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Developing Ethics in Implantable MedTech Devices: A Guide for C-Suite Leaders

Developing Ethics in Implantable MedTech Devices: A Guide for C-Suite Leaders

May 2024

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Healthcare professionals are tasked with jobs demanding a high level of ethical conduct since they deal directly with people’s well-being and health. This expectation of ethics is amplified in MedTech devices, especially implantable devices.

Those who develop and those who implant these devices are held to an even higher standard of integrity because of the gravity of placing technology within someone else’s body. 

The Implantable MedTech Landscape

Implantable MedTech devices include a wide range of technologies, from pacemakers and cochlear implants to neural interfaces and drug delivery systems.  

The implantable medical devices market size exceeded USD 112.5 billion in revenue in 2022 and is expected to grow at over 9% CAGR from 2023 to 2032.  

This rapid growth is driven by factors such as the increasing prevalence of chronic diseases, the aging population, and advancements in miniaturization and biocompatibility. 

The Ethical Implantable MedTech Device Problem

The implantable devices sector is unquestionably expanding, but there’s a parallel rise in concern that ethics may be getting overlooked, not intentionally but by oversight.  

In fact, a study revealed that research in medical technology and ethics tends to focus more on intentions rather than the actual effects on patients. This has led to a worrying shortage of data on real-world outcomes. 

The research into implantable devices is also skewed because the way adverse event reporting is done is less than ideal. Studies show that Adverse Medical Device Events (AMDEs) are largely underreported by physicians.  

Factors such as time constraints, uncertainties regarding the reporting process, and fears of legal consequences contribute to underreporting, and this is especially true for high-risk implantable devices. 

And even when devices function correctly and the implantation is successful, there is a new risk on the horizon: threats to the data collected by these devices.  

Millions of life-critical implantable devices gather extensive digital health data—much of it through apps downloaded by users. This situation poses questions regarding data privacy, ownership, and consent, alongside cybersecurity threats. In the event of a data breach, the implications of who could access the data—and what they might do with it—are serious. 

Ethical Considerations for Executives in the Implantable Devices Sector

When implanting technology into someone’s body, numerous serious ethical considerations must be taken into account.  

Executives in the implantable devices sector need to remain mindful of these during all operations to safeguard against legal problems and reputational damage to themselves and their company. 

1. Patient Safety and Efficacy

The primary ethical concern for implantable MedTech devices is to ensure patient safety and device efficacy. 

Considering the variable failure and adverse effect rates of implantable medical devices on the market, the importance of reliability becomes evident. A study revealed that within an average of 5.1 years, the failure rates for certain device leads, such as Linox, stood at 5.9%, whereas others, such as Endotak and Durata, reported rates of only 1.5%. Achieving a low failure rate, like those of Endotak and Durata, correlates with increased patient trust and a greater likelihood of physician endorsement. 

To circumvent high failure rates and potential liability issues, C-suite leaders must prioritize transparent, thorough, and ongoing testing, clinical trials, and post-market surveillance to decrease risks and improve patient outcomes. 

2. Data Privacy and Security

Implantable devices often collect and transmit sensitive patient data, which understandably raises concerns about privacy and security. And these concerns are well-founded. 

A review of enforcement reports identified 1,845 recalls of medical devices, with 32.8% involving computers and approximately 1.9% storing patient data. Security issues accounted for a considerable proportion of the reasons these devices were recalled. 

Recalling a medical device can be costly. For example, Burke and colleagues estimated that the recall of Medtronic’s Fidelis cost Medicare about USD 287 million over five years for monitoring or replacing the devices. Avoiding a recall due to data privacy and security issues is vital for your company’s financial health. 

For this reason, C-suite executives must implement strict data governance frameworks that comply with regulations such as HIPAA and GDPR to protect patient information. 

3. Informed Consent and Patient Autonomy

Ensuring informed consent and respecting patient autonomy are important ethical considerations, too.  

A study found that patients were regularly not engaged in discussions or decisions about implantable medical devices—this means that a lot of devices are being implanted without the patient’s informed consent (informed is the keyword here). It’s also important to keep in mind that informed consent is not just a singular event but a process that involves continuous education and empowerment of the patient. 

C-suite leaders must develop clear communication strategies to educate patients about the risks, benefits, and alternatives associated with their implantable devices.  

ESG Considerations in the Implantable Devices Sector

The healthcare sector is responsible for a considerable amount of waste and greenhouse gas emissions globally, with it accounting for 4.4% of net emissions. For this reason, no discussion on implantable device ethics would be complete without a brief discussion on ESG and sustainability. 

Fortunately, the “environment” part of ESG is easy enough to address theoretically, although the execution of greener devices is, of course, more complex than simply knowing what needs to be done.  

Generally speaking, medical devices can be made more sustainable in many ways, like by being made more energy efficient or by using eco-friendly materials in their design and production. The onus then falls on implantable device executives to ensure R&D processes include sustainability considerations to protect the environment from any negative effects. 

Beyond environmental factors, C-suite leaders must also navigate the broader social implications of implantable MedTech devices. These considerations include: 

1. Gender Disparities

Women experience disproportionate risks with the insertion of various medical devices. The reasons for this are complex, but the outcome is undoubted.  

There is compelling evidence suggesting that women have historically been underrepresented in clinical research. This has naturally (and very sadly) led to a lack of gender-specific data for medical devices.  

This underrepresentation seems to have resulted in medical devices that are less safe and effective for female patients due to differences in sex and gender that may influence medical conditions. 

To rectify these disparities, it is important to avoid perpetuating the under-enrollment of women in clinical investigations. There is a need to increase sex stratification in R&D to ensure that the development of medical devices takes into account gender-specific responses to treatment and intervention. 

2. Access and Equity

Implantable MedTech devices have the potential to exacerbate healthcare disparities if access is limited by socioeconomic factors.  

There is a growing recognition of the impact of social determinants of health (SDOH) on access to medical devices. Factors such as income, education, employment, and insurance can greatly influence a person’s ability to access and use implantable medical devices. 

It is estimated that clinical care impacts only 20% of health outcomes, whereas SDOH accounts for 80%. This provides the perfect reason for implantable device executives to strive for an integrated approach to patient marketing and product distribution that includes consideration of non-medical factors. By doing so, they can boost the efficacy of their own devices and make them available to a larger patient base. 

C-suite executives must thus consider strategies to ensure equitable access, like partnering with payers, developing tiered pricing models, and supporting initiatives that address social determinants of health. 

3. Effects on Patient Behavior and Social Identity

The impact of implantable medical devices on patient behavior and social identity is another social ethical challenge that executives need to consider.  

The use of certain implants, such as deep brain stimulation devices, not only affects the physical well-being of patients but can also lead to changes in mood and behavior. This may have broader effects on their social interactions and personal identity.  

It is thus of the utmost importance that, firstly, these kinds of products are properly tested and continuously monitored, and secondly, that these products aren’t implanted without the patient knowing that this may be a possible outcome. 

But an executive’s line of thought in terms of ethics should ideally go further than that. Ethical considerations arise regarding the extent to which these devices can and should influence aspects of a person’s psychological and social experience.  

There is a fine line between using such technology for therapeutic purposes and venturing into areas of cognitive and behavioral enhancement that may raise concerns over autonomy and consent. 

Given these challenges, it is important for executives to ensure a balanced approach that weighs the potential social and psychological benefits of implantable medical devices against the ethical considerations of their broader impact on patient behavior and social identity. 

You Need Ethical Executives to Lead Ethical Implantable MedTech Device Companies

The importance of ethical leadership in the implantable MedTech device industry cannot be overstated.  

Executives who make ethics their first priority create a workplace culture that works for the well-being of patients, staff, and the community.  

Research has shown that ethical leadership positively impacts employee behavior and organizational performance, too. One study found that ethical leadership was positively related to follower perceptions of leader honesty, integrity, and trustworthiness. Those are important qualities for a MedTech executive to have. 

On top of that, in 2016 a meta-analysis showed that ethical leadership was positively associated with employee job satisfaction, organizational commitment, and organizational citizenship behavior, while negatively related to counterproductive work behavior and turnover intentions. 

This reinforces a clear message for the MedTech sector—particularly for companies in the implantable device sector—that ethical executives are a must-have. They must be prepared to address ethical challenges proactively while motivating their entire organization to follow suit. 

At Stanton Chase, we have over 30 years’ experience helping companies find ethical leaders. Let us assist you in doing the same—click here to contact one of our consultants

About the Author

Gavin McCartney, a Partner at Stanton Chase London, serves as the Global Sector Leader for the Health and MedTech sector. He brings extensive experience managing executive search assignments for clients at global, regional, and local levels, conducting searches across Europe, US, Africa, the Middle East, and Latin America.   

Gavin’s international executive search expertise includes working with multicultural teams in the life sciences and healthcare industry. He handles mandates ranging from C-suite to VP and director positions across various functional areas. Furthermore, complementary to mature global MedTech organizations, Gavin’s experience extends to supporting early to commercialized-stage start-ups and SMEs, navigating the unique challenges of small, fast-growing, and investor-backed organizations. 

Executive Search
Life Sciences and Healthcare

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