By Jim Kasic, Boulder iQ
Medical device developers are likely more than familiar with the terms “intended use” and “indications for use.” But not everyone understands exactly what they mean, how they are different, and how they are used. While they may sound self-explanatory, the articulation of each term is critical to the successful development of your device and obtaining regulatory approval.
Differentiating between “intended use” and “indications for use” is akin to using the “5 Ws” in information-gathering, problem-solving, and journalism.
Intended Use: What
“Intended use” is about what the device does. It’s the claim on the label about what the device is used for and how it works (not what it could do). Note that the FDA uses the term “intended use.” In the European Union (EU), “intended use” and “intended purpose” are often used interchangeably. Both terms are mentioned in the EU’s Medical Device Regulation (MDR).
Indications For Use: Who, When, Where, How
“Indications for use” are about how and when a user will use the device: the reasons and the conditions under which the device will be used. So, indications for use would specify the disease, condition, injury, or illness the device will prevent, diagnose, or treat, along with the circumstances surrounding the device’s use. Indications also look at who will use the device, where, and for how long.
Clearly, developers must create these statements with care. Beyond issues of patient safety, both “intended use” and “indications for use” statements impact marketing, use, and training in the field.
Key Considerations In Developing The Statements
1. How — And When — The Terms Will Be Used
“Intended use” is paramount in deciding whether a product qualifies as a medical device. It’s also a major determinant of risk classification for a device.
“Indications for use” have additional roles, particularly in setting the regulatory path of a device. If you designate a scalpel, for instance, with an indication to cut tissue, that would be a Class I device. However, the same scalpel with an indication for use in retinal surgery could be a Class II device – which carries substantial ramifications in design, development, and regulatory approval.
The terms are important even after market introduction. Manufacturers are responsible for monitoring their device’s performance in the market. Any signs of use beyond the information on the label, or beyond the device’s indicated use, will require reassessment of the statements and even possible changes to the device itself.
Confusion between the terms, or lack of clarity in defining each, have led to a myriad of regulatory issues. One notable example was with metal-on-metal hip implants. The intended use of the devices – hip replacement – was crystal clear, but the indications for use did not fully address the risk that the implants could shed metal particles into the bloodstream. As a result, the FDA issued a number of safety advisories and recommended manufacturers conduct post-market surveillance studies.
2. Impact Of The Terms In Go-To-Market Strategy
Bringing a device to market is challenging and time-consuming for even the simplest device. You must meticulously plan design, engineering, sterilization, quality, and regulatory processes. Intended use and indication statements play a big role in determining how each of these processes plays out.
For instance, using the scalpel example above, taking to market a Class II device means significantly more time and complexities in the regulatory process than would a Class I device. A smart alternative may be to start with a Class I device, with a lower risk classification and general indications for use. Once that product is on the market, the company can focus on more specific and advanced ways to use the scalpel, working on submission of the Class II device down the road.
Class II devices also can sometimes be considered “me-too” devices. In the case of a me-too device, developers must compare their device to a predicate device to obtain a Class II marketing clearance. A predicate device is one that is currently on the market with regulatory approval, used as a point of comparison for new devices seeking approval through the FDA’s 510(k) pre-market clearance pathway.
With a me-too device, a developer can use the intended-use statement and indications for use from the 510(k) submission of the predicate device as a very good starting point for developing their own intended use and indications for use. Similar to the logic explained in the Class I discussion above, the path to market may be easier and faster with a me-too device. Once the new base device obtains approval and is on the market, the developer can expand features and indications for use.
Weighing the costs and benefits of each strategy is important to do as early as possible in the development process, based on your organization, your funding, and your particular device. No strategy is right or wrong, but each will have different impacts on the regulatory process and different results.
You must also consider reimbursement in creating your intended use and indication statements early in the development process. Evaluate whether it’s better for a device to fit into an existing reimbursement code — helping to assure payment for the device once on the market — or to create a device that will require a new reimbursement code.
The answer will vary by developer and device. Some devices may not have the advantage of fitting into different classes, as in our scalpel example. In some cases, developers will be focused on maintaining a competitive edge with a new device and new reimbursement code but must carefully consider how much time and risk is involved in going that route. In addition, reimbursement through the Centers for Medicare and Medicaid Services could be challenging even for a Class I device.
Device developers must carry accuracy throughout development and manufacturing. The clarity and precision of these statements help to guard against misuse, and provide the foundation for all related content, such as labeling, instructions for use, promotional materials, and training resources. Developers should ensure that claims in the statements are evidence-based, which may require clinical data and/or relevant studies.
And, given the continuously advancing nature of the medical device industry, it's a manufacturer's responsibility to periodically review and update the statements as needed once the device is on the market.
5. Off-Label Use
In the world of medical devices, "off-label" refers to the use of devices for purposes other than those that regulatory agencies have approved. The issue of off-label use comes into play when determining indications for use.
If the scalpel discussed above went to market with general indications and a Class I designation, a surgeon might still decide to use the device for a specific purpose not cited in those general indications. In some cases, users have even developed novel treatments with off-label use.
While it is legal for a user — the surgeon in this example — to use a device in additional ways they determine to be safe and effective, it is illegal for a manufacturer to promote off-label use. Doing so can lead to risk for providers, patients, and developers. The use of stents provides one illustrative real-life example. Physicians have used stents originally designed to keep coronary arteries open in off-label applications in peripheral arteries. Some patients benefited, but others experienced complications.
The message here is to be open and honest in communications. In many cases, a Class 1 device with general indications might be the fastest and best route to market – with more specific indications and class designation to follow. But if a device truly is intended for more advanced or specific uses, the developer has a responsibility to create accurate indications for use, regardless of how it will impact the device’s classification.
Conclusion: Every Word Counts
Intended use statements and indications for use may seem relatively less important to developers who are focused on the scientific and practical aspects of creating a new medical device. Yet the development of these statements is critical to the FDA, to provider use, to patient safety, and to the successful market introduction of any device.
Every word counts. Grammar counts. Clarity counts. The ultimate result should be simple, direct, and concise. Drafting, reworking, and revising early in the development process, before prototypes are made, will assure the most direct path to market. Working with device development specialists with extensive experience in creating these statements will go a long way in avoiding major missteps and delays along the way.
About The Author:
Jim Kasic is the founder and chairman of Boulder iQ. With more than 30 years of experience in the Class I, II, and III medical device industry, he holds more than 40 U.S. and international patents. His career includes experience with companies ranging from large multinational corporations to startups with a national and international scope. Kasic has served as president and CEO of Sophono, Inc., a multinational manufacturer and distributor of implantable hearing devices, which was acquired by Medtronic. He also was the president of OrthoWin, acquired by Zimmer-BioMed. He received a B.S. in physics and an M.S. in chemical/biological engineering from the University of Colorado, and an MBA from the University of Phoenix. He can be reached at firstname.lastname@example.org or on LinkedIn.