From Concept to Commercialization: How Nixon Gwilt Law Supports Digital Therapeutics and Medical Device Companies
If you're developing a medical device, digital therapeutic (or “DTx”), or Software as a Medical Device (or “SaMD”), you're at the forefront of healthcare innovation.
The global market size for digital therapeutics is projected to reach $32.5 billion in 2030 (Grandview Research), and the medical devices market will soar to $718 billion by 2029 (Fortune Business Insights). And with that innovation and market opportunity comes risk, as the legal and regulatory environment for digital health products is constantly evolving.
Nixon Gwilt Law helps digital therapeutics and medical device clients find a path to commercialization, even when operating in regulatory gray zones which haven’t caught up to the pace of technological innovations.
Nixon Gwilt Law helps companies like yours:
Click to learn the difference between DTx and SaMD
Digital Therapeutics (DTx) are software-driven therapeutic interventions that are used to prevent, manage, or treat medical conditions.
DTx products are intended to complement or, in some cases, replace traditional treatments like pharmaceuticals or medical devices — and they typically go through rigorous clinical trials to prove safety and efficacy.
Examples of DTx applications include cognitive-behavioral therapy for mental health conditions, digital diabetes management programs, and virtual rehabilitation tools.
Software as a Medical Device (SaMD) is a broader concept defined by the International Medical Device Regulators Forum (IMDRF) as "software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device."
Feeling puzzled? Here's a simpler way to look at it: SaMD is any standalone software with a medical purpose, which may include diagnostic, therapeutic, or monitoring functions. This kind of software can be applied to a wide array of situations and isn't restricted to therapeutic purposes only.
Here's the main takeaway: While all DTx products can be considered SaMD, not every SaMD product is a DTx.
DTx is all about therapy, with a big focus on evidence-based clinical validation. SaMD, on the other hand, covers a wider range of medical uses, like diagnostics and monitoring, so it may not always need the same level of clinical validation as DTx.
Getting the hang of these differences is super important when you're creating and marketing your products. It helps you stay on the right side of regulations and makes it easier to figure out reimbursement pathways.
Navigate FDA pathways for devices, including Software as a Medical Device (SaMD);
Figure out how you can move to market as quickly and safely as possible;
Save time and money by understanding limits and requirements early in the development process;
Choose the best reimbursement and revenue models for your company; and
Design a diverse portfolio of products to strengthen brand recognition and lifecycle management.
By addressing legal issues from the start, your healthcare innovation company can operate with greater confidence, knowing you are well-positioned to grow your business, launch your digital therapeutics or medical device product successfully, and make a positive impact on the healthcare industry.
Clients Say:
“Our first significant experience was during the first meeting, on a Friday at 5pm, when we explained our needs and that they were urgent. Rebecca just said, 'OK, let’s do it,' and started verbally structuring the next steps. This conversation came after a discussion with a 'top tier' firm that took the wind out of our wings with a negative approach.”
DTx and Medical Device Founders Rely on Our Expertise and Practical Experience to Help Them Navigate:
Commercialization
We get this question from smart founders all the time: “How do I monetize my solution?” If you haven’t fully investigated your reimbursement and revenue model options, you could be limiting the market share of your product and/or hindering the growth of your company.
Data privacy and security
DTx solutions track and transmit data, and with evolving federal, state, and international regulations governing privacy, you can’t simply “set it and forget it.” Customers and VCs look for robust data privacy and security measures, so your investment in this area may also impact your level of VC interest and your ability to close deals.
International regulations
We’re in a global economy, and whether you are entering the U.S. market or expanding from it, you want the advice of someone who does this every day—not someone who has to figure it out as they go.
Regulatory compliance
With strict regulatory requirements from agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), founders may find it hard to balance innovation and compliance without a healthcare innovation attorney in their corner.
Product liability:
Besides promoting greater adoption of your solutions by providers and end users, you’ll want clear instructions for intended use and adequate warnings to avoid liability for injuries or harm.
Intellectual property (IP) protection
Consulting with a healthcare innovation attorney before you reveal proprietary information or apply for patents, trademarks, or copyrights means a much better chance of avoiding costly legal disputes, loss of market share, and potential damage to your company’s reputation or market position.
Commercial contracting issues
Envision a pilot arrangement that seamlessly transitions to a customer agreement for full implementation, saving you six months of back-and-forth with the potential customer’s legal department before you earn revenue. Working with a healthcare innovation attorney who knows your overall business goals means getting these kinds of advantages baked in.
When you add a healthcare innovation attorney to your key business discussions, you’ll find it easier and faster to innovate, anticipate, and operate.
Why Legal Advice Early in the Product Development Process Is Critical
Imagine getting your solution to the finish line and then seeking healthcare innovation counsel—only to find out your solution does not fit specific regulatory or reimbursement requirements.
Going back to the drawing board drains your resources and delays getting to market, which can impact revenue and investor satisfaction.
That's why it's essential to consider your device’s regulatory framework from the start and design products with intentional compliance in mind. By doing so, you can avoid expensive mistakes and ensure a smoother path to market.
Clients Say:
It's a good thing [NGL requested a full demo and product walk-through] because it made us review everything before it's too late…we may have been really focused on our business model or our contracts, but then they also brought our attention to the fact that no, you also need to be really careful of how you're laying out your platform, all these different considerations."
Why Digital Therapeutics and Medical Device Innovators Choose Nixon Gwilt Law
Every year we work with hundreds of change agents moving in the same direction: forward. Innovation is our bread and butter, and we solve problems and leap hurdles for our clients every day so they can change the world.
Besides being a 100% healthcare innovation firm with one of the deepest benches in the industry, we’re also innovating in the way we deliver our services.
From alternative fee arrangements so you always know what you’re paying to a collaborative work style that gives you more expertise without adding to your in-house legal team, our law firm allows us to serve innovators all over the world.
We repeatedly get feedback that our “can do” attitude in finding ways to help our clients innovate is what sets us apart from other law firms.
We’re not here to tell you no. We’re here to help you achieve your business goals.
Whether you are a startup developing the next breakthrough medical device or a mature healthcare innovation company seeking to expand your global reach, Nixon Gwilt Law has the expertise and experience you need to succeed.
Schedule an introductory call with one of our attorneys now to find out how we can help your healthcare innovation company navigate the complex legal landscape of the healthcare industry and position your business for success.