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A Few Things SaMD Developers Should Know

Be sure to understand when to seek FDA approval and when to seek IP protection, among other insights from an IP attorney.

Susan Tull, an IP attorney from Finnegan

Susan Tull, an IP attorney from Finnegan

In today’s digital and connected society, clinicians and patients alike are beginning to expect the same capabilities in medicine. There’s tremendous opportunity for healthcare innovation and transformation through software—but as a developer, do you know how to proceed in terms of regulations and intellectual property protection?

FDA’s guidance for Software as a Medical Device (SaMD) provides regulatory answers. When issuing its guidance, FDA cited its adoption of the regulatory framework developed by the International Medical Device Regulators Forum (IMDRF). This voluntary global group of medical device regulators has defined SaMD as the "software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device."

Susan Tull, an IP attorney from Finnegan, says these recently promulgated guidelines have aided SaMD developers in understanding whether they need to seek FDA approval and what is required to obtain that approval. To address the challenges related to getting and protecting patents for SaMD technologies, Tull answered a few questions from MD+DI.

Is there anything unique or particularly challenging given the role software will play in healthcare, a highly regulated market with privacy, reimbursement, and cost concerns?

Tull: SaMD developers will need to be cognizant of privacy regulations and HIPPA requirements when collecting and distributing patient information. Patient information is strictly regulated, and this may be a new concern for developers who are not used to handling this type of information. Insurance reimbursements will also be a new issue for companies that do not typically occupy the medical field and should be a consideration when weighing potential profits versus costs and associated risks.

Today, are SaMD developers typically employees of a medical device company, or are they external vendors working for multiple medical device companies? What are the benefits and challenges with each model, for the developer and for the company?

Tull: Many traditional medical devices already rely on embedded software to operate, so those companies would already have a model in place to develop source code. We are seeing a mix of SaMD developers. Some are employees of traditional medical device companies, others are external vendors developing the software for those companies, and still others are companies that have compatible technology looking to move into the medical device space. An example of the latter are companies that make fitness trackers and heart rate monitors that are looking to apply their sensing technology to medical diagnoses.

The benefits of these different models are largely the same in terms of the final product, namely a SaMD platform. Each company considering this space and the different models would need to consider the cost of employing one or more software developers versus hiring an external vendor to perform the work, how many SaMD platforms or products they are hoping to launch and over what period of time, and how likely is it that the SaMD will require frequent updates. An important consideration for any company using external software developers is to be sure that any employment or consulting contract addresses the question of IP ownership and assignment. You would not want to make significant investments into a SaMD product only to realize after the fact that the developer could sell the same product to other companies.

I imagine there is a lot of testing, trial and error, and ongoing development in SaMD. When should intellectual property (IP) protection be pursued?

Tull: While it is good to consider IP protection throughout the entire development process, the question becomes much more urgent once the product is near final or when FDA approval is sought. Companies will want to ensure that they protect their final commercial product, but early prototypes or concepts should also be considered for IP protection as they may prove valuable in the future.

It is important for companies that are required to submit a 510k application to FDA to seek IP, and in particular patent, protection before FDA clears the product and publishes the approval summary. Once the FDA summary is published, the 510k application is considered public and may be accessed through FOIA requests, including by competitors. A company will only have one year from the publication of that approval to file a patent application before the 510k application can be used to prevent them from obtaining a patent.

When should IP protection not be pursued?

Tull: Before deciding whether or not to pursue IP protection, a company should consider the different types of protection available to it. A company can receive a utility patent on the idea underlying the SaMD, a design patent for the layout or appearance of an app used with the SaMD, trademark or trade dress protection for the brand and name, and copyright protection for the written code.

If those specific categories do not apply, for example, if the SaMD is not unique to the developer or company, then IP protection may not be available and thus should not be pursued.

The length of time it takes to obtain IP protection and the associated costs are also factors in deciding whether to obtain IP. For example, it often takes over two years to obtain a utility patent. Software can evolve very rapidly and by the time a patent is issued, it may no longer cover the commercialized product. In that instance, a company may decide not to pursue IP protection.

In addition, a patent expires 20 years after the date the patent application is first filed. Once a patent expires, anyone is free to use the technology described in the patent. If a company can keep core technologies or concepts confidential for longer than that 20-year period, they may wish to keep the invention as a trade secret. In that instance, not seeking IP protection may make better sense for the company in question.

What challenges are there related to the branding of SaMDs?

Tull: Many SaMDs use phone apps as part of the product. The layout and appearance of those apps may be covered by design patents or trade dress protections owned by a third party. Before pursuing a particular brand or app appearance, a company should make sure that they are not infringing another’s design patent, trade dress, or trade mark.

What other IP considerations should SaMD developers be aware of?

Tull: SaMD developers should also keep in mind issues presented by open source licensing and defensive publications. Open source software is publicly accessible and can be modified and shared by others. Open source software may be used for underlying technology that is not critical to the SaMD, like the operating system or application programming interface. This would include software used to operate a phone’s camera, for example, if the SaMD relied on photos taken by the user. A developer that plans on using open source software should review any accompanying licenses when selecting the open source software. Companies that hire external developers should ask the developers about open source software as well.

If a company has determined that they do not wish to pursue patent protection, they should consider a defensive publication of their technology and ideas. A defensive publication can be used to prevent another company from obtaining a patent on the same technology.

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In most cases developers will be seeking FDA "clearance" (if not exempt), but not "approval". Determining what class your product is in, or likely to be in, is an important early step.