MASHINIi

Integra LifeSciences Holdings Corporation.

IART.US | Manufacture of medical and dental instruments and supplies

Integra LifeSciences Holdings Corporation is a global medical technology company. It develops, manufactures, and markets surgical implants and medical instruments. Their products are used in neurosurgery, reconstructive and general surgery. The company's offerings include devices and implants for wo...Show More

Ethical Profile

Mixed.

Integra LifeSciences has faced scrutiny over product safety, with multiple Class 2 recalls for items like CODMAN BACTISEAL EVD catheter sets and surgical patties due to safety concerns. An FDA warning letter also cited significant manufacturing and quality control issues. The company conducts animal testing for some medical products and received a $10.3 million Department of Defense contract in 2016. On the positive side, Integra donated $300,000 worth of medical instruments for Haiti earthquake relief. Its cybersecurity program includes internal and external audits and incident response simulations, with no material incidents reported as of December 2024, though critics point to a lack of specific details on AI governance.

Value Scores

Better Health for All-60
-100100
Fair Money & Economic Opportunity0
-100100
Fair Pay & Worker Respect0
-100100
Fair Trade & Ethical Sourcing-10
-100100
Honest & Fair Business-30
-100100
Kind to Animals-50
-100100
No War, No Weapons-50
-100100
Planet-Friendly Business0
-100100
Respect for Cultures & Communities-30
-100100
Safe & Smart Tech0
-100100
Zero Waste & Sustainable Products0
-100100

Better Health for All

-60

Integra LifeSciences has faced significant safety issues, including multiple Class 2 recalls in 2024 for surgical patties, strips, and catheter sets.

1
The FDA issued a warning letter in December 2024, citing multiple violations of good manufacturing practice requirements and non-conforming products, with four such reports between October 2022 and June 2023.
2
In February 2010, the company donated $300,000 worth of medical instruments to Haiti earthquake relief efforts through Direct Relief International.
3

Fair Money & Economic Opportunity

0

No evidence available to assess Integra LifeSciences Holdings Corporation on Fair Money & Economic Opportunity.

Fair Pay & Worker Respect

0

No evidence available to assess Integra LifeSciences Holdings Corporation on Fair Pay & Worker Respect.

Fair Trade & Ethical Sourcing

-10

Integra LifeSciences has a stated policy of zero tolerance for human trafficking, slavery, or child labor

1
, and no incidents were reported in their 2021 UK Modern Slavery Statement.
2
The company's global enterprise resource planning system tracks and retains data on products from initial supply through customer purchase
3
, enabling full traceability throughout the end-to-end supply chain.
4
Integra's Code of Conduct for Business Partners applies to all suppliers and third-party intermediaries
5
, establishing minimum requirements and expectations for ethical conduct, including human rights and labor.
6
The company complies with conflict minerals reporting requirements of the Dodd-Frank Act
7
and uses the Transparency International Corruption Index to identify high-risk geographic areas for due diligence.
8

Honest & Fair Business

-30

The company has reported a correction of an error to previously issued financial statements in a recent filing.

1
Additionally, a measurement period adjustment was recognized in the second half of 2024, and prior period revenues were reclassified.
2
The majority of Integra's manufacturing facilities participate in the Medical Device Single Audit Program and are audited annually for compliance with quality systems for the US FDA, Canada, Australia, Brazil, and Japan.
3
These facilities are also audited annually by a recognized Notified Body to verify compliance with the ISO 13485 Quality System standard.
4
The company states it is subject to anti-bribery laws, including the U.S. Foreign Corrupt Practices Act, and has certified adoption of the AdvaMed Code of Ethics.
5
However, there is no specific evidence regarding the frequency of anti-corruption training or effectiveness metrics. The company's ethical claims and compliance are independently verified through annual audits of its manufacturing facilities by a Notified Body for ISO 13485 and participation in the Medical Device Single Audit Program for compliance with quality systems in multiple countries.

Kind to Animals

-50

Integra LifeSciences conducts animal testing for some medical products and clinical research.

1
The company's policy commits to replacing, reducing, and refining animal use where possible, limiting testing to critical elements of product development.
2
It continually reviews and adopts updated standards for non-animal data, such as ISO 10993-23:2021, to include in vitro testing for irritation assessment, thereby further replacing, reducing, and refining animal testing.
3
Integra uses natural collagen material derived from bovine tissue and has products that are porcine tissue-based, as well as products using medical grade leptospermum honey.
4
These animal-derived materials are described as by-products of the food industry, specifically rendering, which supports the fullest use of animals possible.
5
The company has a research and development facility, the Dr. Richard E. Caruso Center of Innovation and Learning, dedicated to bench-top research, analytical testing, cell culture in vitro testing, and advanced imaging analysis.
6

No War, No Weapons

-50

Integra LifeSciences had a $10.3 million contract with the U.S. Department of Defense for 5 years

1
, which represents approximately 0.13% of its FY2024 revenue. The company's Conflict Minerals Due Diligence and Compliance plan conforms with the OECD Due Diligence Guidance for Responsible Supply Chains of Minerals from Conflict-Affected and High Risk Areas.
2
However, 44% of smelters and refiners in their supply chain either sourced from non-Responsible Minerals Initiative (RMI) conformant sources or lacked sufficient information to confirm RMI conformance.
3
The company's expectations are informed by international conventions including the UN Guiding Principles on Business and Human Rights
4
, but implementation is uneven across divisions. Integra conducts an annual Reasonable Country of Origin Inquiry (RCOI) of suppliers
5
, and any distributor ranked “high risk” is re-screened annually.
6
In 2024, 84% of distributors completed the company’s anti-bribery and -corruption training.
7

Planet-Friendly Business

0

No evidence available to assess Integra LifeSciences Holdings Corporation on Planet-Friendly Business.

Respect for Cultures & Communities

-30

Integra LifeSciences has over 20 formal partnerships with various organizations, including medical societies and community groups like the Children’s Brain Tumor Foundation and Hydrocephalus Association.

1
The company reported no cultural appropriation incidents.
2
In 2024, Integra Foundation made over $596,000 in grant donations to 109 nonprofits, representing approximately 0.037% of its $1.61 billion revenue.
3
In 2023, $4.63 million in products were donated, and $417,000+ in grants were given to 67 nonprofits.
4
The company's workforce distribution shows 70% in the United States, 21% in Europe, 2% in Latin America and Canada, and 7% in Asia Pacific.
5
Integra provides a global, 24/7, third-party operated Ethics Hotline and internal reporting channels.
6
The Code of Conduct is available in eight languages, and 100% of new hires completed Unconscious Bias Training, while 100% of all employees completed Code of Conduct training in 2024.
7

Safe & Smart Tech

0

Integra LifeSciences reported no material cybersecurity incidents as of December 31, 2024.

1
The company conducts annual cybersecurity training and certification programs for new hires and existing employees, including social engineering simulations.
2
It has incident response programs to address incidents jeopardizing information asset confidentiality, integrity, or availability.
3
The company performs periodic internal and external audits, penetration tests, and incident response simulations.
4
It also states compliance with laws related to the confidentiality of sensitive personal information and standards for electronic health data transmission, with no specific regulatory actions, violations, or fines detailed.
5

Zero Waste & Sustainable Products

0

No specific, quantitative evidence was found in the provided articles to assess Integra LifeSciences Holdings Corporation (IART.US) against any of the 'Zero Waste & Sustainable Products' KPIs. Information regarding waste reduction initiatives, product design, or packaging sustainability was related to INTEGRA Biosciences, a lab supply company, and was not explicitly stated to apply to Integra LifeSciences Holdings Corporation as a whole.

1
, while pertaining to Integra LifeSciences Corporation, focused on manufacturing quality control and regulatory compliance, not waste management or sustainable products.
2

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AI-generated analysis based on publicly available data. Not financial advice. Ratings are expressions of opinion derived from automated models and may contain inaccuracies. See our Risk Disclosure for full details.