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Real-World Data Collection – What Role Could Your Device Play?

Real-world data collection enhances in-office visits and leads to better patient outcomes.

Image by rawpixel from Pixabay 

Doctors often ask their patients to follow specific instructions as part of their prescribed treatment and hope that they do so. However, physicians currently have few ways of tracking a patient’s compliance. They can only base their diagnoses and recommended course of action on what they observe and hear from the patient in the examination room.

When patients are asked to share their own accounts of their health condition and treatment progress, their reports can be limited or incomplete – it’s only human nature. Instead, real-world data should supplement the patient’s own report with additional information, improving the care they can receive and increasing the likelihood of a positive outcome.

With the help of technology, physicians could close the gap between in-office observations and the full picture of a patient’s health. The more accurate and complete information a doctor has, the more they are able to provide appropriate treatment.

FDA recognizes the potential of technology in this effort and is developing a framework to advance the collection of real-world data in the hopes of focusing medical studies on the point of care to provide the feedback that can improve the medical community’s diagnostic resources.

Collecting Patient Data

The more passive the data collection, the better. As soon as the patient is asked to follow directions and take a specific action, compliance declines by 25%. With each additional step, another 25%. Using technology in passive data systems may be the least-invasive medical solution for better treatment of patients. Examples of this are a connected insulin pump to measure blood sugar levels and deliver insulin in response, in-home motion sensors that can report on patient mobility, and a smarter version of something we all use every day, such as the Rochester Institute of Technology’s toilet seat with sensors that track a patient’s daily weight (which could indicate worsening congestive heart failure). None of these devices requires a change in patient routine or any deliberate action, potentially improving compliance and care for those who may not adhere well to their doctor-prescribed treatment.

By eliminating the need for a patient to alter their daily activities, passive data systems allow for non-invasive monitoring of medication or action adherence and health indicators.

Not only do connected devices make data collection easier on care providers and patients alike, they also can increase quality of life. A study by the American Diabetes Association found that continuous glucose monitors improved overall blood glucose control, reduced hypoglycemia for test subjects, and extended the amount of time patients experienced complication-free, relatively good health.

The Doctor’s Office at Home

Though many areas of healthcare will benefit from new technology and patients’ real-world data, the largest investments today are in the pharmaceutical industry.

Administering biologic drugs, such as some vaccines, autoimmune therapies, and others, adds a layer of complexity due to the physical differences from traditional pill-form drugs, or easily injectable drugs like insulin due to the viscosity of biologics. For this reason, the procedure is often done in a clinic or hospital, which adds additional cost. With technology-enabled home drug delivery systems and wearable patch pumps or connected autoinjectors, care providers could allow patients to take the drug in the privacy of their homes, while monitoring compliance and dosing.

Managing a Wealth of Data

As the need for medical devices grows, medical companies are increasingly moving toward working with external partners as they create and advance these connected solutions. Growing concerns are how they will manage this plethora of data collected from each patient and device and how to encrypt it for user privacy.

In response, partner platforms are emerging to navigate the complex web of security, privacy, and regulatory requirements and technical experience to successfully collect the data and keep it safe. These platforms also evaluate how to extract value from the massive volumes of data that devices like insulin pumps collect. Using algorithms to interpret the data, draw logical conclusions, and provide meaningful, actionable next steps not only give physicians more insight to improve their client outcomes, and companies more information to improve usability and compliance, but also enables patients to make informed decisions about their personal health.

Another challenge encountered by companies is how quickly they can scale production while minimizing the expense of manufacturing. Companies may know how to manufacture the devices, but they don’t always have the knowledge or resources to scale production or work with global markets. This is where an external manufacturer can help, providing the expertise to produce quality, fully connected and functional devices. Outsourcing innovation and manufacturing to a partner allows health companies to focus on core competency – creating and bringing to market new and differentiated therapies – instead of ramping and scaling manufacturing and developing necessary expertise in integrating connectivity.

If medical and pharmaceutical companies are able to help more patients adhere to their treatments by monitoring whether or not the patient is taking their full dose, or if a patient is moving around their house after a hip replacement, the combination of collected real-world and in-office data will be able to show a more comprehensive picture of their health and therapy progress.

In turn, this can improve patient care and increase positive outcomes. With a broader pool of real-world data to pull from, care providers will be able to identify symptoms and diagnose issues more quickly and easily than before. Over time, integrating these connected devices and the real-time data they provide into the medical industry will allow for broader insights into health and disease, with the potential to reduce diagnosis time, improve outcomes, and enhance patient quality of life.

John Carlson

John Carlson

John Carlson is the president of the Health Solutions group at Flex Ltd., where he has led the transition of the medical business from a primarily manufacturing focus to a Sketch-to-Scale solutions focus that extends from a human-factors-based user needs definition through innovation and design, to ramp up, full scale production, and supply chain management. The Health Solutions group is able to leverage technology, expertise, and scale across Flex Industries to offer unique and better solutions to its customers. Prior to Flex, Carlson spent 15 years in leadership roles at Johnson & Johnson in research and development, most recently as vice president of the innovation portfolio, where he led research and development activities across the pharmaceutical, medical device, and consumer health segments of the company and identified new growth areas. He also served as worldwide vice president of research and development for the Ethicon Endo Surgery group and for the Diabetes Care franchise. Carlson also held previous research and development positions with medical device startup companies in the San Jose, CA, area.

Carlson holds a Bachelor of Science degree in Bioengineering and a Master of Science degree in Mechanical Engineering from the University of California, San Diego.

About Flex Ltd.
Flex is the Sketch-to-Scale solutions provider that designs and builds intelligent products for a connected world. With approximately 200,000 professionals across 30 countries, Flex provides innovative design, engineering, manufacturing, real-time supply chain insight, and logistics services to companies of all sizes in various industries and end-markets. 

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