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Leaning back in my post-Thanksgiving glow, I snuggled in my easy chair, put my feet up, sighed, and read

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

my book until the need for a nap overtook me in a few moments. We all like our comfort. As a culture

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

Examples of combination products may in

we certainly prefer comfort to discomfort. The problem is that being in a place of comfort lulls us. I

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

t lulls us from thinking, from learning, from activity, from progress, from growth. It’s exactly the sa

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

e in business.

Comfortable businesses tend to coast. They stagnate. They have reached a comfortable s

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

Combination pro

tate of existence with comfortable earnings, comfortable staff, comfortable systems, comfortable levels

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

of stress. They have stopped getting better because they don’t need to get better (or don’t think they

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

need to get better). That’s a nice place to be but a difficult place to stay.

While your company is se

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

tling back into that easy chair and taking a mid-day nap, your hungry, lean-and-mean, unsatisfied compet

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

itor is working hard to make your customers defect. At the same time, your marketplace is changing – th

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

e products and services they want are not the products and services they wanted last year or will want n

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

Following aspects would a

ext year. New technologies have shifted the playing field and it is not going to stop soon, or ever.

I

dd to the challenges in developing combination products:

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

your business is comfortable it is time to throw a bucket of ice-cold water on that napping, comfy exis

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

tence before exterior forces demand you wake up and do something about it. How do you start towards unc

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

omfortableness? By becoming unsatisfied.

Take a look at the goals you are working towards. Become uns

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

atisfied with one specific goal and stretch it. If the goal calls for producing 100 widgets per hour st

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

Professional from academic institutions, pharmaceutical industries, health care indust

etch it and demand 110 per hour. If it is increasing the staff retention rate by 10% per year stretch i

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

t and demand 15%. Over time, stretch more goals. Inspire the staff, commit the resources, create accou

.

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

ntabilities and bring the snap of vitality to your organization.

Resting comfortably is great once in a

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

Companies that provide selfless information through particip

while, but come back with a “fire in the belly” instead of one more piece of that delicious pumpkin pie

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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Whether you're marketing your business to a local community or to the world, you should strive to create a brand for yourself. By branding your company, you not only set yourself apart from your competitors, but you make your company easier to identify in the marketplace.

This article is about different values for each employee. Some prefer a salary over a company culture and vice versa.

Superficial actions will not do in this competitive market. All of us can take the medicine for our ailments, but the objective is to be cured. Every company can take an order, but at the end of the day, it aims to secure a loyal customer.

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