Getting your medical device to market as soon as possible is the usual goal for companies developing a new device.
It’s fair to say that while many companies do this successfully every year, there are several more that are unsuccessful. This can come down to a number of reasons, but a common issue is not adequately accounting for the critical steps to the commercialization of a medical device.
There are five key steps that are necessary for every new medical device to reach the market; here’s what you need:
#1. Regulatory pathway
Firstly, you’ve got to know and understand your device’s risk category and the regulatory pathway you will need to take it to market. A large portion of the pre-work for getting your device to market hinges on the regulatory track you have decided to take.
It’s important to note that yes, you can to some extent decide your regulatory pathway. Regulatory as a strategic measure can be useful for putting you in a competitive position. For example, if you are a startup with limited funds, your goal might be to get your device to market as soon as possible so you can start generating revenue. You might work to document evidence that predicate devices exist for your new device, proving that you should take the 510(k) pathway.
On the other hand, companies that are well-funded can gain a competitive advantage from the costlier, more involved PMA pathway. Taking this route means competitors can’t use your device as a predicate and must also take the longer path to market.
Besides strategic advantages, defining your pathway to market helps to ensure you get there faster. Companies often make the common mistake of doing all the work for designing their new device, while leaving regulatory requirements until later, when they feel ready to go to market. This often leads to a last-minute scramble to get all of the required documentation together, and the discovery that there are things they should have done much sooner.
For example, reconstruction of a Design History File is difficult – your task is much easier if it is kept updated as you go. Or, you might find that certain types of testing are required for your regulatory pathway – those can take time to complete, often requiring third-party testing facilities.
The bottom line is that a regulatory pathway is always required for medical device commercialization.You can do it the hard way by waiting until later, or the easier way by defining your pathway early.
#2. Reimbursement strategy
One of the keys to medical device success is getting a high enough number of users for your device. Insurance plays an important role, especially in the US market. Specifically, devices that are approved for private payer and/or Medicaid/Medicare reimbursements will be easier to sell.
Reimbursement strategy is another aspect to plan for early in the device development process. Who is going to pay for it? Reimbursement mechanisms have very specific definitions and requirements around them. For example, reimbursement codes can relate to a specific range of settings on a device, the number of sensors, or the application of the device. If your device deviates from those specifics and there isn’t an existing code that it will fall under, you can wait for years until your device is finally approved for reimbursement (at considerable investment from your company!).
Your reimbursement strategy can impact the clinical trials that you need to conduct prior to entering the market. It’s important to note that insurance companies or Medicaid/Medicare may require specific testing parameters that the FDA doesn’t require for market approval. Defining these early on will help to ensure that you don’t have to repeat costly testing just to satisfy reimbursement requirements.
Your reimbursement strategy should go hand-in-hand with your regulatory pathway. For example, indications for use are compulsory for regulatory approval and for reimbursement. You need to ensure that those indications for use work for both, rather than submitting the regulatory under certain indications, then discovering you need different indications for use to get reimbursement.
#3. Connectivity strategy
These days, most medical devices leverage cloud connectivity to support a bevy of additional features and data analytics. Connectivity brings multiple benefits, such as the ability to layer services on top of data; a more efficient, convenient experience for patients and clinicians; and an improved ability to trace the outcomes of your device (important for reimbursements, too!).
And while we’re on the subject of getting your new device to market, connectivity can play a key role in the critical post-market surveillance phase, too. For example, connectivity allows you to monitor device effectiveness more easily at scale.
A strategy for connectivity pre-market is important because if you ultimately want a connected device, you need to plan how you will achieve that. For example, engaging a custom software developer will take time and large amounts of cash. You’ll also be responsible for the ongoing management of the connected device, including updates and security protocols. All of this must be compliant with the FDA regulations and included with your submission.
You might consider bolting on connectivity after your device reaches the market, but this does tend to be inefficient. You will have to prepare a new submission for the connectivity aspects of your device, proving you’ve met the requirements. Besides that, device connectivity in the first place is increasingly an expectation – you may find it makes no sense to enter the market without it already in place.
Another option is to go with a connectivity infrastructure that has already been built to support medical devices – the reason Galen Data exists. Taking this option helps to lower the development costs and overall time to develop device connectivity. It also takes some of the risk burden (such as cybersecurity) and puts it on the third-party platform.
Planning your connectivity strategy early will help you with accurate budgeting, regulatory compliance, and your reimbursement strategy.
#4. Quality management system (QMS)
You can’t do any of these first three steps without a quality management system (QMS). Well, you could, but you won’t get very far! Your QMS supports your regulatory submission AND your post-market surveillance requirements.
In fact, every major market requires that you have a QMS implemented as part of the submission process for your medical device. Your QMS is a structured system of processes and procedures that set out all aspects of your device, from design controls, to risk management, to supplier management to manufacturing. The documentation in your QMS is proof that you’ve met regulatory requirements for your device.
The most efficient way to tackle quality management is with a reliable electronic QMS system. Traditional methods, such as keeping spreadsheets or files of paper are prone to mishap and error. For example, papers go missing or files don’t get updated regularly. Version control can be difficult when you can’t necessarily tell when it was last updated.
Choosing the right type of QMS is a key step to getting your device to market.
#5. Cash-flow to support go-to-market
Finally, you’ve got to have the cash flow to support the go-to-market phase of your device. Medical devices are often capital intensive, requiring development, clinical trials, and regulatory approval before they’re available on the market. How many companies have desperately tried to scrape more cash together in order to finish development or testing?
You’ve got to have enough money to cover all of these costs if you want to successfully get to commercialization. Part of this is carefully planning out each phase of development. Different phases have different capital requirements and the timing and careful management of these phases help with an accurate budget. Sometimes, if you’re seeking external funding, it depends on milestones being achieved, so you need to be on top of planning.
Your regulatory pathway again plays an important role. You’ve got costs associated with your application, with testing requirements, and potentially with professional consultants to help smooth your pathway. This is another reason why it’s important to sort out your regulatory, reimbursement, connectivity, and QMS strategy early – so that you can prepare a budget with as much accuracy as possible.
The five steps outlined here are necessary for the commercialization of your medical device. Each requires a high level of planning and should be considered as early in the process as possible so that you don’t face unnecessary delays in getting to market.
For help with your connectivity strategy, Galen Data is available with a purpose-built cloud platform for medical devices. Talk to us today about how we can help to get your medical device connected.