What is Software as a Medical Device?
- A mobile application for imaging MRI on your Mobile Phone.
- Sleep detecting application that displays data and results on the mobile phone.
- Software clone of the digital mammogram machine used during the breast cancer detection.
- Software for monitoring the pacemaker activity on your mobile phone.
What’s Different About SAMDs
Standalone
SaMD is a standalone software that performs 1 or more medical purposes without being a part of a hardware device.
Classification
Care about the SaMD classification to know what information to provide and understand the impact of its safety profile when a failure or defect occurs.
Non Embedded
Embedded firmware and software that monitors performance of a hardware device are not SaMD. They are still software and an integral part of the device.
Consultant
Manufacturers should be in constant contact with the FDA and consultants about regulations because of frequent changes and additions.
Planning
FDA’s guidance is not enough for many applications, so it is planning and engaging in new activities and programs for future SaMD applications.
QMS
SaMD companies need to have a quality management system (QMS) during the development process to address regulations; don’t wait until it’s too late.
Life Cycle
62304 Standard: Consensus standard for manufacturers on how to manage their software lifecycles. Initially, classification determination was unclear.
Methodology
No regulatory standard of method to use or not use; but describe, define, and document your methodology.
SaMD and Ecosystem
SaMD companies are meaningfully different from consumer health companies, which sell wellness, oral health, nutrition, and skin health products directly to the consumer. While SaMDs have much higher barriers to entry in the form of upfront R&D costs and regulatory requirements, they can target specific populations and make claims about benefits. Moreover, they have access to the reimbursable market and a much greater value pool. By contrast, consumer companies have access to a larger population, but they also have to deal with challenging competitors like Apple, with its smartwatch apps.
The global SaMD market is ready to take off. The Insight Partners projects a five-year CAGR of 21.9%, reaching $86.4 billion in 2027. Several SaMD companies have attracted major investment over the past three years, and a few, including Livongo, Noom, and Biofourmis, have achieved unicorn status.
Eager to capitalize on the opportunity, hundreds of companies have developed at least one SaMD product. But most of these companies are not positioned to see stable, long-term growth. Only a few have had high valuations, even fewer have generated meaningful revenues, and almost none are profitable. That’s primarily because payers are reluctant to reimburse for a SaMD without sufficient clinical evidence of efficacy at scale, so it’s difficult to engage significant numbers of patients and physicians.
Recipe for SaMD approval? be commercial?
Three elements are essential if SaMD is to reach its full potential. First, as the business explores various insurer, provider, and regulatory avenues, a solid business model will offer a clear path to revenue and profit through tried-and-true means. Second, establishing a clear operational model will guarantee top-notch product development from start to finish, solid clinical outcomes, and a timely launch. Third, encouraging physicians to embrace and use the product in practise will help to increase stakeholder confidence in those clinical results.
BUSINESS MODEL
Although software is the product being sold, effective SaMDs are distinguished by their innovative business models rather than their technological advancements. The secret to commercial success is creating a scalable and repeatable model that maximises a product’s value in its intended use cases.
Pricing. Similar to traditional software providers, SaMD providers must take into account two types of pricing: access (for an app store download or licence) and recurring (subscription and pay for use). But because the market is so new, it can be difficult to determine the best price (or prices). Simply put, there aren’t enough comparable products on the market to utilise as benchmarks for price discovery.
Two-Step Method. To get early experience and feedback without facing any regulatory obstacles while working on a SaMD, several businesses produce a general consumer wellness product. After that, they turn their attention to the SaMD and make sure they have the regulatory competencies necessary for a smooth go-to-market strategy with employers and perhaps pharmacy benefit managers. Companies like Noom have found success with this tactic after developing a weight-loss app before turning their attention to treatments for long-term illnesses like diabetes.
A SUCCESSFUL OPERATING MODEL
Successful SaMD producers create cutting-edge operational models that adhere to agile software development best practises while upholding the standards for quality, safety, and clinical rigour necessary for a regulated medical device.
Product development and launch are related. Many product and launch decisions, including use cases, the creation of evidence, and available commercial channels, are significantly impacted by the business model. Therefore, SaMD firms should coordinate product development with the creation of business models and strategies for commercial launch, such as launching the SaMD as a stand-alone solution, connecting it to a physical device, or delivering it as a service.
Cross-Functional Reviews It’s crucial for businesses to involve a diverse range of stakeholders as early as possible in the development process and then on a regular basis as it moves forward. These experts have competence in the areas of commercial, clinical, regulatory, and product development. There should also be participation from other functional areas like privacy, health equity, human aspects, compliance, and quality.
Cross-functional reviews are essential during review cycles to make sure that all facets of the product are on track to achieve goals. To meet stated agile “ready and done” standards, quality management system papers can be jointly created and reviewed with requirements and code. This strategy will assure quick progress and lessen decision paralysis.
To guarantee that the device will function as planned in studies, clinical safety and efficacy reviews should be carefully controlled. The risks connected to agency submissions and provider adoption, where there is little room for error and where doing it over again can add a significant amount of time to the schedule for product development, will also be reduced by proactive management.
It’s critical to ensure that the software release cycles are aligned with the clinical development plan.
Agile “Medical” Development Iterative build, test, and learn cycles that take into account the many needs necessary to satisfy patients, healthcare providers, payers, and regulators should be a part of the SaMD product development process. Rapid pilots are the best method for obtaining patient and carer feedback in real-world settings, which is becoming more and more crucial for improving product features and data models as they are being developed. The product development process should incorporate these insights so that not only the product roadmap but also the clinical and regulatory strategies are informed.
It is crucial to make sure that the software release cycles are in line with the clinical development plan since clinical plans have an impact on software development. This is difficult because clinical evidence is created over time, whereas software is developed quickly and continuously. Successful SaMD businesses create the two at once. They use agile methods, automation dry runs, cloud-based platforms, and usability tests to cut risk and guarantee the quarterly release of high-quality software while also lowering the risk associated with formative, summative, and post-market studies.
Parallel Development of Product Features Subject to Regulation. Regulatory compliance requirements for SaMDs are frequently higher for components with higher-level risk profiles in order to allow for flexibility and quick time to market. We advise businesses to modularize their development processes so they may concentrate compliance efforts on parts with higher-risk code and data. This modular strategy can greatly reduce the requirement for expensive compliance efforts in some aspects of product development because the FDA exempts regulatory enforcement on mobile medical apps in broad health categories that aren’t in the critical-care pathway.
INCLUSIVE STAKEHOLDER
Despite recent advancements, it can still be challenging to persuade key players in the healthcare ecosystem that SaMDs are a reliable method of diagnosis and therapy. Therefore, businesses must go above and beyond to ensure that their products are viable in the eyes of patients, HCPs, payers, and regulators.
Create products that are patient-centric. Companies must prioritise health equality from the beginning of product development onward in light of COVID-19, which brought attention to the gaps that prohibited some sections of the population from accessing health care. Health equity criteria are used in the design of clinical development and market access initiatives by successful SaMD businesses to guarantee that datasets are applicable to larger populations. They then guarantee that the testing population is diverse and build products with a grasp of the contextual details of the data, such as inequities or cultural preferences. These safety measures are particularly crucial when creating artificial intelligence-based products because if biassed data are utilised to train an algorithm, the result could be diagnoses or suggestions that are incorrect.
The importance of privacy concerns has increased, much like health equity. Consumers are especially opposed to major organisations having any control over their data as security breaches become more frequent. As a result, med tech businesses must make investments in infrastructure for patient privacy and cybersecurity in order to have a solid architecture for all markets.
Successful SaMD companies makes Health Equity a Priority
Minimize the providers’ workload. Health care providers (HCPs) need to find it easy to use SaMDs, as even the most useful solutions won’t be adopted if they involve more effort or time. The products must be simple to integrate into current clinical workflows and routes in order to win over HCPs, obtain significant quantities of prescriptions, and increase the number of claims processed over time. In order to prevent bottlenecks from forming during regular tasks like inputting patient data into electronic medical records, new SaMDs must be interoperable with providers’ existing health IT systems, tools, and processes.
The development process should incorporate regular input and ongoing product testing with providers and carers who are actively involved in patient care to guarantee that goods meet these needs. Co-promotion agreements with current suppliers of readily available medications and equipment have been discovered by some SaMD businesses to speed up physician HCP uptake and permit payer reimbursement.
Engage customers early and often. Proof that the SaMD delivers results that are worthwhile of payment is necessary to win over payers. Therefore, businesses must create strong clinical and economic evidence and convert it into persuading value propositions. This calls for conducting dozens of thorough studies proving that the SaMD results in improved health outcomes and lower total costs, faster time to diagnosis and treatment, or higher patient throughput when compared to conventional treatments or therapies.
Additionally, SaMD firms should define reimbursement strategies early in the product development cycle and constantly engage major payers throughout the development process because clear reimbursement paths still do not exist at scale. To compensate doctors for the time they spend using SaMDs, one method would be to employ remote patient monitoring codes; another would be to designate doctors who use SaMDs as virtual service providers with the proper medical code.
Use the same exacting trial controls as you would for conventional items. SaMD producers are allowed to customise clinical studies to the unique product, unlike standard medical device businesses, when it comes to complying with regulatory regulations. SaMD businesses should maintain the same stringent controls as conventional trials notwithstanding this flexibility. That entails switching from using smaller, academic studies without adequate controls to using recognised trial methods, registering with regulatory bodies, and submitting dossiers. Traditional clinical trials will produce the substantial body of clinical evidence that regulators want, despite their lengthy timetables and high costs.
Additionally, businesses need to be aware that data security, privacy protection, and quality control are prerequisites for regulated software. Therefore, it’s crucial for firms to carefully document their legal, regulatory, quality, and cyber-security processes in order to receive regulatory approval.