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Medtech’s Role In The Carbon Neutral Challenge To Counter Climate Change – The UK View

Net zero environmental sustainability needs are bringing new ‘compliance’ requirements

 
• By Ashley Yeo

“Sustainability executive” is a new job role for a new era. The UK’s largest healthtech industry association has appointed one, and many medtech companies in every geography might eventually do likewise, as the drive for nations to achieve carbon neutrality picks up pace. Medtech Insight spoke to the ABHI’s new incumbent Addie MacGregor and director of value and access Luella Trickett to gauge the size of the task before the medtech industry.    

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Medical device, digital and diagnostic companies, wherever they may be based, have long been accustomed to market access challenges.

Now, they are facing a new test of their abilities, where the stakes are higher, not confined to the health care space, and where participation is not optional

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Inclusive By Design: UK Invites Sponsors To Submit Trial Diversity Plans

 
• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.

Disparities — Including Financials Shortcomings — Remain In Women’s Health, Execs Say

 
• By Brian Bossetta

FemTech leaders discussed some of the barriers that remain in unlocking the full potential of the women’s health market during SiS New York last week. They also offered solutions.

FDA Scrubs ‘Gender’ From Final Guidance On Sex-Specific Data But Encourages More Women In Clinical Trials

 
• By Brian Bossetta

The US FDA has published its final document to guide sponsors on using sex-specific data in designing clinical trials of medical devices. However, the guidance removes all references to gender that appeared in January’s draft guidance, released before the Trump administration took office.

Drop Email Pronouns And Return To Work, Administration Orders FDA Staffers

 
• By Brian Bossetta

Chaos continues at the FDA’s device center as reinstated staffers begin daily commutes to comply with the administration’s return to office policy. Staffers can no longer publicly share their pronouns per Trump’s “Defending Women” executive order.

More from Medtech Insight

Plans For Specific EU Orphan And Pediatric Device Expert Panel Need To Go Further

 
• By Amanda Maxwell

Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.

First Alzheimer’s Disease Diagnostic Blood Test Cleared By FDA

 
• By Natasha Barrow

Fujirebio Diagnostics' Alzheimer's disease test, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, has been cleared by the US FDA.

MORE Details On MHRA’s Online Platform For Post Market Surveillance

 
• By Ashley Yeo

Post-market surveillance regulations for medtech system users in Great Britain coming into force on 16 June will make new data requirements under new compliance deadlines.