Balancing AI Potential in Medical Devices: Optimization and Human Thinking

The integration of artificial intelligence (AI) into medical devices has shown tremendous promise in revolutionizing patient care, diagnosis, and treatment. From detecting subtle anomalies in medical images to offering predictive insights, AI-powered medical devices offer remarkable potential.

However, as society embraces this transformative technology, it’s crucial to strike a balance between harnessing AI’s capabilities and preserving the indispensable role of human expertise. One key consideration is the optimization of both hardware and software in AI-driven medical devices. Cutting-edge AI algorithms are only as effective as the hardware they run on.

Ensuring that devices are equipped with the necessary processing power and memory to handle complex AI computations is paramount. Moreover, ongoing software updates are essential to refine AI algorithms, enhance accuracy, and address emerging medical challenges. Regular optimization ensures that medical devices remain relevant and effective throughout their lifespan.

While AI can greatly enhance efficiency and accuracy, it must not overshadow the importance of human thinking. Medical professionals possess a wealth of knowledge, experience, and intuition that AI cannot replicate. The human touch in diagnosis and treatment encompasses empathy, ethical judgment, and critical thinking, which are vital in complex medical cases and patient interactions. AI should be seen as a valuable tool that aids medical professionals rather than replacing their expertise.

To strike the right balance, interdisciplinary collaboration is crucial. Engineers, data scientists, and medical practitioners must collaborate to develop AI-powered medical devices that align with clinical needs and ethical standards. Regular feedback from healthcare providers can help fine-tune algorithms and ensure that AI recommendations are clinically sound as well as patient-centric.

Adopting a Sustainable Mindset to Combat Medical Device Waste

green medtech

Sustainable business practices allow companies to acknowledge and address environmental issues while also creating value, increasing revenue, and gaining cost savings. Environmentally aware organizations typically integrate a sustainability mindset into all of their activities, embedding it into their corporate strategy, purpose, and culture.

In the medtech industry, the sustainability conversation often begins with the problem of medical waste and the role of disposable plastic packaging to ensure the safety of patients and healthcare workers, as well as how to balance a sustainable approach with health and safety.

Many experts believe it is essential for medical device developers and manufacturers to embrace sustainability in order to ensure regulatory compliance and future profitability. “Sustainable medical devices are better for the environment and attractive to consumers and can provide cost savings, investor interest, and improved brand and competitive advantage,” notes a recent Medtech News article.

However, a sustainable approach to medical device production is not limited to discussions about disposable packaging and whether or not the device is recyclable. Instead, it means considering “how to reduce carbon emissions, energy and water use, and material waste across its entire lifespan, from design and material selection, to supply chain, to manufacturing and distribution,” said Medtech News.

The Lowest Possible Environmental Impact

Developers and manufacturers must consider all of these factors, as well as the safety and usability of the devices for patients and end users. They should “strive to achieve products with the lowest possible environmental impact throughout the product lifecycle without compromising performance, patient safety, functionality, aesthetics, quality, or cost,” notes the pharma industry news publisher On Drug Delivery.

According to these sources, an “eco-design” approach to device development and manufacturing could include:

  • The use of eco-friendly device materials
  • Designing “small” to minimize the use of unnecessary materials
  • Designing to maximize use of existing technologies, such as wireless technology
  • Manufacturing processes that minimize energy and water use
  • Minimal packaging using recyclable or degradable materials
  • Designing devices to ensure easy disassembly, facilitating reuse and recovery of device components at end of life

Medical device manufacturers and distributors, as well as healthcare companies, can also benefit the environment by finding a thoughtful and effective waste management partner. These partners will help ensure that discarded items are destroyed properly and in a sustainable manner, says Medical Device + Diagnostic Industry (MD+DI).

Sharing the Vision

According to MD+DI, the right waste management partner will:

  • Have a shared sustainability vision with its customer
  • Offer customized solutions for the customer’s needs
  • Take a dedicated, personalized approach to recycling and beneficially reusing waste that would otherwise end up in landfills
  • Offer enhanced data tracking and reporting of waste stream management and how efforts align with financial sustainability and corporate goals

The Dynamic Technology Solutions team heard plenty of buzz first hand this past year at industry events, including the Women’s Business Enterprise National Council conference and the Diversity Alliance for Science conference, about the need for businesses to adopt an environmental, social, and governance (ESG) perspective and how ESG is more important than ever. Medical device developers and manufacturers must embrace sustainability strategies and practices or else risk being left out of future business opportunities with companies that are prioritizing ESG.

Here’s another recent Dynamic Technology Solutions story on sustainability and ESG:

The Supply Chain Connection with ESG Performance

 

How to Manage Medical Device Verification and Validation Risks

Validation

Verification and validation ensure that medical devices meet appropriate standards and will provide intended benefits. Both steps are essential in meeting regulatory requirements, so it’s important to consider verification and validation early in the design stage when developing requirement specifications for the product.

“Inadequate process validation is one of the most common issues leading to warnings from the U.S. Food and Drug Administration (FDA),” notes Regulatory Focus, a publication of the Regulatory Affairs Professionals Society, which reported that the problem may be difficult to address if regulatory and quality professionals don’t understand what validation consists of.

It’s important to recognize the ways in which validation can be defined, as well as how it differs from verification. Under Code of Federal Regulations 21CFR820, the FDA has separate definitions for process and design validation. Design validation ensures that devices conform to defined user needs and intended uses and include testing of production units under actual or simulated use conditions. Process validation gives evidence that a process consistently produces a result where specified requirements continue to be met.

While validation is concerned with the end product, verification ensures each element of a device meets specifications and standards. For this reason, verification should always be the primary consideration. Regulatory Focus provides a helpful cooking metaphor to remember: verification involves the meal’s ingredients and the recipe, and validation involves how the meal tastes.

Managing Validation Tools is Essential

Medical device validation is a complex process that requires specific expertise across a broad range of technical issues. If a company doesn’t employ at least one qualified validation professional on staff, it should consider outsourcing the role.

“Process validation is a key element of identifying and mitigating risks for medical devices,” which is a significant focus of the FDA and other global regulators, said Regulatory Focus. Additionally, today’s connected medical devices require software validation in addition to traditional forms of device validation to help identify and mitigate risk and reduce vulnerability to cyberattacks for these products.

Even the tools used to validate medical devices require their own validation. According to Intland Software, tool qualification in medtech development is the process of evaluating, documenting, and demonstrating whether a tool used to create a medical device is up to standards. They note that best practices in medtech tool validation include:

  • Use industry guidelines – Industry guidelines with accepted standards will make the validation process easier and clearer.
  • Involve stakeholders from the outset – Identify team members and set expectations for the project up front, to ensure that input and approvals can be quickly and easily obtained as the project progresses.
  • Use vendors as a resource – Ask service providers to review validation documentation before it’s executed and to provide expert guidance on their tools.
  • Document everything – This serves as evidence that shows the intended use of the tool and that it’s been tested to ensure functionality, which provides proof if needed by customers or auditors later.
  • Future-proof your setup – Once validated, a tool must maintain its validated status. Place all tools under change control processes so when they’re upgraded, they can retain validated status.

What happens at the medical device verification and validation stages can have an impact on cost, final design, and overall manufacturability. To manage these risks in an effective manner, company leadership and product designers must proactively invest the time and resources that are required.