ONE BIG STEP FORWARD IN DIGITAL HEALTH WITH SAMD

Innovation in the healthcare industry is accelerating as digital technology is infused in every aspect of healthcare delivery. The application of IoT, Cloud, AI, Augmented Reality, 5G, and other technologies into medical devices is increasing, resulting in better diagnoses, treatment, and patient monitoring without the need for human contact. This transformation is creating numerous challenges in the field of Software-as-a-Medical-Device (SaMD), which can be overcome by leveraging the Capgemini Engineering SaMD framework.

The global digital healthcare market is expected to grow 28.5% by 2026, while the global connected medical devices market is forecast to grow 18.9%. These numbers reflect the digitalization shift that all players in the healthcare ecosystem are embracing. SaMD is emerging as an opportunity to improve the quality of life for patients with software. It offers new, more efficient ways for healthcare professionals to interact with patients. By merging the physical and digital worlds, the patient gains the power to manage their own healthcare with software that includes all their health information.

Market trends and challenges

Despite the expectation of SaMD’s solid market growth, there are still many challenges to address. Here we focus on six:

1. Improving health outcomes by using data and fast feedback loops to speed up product iterations and guarantee data quality improvements
2. Integration and interoperability are evolving rapidly, spurring diverse, interconnected digital health and wellness ecosystem components. The challenge is to safely, securely, and effectively integrate data into the network and exchange and use information.
3. Ensuring patient safety and privacy in an environment of increasingly sophisticated cybersecurity threats is a constant challenge. With connectivity increasing, personal data must be kept secure and private, especially medical-device data.
4. Regulatory compliance is essential as more stringent regulations and new technologies emerge to serve global and local needs. The challenges are a significant concern for companies working in this area. They need to know if they comply with all the required regulations, which is not easy. The Capgemini Engineering SaMD framework will help companies address their concern.
5. Identification of marketable opportunities that satisfy evolving stakeholder needs. In some cases, companies intend to invest in SaMD, but they lack the expertise to integrate this digital product and are uncertain the market will accept it. This hesitancy is an innovation blocker, which could jeopardize their future growth.
6. Accelerating development cycles without sacrificing safety, efficacy and compliance. The industry is familiar with a ten-year development and integration cycle for drugs. Now, the cycle is much shorter if companies expect to be one step ahead in the market.

The “why” of the Capgemini Engineering SaMD framework

A few years ago, Capgemini Engineering recognized the market urgency for SaMD solutions as a new era was beginning. In 2019, the company started to build a robust foundation that enabled it to support the future developments of SaMD applications and develop reusable components to use in combination or independently in future SaMD applications. These early decisions gave Capgemini Engineering a firm foundation that enables SaMD application development. Over the long term, this position ensures the company will be more agile, get products to market faster, be in regulatory compliance, and reduce costs.

What is a SaMD framework?

The best term to describe a SaMD framework is integration. That is, integrating people with the necessary expertise and knowledge; a qualified toolchain for medical devices development and testing as required by regulators; a quality management system with documentation that supports the regulatory landscape; robust risk-management activities; and a flexible and robust architecture. Integration is the sum of all these components that will allow companies to comply with regulations, add agility, flexibility, and scalability to their solutions, which combine to get them to market faster.

The four challenges fulfilled by the Capgemini Engineering SaMD framework

This article is not about simply sharing the success story behind the Capgemini Engineering SaMD framework. It is about exploring the challenges that led us to the point of being able to support our customers on their journey to develop their SaMD products. For clients not so familiar with the regulatory processes, Capgemini Engineering also helps them provide the software elements and all the complementary (and mandatory) documentary evidence, such as technical documentation, etc.

1. The importance of a robust and qualified toolchain: A synonym of the framework is integrated tools. It is not necessary to discuss which tools to use or if some of them have to be qualified or not. The entire toolset is already established, so the client does not need to worry about the tools and their maintenance.
2. To assure compliance: “If something is not written down, it didn’t happen.” This statement captures why it is essential to have documentation to establish plans, results, reports, and next steps. However, it is a delicate process to assemble all the necessary documentation from the regulator’s point of view. The journey is not easy and depends a lot on the projects, products, and markets.Yet, when the client chooses to work with Capgemini Engineering, an important organizational step has been taken on the journey.
3. Fitting agile in medical devices development: Traditionally, software developed in the regulatory environment follows the waterfall model. All the requirements are defined up-front, the product is developed (behind closed doors), and is presented at the end of the process. However, the trend in software development requires an agile approach. This brings with it the challenge to assure compliance and documentation for each iterative cycle (sprints).
4. The approach to architecture: Thefirst Capgemini Engineering versions of the SaMD framework were developed with some modular features (e.g., chatbot, gamification, and connected devices), but the overall architecture was a monolithic application. This limitation reduced the potential for reuse of all layers of the architecture, which is essential for adapting to the clients’ differentiated and personalized needs. Furthermore, with cloud services growing in popularity, the backend architecture was transformed into a hyper-agile architecture based on microservices, resulting in a more flexible, scalable, and resilient solution.

The advantages

By adopting the Capgemini Engineering SaMD framework, clients are already ahead of their competitors since we already have a formal set of modules that are easy to integrate into any solution. What can be more advantageous than not having to develop software from zero?

The modules include:

• Assets and building blocks that can be reused (i.e., gamification, chatbot, connected devices, etc.), enabling customers to produce what they want. This approach allows them to reduce time-to-market once the development of some features is complete.
• One framework with multiple combinations allows the customer to construct customized mobile solutions according to their needs. For example, Capgemini Engineering can develop an app from nothing or incorporate a new feature in an existing app.
• Easy integration with other systems and third-party components (i.e., apps, devices, systems, software, etc.).
• Compliance with regulations and standards (i.e., MDR, CFR 21 Part 820, ISO13485, ISO14971, IEC62304, ISO27001, etc.) requires a team of experts in regulations and quality, and compliance that can support the customer’s market submission and post-market activities.
• Robust post-market product maintenance and lifecycle management (i.e., software updates and enhancements, quality management, regulatory affairs, etc.) supported by product-dedicated teams.

Digital health will leverage an era full of opportunities for the healthcare industry that is developing new ways of delivering care and for patients, who can improve their health and well-being faster and more effectively. Technology arises as a healthcare enabler once it emerges as an aggregator, connecting patients with caregivers no matter where they are in the world.

Increasingly, we will hear more about advancements in telemedicine, digital therapeutics (DTx), intelligent connected devices, and much more. Inspired by our clients to prepare for this future of health, Capgemini Engineering started the SaMD journey with the idea that was converted into a framework with multiple features. Now it is an ISO13485 certified ecosystem.

The next post will be dedicated to the consolidation and development of the infrastructure, focusing on assuring the best value for good health.

Our framework in practice

Capgemini Engineering has developed and tested a mobile solution for COVID-19 home-quarantined patients and non-critical hospitalized patients. The app monitors patients remotely, allowing them to analyze their health through a questionnaire that analyzes symptoms and, based on the results, suggests a medical appointment or medical intervention.

Janet Nason

Project director

Pedro Mauricio

Engineer, Capgemini Engineering Portugal