If you think your product is ready for the market and you’re looking into distribution, you’re in the right place. Hopefully, you already realize how complicated distribution is and you’re not planning on tackling this task on your own. However, some people might wonder if it’s possible to sell your product from your own garage. Well, here are the top 5 reasons why selling a product from your garage is a horrible idea.
1. Product Identification and Record Keeping
When working with distribution, a huge factor for success is keeping things organized. This means establishing and maintaining procedures for identifying products to prevent mix-ups. This is a requirement to know when and what you are selling as well as who you are selling to. Keeping a record of products prevents damage, deterioration, contamination, and other harmful effects from occurring during handling. It’s also mandatory to ensure all records are accessible to the FDA. All of this is basically impossible to do on your own. Hiring a distributor to stay organized with your records and product identification will keep you out of trouble with the FDA and avoid negative effects to your product.
2. Responding to Complaints
It is essential to respond to complaints and feedback regarding device use at all times, which must also be reported to the FDA in a timely manner. Each distributor needs to implement procedures for receiving, reviewing, and evaluating complaints which must be documented for FDA review. Whether the complaint involves failure of the device, labeling, packaging, or other errors, it must be addressed and corrected. The documented complaint then must be updated and submitted with relevant information for review. This is a full-time job that requires attention to detail and cannot be done by just one person, which is why hiring a distributor is important for successful distribution.
3. Managing Your Suppliers
Another major part of distribution is managing your suppliers. Your product’s success in the market is often dependent on the commitment of your suppliers, so managing your suppliers’ performance is crucial. To select the right supplier for you, you have to analyze their ability to meet specific performance requirements. Once you hire a supplier, you have to maintain recordings of who they are and important information about their work for FDA evaluation. Then, you have to document purchasing data that references specified requirements for purchased products that includes an agreement that the suppliers agree to notify you of changes in the product. This is not a part time effort, especially in today’s time of supply chain upsets and delays, so it's best for you to hire a distributor to do it for you.
4. Handling and Inspection
Handling and inspecting products is also important for successful distribution. You have to inspect a product to determine whether it conforms to the requirements as listed with your agency. This could mean examining products and their packaging to look for obvious problems with product quality. You will then need space to store your products and to perform inspection procedures. Your garage will probably not be big enough to hold all your inventory. This is not a one-and-done type of step- the process is painstakingly long and tedious, so you should really consider hiring a distributor to manage it for you.
5. Being Busted By the FDA
Last, but not least, you really don’t want the FDA to show up at your door. If you aren’t following FDA compliance, like trying to sell a product from your garage, you will get in trouble. It is illegal to sell a medical device in the U.S. without receiving approval from the FDA. To gain approval, you must prove that the device is safe and effective for its designed use. At this point, you should know what the advice is for avoiding getting in trouble with the FDA- hire a distributor. They will do the work so your product is approved for distribution, and in turn you won’t be thrown in jail.
If you’re looking for a distributor, Vita Group has established these controls and is ready to implement them for your idea in medical device development. Book a call with Vita Group's COO, Jason Scherer, to learn more.