The worldwide medical device industry is booming with activity, projected to grow to a little over $700 billion in 2029 from the current $490 odd billion. In 2017, 22 % of spectacle wearers purchased their prescription eyewear online. Come 2020, this number grew to over 44%.
There are two catalysts driving this trend.
Chronic disorders are prevalent because of our sedentary lifestyle. And the rise of these disorders have become a burden to healthcare institutions worldwide.
There has also been an economic impact due to the rapid increase of patients requiring in-patient monitoring. As a result, there is a paradigm shift toward home care. This shift necessitates the use of wearable or portable medical devices.
Patients order their eyewear, glucometers, and test strips online. Clinics and hospitals shop for supplies such as tongue depressors and speculums using eCommerce tools. Online sales of medical devices have removed the hurdle that was inaccessibility.
Most neighbourhood retail pharmacies only carry a couple of brands in each medical device category. In contrast, specialized wholesale medical stores have more options in their inventory. But they are not conveniently located.
And we cannot overlook the price variance between retail and wholesale stores. Shoppers are often shocked when they notice the 100% price surge on the tag.
Those in poor health and seniors with mobility issues tend to rely heavily on neighborhood pharmacies. Hence, they often missed out on better products and deals.
Unable to travel to purchase what they needed, they depended on others like caregivers to help them out. This limited the choices of those in dire need of medical devices.
However, eCommerce stores rescued them from their plight, and customers were no longer at the mercy of physical stores. Online pharmacies had better prices and product ranges present in eCommerce marketplaces.
And customers could get their medical devices as quickly as the day they placed the order or within the next couple of days. Even if the customer was in a hurry and opted to pick up their product at a retail store, they could always shop for refills and accessories online.
The fact is that eCommerce stores cater to those not in the best of health. They offer a convenient shopping mode, hassle-free payment, and delivery options. They also stock a greater variety of products at a better price.
Medical devices bought online are either returned or recalled for one main reason. Safety.
Defects of all kinds lead to the return of medical devices. A non-functioning product or one that gives the wrong reading poses a hazard. The product may not work as it should or as described. Sometimes users may experience undesirable effects when using the device.
All manufacturing processes must undergo rigorous testing and quality control procedures. This is to ensure that the devices are safe for patients and physicians.
However, sometimes even the best products can have defects that go unnoticed until they cause problems. When this happens, a recall or return may be necessary in order to correct the issue.
Recalls or returns typically begin with safety or manufacturing issues. These are identified by the device maker, physicians, or patients. In some cases, a device may be recalled due to a single reported incident; in others, multiple reports may be required before a recall is issued.
Once a recall is initiated, the manufacturer will work with the FDA to determine the cause of problem and take steps to rectify it. If necessary, the recall may extend to distributors and retailers selling the affected product. Returns are typically handled case-by-case and may involve replacement of the defective device or refund of the purchase price.
Medical device recalls, and returns can be disruptive for patients and manufacturers, but they are vital to patient safety.
Reusable medical devices must be decontaminated or disinfected. Every returned medical device is a hazardous bio-contaminated material. These need to be transported and discarded. Other devices should be disposed in-house or through commercial services.
While a necessary part of keeping people healthy, the returns of medical devices can also have a negative impact on the environment. For example, many medical devices are made with harmful chemicals. They can leach into the ground and contaminate soil and water supplies.
In addition, the disposal of medical waste can attract vermin and other pests, spreading disease. As such, the medical industry must take steps to minimize the environmental impact of its activities.
Medical device manufacturers receive customer returns for various reasons, including failure investigation. Your company should establish procedures at both ends of the supply chain for the shipping, handling, processing, and disposal of such products.
Handling and processing eCommerce medical device return appropriately is the responsibility of both the manufacturer and the customer.
At the manufacturing end, controls should be in place to ensure that returned products are handled safely.
Products should be shipped in leak-proof containers and labeled as potentially contaminated. Processing should be done in a designated area using personal protective equipment. All product disposals should be done in accordance with local regulations.
Procedures should be in place to ensure that potentially contaminated medical devices are properly packaged and shipped. Customers should be given instructions on how to dispose of potentially contaminated medical devices safely or package them for return.
There are seven key areas any business dealing with eCommerce returns of medical devices should work on.
In today's litigious society, product manufacturers must establish policies and procedures. These are needed to adequately address and control the status of potentially contaminated returned medical devices. Doing so can minimize liability and increase public, environmental, and employee safety.
Understandably, some customers might want to return a used or potentially contaminated product. However, it is in everyone's best interest if manufacturers discourage the casual return of any potentially contaminated medical device.
With proper policies and procedures in place, manufacturers can help to ensure that returned products are handled safely and appropriately, preventing further contamination and protecting both consumers and employees.
Before a manufacturer or distributor can develop a policy for handling contaminated medical devices, it's essential to sit down and evaluate the potential impact on various departments within the company.
What will be the most significant challenges? How will this affect the flow of work? What changes need to be made in order to accommodate the new policy? Flow charts can be a helpful way to visualize both the old and new process cycles.
They can help people see where bottlenecks might occur and identify potential problems that need to be addressed.
Your company may choose to provide return kits on your customers' request. Return kits will need to contain instructions that the customer will have to follow. You will also need to enclose forms, special shipping containers, or any required biohazard/warning labels.
Providing these materials makes it convenient for the customer. They also help you conform to any regulatory compliances or requirements. These materials will also provide validation of protection offered by the package.
Return kits also reduce the cost and time associated with a damaged or missing product. They also help you avoid potential international issues concerning customs or other import/export regulations.
Whether your customer is returning a product for warranty purposes or for regulatory reasons, having a return kit can save your company time, money, and headache.
When it comes to returning a medical device, you are responsible for ensuring that the product is repaired or replaced. This is provided conditions that are laid out by your store’s policy are met. You should clearly state the conditions under which a customer can return a product.
Take the time to explain how the product should be returned and send them specialized packaging should their returns warrant its necessity. Share the shipping address for return with your customer or send them a return label.
An RMA, or Return Merchandise Authorization, can be a vital part of managing customer returns for a medical device company. RMAs can ensure that returned items are handled in a compliant manner. They can also aid in tracking items' status.
Two factors drive the need for prompt returns of medical devices. The fact is that most medical devices are expensive commodities and have associated risk factors.
Choose a well-connected shipping partner who is well-versed in handling potentially bio-hazardous materials, i.e., returned medical devices. Ensure they possess the infrastructure to ensure safety compliance and speedy transit.
Dealing with returns in the medical devices category can be a tricky business. Not only do you need to deal with the customer's frustration, but you also need to make sure that the product is handled correctly. You need be certain necessary safety procedures are followed.
Medical devices may pose a severe risk if they are not appropriately handled. That's why employees must have access to and training in the proper procedures for handling and decontaminating medical devices.
Any and all personnel who come in contact with the product must be trained in safety measures. This includes personal protective equipment (PPE). PPE should be selected based on the risk factor and type.
They may include lab coats, gowns, gloves, head and foot coverings, face masks, and eye and respiratory protection.
All staff belonging to the waste-disposal team or housekeeping should be trained well to handle the returned medical device safely. Taking these precautions will ensure the that everyone who comes in contact with the product will remain safe.
Medical devices should be decontaminated or sterilized before being returned to a company. This helps ensure that the medical device is safe to use and eliminates the possibility of cross-contamination.
However, sometimes it is not desirable or possible to decontaminate or sterilize the product. Sanitizing a product could mask the reason for rejection and return.
Manufacturers should always consider all returned products as contaminated. They should run through the process of disinfection in-house before putting it on the shelf.
All medical devices need to be sterilized before disposal. This is to ensure all harmful or infectious bacteria and virus are destroyed. And that the disposed product will not be a health hazard.
All cleaning supplies that have been in contact with the returned medical device must be sterilized or decontaminated. If they are going to be disposed in a “red bag”, they don’t require decontamination prior to disposal.
However, it's always a recommended to check with state-specific agencies for disposal guidance, just to be safe.
When it comes to returned medical devices, implementing an appropriate RMA along with an automated returns software will make your returns hassle-free while also giving you data to reduce your returns. ClickPost can help with your online returns by providing your company with a returns management software solution.
ClickPost automates your return requests and creates and prints labels for your returns. It then assigns pick-up notices to designated logistics partners and sorts out potential non-pick-up reports. It also gives you a unified tracking page to view all of your product returns.
ClickPost can take over your returns management and allow you to focus on the post-return quality and safety protocols that need your supervision.
It is extremely crucial to stay on top of all your returns processes when it comes to eCommerce returns of medical devices. This is especially vital considering the potentially bio-hazardous nature of these products.
By tweaking a few key processes in your returns operations, you should be able to handle the reverse logistics and disposal of any returned products in a compliant manner.
Defective glucometers can be returned. Ensure you follow all the processes outlined by the manufacturer to process your returns.
Some stores may charge a restocking fee for non-defective products. Ensure you go through the store’s return policy to see if you are eligible for a full refund, exchange, or store credit. Follow the instructions for return as outlined in the store’s policy.