As the rates of infectious and chronic diseases grow around the world, so does the demand for medical devices, as well as the increasing complexity required of those devices.

A year ago, industry trends included wearables, robotics, and artificial intelligence; all of these require innovation and additional amounts of software, whether embedded in the device or delivered as associated applications. Greater complexity adds to the challenge of delivering new products ahead of the competition, as well as managing costs to ensure profitability.

While those trends remain relevant, the COVID-19 pandemic has brought additional challenges. Lockdowns led to distributed teams working remotely. The move towards virtual medical practice and layperson use of devices accelerated. Critical needs for devices like ventilators, accompanied by supply chain issues and material shortages, led to multiple contests to develop innovative new devices that could be produced quickly, cheaply, and easily.

Of course, “quick, cheap, and easy” isn’t enough. Quality and safety are critical, possibly more so as the surge in telehealth services and continued consumerization put devices in the hands of laypersons. The list of regulatory standards for medical devices continues to evolve, including MDR and Regulation (EU) 2017/745, IEC 62304, ISO 13485, ISO 14971, 21 CFR 820.30, to name only a few. Regulatory compliance is imperative – and in many cases, can be cumbersome and costly.

These are not insurmountable challenges, but require that you leverage the right engineering tools and processes, supported by experts in industry and solutions.

With help from Persistent Systems and the IBM Engineering Lifecycle Management (ELM) solution, product development consultant Cambridge Consulting was able to design and deliver a new life-saving ventilator in just 46 days.

How are companies like Cambridge Consulting achieving these results, and what can you do to realize this level of success within your organization?

Speed delivery with collaboration around a single source of truth

When building a complex product, coordinating across teams becomes critical. Manual, document-based collaboration is too slow and error-prone. With a data-centric, web-based approach, teams can easily access the artifacts they need and collaborate in the context of those artifacts, including discussions and reviews, with changes reflected in the artifact’s history. Linked data principles are core to the ELM solution — with traceability from granular requirements through to design, code, and test artifacts, all teams work with a single source of truth.

Improved collaboration accelerates our development time”: By connecting all stages of the development cycle, Diagnostic Grifols reduced time to market by 20%. 

Linked lifecycle data also makes it easier to analyze the impact of change, and to communicate and manage change across teams. Leverage scaled agile practices instantiated in the applications to plan and track changes and all work across the solution and team levels, are able to help in managing dependencies and optimizing delivery.

Based on open standards, ELM can integrate with other tools to extend collaboration even further. And if you are producing product variants for different target markets, ELM offers advanced capabilities for managing variance without copying, promoting reuse at the artifact and component level to streamline product line engineering.

Ensure quality and manage risk through the entire lifecycle

You can’t test quality into a product, you need to build it in. ELM offers capabilities across the lifecycle to support systematic quality in alignment with ISO 13845. With advanced requirements management to clearly and granularly capture regulatory, safety-critical, functional, and non-functional requirements at all levels to drive design and test activities. You can even apply artificial intelligence to improve requirement quality.

The later issues are found, the more costly the resolution – especially after production. System modeling, reviews, and design simulations help identify potential issues early in the cycle when they are easier to address. Apply comprehensive test planning and execution capabilities to verify and validate on both sides of the system V, confirming all requirements are met. Identify, address, and track risks at all points of the lifecycle, with shared visibility across teams, providing comprehensive risk management as mandated by ISO 14971.

A leading analytical laboratory instrument manufacturing company improved performance and throughput of assays, while their auditor “was just blown away on how effective the tools were in terms of addressing all of his audit questions.” 

Reduce the cost of compliance by embedding it in your tools and data

Manually compiling compliance evidence from disparate documents can be time-consuming and difficult. With lifecycle traceability, you can easily show the thread from requirements (regulatory and otherwise) to validated implementation. In addition, ELM applications embed and enforce processes including workflows, permissions, and e-Signature approvals, making the process executable, configurable, and repeatable.

Leverage process templates and practices aligned with IEC 62304 and 21 CFR 820.30 to generate plans, activities, and artifact types that guide your implementation and help establish your quality management system. With evidence built right into your data, you can generate reports, documents, and interactive visualizations to demonstrate compliance, even customizing the generated output. 

Solve your challenges faster with IBM Engineering and Persistent Systems

According to industry analyst Ovum, IBM Engineering Lifecycle Management is the industry-leading portfolio for complex systems and software engineering. Nine of the top ten medical device manufacturers leverage ELM, as do leading companies in other industries with complex solutions like automotive and aerospace.

Persistent Systems partners with IBM to develop the ELM solution, uniquely positioning Persistent to advise and assist clients in adopting, managing, and extending the solution. In addition, Persistent offers over 15 years of experience enabling innovation and compliance in the medical device and healthcare industry, with services spanning digital transformation, machine learning solutions, device development, and end-to-end product design.

RenalytixAI partnered with Persistent to accelerate delivery of diagnostic tests leveraging AI capabilities to predict the likelihood of rapid renal function decline. “With the scale and breadth of Persistent… we can bring 2 key aspects together: the data science and artificial intelligence capabilities, coupled with the development of complex and integrated software solutions”. 

Persistent has helped clients like RenalytixAI, Cambridge Consulting, and over 120 others in the industry to successfully deliver innovative solutions while addressing the challenges of complexity, compliance, and cost.

Learn how Persistent Systems and IBM Engineering Lifecycle Management can ensure you succeed in accelerating innovation and compliance for your medical devices. Whether you are just starting up, or well-established, let’s talk about how we can grow your business and help you achieve the standard of excellence you expect from your tools.

Today’s market reality demands compliance, cost-effectiveness, complexity, and collaboration. With ELM solutions from IBM and Persistent, you’ll be set up for success in your medical device journey.

Click here to learn how to build a lifesaving ventilator at lightning speed with Persistent Systems and IBM.