Monthly Archives: March 2015

Massachusetts exemplifies the importance of small-scale device companies

Having competition in the market gives doctors and hospitals more choices when it comes time to purchase new medical devices. Companies big and small are all vying for a spot in the offices of doctors across the world. 

But in an economy where big names and large companies typically have a leg up on the competition, do small medical device manufacturers even have a place in this vast market? Do the same rules apply in the medical device world? You may think that the big names get all the attention, but start-ups can take advantage of opportunities the big companies miss.

There has actually been a push by The Massachusetts Medical Device Industry Council (MassMEDIC) to raise awareness of the benefits of small suppliers. Massachusetts is home to about 400 medical device companies, most of which have fewer than 75 employees. According to a survey conducted by MassMEDIC, Massachusetts medical device makers got 51 percent of their supplies from in-state suppliers.

The various sizes of companies can benefit one another greatly. In Massachusetts the sheer number of small medical device companies holds up 24,000 workers and produces the state’s top export, but small businesses need the support or larger manufacturers.

MassMEDIC plans to bring and large and small manufacturers together under a program called MedTech Match, which selects small suppliers to make presentations before representatives from large device makers. While this doesn’t guarantee large device makers will sign small manufacturers as suppliers, it does give each company the means to reach their goals. It also allows doctors and hospitals better options when it comes time to purchase devices.

Return Policies to Ensure Satisfaction

When purchasing large-ticket items, you want to know that you are getting the best fit for your office or practice. Buying medical devices online is typically very simple, but if you realize the item you ordered is not what you hoped once it arrives, you don’t have to eat the total cost of the equipment. As a growing practice, that type of financial blow could prove to be a large setback. Fortunately, if the device is not the one you need or want, Medical Device Depot allows you to return it within 30 days of purchase. Aiming for complete customer satisfaction, Medical Device Depot accepts all returns that are unused and clean. The product should have its original packaging, materials, and not have any damage – unless it occurred during delivery.

There are some unforeseen incidents that happen by no fault of your own, and a good supplier will understand that. Medical Device Depot is happy to pay for the return shipping cost if the product shipped was different from the one ordered, or the order was damaged. In all other instances, the buyer is responsible for paying all shipping costs and a restocking fee. In order to ensure a refund, follow the instructions outlines in the Return Policy.

With such a vast collection of items at Medical Device Depot, it can feel difficult to make the right decision. In order to ensure that you order the correct device for your use, speak with one of the many experts on hand. A representative will be available to chat online or speak over the phone to answer any questions or help you find the perfect device to fit your needs. This will ensure that you make the right choice the first time around, saving some of your valuable time.

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.