Be the first to like this
While the recent economic climate has generally affected most market sectors, cutbacks at hospitals and other healthcare centres, new regulatory policies and changes
to reimbursement strategies are having a particularly strong effect on companies in the medical device sector.
In parallel, there are growing babyboomer healthcare needs, a marked transition of
point of care towards the home environment and a variety of emerging markets to consider.
This combination of changing market and user characteristics and increasing cost and price pressures mean that the underlying demand for innovative products and solutions is only going to increase. This innovation will now, more than ever, also need to result in cost effective products that demonstrate higher levels of usability and health effectiveness.
With more than 25 years experience working with clients as an end-to-end product development partner, Sagentia is well placed to help medical device companies respond to the industry’s challenges. We focus on delivering innovative medical products in three key areas: point of care diagnostics, surgical devices and patient care.
We have delivered innovation and value to a wide range of clients including: Johnson & Johnson, AstraZeneca, St Jude Medical, T2 Biosystems, Titan, Prosurgics and Photocure.
• Experts in complex medical device developments that meet aggressive timescales
• Accreditation to ISO 9001:2008 and ISO 13485:2003
• Deep science and technology expertise
• Multidisciplinary and cross sector teams providing broad insights
• Delivery of practical and commercial solutions that meet real user needs
• Global perspective and experience and worldwide delivery capability
• Customer friendly approach to IP
We understand the stringent needs of the highly regulated medical device environment
• ISO 13485:2003 certification and extensive industry expertise
• Compliance with international market regulations
• Product development leading to fully validated manufacturing processes
• Controlled DHF to support regulatory submissions
• Support or fully manage ancillary activities
• Device development spanning risk classifications from Class I to Class III