Biomedical Engineering Reference
In-Depth Information
same time, the potential bonanza for the company that gains a significant foothold
in this space encourages continued attention and investment by Wall Street.
2.5
Conclusion
Despite scientific advances over the last 40 years in engineering more sophisti-
cated skin substitutes, their failure to achieve a major share of this enormous
market has been notable. Certainly cost and the lack of clear and reproducible
success associated with these various therapies have been partially responsible.
The length of the FDA-approval process for biologically based skin substitutes
increases the cost of the various products and limits investor enthusiasm for new
research and development.
The market for skin substitutes, theoretically, should continue to expand for the
foreseeable future. There is no end in sight to the increasing prevalence of diabetes,
obesity and vascular disease - all key contributors to the development of complex
wounds. Perhaps because these already daunting numbers are increasing so
rapidly, the proposal of expensive, engineered skin substitutes as the solution will
continue to meet resistance. None of the products described in this chapter
represents the silver bullet for complex or advanced wounds. With a potential
patient population in the tens of millions, expensive, imperfect solutions will not
be welcomed by payors.
Simultaneously, the rise in negative pressure dressings for complex wound care
has also made the choice of expensive bioengineered substitutes a more difficult
one. The VAC dressing system (KCI, Inc) is relatively inexpensive, flexible,
consistent and easy to use. Through transduction of micromechanical forces, the
VAC dressing accelerates wound healing in a myriad situations and anatomical
locations. The clinical results from its use in all of the above-mentioned circum-
stances (except epidermolysis bullosa where this has not been described) have
been adequate to excellent.
The key to gaining prominence in the skin replacement marketplace in the
upcoming years seems to demand development of less expensive technologies that
can be used to treat the millions of patients who will require care for complex
wounds. The technology that will win the day in this marketspace is going to be
disruptive - inexpensive and just good enough. The answer is probably not in the
development of more costly and advanced solutions. Neither the medical commu-
nity nor the market has responded favorably to this line of attack over the past two
decades.
2.6 References
1 Pruitt BA and Levine NS. 'Characteristics and uses of biological dressings and skin
substitutes'.
Arch Surg
, 1984,
119
, 312.
2 Smith DJ Jr. 'Use of Biobrane in wound management'.
J Burn Care Rehabil
, 1995,
16
,
317.
