Stimulating medical device innovation in a SME
Submitting InstitutionsUniversity of Brighton,
University of Sussex
Unit of AssessmentAllied Health Professions, Dentistry, Nursing and Pharmacy
Summary Impact TypeTechnological
Research Subject Area(s)
Chemical Sciences: Macromolecular and Materials Chemistry, Medicinal and Biomolecular Chemistry
Engineering: Biomedical Engineering
Summary of the impact
A sustained joint research partnership with Biocompatibles UK Ltd has
stimulated innovation underpinning the company's product development
pipeline. Products include a family of soft contact lenses, enhanced
medical device coatings, and novel treatments for liver cancer. Innovative
enhancements, such as the unique non-biofouling nature of the company's
ocular and cardiovascular devices and the practical utility of its drug
eluting therapies for targeting liver malignancies, have delivered
improved clinical performance and differentiated these products from those
of competitors in the same markets. The company's continuing success in
developing innovative medical technology products was recognised by the
sale of Biocompatibles UK for £177m in 2011.
The research partnership between University of Brighton (UoB) and
Biocompatibles UK (BUK) was originally established in the early 1990s
through an MRC/SERC/DTI/DOH Medical Implants LINK Programme to support the
synthesis, characterisation, evaluation and development of novel
phosphorylcholine (PC) polymer materials for medical device applications
in the ophthalmic field. This fuelled the development of PC coatings and
bulk materials for a wide range of medical device applications, including
the development of novel contact lens and intraocular lens materials and
provided a range of clinically reflective assays for assessing the ocular
compatibility of novel biomaterials [references 3.1, 3.2], which were
ultimately translated from the University of Brighton to the company
through a Teaching Company Scheme. These assays offered more clinically
relevant approaches of assessing ocular biocompatibility in vitro
than those that were required at the time by regulatory authorities and
helped to demonstrate the advantages of the PC materials.
The joint research extended into the evaluation of biocompatible coatings
based upon sulfo- and phosphobetaines, physi-sorbed and cross-linkable
systems, blends and systems modified with cationic charge through internal
company investment. This work enabled the university to jointly
demonstrate advantages for PC coatings over conventional hydrogel coating
systems, extending beyond ocular biomaterials into other areas, including
blood-contacting devices such as extracorporeal circuits, coronary
guidewires, catheters, stents and a variety of urological devices [3.3].
Focus within BUK switched to the development of drug eluting stents and
through the collaboration with Professor Steve Armes of the Chemistry
Department at the University of Sussex, UoB researchers also collectively
sought to develop further drug delivery applications for new PC polymers.
This involved exploring novel architectures provided by controlled radical
polymerisation and the self-assembled structures that these materials
could generate, including the first reports of thermo-responsive PC
polymer gels and pH-responsive PC nanoparticulate systems [3.4]. The
success of this partnership was recognised with the accolade of the Sussex
Business Award 2002 for `Best Industry-University Collaboration'.
In 2002, BUK sold both its contact lens and cardiovascular divisions and
started a new business in the field of embolotherapy, with a view to
develop novel drug-eluting bead (DEB) systems for the treatment of liver
cancer. UoB was intrinsically involved in the characterisation of these
novel systems, supported by a number of EPSRC/BBSRC CASE studentships and
industrially funded PhD projects, the majority of which were based within
the company's laboratories. This has extended our knowledge of the DEB
technology, particularly its drug loading and release properties [3.5,
3.6]. Further work has extended into DEBs based on alginate biopolymers as
a degradable embolic agent and currently the research partnership is
focused on development of novel cell-based assays for the evaluation of
drug combinations in both normoxic and hypoxic conditions and the
development of a novel hypoxia-responsive DEB system.
||Professor of Pharmaceutical and Applied
Microbiology (Jan 1991-Oct 2003).
||Research Fellow (Jan 1994-Aug 2000), Senior Research Fellow (Sept
2000-Mar 2003), Principal Research Fellow (Apr 2003-July 2009)
Professor of Biogerentology (Aug 2009-to date).
||Lecturer (Sept 1983-Aug 1988), Senior Lecturer (Sept 1988-Nov
2001), Principal Lecturer (Dec 2001-Mar 2009), Reader (Mar 2009-Sept
2013), Professor of Experimental Therapeutics (Oct 2013-to date).
||Research Assistant (Jan 1976-Dec 1978), Lecturer (Jan 1979-Aug
1982), Senior Lecturer (Sept 1982-Aug 1992), Principal Lecturer
(Sept 1992-Nov 1999), Reader (Nov 1999-Dec 2003), Professor of
Pharmaceutical Microbiology (Dec 2003-Sep 2012).
||Research Assistant (Sept 1986-Aug 1989), Lecturer (Sept 1989-Aug
1993), Senior Lecturer (Sept 1993-Aug 1998), Reader (Sept 1998-June
2000), Professor of Biomedical Materials (June 2000-to date), Dean
(Aug 2003-to date).
||Reader (Oct 2006-to date).
||Research Fellow (Apr 1994-Sept 1996), Lecturer (Oct 1996-Aug
1997), Senior Lecturer (Sept 1997-Feb 2001), Principal Lecturer (Mar
2001-May 2001), Reader (May 2001-June 2003), Professor of Materials
Chemistry (June 2003-to date).
||Research Officer (Jan 2002-Aug 2002), Research Fellow (Jan
||Research Assistant (Dec 1990-May 1994), Research Assistant (Jan
1995-Dec 1995), Research Officer (Dec 1995-Dec 1996), Research
Fellow (Jan 1997-Feb 2002), Senior Research Fellow (Mar 2002-July
2006), Principal Research Fellow (Aug 2006-to date). Deputy Director
of Postgraduate Studies — Science & Engineering (Nov 2011-July
||Research Officer (June 2004-July 2009), Research
Fellow (Aug 2009-to date).
References to the research
Optimisation of ophthalmic lens material:
[3.1] LLOYD, A.W., FARAGHER, R.G.A., WASSALL, M., RHYS-WILLIAMS, W.,
WONG, L., HUGHES, J.E. and HANLON, G.W., (2000) Assessing the in vitro
cell-based ocular compatibility of contact lens materials. Contact
Lens & Anterior Eye, 23, pp.119-123. DOI:
10.1016/S1367-0484(00)80004-1 [Quality validation: leading peer-reviewed
[3.2] LLOYD, A.W., DROPCOVA, S., FARAGHER, G.A., GARD, P.R., HANLON,
G.W., MIKHALOVSKY, S.V., OLLIFF, C.J. and DENYER, S.P. (1999) The
development of in vitro biocompatibility tests for the evaluation of
intraocular biomaterials. Journal of Materials Science-Materials in
Medicine. 10, pp.621-627. DOI: 10.1023/A:1008935707910 [Quality
validation: leading peer-reviewed journal].
Biocompatible coatings for medical device use:
[3.3] GOREISH, H.H., LEWIS, A.L., ROSE, S. and LLOYD, A.W. (2003) The
effect of phosphorylcholine-coated materials on the inflammatory response
and fibrous capsule formation: in-vitro and in-vivo observations. Journal
of Biomedical Materials Research Part A, 68A, pp.1-9. DOI:
10.1002/jbm.a.10141 [Quality validation: leading peer-reviewed journal].
Self-assembled drug delivery systems:
[3.4] SALVAGE, J.P., ROSE, S.F., PHILLIPS, G.J., HANLON, G.W., LLOYD,
A.W., MA, I.Y, ARMES, S.P., BILLINGHAM, N.C, and LEWIS, A.L. (2005) Novel
biocompatible phosphorylcholine-based self-assembled nanoparticles for
drug delivery. Journal of Controlled Release, 104, pp.259-270.
DOI: 10.1016/j.jcornel.2005.02.003 [Quality validation: leading
Drug eluting embolisation materials:
[3.5] LEWIS, A. L., GONZALEZ, M. V., LEPPARD, S. W., BROWN, J.E.,
STRATFORD, P.W., PHILLIPS, G.J. and LLOYD, A.W. (2007) Doxorubicin eluting
beads-1: effects of drug loading on bead characteristics and drug
distribution. Journal of Materials Science-Materials in Medicine,
18, pp.1691-1699. DOI: 10.1007/s10856-007-3068-8 [Quality validation:
leading peer-reviewed journal]
[3.6] LEWIS, A.L., GONZALEZ, M.V., LLOYD, A.W., HALL, B., TANG, Y.,
WILLIS, S.L., LEPPARD, S.W., WOLFENDEN, L.C., PALMER, R.R. and STRATFORD,
P.W. (2006) DC Bead™: in-vitro characterisation of a drug delivery device
for transarterial chemoembolization. Journal of Vascular and
Interventional Radiology, 17(2), pp.335-342.
DOI:10.1097/01.RVI.0000195323.46152.B3 [Quality validation: 112 cites].
Peer-reviewed research grants:
Medical Implants LINK Programme `Biomimetic Polymers to Improve the
Ocular Compatibility of Intraocular Lenses' MRC/SERC/DTI/DOH (1993-1997).
Total funding: £904k.
Medical Implants LINK Programme `Advanced Glaucoma Filtration Implant
MRC/SERC/DTI/DOH (1995-1997). Total funding: £360k.
`Synthesis and characterisation of novel betaine-based copolymers for high
performance biocompatible coatings' BBSRC Project Grant (1999-2002). Total
Details of the impact
The impact of the research has been in supporting the cyclical innovation
within an SME through joint research and development programmes. The
integrated partnership has: (a) involved the placement of university
researcher(s) within the company (as part of Knowledge Transfer
Partnerships and EPSRC/BBSRC CASE Studentships) to work alongside company
employees, and; (b) allowed company employees to register for higher
degrees and to work alongside university academics and researchers within
the university. Innovation oversight has been managed by LLOYD (UoB) and
Professor Lewis (BUK) and further informed through LLOYD's membership of
the company's Scientific Advisory Board from 2003 to 2008 and appointment
as an ongoing scientific consultant to the company. The joint advancement
of knowledge through the partnership has stimulated and supported
innovation within the company, leading to on-going marketing benefits for
existing products, new material applications, new products and patents, as
Product performance data: The development and marketing of the
Proclear® family of soft contact lenses by the EyeCare Division of
Biocompatibles UK Ltd. The Proclear® family of lenses was launched and was
able to establish a niche in the monthly disposable segment, supported by
strong scientific data generated through the collaboration with UoB that
demonstrated significantly less bio-fouling with proteins and bacteria,
leading ultimately to a more comfortable contact lens — using assays that
were originally developed to support material optimisation for a novel
intraocular lens and glaucoma filtration device. These assays became
standard in-house test methods for the company (source 5.2). The data
produced by UoB researchers underpinned the submission to the U.S. FDA for
the claim: `may provide improved comfort for contact lens wearers who
experience mild discomfort or symptoms relating to dryness during lens
wear'. This is the only contact lens worldwide cleared for this claim.
This contact lens business was sold in 2002 to the Cooper Group for ~£70m
and was then the 6th largest contact lens business. In 2011, net sales of
CooperVision's PC Technology products represented 28% of CooperVision's
soft lens net sales of £650m and with forecast sales of >$1.3bn in
2013, the Proclear sales are now worth circa. $300m per annum (5.1, 5.2,
New material applications: Early work by the company had
identified the potential use of PC-materials in blood contacting and
protein biofouling applications. The early observations made through the
joint research programme into the propensity of these coatings to reduce
cellular adhesion and activation increased the scope of the PC-coating
applications. The optimisation of the biological performance of PC
coatings through the research undertaken by UoB contributed to the broader
regulatory approval of PC-coated medical devices for clinical use and
assisted in the development of the BiodivYsio® family of coronary stents
and the Yellowstar® family of urological catheters and stents. The coating
technology was licensed to Vertellus Specialities UK Ltd, which has
continued to exploit the PC technology in a wide range of medical device
applications based on the data originally generated by UoB and BUK. The
research publications derived from this work still form part of the
company's marketing data and the data is used by Vertellus to inform
development programmes with companies around the world (5.2, 5.4).
New products: (i) Celluminate®, a fluorescent cell-tracker system,
developed and marketed by BUK from 2008 until 2011, is based on the
research funded by BBSRC into novel bioresponsive self-assembling PC
polymers. (ii) DC Bead® Technology — a novel combination product for the
treatment of liver cancer, was developed initially as a bland embolic
device intended for the purpose of embolising the blood vessels of a
variety of hypervascularised tumours (e.g. uterine fibroids) and
arteriovenous malformations in-licensed by BUK. The DC Bead® drug-eluting
bead technology arose as a consequence of the company's experience in drug
eluting devices and interventional procedures. A series of joint research
programmes funded by BUK, EPSRC and the Royal Commission for the
Exhibition of 1851 broadened the potential of this technology and provided
much of the scientific underpinning that supports the product in market.
It has been evaluated in clinical trials worldwide and is rapidly becoming
recognised as the gold-standard treatment for intermediate primary liver
cancer. The product is now available globally in over 600 hospitals in 50
different countries and there have been over 100,000 reported procedures.
The value of this business was recognised in early 2011 when BTG Limited
successfully acquired Biocompatibles for £177m (5.5 and 5.6).
Patents: (i) LEWIS, A.L., ARMES, S.P., LLOYD, A.W. and SALVAGE,
J.P. (2002) Drug Carriers comprising amphipathic block copolymers
US2012157550. (ii) LEWIS, A.L., FORSTER, R.E.J., GONZALES-FAJARDO, V.M.,
TANG, Y., LLOYD, A.W. and PHILLIPS, G.J. (2007) Delivery of Drug
Combinations US2011229572 (iii) ASHRAFI, K., LEWIS, A.L., HEAYSMAN, C.,
LLOYD, A. and PHILLIPS, G. (2011) Drug Delivery Systems WO2012101455.
Sources to corroborate the impact
5.1 Testimonial available from Director of Research & Development,
Biocompatibles UK Ltd. This testimonial confirms the partnership with UoB
and the effect of cyclical innovation within the company.
5.2 Testimonial available from Business Director, Vertellus Biomaterials
Ltd that confirms the effect on product performance, innovation and the
use of the data in marketing materials and development programmes.
5.3 Cooper Companies' financial statements, `The Cooper Companies, Inc
and Subsidiaries — Valuation and Qualifying Accounts.' Three Years Ended
October 31, 2011. Available at:
[Accessed: 8 November 2013] This confirms the sales data included in the
5.4 `Vertellus Biomaterials — Biocompatible Coating Material'. Marketing
data available at:
[Accessed: 8 November 2013]
5.5 `Celluminate® intracellular delivery system' product release.
08/27/2009. Available at:
[Accessed: 8 November 2013].
5.6 `Biocompatibles UK Ltd Wins The 2011 Prince Philip Award for Plastics
in the Service of Mankind for DC Bead®' 24 Oct 2012. Available at:
[Accessed: 8 November 2013]. This confirms that the product is now
available globally in over 600 hospitals with over 100,000 reported
procedures and that this product was acquired by the BTG Group for £177m