Navigating the medical device space can be complicated. Boiled down, though, there are common areas of interest from the medtech community when it comes to getting a new product to market whether your company is a startup or an industry leader. Five of the main categories to consider are regulatory, reimbursement, quality, clinical and funding. Within each bucket, there exists a number of common considerations. Let’s highlight a few.
What’s My Regulatory Strategy?
Everyone knows the medical device industry is highly regulated. It costs money and time to get clearance or approval. Determining a regulatory strategy is a huge need for companies. You may find yourself asking questions such as: What market should I focus on? Do I approach the U.S. market? Do I try to get into Europe first? Do I focus on the emerging markets? A well-thought out plan should be determined so that you can weigh the costs of time and money, as well as evaluate the different hurdles involved within each particular market.
Another question is, “what type of submission do I pursue?” You might consider a 510(k), de novo, PMA or CE Mark. Also take into account emerging trends like combination products and that pharma companies are looking at medical device regulations and medical device companies are looking at pharma regulations. Understanding the strategies, best practices and relevant needs related to each submission type, and also who you are submitting to, is important before moving forward. Some organizations are determining early on whether to squash a project based on the regulatory pathway. For example, some companies don’t even consider Class III devices because of the time and costs it takes to get through the regulatory process.
What’s My Reimbursement Strategy?
Ask any reimbursement expert about the best time to start exploring reimbursement and they’ll tell you “start early.” A reimbursement strategy has even become a standard requirement when approaching organizations for funding. They want to know how payers are going to view the product you’re developing.
Coverage, coding and payment are important considerations since there is so much time and cost involved in the process. And, unfortunately, there have been countless instances where a company starts down the road only to realize they didn’t have a firm grasp on a reimbursement strategy, which ends up being a product killer. Incorporate reimbursement planning into your strategy early on in the development process.
What Type of Quality System Do I Need?
Do I even need a quality system? Compliance to standards in a visible, organized way is crucial. Effective document control is imperative if you want to move forward in the medtech development process. The biggest areas where we hear needs for expertise are in the areas of design control, CAPAs and risk management.
Another common story we hear relates to the size of the quality system needed. Too often we hear about people trying to implement a quality system from a Fortune 500 into a startup; it just doesn’t work. What’s exciting is that new quality management system models are emerging. Electronic quality management systems (eQMS) are allowing small to mid-size companies to utilize SaaS-based (software as a service) solutions in a pay-as-you-grow model so that they can use what fits their needs.
How Should I Run My Clinical Trials?
When it comes to clinical trials, you probably will have a lot of questions you didn’t anticipate having. How should I design my clinical study? What sites should I choose? How many? How many patients do I need as part of the trials? What clinical protocols need to be put in place? Who will do the monitoring? All of these considerations cost time and money, and there are procedural and cultural differences on where in the world you gather this data. Having a strong plan in place from as early on as possible can help drastically cut down on costs and time.
Where Do I Find Funding?
Investors are putting less money into early stage medical device companies. So what are a few opportunities for raising capital? Angel investors and angel funds are emerging as even more of a focus. In Minnesota, we have the Gopher Angels and the Twin Cities Angels. Minnesota’s Angel Tax Credit program supports these angel investors when it comes to helping medical device companies get funded.
Another route involves taking innovations from universities through commercialization. Many universities have programs structured around taking university developments to market.
These 5 Areas are Just the Tip of the Iceberg
There are numerous considerations for companies going to market or looking to expand in the market. Above are just a few of the commonly addressed areas for medical device companies, regardless of whether you’re a startup or an established giant. Having a plan that addresses the above will be extremely helpful when communicating development to yourself, your team and others outside your company. Taking a product to market is a journey, and getting exposed to as much information as possible on the front-end will surely pay dividends throughout the process.
What are a few other commonly addressed areas you’d like to share with the rest of the community? Share your comments below!
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