Without a doubt connecting medical devices to the cloud brings numerous advantages like real-time monitoring, remote access, and data analytics, all of which can greatly enhance patient care and improve outcomes. However, it does not come without challenges and risks. Regardless if your organisation successfully tackled those on its own or you are still in the process of figuring out what to do, we invite you to keep on reading. In this blog post, we will explore the five things you need to keep in mind when embarking on a project to introduce cloud infrastructure, modern software development practices and pair them with point-of-care medical devices, ensuring patient safety, security and compliance whilst not jeopardising velocity and agility.
1. Determine your organisation’s readiness for cloud-native software development
Modern cloud-native software development does not exist without software development teams using short iteration cycles and frequent releases, and it has become a popular approach for building software that is agile, scalable, and reliable. But is your organisation ready for this fast-paced development approach.
Cloud-native software development requires a collaborative culture where teams can work together seamlessly to deliver software quickly and reliably. If your organisation is siloed, hierarchical, or resistant to change, it may be difficult to adopt a collaborative culture that supports cloud-native software development.
One factor to consider is the skills and expertise of your software development organisation. Cloud-native software development requires a different skill set than traditional software development. Your team should have experience with modern programming languages, containerisation, microservices architecture, and DevOps practices. If your teams don't have the necessary skills and expertise, you may need to invest in training or hiring new talent to support cloud-native software development.
"Teams should be built around value streams, responsible for delivering a complete solution, from ideation and design to development, testing, deployment, and support."
Another factor to consider is the design of your software development organisation. Teams should be built around value streams, responsible for delivering a complete solution, from ideation and design to development, testing, deployment, and support. This allows the teams to have a clear understanding of the entire value stream and to respond quickly to changes in the product or market. In order to optimise team cognitive load, well-defined team boundaries, clear roles and responsibilities, and effective communication channels should be used. Value stream teams usually include of a Product Manager, an Engineering Manager, and sometimes an Engineering Lead role, who collaborate to define what needs to be built, who will build it, and how it will be built.
Value stream teams often need additional support. That support can be provided by “Enabling Teams” composed of individuals with specialised skills and expertise, such as security, compliance, infrastructure, or data management. These teams are responsible for providing support and guidance to other teams in the organisation, ensuring that best practices and standards are followed, acting as a bridge between teams, and fostering a culture of learning and improvement. Another type of supporting teams are “Platform Teams” which provide standardised infrastructure and tooling that reduce duplication of effort, enable teams to focus on core responsibilities, and ensure compliance with regulations and industry standards.
2. Assess your IT department. Are they your enemy or your partner?
In today's fast-paced digital landscape, the ability of internal IT to support new digital initiatives is critical to the success of any organization, not just medical device vendors. If your organisation is still reliant on traditional IT infrastructure and tools, it may be difficult to adopt cloud-native software development practices.
Historically, traditional IT departments have focused on maintaining stable, reliable, and secure technology systems with an emphasis on physical infrastructure and on-premises software. However, this approach can be project-driven and lead to slow response times, hindering the ability to quickly meet business needs.
In contrast, modern IT departments leverage cloud-based technologies and are designed to be more agile and responsive. They are viewed as strategic business partners, enabling innovation through technology. Modern IT offers supporting services for software development teams, such as self-service procurement of cloud infrastructure, modern developer tools that enhance productivity, and API integrations with other IT systems (ERP, identity and access management, …).
Concepts like "paved roads" and guardrails, which come in the form of IT-prepared and supported infrastructure and service blueprints, organisation-wide cloud-provider-defined policies, and centralised billing, all lead to higher autonomy for software development teams while ensuring teams do not miss on any requirements.
IT should also help optimise the cost of cloud usage by monitoring and optimising cloud resource usage, implementing cost control measures, and identifying cost-saving opportunities.
3. Do you have the data under control?
The ability of organisations to effectively manage and leverage their data is crucial to their success. However, many organisations struggle to keep their data under control, which can lead to issues such as data silos, inconsistent data quality, and difficulty in pinpointing what type of data is stored or transmitted in a complex system.
Data-related decisions can be heavily impacted by these issues. Organisations struggle the most with handling sensitive privacy data, which is often the case for medical device vendors. When an organisation lacks a mature engineering organisation, applying data management and governance practices can become a bigger task than deemed necessary. This can lead to incorrect technical decisions based on a lack of understanding and fear of breaching compliance requirements, especially when storing data in a public cloud is being discussed. As a result, data may become a crippling factor for the entire business rather than a driver and facilitator for the future.
"Effective data management is critical for organisations to remain competitive in today's data-driven world, but it needs to be done correctly."
Effective data management is critical for organisations to remain competitive in today's data-driven world, but it needs to be done correctly. Trusting your software development teams while empowering your IT organisation to build the necessary policy framework and guardrails for data governance will enable your organisation to leverage modern technologies and increase collaboration across departments. This approach will bring the organisation closer to data-driven decisions, which will drive business growth while ensuring compliance when the privacy and security of the data is in question.
Data segmentation, labeling, and separation (clinical and non-clinical), as well as understanding the structure of the data (legacy human-readable vs. machine-readable), are crucial components of effective data management. In addition, ensuring data privacy both at rest and in transit and implementing different levels of encryption and data audit trails are important steps for organisations to take to have their data under control. Fortunately, using cloud services for data processing and storage provides many built-in features that simplify the process of creating a proper data governance framework, reducing the time and resources required to do so.
4. Have you managed to remove friction from your processes?
Agile and lean methodologies have become increasingly popular in the software development industry for their ability to increase productivity, efficiency, and quality. However, the success of these methodologies is not just dependent on implementing modern software development practices. To truly achieve success, it is necessary to optimise and automate all company processes, from manufacturing to operations.
Operations, in particular, can be a major source of friction that can hinder the effectiveness of agile and lean methodologies. Traditional operational processes are often slow, cumbersome, and inefficient, leading to delays, errors, and increased costs. To address these issues, companies must focus on streamlining and automating their operational processes.
Automation can help to reduce the time and effort required for routine tasks, freeing up employees to focus on higher-value activities. It can also help to eliminate errors and reduce the risk of accidents, resulting in better quality and improved safety.
"Companies must be willing to examine their existing processes, identify areas for improvement, and implement changes as necessary."
Optimising operational processes also requires a focus on continuous improvement. Companies must be willing to examine their existing processes, identify areas for improvement, and implement changes as necessary. This requires a culture of innovation and a willingness to experiment with new ideas and technologies.
5. Choosing the right partnerships
If you are only starting your cloud endeavour, choosing the right cloud provider is a critical decision that can greatly impact the success. One of the biggest difficulties when choosing a cloud provider is navigating the complex landscape of cloud offerings. Understanding the differences is challenging, and a common pitfall is to base the decision on comparison of cloud providers listed technical capabilities which is not a true differentiator while letting the compliance team drive the cloud selection.
If you handle sensitive patient data, and are subjected to regulations such as HIPAA, GDPR, or the CCPA your compliance team should definitely get the sit at the table, but they should not be the ones making final decisions regarding technology, but rather voice their requirements so the right technology choices are made when selecting cloud provider.
The importance of choosing the right cloud provider cannot be overstated. A poor choice can lead to increased costs, poor performance and reliability, and failing to meet compliance in practice. On the other hand, a well-chosen cloud provider can provide the technical capabilities and compliance certifications needed to support a successful cloud adoption initiative.
"One of the biggest advantages of partnering with the right companies is access to their expertise."
In addition to choosing the right cloud provider, it's also important to carefully select the right partners to work with when building your cloud infrastructure, especially when you lack internal skills and competencies. One of the biggest advantages of partnering with the right companies is access to their expertise. Cloud technology is complex, and it's not always easy to know how to make the most of it. A partner with deep experience and knowledge can help guide you through the process and make sure you're getting the most value out of your investment.
To avoid these pitfalls, it's important to carefully evaluate potential partners before making a decision. Look for partners with a proven track record of success, deep expertise in the technologies you're using, and a strong understanding of your business goals and objectives. Be sure to ask for references and case studies, and speak with their past clients to get a sense of their experience.