As the biopharma space becomes more competitive and the era of blockbuster drugs seems more distant, biopharma companies are investing in digital to find new and innovative ways to differentiate themselves. Digital leaders are turning to software as a medical device (SaMD) to help diagnose or treat disease.
These next-generation tools create more personalized experiences for patients, more information to guide clinical decision-making, and a wealth of data that biopharmaceutical companies can use to continually improve therapies and advocate for reimbursement. Along with this growth, several developments in the regulatory space have impacted how SaMD products are classified and how they can be used.
According to the International Medical Device Regulators Forum (IMDRF), software as a medical device is software intended to be used for one or more medical purposes and is not part of a physical medical device. These purposes vary and may include aiding in the diagnosis or treatment of disease, aiding in symptom management, or as diagnostic software complementary to medication. There are also many other uses.
SaMD software should be developed under a quality management system, like hardware devices. There are standards and guidance documents that apply specifically to SaMD. For example, IEC 62304 Medical Device Software – Software Lifecycle Process is an international standard that provides a framework for the development and maintenance of SaMD and software in medical devices. There are several other standards and guidelines applicable to SaMD products.
Several trends around the development of SaMD impact how these products are classified and regulated, or present challenges to these processes. Here are five of the top trends.
Trend 1: Widening of the gap between US and EU regulations in the classification of a SaMD product
The rapid growth of the SaMD market is driving the increased use of existing digital products in new ways that may change their classification, as well as the evolution of regulator classifications.
It is therefore difficult for US biopharmaceutical companies to bring a SaMD product to market if it does not fit easily into the rules-based classification system of European medical device regulations or is not substantially equivalent to a predicate device in the United States. These regulations are targeted more at traditional medical devices, so software classifications can be more difficult to determine.
SaMD products may also contain software of unknown pedigree or provenance (SOUP). This is software that IEC 62304 defines as software that was not developed for the purpose of incorporation into a medical device, and/or for which adequate records of the development process are not available. For this reason, additional controls are needed to manage the risk of SOUP.
Trend 2: Certification of companies that develop SaMD, rather than every new SaMD product
Another important trend is how SaMD products are treated within the regulatory regime. The FDA is working to pilot some programs that will help here. The idea is for the agency to provide a streamlined and efficient regulatory approach through SaMD developer pre-certification first, rather than product-first.
This would ease the ongoing monitoring burden on these companies and could reduce content submission, speed up review, or both. The advantage comes from the fact that changes in software usually happen much faster than they do in traditional hardware products.
Some of these products also use software-as-a-service type models. In these cases, the software may undergo continuous changes. The challenges become how to manage these changes, maintain software compliance and ensure the changes do not affect a device’s functionality?
Trend 3: AI and machine learning create a need for a framework that enables continuous change
The increased use of artificial intelligence and machine learning technologies has a significant impact on SaMD products. These advanced technologies allow the software to “learn” continuously. It is great for patient care, especially for cancer diagnosis and treatment. AI and ML are becoming an even bigger part of SaMD offerings. But that also means that these products are continually changing.
Regulation will have to follow these learning algorithms. It is important that the algorithms continue to learn and perform advanced data processing to take full advantage of it. The traditional paradigm requires the learning algorithm to be “locked in” and would likely require the FDA to conduct premarket review of any changes.
A new regulatory approach could enable a continuous learning environment, where the algorithm can continue to learn and change, but it also has adequate regulatory oversight to ensure safety and efficiency are maintained. Although discussed by the FDA, this model does not yet exist.
Trend 4: Bringing devices to market that don’t have sample predicates
A growing experience for many organizations is that a new SaMD product they wish to bring to market is completely new or unique. If a pharmaceutical company plans to use the traditional FDA 510(k) route to market entry, it generally requires that the company have a predicate device or substantial equivalent.
In many cases, there is no predicate device available, so the FDA 510(k) route to market clearance cannot be used. The organization must have the device classified through a De Novo Classification Application or go through FDA premarket approval, which is more rigorous, time-consuming and expensive.
Trend 5: An emergency need for successful partnerships with third parties
Another growing trend is the need for pharmaceutical companies to have trusted third-party partners who can help build and then bring SaMD products to market, as well as navigate the complex regulatory pathway along the way.
The ideal partner is one who knows the current regulatory climate, but also knows what is happening that will impact future product development. Such a partner can create the products under a medical device quality management system, bring the product to market, and overcome regulatory hurdles on behalf of the customer.
Some third-party vendors may be able to help develop software, but a truly valuable partner is one who can help manage risk during the development cycle and address any other regulatory issues or concerns a SaMD product may encounter. on its journey from drawing board to market.
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