If you’re a manufacturer of a medical device, beware. Over 250 journalists spanning 36 countries and representing over 50 media outlets spent the last year researching medical device safety. They considered everything – how the devices were tested, how they gained approval and how regulatory agencies monitored them. The results of their investigation were unsettling to say the least.

1.7 million injuries and 83,000 deaths allegedly linked to medical devices were reported to the Food and Drug Administration (FDA) over the last 10 years.

Yes, if you’re a manufacturer of a medical device, beware. Not only is the press exposing unsafe and ineffective devices, but patients are speaking out and the public is all ears. You can’t blame them. While medical innovations in the $400 billion medical device industry are changing healthcare and improving countless lives, there is zero room for error. Error in this industry can lead to catastrophic injury or even death.

Just last week, a beloved Fox TV meteorologist and mother-of-two committed suicide after allegedly suffering complications from Lasik laser eye surgery. The blame in this case is not on a medical device just yet, but we’re expecting that could soon be the case. The headlines are already announcing:

Did Lasik Surgery Lead to Suicide of TV Meteorologist?

REVEALED: The other laser eye surgery patients who have committed suicide, as questions continue over the risk of the procedure after a beloved Fox TV meteorologist killed herself

This is just one story. All you have to do is Google “medical device safety” and the hits keep coming…

Insulin pumps have most reported problems in FDA database

Patients shocked, burned by device touted to treat pain

Spinal-cord stimulators help some patients, injure others

We could go on and on. And we know what you’re probably thinking if you’re a manufacturer of a medical device: The FDA has guidelines, and as long as you meet them, your company’s name will never be smeared in the news. Your company’s name will never be uttered in a courtroom by someone who lost a loved one due to a faulty medical device.

Are you 100% sure about that?

Just one day after the investigation of medical devices was published by news outlets all around the world, the FDA made a major announcement. They are now proposing modernized safety feature changes to their 42-year-old 510(k) premarket clearance process – something they claim was in the works and had nothing to do with the investigation. The jury is still out on that. The FDA has repeatedly been heavily criticized by journalists, patients and healthcare providers for pushing devices through the abbreviated approval process, and then taking far too long to respond when it comes to making companies improve products that could endanger lives. It seems the FDA is finally taking note. They’ve announced that they are now considering using a market-based, competitive approach that gives patients a choice between newer and older versions of a device. To do this, they may publish a list of medical devices that were approved based on predicate devices that are over 10 years old. They’re also considering phasing out some older devices.

“We believe firmly in the merits of the 510(k) process. But we also believe that framework needs to be modernized to reflect advances in technology, safety, and the capabilities of a new generation of medical devices,” FDA Commissioner Scott Gottlieb and Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health recently announced in a joint statement.

Although Gottlieb described this news as “the most significant modernization” of the agency’s review pathway in a generation, the truth is that some of the proposed reforms could take many years to implement. So how do you ensure that your medical device is safe and effective? How do you navigate through the 501(k) and its changes while ensuring that your device succeeds?

Medical device safety begins and ends with human centered design.

If you’re familiar with the 510(k), then you know that it already has human factors requirements that medical device companies must meet. These will become even more important with the proposed new changes. Human factors is absolutely crucial when it comes to meeting the needs of both the patients and medical professionals. It’s the #1 key to a device’s success. But as experts in human factors, time and again we see medical device companies struggling most with implementing these requirements. In our experience, issues most often occur for medical device designers, who face tough challenges when it comes to implementing strategies within their product development and engineering plan that meet the FDA’s human factors requirements without causing issues with schedule and costs. The good news, however, is that we can help simplify and ease the burden of knowing how and when to incorporate human factors elements into your existing project schedule. This helps to reducing costly redesign or schedule slip issues while ensuring the risk of use injury is mitigated successfully.   

As human centered design experts, our specialty is helping your medical device designers, business strategists and engineers work as a team with the end users at the center of the design process. We can assist with many aspects of the design process including focus groups, benchmarking, user formative and summative testing and design requirements. This ensures that the needs of the user are put first from the very beginning of the design, research and testing processes. It also ensures that your business has a safe and successful product once it’s brought to market. Far too often, devices fail and afterwards studies are done to find out why. This is totally unacceptable. We ensure that patients using your device will never be guinea pigs.

There is nothing more important than safety and usability when it comes to medical devices and the people using them. As the saying goes: The best way to predict the future is to invent it. When you work with us, we’ll help you create a better world through your innovations that not only meet the market needs but excel in user experience and safety. 

Ready to change lives for the better?

At Sophic Synergistics, we work with organizations to seamlessly integrate human factors into existing project schedules, minimizing impact to the project and increasing success in meeting the human factors requirements for FDA submission efforts. We currently work with clients such as the Texas Medical Center, NASA and Oculus to build environments, products, and services that deliver the best in human-centered designs and user experiences. Contact us today.