table should match the needs of the office it’s in. Tables with armrests or lower treatment heights are perfect for senior visitors, while tables with pull-out pads, pans or stirrups may be beneficial elsewhere. Purchasing a table with options that match the needs of the office will reduce future expenses down the road.

What does your office need from its medical exam tables?

Top industry influencers of 2015

It is important to embrace that collaborative spirit while you work to stay up to date on the advances in the medical device world. With news coming from numerous manufacturers and all over the world, it helps to be tuned in to a variety of inside voices that can keep you privy to the latest and greatest. Whether you are interested in a small segment of the industry or want to have an overarching idea of the general happenings, industry influencers should be your go-to source of quick information.

Be sure to follow the musings and news from these top medical device influencers:

  • Joe Hage – He is the leader of the world’s largest medical device community, Medical Devices Group. Follow his Twitter account @MedicalMarcom for the latest.
  • Medical Device Daily - The industry’s most prominent news source. Follow their Twitter account at @MedDevicesDaily.
  • Rob Stein – Follow the correspondent/senior editor at NPR, who focuses on health, medicine and biomedical research at @robsteinnews.
  • Qmed – The @QmedNewss account is run by the editors of Qmed News, who track news and supplies in the industry.
  • Medical Device Manufacturers Association Following leaders like MDMA @medicaldevices will help you to keep track of the most influencial events and laws.

And don’t forget to add @MedDeviceDepot to your list. We will keep you up to date on industry happenings, as well as new devices that are in stock.