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By Jennifer Samproni
In the early days of the Covid-19 pandemic, the world faced travel bans, physical lockdowns, heightened consumer demand, and supply chain disruptions across every industry. This was especially true of the healthcare industry, which struggled to maintain business continuity while needing to become more agile and scalable to save lives. Time was of the essence, and this served as a forcing function for healthcare companies to rethink almost every aspect of their operations to be more resilient at every phase of the product lifecycle: from ideation to production and beyond.
Within healthcare, the pandemic served as a motivating call to develop a more agile and responsive approach to product design and innovation. Historically, our sector has operated within a well-established playbook. This has kept the system running smoothly in normal circumstances, but there is little room for deviation in the highly complex ecosystem of medical device and healthcare equipment ideation, manufacturing, and delivery. Within our highly regulated industry that demands extensive testing and validation for the utmost in quality and safety, product development generally takes longer, with devices taking seven to ten years to get onto the market.
Moreover, medical technology equipment and devices are often designed as iterations of previous versions, locking manufacturers into a design and set of materials that may not allow for flexibility, or sustainable business practices. Healthcare is notoriously insular and so collaboration across industries, organizations, and supplier ecosystems is often the exception and not the norm.
In the face of major disruptions—the global pandemic and supply chain shortages—this approach has made it difficult to pivot, speed up time-to-market, and scale breakthrough product innovations that save and enhance lives globally.
In the last few years, healthcare product companies have been challenged to act with greater speed and resiliency, accelerate innovation and transform healthcare delivery and patient care to meet the needs of a global population. As practitioners, we’ve learned valuable lessons that can easily be applied throughout the product lifecycle—from the product design phase all the way through to end-of-life.
Healthcare companies seeking to remain competitive must reset their playbooks to become more resilient in the face of unforeseen challenges and to be prepared for a more connected and digital world.
Step 1: Future-proofing in the product design phase
Future-proofing is a crucial exercise in product design and involves designing a product to minimize technical obsolescence and other impacts of future risks. This exercise is now a crucial one for medical product designers. These professionals must adopt a broader point of view and consider everything from electronics component and material availability, new technologies and techniques, cross-industry learnings, future regulatory compliance needs and sustainability goals.
Instead of defaulting to iterative designs that rely on legacy electronics, healthcare grade plastics and other materials, designers must prioritize standard or widely available components to avoid future supply chain issues. When possible, products should be designed with redundancy in validated and certified components that can be accessed through a localized supply chain if needed.
It is also important to consider parts count and component durability. Fewer overall parts mean a lower risk of supply chain impacts (if there are built-in redundancies). And using more robust components that are easily maintained comes with enormous benefits. By designing for durability and ease of maintenance, a company can expect to spend less on field calls while also providing a simple pathway for the customer to repair the device themselves. Additionally, products that are built to last are more sustainable and some healthcare products provide aftermarket opportunities to maximize value through reuse and refurbishment.
Intensive testing is a baseline expectation in the process because products must be safe, compliant, and effective. However, advanced technologies now make it possible to speed the process while maintaining the same high standards and level of rigor. Recently, regulatory bodies have begun accepting some modelling and simulation to substitute for patient trials. For example, digital twin technology is proving to be a game changer.
By creating a real-time digital twin of the entire manufacturing process, design teams can change variables and observe outcomes faster than they could with a physical prototype alone. This leads to reductions in costs and schedules, optimized processes and the ability to iterate on designs more effectively and efficiently. Flex worked with a customer on a Class II diabetes product and created a digital twin of factory operations. A testing process that would have normally taken three months was shortened to three weeks, and we were able to optimize processes to increase station output by 70% and produce 47% more units per quarter.
Step 2: Embracing multi-dimensional industry and technological expertise
Healthcare companies should partner with a manufacturer with a broader range of capabilities and perspectives across different industries. The ability to apply learnings from faster-turn industries—like consumer electronics or home appliances—and to apply best practices, technologies and processes to address healthcare sector needs, can become a key differentiator and enable healthcare companies to achieve greater resiliency and agility.
Fostering a culture in which designers and engineers are encouraged to learn from other industries and stay abreast of emerging technologies improves adaptability and opens the door to greater design innovation. As medical devices and healthcare equipment evolves to integrate with consumer devices, the healthcare industry will increasingly need to understand connectivity, smart devices, Internet of Medical Things (IoMT) and nascent technologies from other industries.
Step 3: Being ready for future regulatory requirements
Though we cannot predict the future, we can all see that regulations will continue to grow and change as innovations are introduced into the medical devices and healthcare solutions space.
It’s clear that with the rapid introduction of new technologies, it may take time for regulatory bodies to catch up and establish directions and requirements. When designing with new technologies, companies must think through the possible repercussions and risks, within the context of the opportunities ahead. For example, the ubiquity of connected devices enabled through the cloud and 5G is making healthcare more accessible and affordable. But this often leaves patients, providers and hospitals vulnerable to cyber-attacks. Engineers must address this reality and ensure the safety and security of products and patient data.
Where do we go from here?
At such a critical time, the opportunities to partner and influence the next wave of innovation are endless for manufacturers of medical devices and healthcare solutions.
The past few years have not been easy for the healthcare industry, but it has pushed us to learn and grow to be more adaptable and resilient. This will serve us well as we move toward a new era in healthcare innovation, one in which we openly share ideas, think expansively, and take the steps to optimize manufacturing and design. There is much to look forward to: from wearable electronics that combine medical technology and consumer electronics, to more predictive systems that tap into the capabilities of Artificial Intelligence (AI) and machine learning.
The future of healthcare looks bright. We have the playbook to bring it to life improve outcomes and patient care.
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Jennifer Samproni is Chief Technology Officer for the Health Solutions business at Flex, the global manufacturing partner of choice that helps a diverse customer base design and build products to improve the world. Ms. Samproni leads the global product development organization made up of over 650 medical engineering professionals supporting the innovation of medical devices, medical equipment, and pharmaceutical products.
With over three decades of experience in medical device product development spanning R&D, strategy, and manufacturing, Ms. Samproni is an expert on how product engineering and design teams can overcome complex challenges such as incompatible designs, limited supply, broken systems and countless other scientific challenges. She is a recognized thought leader in healthcare diagnostics, digital health, next generation technologies, and advanced manufacturing. Prior to Flex, Ms. Samproni spent 13-years at Siemens Healthcare Diagnostics, where she served as Vice President, Head of Critical Care Systems R&D.
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