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I was watching an episode of the Home and Garden show “NEAT”, which is a show where a crew comes in to help clutterbugs reorganize and systematize their homes. There is major change going on for t

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

he homeowners, including a lot of tossing out, giving away and rearranging of their home and life.

I turned to Rob, my life partner and even though I am an Amiable personality type which means I

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

Examples of combination products may in

m into teamwork and everyone getting along, I said “If I was honest with myself, I think I would turn into Linda Blair‘s possessed character from the Exorcist if people started trying to force me

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

nto so much change.”

Amiables, by tradition, do not adapt as well to change, but all personalities if they are not consciously aware of it or do not have positive, accepting ways of handling it,

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

ill go into resistance when someone imposes change on them. Even if the other person is including the first person in the decision-making process for the change, the simple fact that the other per

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

Combination pro

son initiated the change is enough to throw the first person into resistance.

This is a major power struggle is that hidden in most relationships that result in one person feeling threatened or e

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

croached upon by the change and the other person feeling attacked or even abandoned because the first person is resisting their plans.

In an article prepared by the City of Winnipeg Employee Assi

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

tance Program, 1992. They have the following to say about change:

“Change is always a new opportunity and a loss of the familiar.

Change is a shift in what is required, anticipated and valued, s

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

we must move differently and that requires energy… change requires energy.

Expect a variety of reactions to big changes. If you are not part of what’s making the change happen, you may feel thre

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

atened and react automatically with anger, blaming, fear or some other style. What’s your style?

Slow-to-be- realized- changes may be ever more threatening, and so you put the idea of what’s happ

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

ning out of your mind as much as possible. This is like the death of someone close to you, that you don’t want to face. Expect the three stages of Resisting the Change, Accepting the Transition, a

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

Following aspects would a

d Opening up to a New Beginning.

Resisting is about denial, then anger, and then bargaining urgently to keep the old ways.

Accepting Transition is to first appreciate, and then get upset over wh

dd to the challenges in developing combination products:

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

t is being lost (mourning). Then we can accept the task of getting along without. Naturally, there is a time “in between” when we feel lost and without motivation or direction.

Finally, after som

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

e experimentation, we can become enthusiastic about some New Beginning.

It all takes time. Be aware of what you are up to, you can take care of yourself.”

Now instead of trying to change the sta

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

es, it is more important to just be aware of them. You can then gently flow through the stages without further resistance or without being down on yourself for reacting a certain way. It is also i

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

portant for your partner to understand the stages too so they know not to take it personally and not be in resistance to you either.

I was unconsciously going through the stages when Rob and I we

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

Professional from academic institutions, pharmaceutical industries, health care indust

e doing some major renovations in our house. I was trying not to resist and feeling bad because I felt like I was being a stick in the mud, although I was trying not to. Once I realized the stages

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

though, it really helped by just allowing the stages, and it became easier and easier to adapt to change.

In addition to accepting the stages, here are few positive beliefs to keep in mind about

.

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

changes:

• Change is a chance for new opportunities and to learn new things.

• There is nothing to feel bad about if there is something that you need to change about yourself. You are perfect to

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

Companies that provide selfless information through particip

begin with, if you find out the reality about yourself and that there is something you need to change, you are actually rediscovering your true self that has been lost during your life experiences

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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