The profound impact of digital transformation in medical device manufacturing

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The MedTech sector in India has demonstrated its worth over the past two years by solving several real-world problems that have plagued the healthcare system. Today, there is greater momentum towards optimizing productivity to meet the challenges posed by current economic conditions, public expectations and stricter regulatory standards. The sector itself has significant potential, as Frost & Sullivan’s report on the MedTech industry highlights. The study reveals that MedTech is poised to grow at a stable CAGR of 6.3% from FY2020 value of USD 394.4 through FY2025. In this scenario, MedTech uniquely positions India to become a high quality medical device manufacturing hub that produces for the world. However, the potential to capture such value lies in embracing digital transformation in manufacturing.

The realization of MedTech 4.0

Having embarked on the digital journey early on, leading medtech companies began by carefully developing and implementing a digital strategy roadmap to make small but immediate changes to certain processes within the organization. industry. This was followed by developing and retaining a digitally savvy workforce, adopting agile methodologies, and tackling possible cyber threats. As a result, large MedTech companies have seen success in inventory management, logistics and distribution, device maintenance, product development, and warehouse operations.

MedTech Industry 4.0 – The integration and realization of digital transformation in production facilities throughout their operations has paved the way for improved quality and standardization of results. Some of the areas that have seen successful implementation are:

  • Internet of Medical Things (IoMT): Advances in device miniaturization, portability, and connectivity have underpinned connected healthcare infrastructure. This ecosystem connected through the IoMT allows the manufacturer to access real-world data which can then be used to make improvements to their products. Data collected is used to develop end-user usage information, meet interoperability requirements, and gain a deeper understanding of the product’s operating environment.
  • Advanced design engineering: With advancements in AI, deep learning, graphical modeling, and 3D printing technologies, the speed of conceptualizing and developing medical devices has increased significantly compared to the previous process. This has helped manufacturers work more towards products that have better endurance, efficiency, and ergonomics. Inclusions of artificial intelligence in the area of ​​production quality control, yield optimization and predictive maintenance have shown significant improvements in production over the years
  • Cloud computing: Today, with many large organizations moving their data and software to the cloud, there is a much greater focus on cloud computing. These new-age capabilities have given a much-needed boost to manufacturing operations that are managed through enterprise resource planning tools.

Digital solutions to support device traceability

As part of major implementation changes, one of the most significant changes that have been made in the MedTech industry is the implementation of device traceability – from development to expiration . However, during the manufacturing stages, the traceability of design controls is the key to product safety and efficiency. This gives regulators confidence that the desired product will reach the end user. Digital solutions provide the much-needed guidance for these processes and the established workflow. As part of the quality control and assurance process, digital traceability allows easy identification for a continuous iterative improvement plan.

In addition to traceability, another important parameter that digitization has simplified is the change management process. This is especially important when it comes to aspects such as design review, verification, validation and approval during the development and manufacturing stages of the device.

In India, we have large MedTech organizations that have already implemented these aspects and reaped the benefits associated with these implementations. This has not only helped increase productivity, but also reduced quality problems and, more importantly, opened up new prospects for exports to developed markets. As more and more MedTech companies in India and other parts of the world maintain their focus on digitizing medical device manufacturing, the overall quality of products currently available in the market will increase. One of the profound consequences of such a transformation will undoubtedly be remarkable changes in the broader healthcare ecosystem.



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The opinions expressed above are those of the author.



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