Industry
Life Sciences
Patient-centered Care Models Taking Center Stage in Life Sciences
Highlights
- Model-Based Systems Engineering (MBSE) can be employed in the medtech domain as it is an engineering methodology that replaces traditional document-centric approaches with digital modelling. This helps in creating a single source of truth for all the teams to refer to throughout the product lifecycle.
- Considering the product complexity, it is impossible to establish traceability when the design is document-centric. With MBSE, it is possible to navigate the complex requirements with clarity and transparency.
- Compliance with regulations is crucial in medical devices. MBSE provides traceability, and simulation results can be used as evidence for Food and Drug Administration (FDA) compliance.
On this page
On this pageinpage
Why Model-Based Systems Engineering (MBSE)?
The medtech industry is characterised by rapid innovation, with average product lifecycles lasting just 18 to 24 months. In addition, medical devices are becoming more complex, a hallmark of modern product development. Evolving customer expectations demand shorter time-to-market while adhering to statutory and regulatory compliance requirements.
As device complexity increase, the architecture of the medical device, which has thus far occupied relatively less real estate, needs a larger landscape. Interactions between hardware and software are complex and so difficult to comprehend. As traditional product development relies heavily on documents, linking these documents with each other [PK6.1][VP6.2]to establish the connection between them is a herculean task. This has a huge impact on the product development lifecycle, and there is an immediate need for an engineering thread that ensures seamless design flow. Model-Based Systems Engineering (MBSE) is therefore a timely approach to orchestrate the digital thread for product development.
How can MBSE can transform complex product design?
Model-Based Systems Engineering (MBSE), an engineering approach underpinned by digital modelling, replaces traditional document-centric approaches. It employs interconnected digital models as the single source of truth to design, analyse, verify, and validate complex systems throughout their entire lifecycle.
Technology is advancing at breakneck speed, which triggers technological obsolescence, leading to an item or system being replaced by an advanced version even if it still functions as per the specifications. For example, let’s consider a mechatronic system such as an MRI machine, where hardware and software are closely linked. The software manages the timing of hardware components. The properties and constraints of the hardware determine the limits the software algorithms can stretch to create a high-fidelity image. Easier said than done, as many tools and methodologies are involved. Hardware defined one tool, an architecture definition realised in another, and requirements distributed across numerous documents. When there is a need to change a component or subsystem during design, obsolescence management, or sustenance engineering, engineers must initiate a comprehensive search across the impacted subsystems or software modules to prevent failures or compromise patient safety. With MBSE, which creates a digital model of the systems as a single source of truth, the change and its impact can be easily identified across the system. One can ensure via simulation that the change hasn’t introduced any risk when it occurred. This ability to identify potential issues at an early stage is a boon, as the cost of fixing a problem at the end of product development increases exponentially.
How does MBSE enable knowledge management?
As they say, the most dangerous person in your team might be your “Hero Employee”. This is true in almost all teams, where the most dedicated, knowledgeable person will have the entire design in their head. A brilliant systems engineer will be carrying all the explicit knowledge, not to mention the tacit aspects. This creates dependency, disguised as excellence, which poses an organisational risk. This is also the case when people leave the organisation and there is a lack of information about the product development stages and the context needed for effective product continuum.
This is where MBSE can help. If complexities are the raging bulls, then MBSE is the matador. For the development team, the model can act as the shared source of truth, promoting clarity in communication and seamless exchange of information across cross-disciplinary teams.
This digital representation creates a digital fabric of the product lifecycle, in turn eliminating the tedious process of writing and maintaining system documentation. It is possible to generate documentation from the system model, which reflects the latest status.
How does MBSE improve patient safety?
Patient safety is of paramount importance, which is the primary objective of stringent regulatory compliance mechanisms. One of MBSE's greatest strengths is its ability to ensure transparency and compliance with requirements and specific regulations. By using models to represent, analyse and simulate system components and functionalities, engineers can employ a shift-left approach to validate subsystem integration. This not only enhances reliability but also ensures that there are no surprises in regulatory compliance certification and minimises the risk of costly setbacks in the final stages. By following MBSE methodology, the medical device industry can move ahead with more assured steps and minimise catastrophic adverse events.
How can medical device manufacturers stay ahead of the competition?
The medical device industry is witnessing a growing global demand for advanced and diverse products. In this survival of the fittest world, to stay ahead, manufacturers must focus on innovation and maximise cost-effectiveness across the globe. High quality geo-localised products command higher market share. One of the ways to manage global product variations is to use MBSE and Product Line Engineering (PLE). Together, MBSE and PLE can enable medical device manufacturers to focus on innovation and getting ahead of the competition via differentiation while still consistently meeting quality and compliance standards.
Processes can be streamlined, costs reduced, and safer, bespoke medical devices delivered through MBSE’s system analysis and PLE’s systematic asset reuse.
How can AI help in faster product development?
MBSE provides high-quality, structured, and context-rich data which will enable AI to produce sophisticated engineering analysis and outcomes. This model can answer “what if” questions, especially in the case of obsolescence management and ever-changing regulatory compliance needs.
AI co-pilots that can interact with system models can create impact analysis that will accelerate time-to-market.
Is MBSE the answer for more robust devices?
MBSE offers a shift from the V model to a W model, with the apex point representing the point at which simulation can be introduced. MBSE adoption is not just new software, but a strategic reset of the design approach. As Newton said, “if I have seen further, it is by standing on the shoulders of giants,” which is true, considering what medtech can learn from other mission- and safety-critical domains such as aerospace and automotive, which have adopted MBSE. With an immersive approach in which MBSE specialists embed directly within product development teams, it is possible to manage today’s highly complex cyber-physical systems while remaining flexible to accommodate AI-led innovation.