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We hear many companies and individuals claim that they are client-focused. And we hear that cli

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

ents will leave if we do not focus on their needs and if we are not providing better services an

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

Examples of combination products may in

products than others. If we pause for a moment and think about this, could it be that the clie

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

nt-focused concept we often hear about is almost always about the benefits to the provider of th

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

services and products? Do you really want to serve our clients with the best service for their

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

Combination pro

benefit or for your benefit? Let’s look at his with the aid of some strategic thinking.

First,

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

let’s define a client as the end user of the professional services and/or products we provide.

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

And let’s define client-focus as the attitudes, behaviors, experience, tools and practices we us

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

e to understand what the end user wants and needs. Furthermore, let’s also define our client-fo

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

us approach as meaning the end user is at the center of the development, design, evaluation and

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

elivery of the professional services and/or products.

Here are ten (10) insights from Your Stra

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

Following aspects would a

tegic Thinking Business Coach to assist you in becoming more client-focused, based upon the defi

dd to the challenges in developing combination products:

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

itions above.

Insight #1: collaborate with your clients on developing the strategy, which wil

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

l include a definition of the client’s vision, mission and business goals.

Insight #2: develo

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

tactical and strategic recommendations in concert with your client.

Insight #3: involve your

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

clients with your team.

Insight #4: involve your clients in “brainstorming sessions” and “thi

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

Professional from academic institutions, pharmaceutical industries, health care indust

nk tanks.”

Insight #5: report your outcomes to your clients.

Insight #6: ask questions of

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

our client groups.

Insight # 7: create networking opportunities with your clients.

Insight #8

.

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

: share discoveries with your client.

Insight #9: know industry trends of interest to your cl

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

Companies that provide selfless information through particip

ent.

Insight #10: understand learning styles of the members of your team and the client’s team

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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