European Technology for Business Ltd Applying micro- and nanotechnologies in the health sector: Opportunities and barriers Denis Hodgins Operations Director ETB ETB Ltd, Codicote Innovation Centre, St Albans Road, Codicote Herts, SG4 8WH www.etb.co.uk Phone 01438 822822 Fax 01438 822811 email info@etb.co.uk
European Technology for Business Ltd Why is MNT needed in the medical field? • The body comprises a number of small orifices, flexible tubes • Bacteria often causes growth on foreign bodies, so size should be minimised and biocompatible coatings small crystals, 100-200 µm long growing in a valve are essential ETB Ltd, Codicote Innovation Centre, St Albans Road, Codicote Herts, SG4 8WH www.etb.co.uk Phone 01438 822822 Fax 01438 822811 email info@etb.co.uk
European Technology for Business Ltd Example from Healthy Aims - Glaucoma sensor using MNT ETB Ltd, Codicote Innovation Centre, St Albans Road, Codicote Herts, SG4 8WH www.etb.co.uk Phone 01438 822822 Fax 01438 822811 email info@etb.co.uk
European Technology for Business Ltd Example from Healthy Aims - Modiolus electrode from ITE • Silicon based • Direct insertion, no stylet needed • Dense electrode array • Potential to integrate active devices – Force sensor – Multiplex addressing ETB Ltd, Codicote Innovation Centre, St Albans Road, Codicote Herts, SG4 8WH www.etb.co.uk Phone 01438 822822 Fax 01438 822811 email info@etb.co.uk
European Technology for Business Ltd Example from Healthy Aims – Electrodes for retina implant • In this application the electrode structure is very thin (10µm) • The electrode tips are formed as truncated pyramids, spacing around 200µm • This improves the contact to the tissue ETB Ltd, Codicote Innovation Centre, St Albans Road, Codicote Herts, SG4 8WH www.etb.co.uk Phone 01438 822822 Fax 01438 822811 email info@etb.co.uk
European Technology for Business Ltd Example from Healthy Aims – Human body motion using inertial systems Wireless 3-axis accelerometer Reach and grasp trials for FES trigger Detecting balance ETB Ltd, Codicote Innovation Centre, St Albans Road, Codicote Herts, SG4 8WH www.etb.co.uk Phone 01438 822822 Fax 01438 822811 email info@etb.co.uk
European Technology for Business Ltd Example from Healthy Aims – Human body motion ETB Ltd, Codicote Innovation Centre, St Albans Road, Codicote Herts, SG4 8WH www.etb.co.uk Phone 01438 822822 Fax 01438 822811 email info@etb.co.uk
European Technology for Business Ltd Assembly, Packaging and encapsulation • Any medical device requires: – Assembly, where size and shape of the components is critical for the final application – Packaging, where the application defines the overall space envelope – Encapsulation, where the application defines the level of biocompatibility required. Implants have the most stringent requirements. ETB Ltd, Codicote Innovation Centre, St Albans Road, Codicote Herts, SG4 8WH www.etb.co.uk Phone 01438 822822 Fax 01438 822811 email info@etb.co.uk
European Technology for Business Ltd Medical devices utilise a range of technologies These include: MST/ MNT sensors Electronic components – some active, some passive. Implantable energy source. Body Area Network to communicate from in or on the body to base station up to 3m away. Micro-electrodes interfacing to the implantable electronics on non Silicon substrates. Biomaterials ETB Ltd, Codicote Innovation Centre, St Albans Road, Codicote Herts, SG4 8WH www.etb.co.uk Phone 01438 822822 Fax 01438 822811 email info@etb.co.uk
European Technology for Business Ltd Exploitation of Medical products requires: Medical devices manufacturers Medical Systems suppliers Medical Approvals bodies Surgeons and clinical teams from hospitals Medical Service providers e.g Social Services Local medical practices Purchasing teams, e.g NHS in the UK Medical Insurance groups So make sure these are involved early on in the development programme . ETB Ltd, Codicote Innovation Centre, St Albans Road, Codicote Herts, SG4 8WH www.etb.co.uk Phone 01438 822822 Fax 01438 822811 email info@etb.co.uk
European Technology for Business Ltd The barriers for medical devices Before any medical product can be brought to market it must have undergone clinical trials, which requires ethics approval and subsequently CE marking. Medical teams need to work with the R&D groups and manufacturers. All work must be fully documented. Clinical efficacy may take years and require a number of clinical teams to trial the system. Typical time to market for an implant is 10 years from initial concept. Cost for medical trials, including insurance is high. ETB Ltd, Codicote Innovation Centre, St Albans Road, Codicote Herts, SG4 8WH www.etb.co.uk Phone 01438 822822 Fax 01438 822811 email info@etb.co.uk
European Technology for Business Ltd Types of Partners required for future MNT based medical projects • Research Groups in micro and nano technology • Biomaterials experts • RF communications experts • Power sources experts • Design teams • Medical Device manufacturers • Surgeons and clinical teams, including ethics ETB Ltd, Codicote Innovation Centre, St Albans Road, Codicote Herts, SG4 8WH www.etb.co.uk Phone 01438 822822 Fax 01438 822811 email info@etb.co.uk
European Technology for Business Ltd End 2006 End 2008 End 2010 End 2012 Power system for external trigger developed for medical applications 2007 FES, with external systems New MST internal power system for long term implant 2010 FES, with no external systems Develop implant systems - stand alone, 2008 Active implants intelligence in large external unit. Expensive niche markets 2007 Monitoring implants Reduce power source size, but remain external FES with 2010 Alarm treatment system macro Biomaterials for coatings developed (nano) external unit 2012 Remote controlled system M eye, ear i c r o - e o l f e Micro-electrodes/cables developed to reduce size c shoulder, arm t t h r o e n b i o c d s y ) f o r Sensors developed for external triggering n e r v D e e v d e l e o t e p c t i m o i n n i d a t u e v r e e l o s p y e s d t e m ( b s r a i w n i t h o r n o e w t h FES with e Implants with t r r i g p g a e r r t s external m e no external c h New internal sensor a n i s Develop Biomaterials for sensors,actuators unit for m s trigger and developed eye, ear minimal or fingers, no external unit toes s i n g p r o c e s f i c s i g n a l o m s p e c i u l e , c u s t r n a l m o d i n t o i n t e n t e g r a t e d i g e n c e i I n t e l l Active implants with only the Improved electrodes functionalit v e n a t i t e r h a l New micro pumps/valves developed w i t r k w o and t o y for a n t m p l i l o p d s e v e t h o D m e n g p l i c o u active active a d a t w e r / p o sensors implants internally produced t u a t o r s n s o r s a n d a c a l l e l w i t h s e l o p e d i n p a r I m p l a n t d e v e e.g. heart pacemaker Implants to Sensors developed for internal use (e.g. accelerometer, Call for gyro, pressure sensor) monitor treatment/ functions alarm trigger system n e e d o f c a b l e s a n d r e c e i v e r m e t h o d s d e v e l o p e d t o e l i m i n a t e t h e D a t a / p o w e r c o u p l i n g Remote controlled Develop external communication to implants (e.g. RF blue tooth) + links to hospitals/doctors/treatment providers implants ROADMAP FOR IMPLANTS AND STIMULATORS ETB Ltd, Codicote Innovation Centre, St Albans Road, Codicote Herts, SG4 8WH www.etb.co.uk Phone 01438 822822 Fax 01438 822811 email info@etb.co.uk
European Technology for Business Ltd Summary • All intelligent medical systems integrate MNT with a variety of other technologies. • Technology development is driven by medical applications. • Number of technical issues relating specifically to the application, can only be resolved when working closely with clinical experts. • Commercial aspects needs to be considered from the outset of any new medical product development. • Examples from the Healthy Aims project detailed on www.healthyaims.org ETB Ltd, Codicote Innovation Centre, St Albans Road, Codicote Herts, SG4 8WH www.etb.co.uk Phone 01438 822822 Fax 01438 822811 email info@etb.co.uk
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