Case
Studies
#4.
Morphing a device into a drug
The emergence
of increasingly sophisticated therapeutics has
focused increased attention on the drug/device interface. In many
instances, the clinical value of these therapeutics - be they
proteins or small molecules with therapy limiting side effects
- cannot be realized without a sophisticated medical device solution.
Devices can assure the therapeutic is delivered to the right location
in the right concentration, in some instances penetrating previously
impervious cell types. Yet the manufacturers of these facilitating
devices have not always participated fully in the value created
by their contributions.
BDF advised
a company with a development stage medical device, which promised
to pinpoint cellular delivery of certain genes, proteins, and
small molecules in developing business strategy. The BDF team
carefully analyzed the situation and suggested that management
of the company pursue a much different strategy than anticipated.
Rather than seeking to sell the device on an OEM basis, BDF counseled
the company to take a broader view of the business by combining
the device and certain proprietary and non-proprietary products
into drug/device units, thereby capturing a far greater share
of the total value created.
Clinical trials
confirmed that an older "generic" compound delivered with the
company's new device technology created a "new drug" with efficacy
heretofore unavailable. The combination further yielded substantially
greater patent and regulatory exclusivity than would have been
possible with the device alone. Best of all, the manufacturer
was better positioned to capture the value created.
The manufacturer
has since used this project as a springboard for several similar
efforts, creating multiple new revenue opportunities and may offer
the technology to pharmaceutical companies seeking to extend exclusivity
of vulnerable brands.
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