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In a recent article, I wrote about the four influencers in a B2B sale. I then wrote an article about the Financial Infl

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

uencer and an article on the User Influencer. In this article I want to focus on the Gatekeepers. As a quick review, he

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

Examples of combination products may in

re are the four influencers again.

1. The Financial Influencer(s)

2. The User Influencers

3. The Gatekeeper(s)

4. Y

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

ur Champion or Sponsor

This week we will focus on the gatekeepers.

The Gatekeepers

The gatek

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

eeper can also be referred to as the technical buying influence. The role of the gatekeeper is to screen out or block y

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

Combination pro

ur proposal. They are there to ensure you meet the many technical requirements most companies want. There are many grou

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

ps who may be gatekeepers.

They may include the following.

· The finance department

· The legal group - may be insid

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

e and/or outside the company

· Human resources

· The IT department

· Engineering

· Operations

As you can see, depe

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

ding on the technical and financial influence of your product and service, there are many groups that can be involved.

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

Also, the impact your proposal has on their organization will determine how many of the above groups will get involved.

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

These people generally will only be involved for a short time, and then not be involved at all after your proposal has

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

Following aspects would a

been accepted.

The keys for these groups are the following.

· They judge the measurable and quantifiable aspects of

dd to the challenges in developing combination products:

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

your proposal.

· They are mostly box tickers. They have certain specifications that have been set up beforehand, and t

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

ey tick off whether you meet those specifications or not.

· They can and will make recommendations

· They cannot say

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

yes, but they can say no, and their vote carries quite a bit of weight.

The users often develop many of the specificat

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

ons for a proposal. This group acts as the gatekeepers to ensure you have met those specifications. You need to underst

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

Professional from academic institutions, pharmaceutical industries, health care indust

and who these groups are. It is often difficult to get to know them personally, because they are usually only involved

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

for a short time during the proposal phase.

The key to this group is understanding that they are usually part of any p

.

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

oposal that will alter the way your prospect will do business, because of your proposal. However, you need to be aware

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

Companies that provide selfless information through particip

of their influence, and if possible make every effort to meet and understand how they operate during the decision cycle

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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Our mental perspective is much like our eyesight. Without new glasses to help us see the world in new ways, we can gradually lose our focus, take things for granted or just assume we know how things are, even if they are blurry. We can always benefit from a fresh perspective…

Managing is often equated with controls rather than leading and developing a business. The manager feels more comfortable and secure when they are able to put in strict controls on everything that happens in a business organization. This is so especially of Senior Managements where the controls and directing becomes so severe that it erodes any creative freedom for the middle managers to work towards achieving the goals set out for them.

Do you like to keep all your paperwork in one place? Then why not sort out all your paperwork and place it in different vinyl binders? Put the vinyl binders in categories and that’s it, job done.

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