We all are aware of some of the special regulations with which healthcare companies need to comply (think HIPAA or FDA regulations and approvals). It should come as no surprise, then, that healthcare exhibiting also has specific regulations and best practices you should be aware of, especially since mistakes can be very costly.

As an example, let’s consider a hypothetical healthcare exhibitor called Medical Technology Innovations (MTI). As a startup, they’ve developed a cutting-edge AI-powered diagnostic tool and are eager to make a splash at an upcoming medical technology expo. MTI’s team has put together what they believe to be an outstanding booth to showcase their innovative product. However, they’re about to learn a valuable lesson about FDA regulations for unapproved medical devices.

As the expo begins, MTI’s booth stands out with its sleek design and eye-catching banners proclaiming, “Revolutionary AI Diagnosis – 99% Accuracy!” Visitors are drawn to the booth, where MTI representatives enthusiastically distribute detailed brochures outlining the specific medical conditions their tool can diagnose. The centerpiece of their exhibit is a series of live demonstrations, where the team proudly shows off their software using real patient data collected during beta testing.

The MTI team is riding high until our fictitious company was informed that they were in violation of several regulations:

  1. Making specific efficacy claims about an unapproved medical device.
  2. Promoting off-label uses of the device.
  3. Using real patient data without proper consent and anonymization protocols.

So, our startup had to make changes on the fly to quickly adjust their exhibit strategy. In real life, we have assisted our healthcare clients in just this type of scenario. And it happens more than you think.

Let’s delve into some key points for health care exhibitors to consider:

1. Compliance with Industry Regulations

FDA Regulations: If you’re promoting pharmaceutical products, medical devices, or anything under FDA jurisdiction, ensure that all promotional materials are compliant. This includes truthful, non-misleading information and proper disclosure of risks. Be sure that you’ve included all disclaimers and avoid making any claims that have not been vetted by legal counsel.

HIPAA Compliance: Be cautious about collecting and sharing patient information. Ensure that any personal health information (PHI) is handled in accordance with HIPAA regulations.

Sunshine Act: Be aware of the Physician Payments Sunshine Act, which requires the reporting of payments or items of value given to physicians and teaching hospitals. Because of this act and the regulations set forth by show management, exhibitors may not be allowed to pass out SWAG or giveaway any items of value.

2. AdvaMed and PhRMA Codes

Both codes significantly impact how companies exhibit at medical trade shows and set the standards for interactions with healthcare professionals. For example, offering meals or gifts at an exhibit, if you are allowed to offer them, should be modest and related to the business purpose. Exhibits and interactions must have a clear educational or informational purpose, rather than being purely promotional.

3. Booth Design and Messaging

Truthful Claims: Ensure that all claims are substantiated and don’t exaggerate the benefits of a product or service. Again, make sure your legal counsel reviews all graphics for your display before going to print.

Risk Information: When promoting drugs or medical devices, risk information must be presented prominently alongside the benefits. Be sure you list all appropriate disclaimers.

Fair Balance: The information provided should maintain a fair balance between the benefits and risks of the product.

4. Gifts and Giveaways

Healthcare exhibitors often face strict rules and regulations regarding the types of promotional items they can distribute at trade shows and are often caught off guard at the types of swag that can be given away. These regulations are in place to ensure ethical practices and to avoid any potential conflicts of interest.

Value Limits: Keep giveaways modest and within industry guidelines. Avoid anything that could be construed as a bribe or inducement.

Educational Purpose: Items given away should have an educational purpose or be relevant to the healthcare setting.

5. Interactions with Healthcare Professionals

Transparency: Be transparent about the nature of interactions, especially if they involve any form of compensation or benefit to healthcare professionals.

No Off-Label Promotion:  Our hypothetical company got in trouble for this one. Avoid discussing or promoting off-label uses of drugs or devices unless in a setting that is clearly educational and non-promotional.

6. Documentation and Reporting

Track Interactions: Maintain detailed records of all interactions and transactions with healthcare professionals for compliance and reporting purposes.

Training: Ensure that all staff working the exhibit are trained in the relevant compliance requirements and industry codes. Be sure that they understand what can and cannot be said about the products they are promoting.

7. International Regulations

If exhibiting internationally, be aware of the local regulations, which can differ significantly from U.S. standards. For example, the European Union’s GDPR has stricter data privacy rules than HIPAA.

8. Ethical Considerations

Professionalism: Maintain a high standard of professionalism in all interactions to uphold the integrity of the healthcare industry.

Patient-Centered Focus: Keep the focus on how your product or service benefits patients, avoiding hard-sell tactics that could undermine trust.

Today attendees expect a compelling experience with brands, including healthcare. While navigating healthcare regulations may seem daunting, there are still numerous ways to create an impactful and compliant exhibit at medical trade shows. We often advise our clients on strategies to bring excitement and distinction to their booths while adhering to regulatory requirements. Here are just some examples of how to create memorable experiences for attendees:

  1. Live Demonstrations
  2. VR or AR to create immersive experiences
  3. Workshops and Mini-Seminars
  4. Infographics and Interactive Displays
  5. Patient-Centered Storytelling featuring patient testimonials and visual narratives
  6. Gamification

TPG Presenter delivers the pitch for our client, Bayer at RSNA.

Standing out in a healthcare exhibition, where there are significant restrictions, requires creativity, a strategic approach, and yes, even bravery. If you’d like to explore ways to make your exhibit memorable and effective at your next healthcare exhibition, let us be your guide. There is a lot to know, and you don’t have to go it alone to ensure your trade show presence is both compliant and impactful. Explore some of our work in healthcare and other industries. Don’t be caught by surprise, like our hypothetical company mentioned at the top of this article. By focusing on interactive, educational, and personalized experiences, you can create an exhibit that resonates with a healthcare audience while staying within the regulatory boundaries.

Christina Piedlow, TPG President and CEO