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Birds of a Feather May Be Turkeys
By Gene Griessman, PhD

Birds of a feather do flock together. It's true. Given a choice, most of us will seek out people

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

who think like
we do, people with whom we feel comfortable, those we won't quarrel with. Visit any company cafeteria and you will notice
that the people

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

at the tables will be in groupings from the same discipline, department or ethnic group.
As a general rule, relationships do not usually thrive when there

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

re profound differences in values, abilities,
temperaments or lifestyle. Differences attract, but -- more often -- they repel. Individuals sometimes get invo

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

lved in
relationships with unlike individuals, occasionally even conflict-ridden ones. These may be
exciting for a while -- but unless the principals agr

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

e on core values, such relationships
become artificially polite or unravel over time.
Ways to work together. This general rule, however, needs fine tunin

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

g when it comes to science, engineering and
business. Skillful managers often deliberately create teams comprised of very different kinds of people. They are

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

willing
to forego the comfortable, easy feelings associated with clone-like groups in order to bring diverse skills to bear upon
a problem. Such a team

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

might include designers, engineers, physicists, marketing people, social scientists and lawyers.
Managing diversity is not easy. Accountants, engineers, com

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

puter specialists, lawyers, psychologists and marketing
people do not speak the same occupational language. Each field has its argot, its own version of alph

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

bet soup. Specialization
always produces groups with proprietary feelings about concepts and terminology. Even if two members of a team are engineers,
th

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

ere will still not be one-to-one correspondence. They will have some problems with vocabulary if one is an electrical
engineer and the other is a mechanical

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

engineer. But those vocabulary problems are minuscule compared with the ones that
occur when accountants talk to engineers or designers. A skillful manager w

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

ll be needed.
Cultural chasms need bridging. The differences go beyond vocabulary: values, goals and objectives many be different
too. As more businesses

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

globalize, team members are more likely to come from different cultures. They will differ not just
in the way they approach a technical or marketing problem

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

but in the way they view the world. We will have more of this,
not less. Unfortunately, what we know about managing diversity is more an art than a science.

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

If managing diversity is so difficult and so potentially stressful -- even disrupting -- is it worth doing? Absolutely.
Warm, comfortable, birds-of-a-fe

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

ather groupings may actually be dysfunctional in business, science and engineering.
If you want to do the job right, consider choosing people with different

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

languages, experiences and perspectives.
The group may be hard to manage and the outcomes difficult to predict, but such a strategy offers the potential for

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

unexpected brilliant solutions. When everybody behaves as a clone, someone is probably unnecessary and the group may come
to resemble a flock of turkeys

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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