Last time in this blog series we discussed how to determine if your idea is likely to be successful when presented to target customers. In this blog, we’re going to talk about some of the hurdles that your product will have to clear to make it to market – the special requirements and considerations you need to satisfy before you can sell to those eager customers!
To win the race to profit for your great idea, you’ll need to overcome the following three critical obstacles: Regulations, Timelines and Reimbursement.
In the USA, medical devices are strictly controlled by a set of regulations issued by the FDA and you need to work out which type of device you are making to know which regulations you’ll need to meet. There are three classes of device: Class I are low risk devices, such as a Band-Aid; Class II are medium risk devices, such as a powered wheelchair or some pregnancy test kits; finally, Class III are the highest risk of device, such as life-support machines. The type of classification of your device can greatly impact the cost of testing and certification timing, so it is important to get it right. This classification will also affect how you take your product to market; for example, most devices in Class II and all devices in Class III require intensive review of technical data by the FDA before you start marketing your device, which can be a very lengthy process. Additionally, classification for a product may vary based upon the claims made and how the product is used. Some companies have opted to go to market as health aids vs. medical devices to lower investment and speed time-to-market.
PRODUCT DEVELOPMENT TIMELINES
Medical devices, due to their nature and classification, will require extra documentation, verification and validation (V&V) testing, and maybe even clinical trials, to gain FDA clearance before they can sell into the medical device market. You should make sure that your business plan allows for this extra time and resources, which sometimes takes more than 12 months, as you will need to stay in business while these steps are completed before you can start to sell your product.
Having jumped over the previous two hurdles you would think that your newly-certified device is going to fly off the shelves. Sadly, in the United States, hardly anyone will buy a medical device if it does not come with a “Reimbursement Code” system. Getting this system in place will take a long time, even longer than your development, certification and clinical trials; so, even after your product is ready to sell, it might take a while for you to start making the profits you want. During the development stage of your product you should create a team of people to run this program, as you will need to collect data throughout the product’s life from this point on, as well as start to gain supporters in the medical communities (government, foundations, etc). As you near completion of your regulatory testing, you’ll need to start to try to obtain the “codes” for your product and then talk to payers within the insurance companies and provide excellent customer support. Something else to consider is that often companies will identify codes that their products will fit into to avoid the risk of trying to get a new code through the approval process (something that may not happen).
Overall, there are many variations and strategies that can be employed to aid your product’s journey through the rigors of the go-to-market landscape. While this all seems like long, hard work, it will be worth it when your product is a success. PRG is committed to being a partner to you to help make this process as seamless as possible.
In our next blog, we’ll discuss how to take the business model you’ve just created for your idea and try to get funding from investors. In the interim, please be sure to check out our website and some of our previous blogs on MedTech here.