Gartner claims that by 2025 over 95% of new digital workloads will be deployed on cloud-native platforms, up from 30% in 2021. Cloud solutions will be pervasive in the future and anything non-cloud will be considered legacy.
The MedTech industry stands to gain a lot by using a cloud-based infrastructure for internal operations including product design & development, operational execution, quality management, compliance & validation activities, and for improving patient outcomes with cloud-based applications within their products. A recent article on Medical Design and Outsourcing brings together industry leaders from both medical device manufacturing and cloud computing together to discuss how the cloud is transforming MedTech.
Leaders from global giants like J&J, Phillips, GE Healthcare, Amazon, Google, and Microsoft, shared their views on the future of cloud in patient care and the MedTech industry.
Cloud improves patient outcomes – Medical device manufacturers can improve patient outcomes by equipping devices with sensors that capture data and store it in the cloud before applying AI & ML analysis. Complex algorithms deployed over the cloud can predict and detect health-related issues far more accurately and in a fraction of the time when compared to traditional diagnostic methods.
Cloud computing enables virtual care with conformance to care protocols in the ICU and OR. Cloud platforms have the ability to collate patient data and present it to caregivers along a single pathway, for the best possible diagnosis and care. Surgical procedures can be streamlined for comparative analysis and cloud-based data makes connected care available, with device data facilitating collaborative, intelligent, accurate, and more affordable healthcare.
AI beyond intelligence – Industry experts believe thatAI can go beyond delivering smarter results to delivering more proactive and predictive care in the future. The evolution of AI will create the ability to predict possible health events and can be leveraged to deliver care proactively to avoid health incidents rather than treating them after the fact. AI will reduce the variability of care attributed to provider judgment and caregiver skill and improve the standard of care universally. With Cloud, Big Data and AI could make healthcare more equitable, and more affordable, provided the healthcare industry and regulatory bodies create a shared vision for connected care.
When applied to manufacturing AI can wield equally valuable outcomes with predictive quality and predictive maintenance. MedTech manufacturers using an MES application can prevent possible product failures or machine breakdowns that cause recalls and patient injury from defective products. The cloud will facilitate iterative design to improve products based on inputs from operations and data collected from the field.
Benefits of Cloud Computing in MedTech Manufacturing:
There are various possible cloud configuration and deployment options for the medical device manufacturing landscape. Our post on MES and the Cloud covers the basic fundamentals of cloud deployment and is recommended for leaders planning to switch from a local server and application to a cloud infrastructure for their MES and data storage.
Cloud service providers promise high levels of security with data stored redundantly to ensure vital data is never lost. Figure 1 below illustrates how MedTech industry leaders can ensure the security of their data by choosing either private or hybrid cloud infrastructures. Companies can choose to have highly sensitive data stay off the public cloud while being able to host their applications and manage most of their transactional data on it. This flexibility allows MedTech companies to configure the MES application protocols to improve data security using the cloud irrespective of the configuration chosen.
There are significant benefits of cloud computing for medical device manufacturing, partner management, and regulatory compliance in addition to improving patient outcomes and creating a connected, intelligent, and equitable healthcare ecosystem. The cloud also uses big data and AI to standardize operations across the globe at multiple sites.
Unleash AI and ML – With a cloud-based MES, AI and ML can be deployed across multiple sites, and with post-market data from the field, product improvements can happen more iteratively, improving TTM. AI helps manufacturers prevent breakdowns and quality events that may result in recalls by collecting process data for predictive maintenance and predictive quality.
Faster Deployment & Scalability – Cloud deployment is easier and less expensive for multi-site enterprises and for those engaged in M&A expansion by removing local infrastructure set-up and the time, effort, and costs.
This improves the agility and flexibility of the value chain and allows sites to start working under the same overarching MES.
Increased Collaboration & Faster Upgrades – A cloud-based MES allows data sharing across critical functional areas, from design to quality, eliminating data silos with local point solutions. Increased collaboration leads to better decisions and process outcomes. Upgrades in a typical GMP environment traditionally involve high testing and validation costs. With cloud-based MES applications risk assessments and upgrades are automatically tested and validated.
Improved validation – Process validation including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) is the responsibility of the manufacturer. However, to reduce costs, cloud-based automation IQ and even OQ can be provided by the vendor. For multi-site operations, IQ is required only once and the other qualifications can be fully automated, with built-in change control to monitor modifications and provide evidence of modifications made.
Data Security, Reliability & Control – Data maintenance is paramount for medical device manufacturers. The need to be able to produce e-DHRs, genealogy records, and other compliance reports on demand is vital. Most cloud deployments have redundancy and data security from loss or disruption at the local level. Manufacturers can reliably store data on the cloud with security assurance and reproducibility based on set internal protocols. The control that manufacturers have on their data in the cloud increases with the ability to monitor the cloud environment and automatically detect changes.
Better Collaboration with Supply-chain partners – A cloud-based MES makes it easier for manufacturers to collaborate with contract manufacturers and suppliers. Production and design-related data are easier to share if the same application by everyone, and the collaboration extends even further to increase visibility, control, and compliance in the value chain.
The benefits of having a cloud-based MES include reduced HW and SW infrastructure cost, automation of validation activities, and better change control preventing re-validation efforts. Cloud is here to stay and becomes more ubiquitous each day, early adopters will benefit and gain the advantages first movers tend to have! Choose the right MES which is cloud-native, to become an industry leader.
Side Bar: Understanding the current regulatory landscape
While the medical device industry is rapidly moving towards cloud adoption, regulatory bodies are still coming to grips with possible risks this technology might bring. A post from globenewswire.com highlights the guidelines issued by AAMI pertaining to the use of cloud computing for quality systems and medical devices. An understanding of these guidelines can help medical device manufacturers formulate a better strategy when it comes to incorporating the cloud within their operation and product design.
The pioneering guidance document specifically details how to explore six recommendations that stakeholders should consider before implementing cloud-based technologies in a medical device or quality system:
- Identify your intended function of cloud computing.
- Determine whether cloud computing is a good fit for you with a risk-based approach.
- Identify how frequently your cloud computing resource updates and the criteria for revalidation.
- Determine how your cloud computing vendor could adversely impact your process or device.
- Establish a contingency plan for cloud computing-based adverse events.
- Develop a process to detect cloud computing resource updates and/or resulting adverse events.
