Keeping Patients at the Center of Medical Device Development

Keeping Patients at the Center of Medical Device Development

This LinkedIn article was previously published by Forbes. To read the story on Forbes.com, you may view it here.

Some medical technologies are just plain cool. But tech that’s only cool is never enough. It must solve specific health problems, improve each patient’s quality of care, and be easy to use.

To create the best medical technologies, we must thoroughly understand the problem our technology is intended to address. That means conducting real-world research—observing how people live and understanding their daily work routines—to understand the challenges patients and caregivers face each day.

How will the device actually be used? How easy is it to use? Does it align with existing clinical workflows? Who is going to pay for it?

By answering these questions, we can map out the problems that need to be addressed and the rigorous process of solving them in order to improve patient care. Ultimately, the approach comes down to three steps: understanding the clinical needs of the patient, developing the best solution for them and continuously improving the solution over time.

Additionally, the broader tech industry can learn a great deal from this patient-centric approach. Just as medical technology developers must understand the clinical needs of patients, all tech companies must understand how people interact with technology in their daily lives to identify customer needs and pain points. Decisions should be driven by these insights rather than assumptions.

Understanding the Clinical Needs of the Patient

The information we glean from patient studies and other investigations helps us track evolving clinical needs and drive innovation. Too often, products solve problems that don’t really exist. That doesn’t mean the devices are not impressive; they’re just not entirely relevant. Keeping patients at the center of the conversation helps protect against these discrepancies.

To develop products that are both technologically advanced and clinically useful, we must survey the landscape through different lenses and ensure they meet all stakeholder requirements. If it’s physically cumbersome or too difficult to use (or both), we lose patient compliance. If the tech doesn’t fit into the clinical workflow, we lose caregivers. If it’s effective and easy to use but too expensive, we lose payers.

By focusing on customer needs, all tech companies can ensure their products are not only innovative but also genuinely useful and easy to integrate into daily routines. Products that evolve based on real customer feedback lead to innovations that truly enhance the user experience.

Developing the Best Solution for the Patient

It’s not enough to create devices that solve real clinical problems; they must also be designed for real patients. In the past, the industry?relied too heavily on a specific patient profile, which was often people (mostly men) of European descent. Even a cursory look at existing data shows us this approach has not worked.

We must conduct rigorous clinical trials in representative patient cohorts to evaluate and refine each technology. Creating products that provide equitable care for all people, no matter ethnicity, gender or age, is one of our fundamental obligations.

One prime example is the pulse oximeter. These devices use calibrated light and algorithms to help determine oxygen saturation and have become a key tool to help monitor a patient’s condition.?Research has shown?that dark skin pigmentation can impact pulse oximetry results since melanin absorbs more light, preventing the light from penetrating tissue to produce accurate readings. The medical device industry in partnership with the FDA is making a concerted, collaborative effort to revise standards and support making pulse oximetry equitable for all patients.

This brings up a foundational rule across all product development steps: test, test, test.

Throughout the development process, continuous improvement is a must. We are constantly looking at how we collect our data, safely and securely, and how that information is incorporated into design. We need to know how these products will be used, hearing from the people who will actually use them. Our technologies have been widely accepted in the clinic, but that isn’t good enough. We’re going to keep examining, and reexamining, how we acquire and interpret data the right way, and how we translate that information into equitable technologies.

Continuously Improving the Solution Over Time

Continuous improvement means observing how technologies function long after they have gone into the hospital. There, we can observe how these devices are being used by patients and clinicians and learn from their day-to-day challenges. This invaluable, post-market feedback helps us revisit the patient perspective to continuously refine our products and improve care and quality of life.

One example is inpatient monitoring. The problem is that?overstretched nurses and hospital teams can only take vital signs a few times a day. This manual process leaves patients untracked for significant periods, and sometimes a patient’s condition can deteriorate quickly. However, new monitoring solutions, connected seamlessly to a hospital’s electronic system, give care teams the ability to monitor patients thousands of times each day to catch warning signs that their conditions might be worsening.

Similarly, all tech companies can benefit from analyzing customer feedback and performance data post-launch, gaining valuable insights into how their products are being used and where improvements are needed.

Customer satisfaction and experience should be central to this process. By prioritizing these metrics, tech companies can improve products and build stronger relationships with customers. Additionally, leveraging advanced analytics and real-time feedback tools can help proactively identify and resolve issues, enhancing overall user experience and maintaining a competitive edge in the market.

The Ultimate Reward is Improved Patient Care

These are the kinds of results we are always trying to achieve. By adopting a rigorous research and development process, and prioritizing clinical needs for patients, we can create cool products that provide real value. Our ability to focus on patients during this development process ultimately helps clinicians provide the best possible care.

By adopting a similar process and prioritizing customer needs, all tech companies can develop products that offer real value to their customers. Focusing on customer-centric design and continuous improvement helps ensure that products exceed customer expectations, cultivating strong relationships and sustained success.

Robert Abbey

Leading by Quality, enabling Businesses to deliver exceptional Product experiences. How's quality of your software releases? Contact me if you would like to hear how your quality can be improved.

4 个月

"Thank you for sharing, Frank. This is very insightful! Keeping patient needs at the core of medical device development is essential, not just for better healthcare outcomes but for building lasting trust within the industry. Thorough testing plays a vital role here; it ensures that devices not only meet safety and efficacy standards but are also truly usable and effective across diverse patient groups. As the MedTech industry shifts to connected products, QA becomes ever more critical to answer three essential questions: Does it work? Does it scale? And is it secure from vulnerabilities? Continuous testing and real-world feedback allow us to refine products iteratively, addressing potential issues before they impact patient care. Your emphasis on continuous improvement resonates deeply—the ability to learn from post-market feedback and ongoing testing can transform patient care over time. Thanks again for sharing these thoughtful strategies that benefit both the healthcare sector and broader tech industries!"

Nina Goodheart

SVP and President, Structural Heart & Aortic at Medtronic ? Board Member ? Growth Acceleration ? MedTech Innovation ? DEI

4 个月

Thank you, Frank Chan, for sharing these important insights! Improving patient care requires this people-centric mentality to drive innovations and technologies that bring to life our mission at Medtronic. Having this deep understanding of patient needs is a core value to our work and how we help improve outcomes for those impacted by life-threatening health conditions.?

Matthew Paul Brochin, MS, DABT, PMP, CQE, CQA, CISS-RAD

Med Device Multipotentialite | Inclusive Senior Leader | Program Manager | Principal Technical Expert & Consultant | Engineer & Board-Certified Toxicologist | Sterilization, Toxicology, & Biocompatibility @ Arthrex

4 个月

Great article and good to see you again today Frank. Let's reconnect.

Actually believe that as well.

Great thoughts Frank. Foundational differences but the SaaS & Tech industries are well ahead of Healthcare (MedTech, biotech and Pharma) as it relates to Customer centricity. Since 2006 they have raced down the path of codifying customer centricity and weaving it throughout ALL functions in their organization. Their cascade (prdt level or enterprise): Ask, listen, understand, aggregate & innovate. Rinse, repeat and track. Over time these orgs became outside-in guided.

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