Navigating the Future of Medical Device Manufacturing

12 Life Science Trends and Strategies

800x300_Navigating the Future of Medical Device Manufacturing

In the ever-evolving landscape of medical device manufacturing, modern medical technology companies must be leaders in both engineering innovation and business performance.

A recent conversation between NI and Averna shed light on the current trends and strategies that are shaping the future of the medical device industry. The full webinar can be summarized into 12 trends and strategies.

1. Supply Chain Resiliency: Adapting to the Unexpected

The COVID-19 pandemic highlighted vulnerabilities in supply chains across the globe. To ensure continued production, medical device companies are now focusing on building resiliency into the supply chain of their test assets. This includes minimizing exposure to custom or niche components, formalizing lifetime service plans at the point of tester design and embracing platform approaches that support multiple product lines to reduce maintenance burdens.

2. Embracing Modularity: The Power of Building in Blocks

Modular manufacturing is gaining traction. It involves breaking down production processes into smaller, interchangeable components. When a component fails or requires adjustment, it can be replaced or modified without disrupting the entire process. This approach enhances agility and the ability to meet shifting market demands.

3. Effective Documentation Strategies: A Regulatory Imperative

Comprehensive documentation of manufacturing processes and product designs is vital. Well-documented procedures not only aid in regulatory compliance but also streamline changes without the need for lengthy validation processes.

4. Reducing In-House Hardware Design: Off-the-Shelf Solutions

Custom hardware development can be time-consuming and expensive. Medical device companies are increasingly turning to off-the-shelf systems to meet increasingly complex test coverage requirements and meet schedules. This also minimizes redesign efforts during supply chain disruptions.

5. Software Adaptability: A Key to Efficiency

Like hardware, software adaptability is crucial. Companies are seeking ways to update software components without undergoing complete revalidation processes, saving both time and resources. Increased use of abstracted architectures facilitates this with some groups shielding product specialists entirely from the test operations. This accelerates NPI processes and minimizes revalidation efforts as requirements evolve.

6. Automation and Robotics: Enhancing Efficiency

Automated handling and assembly are becoming economically viable in lower production volume environments. Conveyors are now commonly aided by more complex DUT handling with pneumatic “cobots” assisting operators more and more often too. This frees capacity for the workforce to focus on more complex aspects of production and has a positive impact on yield and throughput.

7. 5G and Connectivity: Revolutionizing Data Sharing

The promise of 5G technology lies in its ability to enhance connectivity between medical devices and networks. Although not yet widespread, this technology holds the potential for real-time data sharing and remote monitoring of medical devices.

8. Model-Based Testing: Simulating Real-World Conditions

As products evolve from siloed architectures to software controlled “systems of systems” the ability to shift test earlier in the design cycle becomes imperative to meet design schedules. Model-based testing is therefore becoming common in medical device design, involving the creation of virtual environments to simulate real-world conditions for testing medical devices. This approach proves more comprehensive and efficient, particularly for complex devices.

9. Cybersecurity Concerns: Safeguarding Devices

With increased device connectivity comes growing concerns about cybersecurity. Protecting medical devices from cyber threats is paramount to ensure patient safety and data security. OEMs are looking for strong, long-term relationships with trusted component suppliers to guarantee on both sides that the investment is in place to secure any embedded, wirelessly connected system element.

10. Recruitment Challenges: Meeting Young Engineers' Expectations

Recruiting and retaining skilled engineers, particularly from younger generations, can be challenging. Young engineers often seek varied experiences and rapid career progression. This challenge is compounded by the "silver tsunami” of experienced talent approaching retirement, creating a knowledge drain within departments.

11. Data Analytics and Machine Learning: The Future of Decision-Making

Leveraging engineering data for analytics and machine learning is on the horizon. Companies aim to use data to enhance product quality, predict maintenance needs, and optimize manufacturing processes.

12. Collaboration and Standardization: The Keys to Success

Collaboration within and across teams, as well as standardization of processes and documentation, are pivotal for addressing these trends and challenges. They ensure consistency and efficiency in the industry’s evolution.

In conclusion, the medical device industry is evolving at a rapid pace, driven by factors like supply chain resilience, technology advancements, and cybersecurity concerns.

Blog_Navigating-future-of-medical-devices_medtech-developement_NI Engineering teams must balance the pace of differentiating innovation, with the risk that any new feature introduces to the end user – all while managing their budget. This is not easy. To address this balancing act leading medical companies are building strong relationships with industry leaders like Averna and NI who have a proven track record of medical product design, validation, and manufacturing. To succeed in this competitive world, it pays to not be alone in your endeavor, so help is at hand when you need it.