Book Review
The medical device industry: business strategies for success.
By Jeanette Marchant.
The Economist Intelligence Unit – 120 pp, 26 tables, 27 figures, Feb 1998, ISBN 0
85058 957 6, 775 GBP.
The Economist Intelligence Unit (EIU) has over 50 years’ experience of analysing
international business issues and is well-established as producer of authoritative and
challenging reports in the healthcare sector. In addition to occasional reports such as
this, EIU also produces quarterly subscription publications, Healthcare International and
Healthcare Asia. For this report, EIU has secured the author Jeanette Marchant, previously
Editor of PJB Publications’ international industry newsletter Clinica and now a
free-lance writer, editor and project manager.
As populations age and many governments seek to reduce the burden of taxation on those
still employed, there is a two-fold pressure on the provision of healthcare. To the
factors of innovation, manufacturability, registrability and market attractiveness now has
to be added the problem of justifying the health economics of a new product, to obtain
either reimbursement within publicly-funded health programmes or eligibility for private
health insurance schemes.
This pressure makes it essential that inventors in academic and industrial spheres
understand more than ever before about the commercial context that will affect the
eventual products. Social security, health insurance groups and healthcare providers such
as purchasing hospitals will demand clear evidence of economic (cost-benefit) improvements
if a new product is to replace one already established, or be added to an ‘approved
list’.
This book focuses on the commercial implications of changes and trends in the
biomaterials, devices and healthcare sectors. Its seven chapters take the reader through a
general picture of the health of the industry, the impact of healthcare reforms in USA,
Europe and Japan, the challenge that managing regulations poses for companies, how they
deal with innovations and investment and the ways in which they have had to adapt their
business and marketing strategies for survival. Three companies are selected as case
studies, Becton Dickinson, Medtronic and Corin Medical.
The academic research units generating the innovations that will be the basis for
future success in biomaterials and devices will perhaps find the price puts it beyond
their reach. However, it is a book that should be read by all companies involved in these
areas, and by the people in universities and institutes responsible for assisting
technology transfer, planning company spin-out, or making research investment decisions.
For further information contact london@eiu.com (if
in Europe) or newyork@eiu.com (if in North America)
or enquire in the web-site http://www.eiu.com
Biomaterials Science and Engineering – a new series
focusing on latest developments
John Wiley & Sons Ltd, UK.
The series includes Biosensors in the Body, edited by David M Fraser of the University
of Newcastle UK, which provides a concise overview of leading-edge biosensing technology,
in 272 pages, published March 1997 at 50 GBP. Design Engineering of Biomaterials for
Medical Devices, a practical review intended for a wide audience from industry
professionals to design students, is by David Hill of Rocket Medical plc, UK, published
December 1997, cost 50 GBP. Subsequent volumes include Metals as Biomaterials – A
Handbook, edited by J A Helsen of KUL Leuven Belgium and J Breme of Saarland University
Germany, and Computer Technology in Biomaterials Science and Engineering, edited by Jos
Vander Sloten of KUL.
Biocompatibility Assessment of Medical Devices and Materials, the second volume in the
series, is edited by Dr Julian Braybrook, of LGC (Teddington) Ltd and BioBridge
Associates, who is also the Scientific Co-ordinator of the European Biomaterials Network.
This volume highlights the complex problems of host response and related issues, the rapid
development of regulations and standards, the principles behind their correct
interpretation and use, existing test methods, the advantages of standardised, valid
analytical measurements, intra- and inter-laboratory testing and certified reference
materials, and the application of risk analysis to assessment of biological safety. It has
10 chapters dealing with these topics, as well as surface characterisation of polymers,
sterilisation processes and residuals, explant retrieval and analysis and interactions
with blood. It contains 250 pages and was published June 1997, price 50 GBP.
Advances in Veterinary Drug Delivery
By Tim Wesley
PJB Publications Ltd – July 1998, 102 pages, 15 tables, details on price and
availability from Catherine Owen, PJB Publications, tel +44 181 948 3262
As the foreword says, drug delivery technology has played an important role in the
development of the animal health industry since the 1980s.
This report provides a review of what is happening now in several important sectors of
veterinary medicine and animal health. The take-up of drug delivery innovations has been
most marked in one single sector, that of control of internal parasitic worms and external
insect and mite parasites in cattle and sheep. The total value of this sector is more than
2000 m USD, about 12% of the total animal health and nutrition market. Over the past 15-20
years, a number of products utilising plastics, polymers and erodible metals have been
developed, containing various active parasiticidal ingredients, sometimes as a series of
tablets released through physical or electrochemical changes in the carrier, sometimes
formulated in polymer or other complex matrices or retained within a semi-permeable
membrane. Ear tags for fly control, collars for flea control and pour-on products for
treatment of pigs, cattle and sheep have been developed.
The technology used in veterinary products often seems primitive by comparison with the
biomaterials and devices R&D for human products, including as it does, hardware for
administration of medicines and relatively simple formulation advances that provide
longer-lasting release of actives, taste-masking, rapid-dissolution for tablets, or skin
penetration. Into this class fall recent developments involving antibiotic-containing
polymer formulations for periodontal disease, and mucosal-adhesive polymer patches
containing chlorhexidine and nicotinamide for oral hygiene in dogs after dental treatment.
However, some products and technologies have been extremely innovative, including
complex device engineering and polymer chemistry for dependable prolonged or
repeat-releasing products in cattle and sheep, management of the sub-microscopic structure
of antigens using novel surfactants and adjuvants for vaccines in horses, a pour-on
product containing a notoriously insoluble anti-worm agent for sheep, that contains
wax-coated microparticles given a positive charge to assist retention in the lanolin and
migration through the skin, and shampoos for pet animals sold by a French company,
containing surfactants in multilamellar vesicles developed by CNRS. A novel delivery
system that uses microchips and batteries has been launched in New Zealand that improves
breeding success for cattle, called the ‘intelligent breeding device’. The
product is implanted and releases specific hormones in a timed sequence over defined
periods. The US company Alza has been quite active in innovating delivery systems for
animals, or adapting existing products for humans, utilising its expertise in the
management of polymer-membrane systems that act as osmotic pumps. There are other drug
delivery companies that have sought veterinary uses of developments primarily for humans.
This report is a useful summary of existing products and near-future trends. It does
not go deeply into what current research in human biomaterials might do for veterinary
drug delivery in the longer term. It might have some relevance for companies interested in
the potential of the animal health market as an ‘add-on’ to human medical
business, indeed part of Chapter 4 deals with generic issues in licensing delivery
technology into the animal health area. The final chapter provides quite-detailed profiles
of companies involved in developing drug delivery technologies, adjuvants and vaccine
systems, including Aquila Biopharmaceuticals, CollaGenex Corp, Emisphere Technologies,
Fuisz Technologies, PowderJect, Scherer DDS Ltd, and VRI.
   
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