Hi @atmeh-njit! Excellent post and question. I totally agree that marketing is essential, but also very risky in the medical device field. Marketing is so that the buyers want the product and understand why they should want it. This is a very significant portion of marketing, since helping the audience understand the science behind a medical device would be important to make sure it is being marketed safely. Product, price, promotion, placement, and participation show that marketing is about shaping perception and trust. Using evidence instead of emotional persuasion in the medical devices realm will allow safe marketing of those devices. However, it is imperative to ensure the science you are sharing with the audience is also correct and not misinformation. 

Due to this, I think marketing teams should be required to follow stricter scientific review processes before releasing advertisement materials. However, I think there should be different processes for releasing information to the public versus releasing information to a physician. A physician should also be held responsible for ensuring the science is peer-reviewed and correct before investing in a medical device. However, there should also be guidelines so that completely misleading information is not released to the physician. This would keep the physician safe but also on their toes regarding the latest scientific developments. 

In the Medical Device Widget plan on the Abridged Marketing Plan document, we can see how easy it is for medical device marketing to cross ethical lines. There are direct sales calls and viral marketing, where word of mouth among surgeons would be a key factor. These tactics can be effective, but they can easily blur into promotions that are uncontrolled by the company. The giveaways and special offers can also influence consumers in subtle ways. This is where a check system would be helpful in making sure the science is transmitted properly and that ethics are obeyed, since medical devices can be a matter of life or death, and subtle persuasion tactics can lead to major issues down the line. 

Ultimately, I think marketing materials should go through an internal review similar to design documentation. This would essentially be a smaller level audit before marketing materials are released to the public. Creativity does not have to be stopped, but this would force teams to ensure they are safe and make sure of the data. 

As AI becomes more common in marketing, how do you think regulation should adapt? Should AI-generated content be reviewed as regular marketing content, or should there be a different process for scrutiny? How does medical device marketing mesh with AI? Should there be more use of AI for marketing to better model some functions of the device, or should medical device marketing stay away from AI altogether?

Thank you for the detailed and thoughtful response, @dev-doshi! I completely agree with your point that stricter scientific review should be part of the marketing process, especially in a field like medical devices, where misinformation can directly affect patient outcomes. I also think your idea of having different review standards for physicians and the general public makes a lot of sense. Healthcare professionals usually have more background knowledge, so giving them more technical information can help them make better decisions, while the public-facing content needs to focus more on clarity and safety without oversimplifying or misleading.

I also really like your suggestion about treating marketing reviews like internal audits. Just as we carefully validate device design and manufacturing processes, marketing content should go through a similar verification step before release. This could help catch errors or exaggerated claims early, and it might even improve trust between companies, clinicians, and patients.

Regarding AI, I think it definitely needs the same — or possibly even stronger — level of scrutiny as traditional marketing. AI can be a powerful tool for modeling device performance or tailoring information to specific audiences, but it also has the potential to generate misleading content quickly and at scale. A clear regulatory framework specifically designed for AI-generated marketing content would be a smart move. It could help companies use AI responsibly while still benefiting from its efficiency and innovation.

Overall, I believe the future of ethical medical device marketing will rely on a balance of scientific accuracy, transparency, and technological oversight — and companies that prioritize those elements will likely build stronger trust and long-term success.

Two companies, Kimberly-Clark and Halyard Health, were found guilty of fraud eight years ago for the medical gowns they sold. The gowns were marketed for disease protection and claimed they met AAMI level 4 standards. However, the defendants concealed data and laboratory results on the gown material, which proved the claims to be false. This case serves as an example of unethical marketing and management practices. Nonetheless, having stricter scientific review processes for marketing teams is logical. Activities that can help with compliance are standardizing the review process and establishing software & procedures that guarantee records are being tracked. The marketing team should be collaborating with the regulatory team as early as possible for medical devices. They should have access to the evidence that supports the claims. Proper training and time management are also helpful in preventing non-compliance and errors. Ultimately, effective and ethical promotion begins with a dedicated management team. All scientific testing must be accurate and precise, then interpreted and communicated correctly by the company. 

I think one way to keep medical device marketing effective while still being ethical is implementing something similar to a traceability matrix into the marketing process. This would require every statement used in marketing to be required to be connected to verified sources like clinical trial data, regulatory filings, or peer-reviewed studies. Each claim could also have version controls and documented signatures from qualified reviewers. This would prevent misleading messaging and make it easier for teams to update the matrix if new evidence comes out. Consistent use and further improvement of this system could show a clear level of transparency with hospitals that would likely find desirable. Do you think most customers would view this as unnecessary technical detail, or would improve trust in medical device companies?

Marketing plays such a critical role in the diffusion of medical devices and technology, but in regards to healthcare, persuasive communication and the responsibility to be ethical can be pretty thin. Medical devices are unique in that they directly impact patient safety as well as affect clinical decision making processes. Because of this, marketing teams should be be operating in an isolated environment from scientific/regulation like oversight. Stricter scientific review processes should be a requirement for marketing materials to be released and this also puts pressure on the company to ensure their intended device is both up to code and safe for the patient/user. Despite there being a stricter oversight, this does not eliminate the need for creativity in marketing whatever device is being show; rather, I believe it is important so that it prevents the company from cutting corners for profit and being transparent with their intended audience.

Simultaneously, healthcare professionals also carry the burden of sharing the responsibility of being informative to their patients, of course. They should be practicing evidence based medicine/treatments and verify the authenticity of devices before they can recommend them to patients.

Effective promotion and ethical communication relies heavily on how well the science is communicated. As was mentioned, marketing campaigns should be more closely aligned with the science, however not everyone may be well-versed with the technical or pharmacological aspects of how medical devices work. The audience is what makes advertising medical devices difficult. The audience does not have a uniform understanding. A physician views things differently than hospital administrators. Prospective patients with a college degree may view things differently than patients with less schooling. Compressing the information without making a marketing campaign too misleading or too informative is a very fine line which is difficult to manage. Oversimplifying in marketing content can make the medical device sound impressive to one party, while sounding ordinary to another. On the contrary, too much science in marketing content will make the campaign ineffective as there will be too much to understand for ordinary patients.