Latest news with #medicaldevices
Yahoo
7 hours ago
- Business
- Yahoo
Changing regulations impact medical device market entry strategies
The medical devices industry is always undergoing significant regulatory changes. In the EU and UK there have been new frameworks introduced recently, and as a result the medical device industry is consistently navigating a complex and evolving regulatory framework that has implications on medical device company market strategies. The EU Medical Devices Regulation (MDR) came into effect on 26 May 2021. The regulation introduced several changes to medical device regulation in Europe, including stronger market surveillance, establishing explicit responsibilities for manufacturers, improved traceability, a central database for comprehensive information on medical products, and high-risk device assessment. Additionally, in July 2025, the Competent Authorities for Medical Devices and the Head of Medicines Agency issued a statement advocating for significant medical device regulation reforms in the EU. Specifically, they are advocating for improved coordination, governance, and centralisation of regulatory activities in the EU. Similarly, in the UK, new Post-Market Surveillance regulations have taken effect in June 2025. The new regulations require device manufacturers to track the safety and performance of products to help identify safety issues early. The regulations will ensure manufacturers have a system in place to monitor devices once in use, collect safety data, report serious incidents, and take action quickly when any issues arise. These changes and expansions mean that manufacturers need to navigate complex landscapes of regulations that govern various aspects of medical device production. The need to comply with these regulations can lead to increased operational costs and may limit the ability to rapidly introduce new products. Changes and expansions in regulations can significantly impact market entry strategies. The evolving landscape often results in longer timelines to get necessary approvals, ultimately hindering a company's ability to enter the market with new products quickly. This can divert resources from other critical areas such as research and development or marketing, potentially impacting overall competitiveness. Due to the complexity of regulatory requirements, companies may consider forming strategic partnerships with local companies that have established regulatory pathways. This can facilitate smoother market entry and compliance with local laws. Companies should establish robust compliance programmes to monitor adherence to both domestic and international regulations. Companies that have proactively adapted their product development processes to comply with new regulations tend to perform better. For example, companies that invested in understanding the MDR and preemptively adjusted their clinical trial protocol to align with the requirements likely gained a competitive edge. The implications of medical device regulations on market entry strategies are profound. Companies should be prepared to navigate an increasingly complex regulatory environment. Successful market entry strategies involve a combination of compliance, strategic partnerships, technological innovation, and localised market research. "Changing regulations impact medical device market entry strategies" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Reuters
8 hours ago
- Business
- Reuters
EU approves €403 mln in funding for companies to boost medical device innovation
BRUSSELS, July 22 (Reuters) - The European Commission approved on Tuesday up to 403 million euros ($471 million) in public funding for 10 mostly small and medium-sized companies in a bid to support innovation in medical devices. The funding is expected to unlock an additional 826 million euros ($966 million) in private investments to the companies, the commission said in a statement. The commission said the projects are expected to create around 800 jobs and will include the introduction of new digital and artificial intelligence features in medical devices. ($1 = 0.8548 euros)
Zawya
10 hours ago
- Business
- Zawya
ADIA to invest $200mln in India's $6.6bln medical device firm Meril
The Abu Dhabi Investment Authority (ADIA) plans to invest $200 million in the Indian medical devices company, Micro Life Sciences Private Limited (Meril). A wholly-owned subsidiary of ADIA has entered into an agreement for an approximate 3% stake in Meril. The investment values the Gujarat-based Meril at $6.6 billion. The transaction is subject to regulatory approval by the Competition Commission of India (CCI). Founded by the Bilakhia Group, Meril operates across multiple specialties including cardiovascular, structural heart, orthopaedics, and surgical robotics. ADIA, which established a subsidiary at the Gujarat International Finance Tec-City (GIFT City) last October with plans to set up a $4-$5 billion fund in the special economic zone, has been increasing its India investments over the past year, including in healthcare and pharmaceuticals. Earlier, ADIA acquired a 3% stake in Intas Pharmaceuticals, for approximately $250–$270 million, which valued the Indian firm at around $8.5 billion. The Abu Dhabi sovereign wealth fund also emerged as a key investor in India's Akums Drugs and Pharmaceuticals July IPO, allocating 500 million rupees ($6 million), and representing 6.03% of the anchor investment portion. (Writing by Bindu Rai, editing by Seban Scaria)
Reuters
5 days ago
- Business
- Reuters
Abbott profit forecast falls short, ramps up US investing amid tariff pressure
July 17 (Reuters) - Abbott (ABT.N), opens new tab on Thursday forecast third-quarter profit below Wall Street expectations and estimated about $200 million in annual tariff costs. The medical device maker's shares slid 8%, even as it announced a new plant in the U.S. to mitigate the hit from President Donald Trump's sweeping duties on trading partners. Speaking on a post-earnings call, Chief Financial Officer Phil Boudreau said the impact of tariffs will likely be felt in the second half of the year, as the company works its way through its inventory. Larger rival Johnson & Johnson (JNJ.N), opens new tab on Wednesday halved its expectations for tariff costs this year to about $200 million. Abbott projected a profit of between $1.28 and $1.32 per share for the current quarter, below expectation of $1.34. It estimated annual sales growth to be between 7.5% and 8.0%, compared with the between 7.5% and 8.5% previously predicted. With Abbott shares one of the best year-to-date performers in large and mega-cap medtech, its print needed to be nearly spotless to keep shares moving higher, BTIG analyst Marie Thibault said. The company sees a $700 million hit to its diagnostics segment this year as the unit faces declining COVID testing revenue and pressure from a procurement program in China, which purchases medical devices in bulk at steep discounts. "These headwinds are not going to be there in 2026", Abbott CEO Robert Ford told analysts on the call. Abbott said it planned to build a manufacturing facility in Georgia by 2028 to support its cardiovascular business, adding to its April announcements for projects in Illinois and Texas, which are expected to go live by the end of the year. The company's quarterly revenue came in at $11.14 billion, beating expectations of $11.07 billion, according to data compiled by LSEG. Sales of Abbott's continuous glucose monitoring (CGM) devices, which include the FreeStyle Libre series and Lingo, jumped 21.4% to $1.9 billion in the second quarter. On an adjusted basis, the company reported a profit of $1.26 per share for the second quarter, compared with analysts' average estimate of $1.25.
Reuters
5 days ago
- Business
- Reuters
Abbott beats estimates on medical devices demand as forecast hits shares
July 17 (Reuters) - Abbott (ABT.N), opens new tab beat Wall Street estimates for second-quarter profit on Thursday, driven by strong demand for its medical devices, including continuous glucose monitors. However, its shares fell 5% premarket after the company's third-quarter earnings forecast fell short of expectations. Abbott projected a profit of between $1.28 and $1.32 per share for the current quarter, below expectation of $1.34. With Abbott shares one of the best year-to-date performers in large and mega-cap medtech, its print needed to be nearly spotless to keep shares moving higher, BTIG analyst Marie Thibault said. In April, Abbott had said it expects President Donald Trump's tariffs to begin impacting results in the third quarter, with an anticipated annual cost of "a few hundred million dollars." Investors will likely watch for any comments on tariffs from executives during the post-earnings call after larger rival Johnson & Johnson (JNJ.N), opens new tab on Wednesday halved its expectations for such costs this year to about $200 million. analyst Robbie Marcus said the company's results balance strong underlying growth trends in diabetes care and heart devices against a muted forecast update. Meanwhile, Abbott said on Thursday it planned to build a manufacturing facility in Georgia by 2028 to support its cardiovascular business, as companies seek to mitigate the tariff impact by moving manufacturing to the U.S. This follows the company's April announcements for manufacturing and research projects in Illinois and Texas, which are expected to go live by the end of the year. Sales of Abbott's continuous glucose monitoring (CGM) devices, which include the FreeStyle Libre series and Lingo, jumped 21.4% to $1.9 billion in the second quarter. CGM makers such as Abbott, Dexcom (DXCM.O), opens new tab and Medtronic (MDT.N), opens new tab are riding a surge in demand as diabetes awareness rises, insurance coverage expands, and patients embrace finger-prick-free technology. Abbott's quarterly revenue came in at $11.14 billion, beating expectations of $11.07 billion, according to data compiled by LSEG. On an adjusted basis, the company reported a profit of $1.26 per share for the second quarter, compared with analysts' average estimate of $1.25.
