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  • Alex Hattaway

Why medical device designers need to become more agile — and how they can do it

By MEDTECHDIVE


To stay competitive, medtech firms must center manufacturing in business optimization plans, says Flex’s Jennifer Samproni.



Editor’s note: Jennifer Samproni is chief technology officer, Health Solutions at Flex. She has over three decades of experience in medical device development, leading both engineering and scientific organizations.


As medical device companies strive to remain competitive and agile in today’s fast-paced world, they must center manufacturing in business optimization plans while embracing a design-to-value approach from the start.


The COVID-19 pandemic accelerated the healthcare industry’s transformation, driving faster innovation, open collaboration, optimized speed-to-market and near-instant scalability. Now, traditional healthcare delivery models are shifting, as and consumers demand more control over their health, turning to at-home devices and wearables.


To succeed, our industry must learn from faster-moving industries — such as consumer electronics — that navigate these dynamics well. Consumer electronics companies develop products quickly, collaborate across the industry and continually adapt to meet customer demand and market trends — best practices that are becoming increasingly important to compete in the dynamic healthcare industry.


Adapting to a dynamic market


When the pandemic pushed healthcare (and every other industry) into crisis, providers responded by finding new ways to provide care — from adopting telemedicine and remote monitoring to implementing virtual training systems, robotics and even drone delivery.


The industry’s dynamic evolution made it clear that consumers want products that deliver instantaneous information, a great user experience and care when and where they want it.


Consider the advancements in human-machine interface (HMI) that make operating a smartphone or driving a car with driver assistance features a seamless, enjoyable experience. To satisfy consumers, the same must be true for healthcare devices. Consumers expect easy-to-use, connected devices with interactive applications and smart, data-rich features. The proliferation of wearable devices has raised expectations for lightweight technology— whether providing therapeutic, diagnostic or monitoring services — that seamlessly integrate into their lives.


Moreover, an aging population, chronic illnesses treatment and cost pressures across the continuum of care, present the healthcare industry with both enormous challenges and opportunities. We can overcome challenges head-on and provide greater access to healthcare by acting nimbly, embracing smart and connected technologies and learning from other industries.


A more agile approach to design


Design engineers need to be mindful of the shift in demand toward value-based solutions and outcome-as-a-service models, and apply those approaches through the continuum of care.


That requires agility: the ability to be more responsive to change, expedite time to market and lower costs without compromising quality. However, the medical device industry isn’t currently set up this way. Cross-industry information sharing and collaboration are rare, and the development and manufacturing of healthcare equipment are often constricted by a model that doesn’t support quick responses to the market nor frequently changing regulations.


Five ways companies can become more agile


  • Leveraging advanced technologies: Healthcare companies can use advanced technologies to better navigate constant change. For example, through digital twin technology, which offers modeling and simulations, design engineers can apply changes and observe outcomes to products pre-production. This reduces rework in the physical world and allows companies to get products to market faster.

  • Accelerating testing: Rigorous testing is a mainstay of the healthcare industry, for obvious safety and quality reasons. Companies can speed this up with technology. In some cases, digital twins have also been an effective and quicker testing alternative to patient trials, even recognized by regulatory bodies. In fact, it enabled Flex to test scenarios and complete the optimization analysis of a customer’s Class II diabetes product in three weeks. Without it, it would have taken more than three months.

  • Future-proofing products: Rather than drawing on legacy electronics and materials, product designers should focus on developing products with fewer parts and widely available standard components to help mitigate possible supply chain constraints. Ideally, components would be certified and validated, as well as available via a localized or regional supply chain, in case of international disruption.

  • Parts should also be durable and easily maintained to reduce reliance on the supply chain for replacements while reducing maintenance and repair costs. Reliable components result in more sustainable products, which will help meet current and future regulations to reduce environmental impacts across the product life cycle too.

  • Preparing for regulatory changes: Technology-based companies move faster than regulatory bodies, but regulators will catch up and companies don’t want to be surprised by requirements that disrupt existing processes. When designing new technologies, it’s important to think through the risks and potential repercussions.


The proliferation of connected devices working via the cloud and 5G wireless, for example, does a lot to make healthcare more accessible and affordable but it also gives rise to legitimate cybersecurity and privacy concerns. Engineers developing connected devices need to consider cybersecurity from the start and build data protections into the product’s foundation, rather than trying to add it later.


As the number and variety of medical devices grow, regulations will too. Companies should try to anticipate likely regulations to ensure manufacturing continuity.


  • Breaking out of silos: Thinking and working outside of the insular model of iterative improvements can spur innovation and accelerate development. Looking at top consumer electronics companies, such as Samsung and Apple, and how they respond to both customer demand and the market is a good place to start. Take note of best practices, technologies and processes then replicate them in the healthcare sector.


Medical device designers should also take advantage of smart, connected devices including wearables, which consumers already use to collect data healthcare providers need, plus Internet of Medical Devices (IoMT) and other emerging technologies. Taking advantage of the data and advanced analytics from these technologies, machine learning and artificial intelligence to make their products optimally effective.


Building resiliency into the model


For medical device designers and manufacturers — and regulatory bodies — this means emphasizing agile processes, future-proofed designs and advanced testing methods designed to speed up development and manufacturing while satisfying regulatory requirements. Companies need to consider the entire process, including resource availability, new technologies and techniques, cross-industry information sharing, future regulatory compliance needs and sustainability goals to balance user needs and manage costs.


Constantly applying learnings from the pandemic, plus staying on the cutting edge of the future of healthcare devices, will build a more agile and resilient industry.


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