Advice You - Business

Cold Water Comments - What They Are and How to Manage Them!

Cold Water Comments are those comments, phrases and ideas that are meant to discourage, disparage,

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

discredit and generally douse your ideas! There are several things you can do to keep those comments in someone’s bucket or warm them up once they’ve been tossed.

Plan

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

Examples of combination products may in

ing for the Cold Water - With Towels in Each Hand!

Step 1 - Identify the Possible Cold Water
Make a list of all the comments you have heard in the

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

past and might expect to hear now. Once you have identified the list, determine how you will respond to each of them. (Remember that at this stage you are trying to sell your ide

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

, not start an argument!)

Step 2 - Determine the Source
Ask yourself - who carries that bucket of cold water with them most of the time? When you can envis

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

Combination pro

on not only the water, but the source of the water up front, you can be better prepared to respond.

Step 3 - Is it a Question?
If it’s cold water disguised

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

as a question, just answer the question! For example if you are asked, “Is there money to do that?”, it may just be the question form of the popular cold water “It’s not in the b

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

dget”. If you get questions, consider yourself lucky and answer them… persuasively!

Step 4 - Who’s Got the Authority?
The people manning the buckets, ready

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

to douse you and your idea may have more authority than you - or they may have less. In other words, your boss may have the bucket, your peers may have the bucket, or those who

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

ork for you may be carrying it. It’s important to recognize where the buckets are so you can sell your ideas appropriately.

Acknowledging the Cold Water - Taking a Tea

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

’s Buckets Away

If you want to reduce the use of cold water comments, or perhaps make the water a bit warmer, you can use the suggestions below!

Talk about

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

Following aspects would a

Cold Water Comments
Explain the concept of Cold Water Comments to those you work with. Once people hear the phrase, they will begin to notice the use of the cold wate

dd to the challenges in developing combination products:

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

! Recognition of the tendency is the first step towards reducing its impact.

Bring Your Towel!
Help people get better at planning for encounters with Cold

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

Water Comments by helping them learn how to use the planning steps above - what we like to call the Towel for the Cold Water.

Fight About It!
If you are pla

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

ning a meeting where you want as little cold water present as possible, encourage people to fight back against the cold water! Provide everyone with some paper to make paper wads

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

some Koosh, or Nerf balls. Then encourage them to toss their “ammo” at anyone using a cold water comment. This activity will not only reduce the number of such comments, but the

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

Professional from academic institutions, pharmaceutical industries, health care indust

levity that the throwing brings will reduce the affect of the cold water that is splashed around.

Make ‘em Pay!
Establish a rule for a meeting (or for all

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

eetings!) that people have to pay into the pot (a quarter?) every time they tip their cold water bucket. Come up with a plan for how you’ll use the accumulating cash - coming up

.

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

with that plan would be a good idea generation exercise in itself!

Make a List
Have everyone in your group or organization brainstorm a list of the most pop

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

Companies that provide selfless information through particip

lar and prevalent cold water comments around your organization. Put them all on a list and post them in places where people gather, like conference rooms, training rooms, etc.

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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