Customization and Personalization of Medical Devices

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Customization and personalization are words typically associated with software and high-tech gadgets. But today, through vision and innovation, these terms increasingly apply to medical devices.  Especially in a world of custom-made cars and personalized computers, it seems logical that we take the next step to grant patients with the availability of medical devices made specifically to fit and adapt to each individual.

Human-Centered Design (HCD) is a principle that is today guiding the development of new medical devices that are able to account for the differences that exist from one person to another.  Just as doctor’s shape tailored casts to set broken bones depending on the nature of the injury, some medical devices, even complex life-saving ones, can now be tailored for individual patients.

The trend of customization and personalization is helping physicians around the world get their hands on advanced devices most likely to have the highest success rates.  By creating individual tools, medical device manufacturers are able to save the lives of thousands of patients every year who in the past were unable to be treated due to the complexity of a disease or ailment.

In the case of a severe abdominal aortic aneurysm (AAA), patients who previously may not have been candidates for traditional endovascular repair, are now more likely to have more options in surgery as medical device manufacturers are creating stents and grafts tailored on a case-by-case basis.  Not only is this providing physicians with new options for treating AAA patients who cannot be treated using standard, off-the-shelf devices, but patients have a much higher chance at surviving and recuperating with fewer complications.

Most physicians would agree that having customized devices result in better patient care and better patient outcome.  In most documented cases, the patient recovers faster, has less discomfort, less risk of complications and less likelihood of a repeat episode.  The device also has the potential to last longer or need a replacement less often when it is tailored to specific measurements of the anatomy, potentially decreasing the risk of device migration or reducing the risk of restricting or blocking critical blood flow to necessary organs.

If our age, gender and physical condition have a direct impact on the effects of stimulants we put in our body, it is hard to believe that the same does not account for the reaction to foreign objects implanted inside our bodies.  There are many characteristics which make every patients case unique, sometimes requiring the need for devices to vary case-by-case as well.

In some cases, medical devices are being designed today so they adapt to the individual patient’s body after implantation.  With new innovative technologies, some biotechnology companies now have the ability to regenerate native tissues, allowing the body to use the implanted material as a scaffold upon which to re-grow its own tissues to restore functionality.  Future device development may include combination devices merging traditional medical device design with advanced technology and materials to allow the body to incorporate endografts, stents, venous valves and other devices directly into its own tissues.

Not only are device manufacturers taking on personalization, but drug manufacturers are jumping on the band wagon as well.  An industry widely known for mass standardization is now moving toward new generations of biopharmaceuticals that work more closely with a patient’s biochemistry.  Companies are beginning to support the growing trend toward personalized and even customized therapeutic delivery.  Researchers can now engineer biopharmaceutical products to work more closely with the human cellular metabolism, varying significantly by race, gender, etc., to produce variations of drugs that work more effectively in a specific patient subset.  As further advancements are made, new biotherapeutic agents may even be designed to work with the specific protein chemistry of an individual patient or to block a disease agent at the genetic level.

In this age of technical innovation, it is important for doctors and hospitals to see that a “one size fits all” mentality will no longer do.  While manufacturers are producing devices with unique features and capabilities, it is still in the hands of physicians to adopt the practice and use of custom-made and personalized devices to provide the highest level of commitment to their patients.

Kem Hawkins is president of Cook Group.  He can be reached at

Article By: Kem Hawkins

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