Risk Control & Risk-Benefit

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4 minute read.

This article explains Risk / Benefit analysis and Risk Control methods using performances of Harry “The Hat” Anderson, a comedian, actor, and magician famous for visual humor.

To keep it practical, I’ll apply Harry’s routines directly to risk management requirements in the European Union Medical Device Regulation, a type of law similar to the United States Food and Drug Administration.
One of the most confusing parts of the EU-MDR is reducing risk as far as possible, until the risk-benefit is acceptable. This article may help companies understand and apply risk-benefit analysis to make safer, more cost-effective medical devices.I’ll start by introducing Harry Anderson.

This is Harry


Harry Anderson was a famous comedian, magician, actor, and producer. He was most known for his role as Judge Harry Stone in television’s Night Court, where he played a judge in New York City who did magic tricks. His career had jump-started in 1983 when he appeared on the famous comedy show Saturday Night Live, apparently shoving a needle through his arm.

I remember him fumbling for written instructions with a needle stuck through is bleeding arm, and this “stuck” in my mind as a way to illustrate the concept of risk control. Medical device companies are required to apply risk controls for devices ranging from needles to complex electronic systems, and many companies struggle to balance cost effectiveness, innovation, and applying risk control priorities.

This article uses Harry Anderson’s needle-through-arm to clarify the “point” of risk control and risk benefit analysis.

Risk Control

Harry fumbling for written instructions is why the EU-MDR prioritizes risk control methods:
  1. Make the design inherently safe
  2. Add safeguards
  3. Provide written instructions or warnings

The priorities of risk control are illustrated using household fans in this image, used with permission from Oriel STAT-A-MATRIX, a consulting company.

For example, safeguards on needles are more effective than written warnings, which is why companies must now include some form of safeguards on needles.

Harry’s needle-through-the-arm demonstrated how written warnings aren’t effective; he stuck his arm while fumbling for instructions. This is a real-world challenge for healthcare workers, who would get stuck by needles that had been in contact with patients’ blood. Many workers were infected with life-threatening diseases, such as HIV.

Written instructions were ineffective at protecting healthcare workers, and it was difficult to make needles inherently safe because it must be sharp to penetrate patient skin. Innovative companies found cost-effective ways to add safeguards to needle after FDA regulations for needles required more safety, and those companies excelled in the market. Companies that didn’t innovate lost in the market. In both cases, society benefited.

One day an innovative company may revolutionize needle designs with an inherently safe way to draw blood or inject medicine. When that happens they will become the new state of the art. Until then, companies can be rewarded for innovating more cost-effective and user-friendly safeguards.

Risk/Benefit Analysis

After risk control the needles still have sharp tips, which is why the final step of reducing risk as far as possible is documenting a risk/benefit analysis. In other words, you must show that benefits to the patients outweigh remaining risks.
The EU MDR requires companies to create two documents for determining risk-benefit, clinical data and post-market surveillance. For this article it’s enough to understand that clinical data is simply a list of everything that could be known at the time, including publicly available information about the problem and competitors’ solutions.

Public information on needle sticks:

Competitors’ risk control:

After finding public information and competitor solutions, each company must prove and document that they are as safe as competition for public health. Your company’s risk/benefit must be validated using post-market surveillance, real-world evidence of your device’s risk, adverse events, and trends that would indicate potential risks to future patients.

Risk / benefit isn’t a one-time event, it’s a continuous process of improving safety based on real-world evidence compared against public information and other options for patients. This process must be updated every 1-2 years for devices classified as high-risk, and “as needed” for low-risk devices. Governments require this so that patients don’t have to worry about it.

In a few cases added risk would justified because of benefits to specific patients, such as risky cancer treatments for patients with a unique type of cancer and no safer treatments. That’s not true for most medical devices though. If someone you loved needed healthcare, how would you justify using your product if it were more likely to cause them harm than a competitor’s product? Why shouldn’t every company do that for all of our loved ones? The EU-MDR forces companies to do this so that we don’t have to.

Summary

  1. Risk control and risk benefit analysis are required to sell medical devices in most countries.
  2. International risk management standards requires the highest of three possible risk controls:
    1. Inherently safe
    2. Safeguards
    3. Written warnings or instructions
  3. Risk / Benefit analysis ensures that any remaining risk is justified by comparing your risk controls to competitor products and alternative treatments.
  4. The EU Medical Device Regulation requires applying risk-benefit analysis
    1. “As needed” for class I, low-risk devices
    2. Every 2 years for Class IIa, medium-risk devices
    3. Every year for Class IIb and III, high-risk devices

Next Steps

Learn more in my blog, under categories for Risk, EU-MDR, or Medical Devices. Search the internet for Risk Management, ISO 14971, and the European Union Medical Device Regulation. Or, hire consultants or trainers.

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Parting Thoughts

Harry Anderson passed away in 2018. My thoughts were with him and his family when I wrote an article trying to summarize all of the wonderful things that happened in my life due to the humor and magic he shared with us. If you’re not familiar with Harry’s style of humor, here’s one of my favorite scenes of him on television’s Cheers:

Coincidentally, my first medical device job was with a start-up company that had been founded by the original inventor of needle-stick safety features. In our interview he asked me how I would solve the problem. By then I had designed or invented dozen of magic effects, many of them from Harry Anderson’s appearances on Saturday Night Live. That job led to a series of my own medical device inventions, retirement, and transitioning into teaching using hands-on, project-based learning where many of my students design and perform magic tricks to develop engineering and public speaking skills.

Life’s too short for many people; I wish you happiness.