Choosing a Medical Device Logistics Company in 6 Easy Steps
Providing medical gadgets to hospitals, doctors’ offices, and everything in between isn’t like selling most other things. There are a few things to keep in mind, such as how to store the devices and ensuring that both the devices and how they are handled comply with MHRA approved warehousing UK. In this sense, selecting the right medical device logistics company from a plethora of options is critical and should not be taken lightly. So, you can find yourself in a pickle trying to figure out how to go about doing this.
The following steps should be taken when selecting a medical device logistics company:
• Examine the company’s adherence to FDA requirements.
• Choose a company that has strategically located warehouses.
• Ascertain that the provider can meet your medical device’s specific storage and distribution needs.
• Confirm the company’s transportation capacity.
• As needed, discuss additional services.
• Create a reverse logistics strategy.
We take a detailed look at each stage in our thorough guide below, providing you a complete picture of what has to be done to identify the proper medical device logistics firm.
STEP ONE: OBEDIENCE TO THE FDA FDA regulations are followed
It’s difficult to “rank” the processes in selecting a logistics business to handle your medical devices, but it’s simple to strike a company from the list if they don’t follow the FDA’s laws and best practices for managing the products.
First and foremost, let’s define what a medical gadget is. One might quickly think of complicated technology such as MRI or x-ray machines, but a medical device, as defined by the FDA, might be as simple as tongue depressors or as commonplace as blood glucose monitors. Because the healthcare business and system rely heavily on these products, it is critical that the various medical devices be readily available.
The Food, Drug, and Cosmetic Act has a section 201(h) that governs what the FDA considers to be a medical device. To recapitulate, there are three characteristics that can cause your product to be classed as a medical device:
• It is recognized by the United States Pharmacopoeia or National Formulary.
• The equipment in question is designed to aid in the cure, treatment, or prevention of disease.
• That which has the ability to alter the structure and function of the body without the usage of a chemical action or reaction.
After you’ve determined whether your product is a medical device based on the above criteria, you may check the FDA Product Classification Database to see if the devices you’re planning to sell are already classified. There are a few things you can do while waiting to make this call:
• Use the above-mentioned database to do your search.
• Look for similar products on the internet or in a database.
• By reviewing the device listing, you can find similar devices.
One thing to keep in mind is that software, whether it’s a computer program or a mobile app, might be classified as a medical device. This is referred to as Software as a Medical Device (SaMD).
STEP 2: IDENTIFY THE APPROPRIATE WAREHOUSE SETUP
Once you’ve determined that you have qualified medical devices that are in FDA regulatory compliance, the following step is to select the best location to keep them until they’re ready to be delivered to the end user.
This is an important step toward partnering with the correct logistics provider for your medical devices, therefore it should be treated carefully. The first step, if possible, would be to personally walk through any warehouse where your products would be delivered to be housed. Because medical gadgets can be expensive, you’ll want to make sure they’re being properly cared for. If visiting the warehouse is not possible for any reason, conduct your own study. With the internet’s widespread use, you’ll almost certainly be able to read evaluations of logistics businesses to get a sense of how they operate.
Medical devices, particularly those with electronic components, should be kept in a clean, climate-controlled environment. Despite the fact that medical devices should not be perishable, they should be preserved in the best possible condition. Aside from that, the warehouse should be properly set up to maximize efficiencies and protect the integrity of your medical products (to the best of your knowledge).
A Warehouse Management System (WMS) is also used in many warehouses to keep track of where and how many devices are in the building. These are beneficial because the logistics business can share that information with you, namely the amount, allowing you to fill orders more accurately and know when to send more medical devices to the warehouse.
The location of a warehouse is also very essential. Assume your business is based in Seattle, but you do a lot of business in New York City. The warehouse you’re offered should be close to where the goods has to go, or in a decent centralized location if it’ll be easily disseminated to multiple locations across the United States.
At conclusion, look for a temperature-controlled warehousing option in a convenient location for your company.
STEP 3: CONFIRM THAT THE LOGISTICS COMPANY HAS BEEN REGISTERED WITH THE FDA
You may argue that this should happen before or during the warehouse inspection, but we’re putting it last because you won’t care about this step if you don’t like where the warehouses are located or how they appear to be run.
However, this is critical in many ways because the only way a logistics firm can be FDA registered is if it meets all of the requirements. If the warehouse is to be registered with the FDA, it must be in safe and clean condition (as described above). This implies that there are no pests present, such as rodents or insects.
While this next need may be more applicable to perishable items, it is nonetheless useful to have for medical devices. That is a method of labeling that is both clear and accurate. Expiration dates, temperature requirements, and batch numbers are all items that must be included on the labels. The labels, in particular for medical equipment, provide a clear picture of the chain of custody, which is required by the FDA. Lot control systems are another thing that is similar to labeling regulations.
These systems are set in place so that products within a warehouse are properly stored and organized so that they can be conveniently retrieved at a moment’s notice. The system is in place to distinguish between goods from different batches or brands. If any recalls were to occur, the lot control system would be beneficial in cutting costs.
Any FDA warehouse must undergo routine inspections, keep accident and other emergency procedures in place, and handle product recalls. In many circumstances, the facility should be securely guarded, which means that no one should be able to stroll in and out with access to your medical gadgets.
Classification of Medical Devices
This is particular to the items you’ll be storing and any warehouse that offers medical device fulfillment services. However, the FDA-approved logistics firm you choose should be able to handle both Class I and Class II medical equipment. The FDA divides medical devices into classes to indicate the level of danger they pose to both the patient and the healthcare professional who uses them.
You must ensure that Class I and II medical devices can be handled, as well as that the logistics business can manage the additional labeling required by Class II medical devices.
STEP 4: SHIPPING CAPABILITIES OF THE 3PL
So, you’ve determined that the third-party logistics (3PL) company can appropriately store and manage your medical devices and is FDA-approved. But how are you going to deliver your products from their warehouses to your customers? Although healthcare logistics differs differently from standard logistics, your 3PL business should be able to provide you with some fundamental logistics solutions.
The first is that trucks are readily available to transport your goods anyplace in the United States. Those 18-wheelers should be able to take your medical devices wherever they need to go when you need them. If an 18-wheeler isn’t available, a fully covered 3PL can provide vans for smaller, more secure shipments, or even have relationships that allow for the utilization of ocean, rail, or air freight delivery as an option when it makes the most sense.
You should look at their declared on-time arrival rates or incident reports in addition to their capacity to easily put items on the road, sea, or air (if those numbers are available). This can demonstrate not just that transportation for your medical devices is common, but also that if you agree to have the 3PL in question ship your products, they will arrive on time and in pristine condition. Whatever happens, you should feel secure in the transportation services offered.
While some of these information may be difficult to obtain, it’s also important to ensure that the 3PL you’re considering has financial strength and is in good financial shape. Domestic transportation may be sufficient depending on your demands, but it would be wonderful if they had a global network in place in case you ever needed that type of reach.
Cross docking is one of the services that your company may require. In most circumstances, a cross docking facility allows you to swiftly transfer your medical devices from one truck to another without the need for short-term storage. R+L Global Logistics has various sites across the United States that provide cross docking services.
STEP 5: DO THEY PERFORM ORDER COMPLETION?
Is it true that they fulfill orders?
While the medical device logistics firm you’re considering might store and distribute it for you, it’s reasonable to inquire if they’ll also complete orders at your request. Purchase fulfillment is the procedure through which a third-party logistics provider stores your medical devices in their warehouses and then packages or transports them to the end user after receiving your order. This is a very important step in the supply chain solution list because it makes sense that if you’re using a 3PL’s warehouse storage, you wouldn’t want the items delivered back to you so you could transport them yourself.
If presentation is essential to you, it won’t be good enough for them to dump your items into a box or leave it packaged generically, just like the previous procedures. As a result, you must determine whether they are capable of fulfilling orders in a manner that best represents your company. If you outsource your warehousing, order fulfillment, and shipping, you must understand that your medical device items are out of your control, and you must have a business partner you can trust implicitly, because the next time you’ll hear about it is from the client after it’s been delivered.
You can proceed to the following step if you’ve decided that the medical device logistics firm provides warehouse fulfillment services that satisfy your requirements.
STEP 6: INQUIRE ABOUT REVERSE LOGISTICS
A producer or wholesaler can’t avoid dealing with returns, whether it’s medical equipment or any other type of product. You can have the customer ship the item back to you directly, or you can have the 3PL business that fulfilled the order also handle returns, which is known as reverse logistics.
A great medical device logistics business will be able to provide you with tailored solutions so that your returns are processed the way you want them to be. There are several possibilities, each with its own set of advantages:
You can delegate everything to the 3PL: This is a good option if you’ve trusted them with everything up to this point and don’t want any more headaches on your plate. The 3PL can ship a new product to the original client based on your directions, while discarding, reusing, or salvaging useable parts or materials. Having the goods disposed of or recycled prevents them from being re-routed to you, and recovering resources from a broken medical device can be both cost-effective and environmentally friendly.
You can tell the 3PL to accept returns and then return them to you: If you want to be more hands-on with how returns are handled, or make sure the recycling/salvaging process is done exactly how you want it, you can have them shipped to a 3PL for initial intake, where they can sort them into one of three categories, throw away the garbage, and send the rest back to you so you can figure out what can be salvaged.
You can instruct the 3PL firm not to engage in reverse logistics: if you want complete control, have any customers who have issues with their medical devices send them back to you. You can have the 3PL send them a replacement product right away if they need it, but you’ll have to deal with the broken or non-functioning things yourself.