Advice Pool - Business

You may be aware of them, you may not be. In any case, chances are high that even if you are aware of them, you probably don’t realize the negative

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

impact they are having on your business. What are they? Things you are tolerating in your work environment.

Anything you are tolerating is calle

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

Examples of combination products may in

a “toleration.” Tolerations are situations and experiences that you don’t like, that irritate you and drain your energy. The great news is that yo

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

u do have a choice about what you tolerate.

Here are some examples of things you may be tolerating.

* Stress because you don’t back up your comput

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

r files regularly

* Unorganized office files or bookshelves

* Paper piles everywhere

* Desk Drawers and filing cabinets that are overflowing

* S

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

Combination pro

acks of unread business articles or magazines

* Outdated or barely functioning office equipment (printer/copier, computer, telephone)

* Not having

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

reliable technical support

* Uninspiring office environment (setup, d?cor, comfort)

* Lack of storage space

* Distractions (interruptions, loud

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

oises)

Are you starting to see how tolerations can slow you down and interfere with your ability to run your business in the most effective way?

T

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

ere are many benefits of getting rid of tolerations. Two of them are: feeling ‘lighter’ and having more energy. Even better, as you stop toleratin

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

g things, you simultaneously raise the standard for how you run your business. All of these things allow you to be more focused, effective, and pro

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

itable!

Ready to get rid of all of the tolerations you face every day as you work on your business? Get started by making a list of all of the thi

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

Following aspects would a

gs you are putting up with that irritate you. It doesn’t matter how small they seem to be. There are probably quite a few that have been on your m

dd to the challenges in developing combination products:

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

ind for some time. And there may also be some tolerations that you have simply come to accept and no longer consciously notice.

Walk around your o

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

fice and look at everything like you are seeing it for the first time. Notice all of the details and how you feel as you examine your work space.

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

rite down everything that you want to change. Then make a commitment to take action and eliminate each toleration on your list, one by one, until t

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

hey are all gone.

When you’ve gotten rid of everything you are currently tolerating, make a decision keep your standards high and create a system t

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

Professional from academic institutions, pharmaceutical industries, health care indust

ensure that you don’t fall back into old habits of putting up with things that don’t support your business.

You can do this by establishing guidel

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

nes for your work environment. Things like organizing your work space on a daily basis, always having extra storage space, and maintaining and upgr

.

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

ading equipment.

Once you feel that your work environment is satisfactory, why not raise you’re your standards to the next level and make it fabulo

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

Companies that provide selfless information through particip

s? Remember, it’s not a luxury to have a supportive work environment. It contributes to the profitability of your business!

© Stephanie Ward, 200

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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