It may start with your idea at first but it should really start with your customers’ idea. You don’t need a PHD in the health problem you are trying to cure, but you will need to be intimate with the problem that your customers are facing. Be a detective and investigate what troubles them and they will practically build your product for you. The customers are your friends. Let them vent and you can just listen. This exercise is hard for entrepreneurs because we tend to have huge egos. But, Just take the backseat and listen for a bit. These are the folks that are going to use your product and they know their paint points the best.
From pre-validation, you now have the “intended use” for your product. It’s time to classify your product. Go to FDA’s medical device database to see if there are any already cleared devices that resemble the product that you want to develop. This is the best way to classify your device to find out A) what pre-market submission is required and B) to validate that there is indeed a viable market. If these products are already used in the market, there’s very little barrier for adoption by the user. Think about how much better value you are bringing to the market with your product compared to the existing. The advantage would have to be significant enough for them to abandon the current product for yours. If the existing product is an iphone 5 and you are creating an iPhone 5S, you should rethink your solution. If you are still uncertain, request from FDA for information regarding your device per 513(g).
Gather all the the EN/ISO standards, FDA guidances and certifications that your product will need to meet for submission. Keep in mind that this will vary depending on the country you want to launch your product. I highly recommend you outsource this piece to a regulatory affairs professional to ensure that you are on the right track. Engage them early in the discussion because you will learn that there are a few paths to choose from.
Prioritize what part of the quality system is necessary in the startup stage. Design Controls, Document control, supplier qualification should be on your list.
Do not underestimate document control. A good document management system is an extremely good return on invested time (ROIT). You will save a lot of time in the future by investing in QMS now.
Startups tend to try to do everything by themselves while running extremeley lean. Think about outsourcing: components, services, so you can focus on the things that no one else can do better, such as running your company. Even big corporations like Apple heavily rely on outsourcing to focus on what they are good at. Massimo for example is popular supplier for pulse oximetry and vital signs monitoring companies.
We are at a turning point in history where Tech will do a makeover for Healthcare. I hope these tips will help you and your medical technology startup ideas flourish in this space and provide great benefit to those in need.
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