Advice You - Business

If we are involved in managing change, we will come across the terms Stakeholder Analysis,

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

Stakeholder Management and Stakeholder Engagement. So what is the difference between these

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

Examples of combination products may in

hree concepts? Let’s take a look at some definitions from dictionary.com.

To Analyse

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

li>to determine the elements or essential features of

to examine critically, so as to

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

ring out the essential elements or give the essence of

to examine carefully and in det

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

Combination pro

il so as to identify causes, key factors, possible results, etc

So essentially, Analy

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

is is about understanding.

To Manage

to take charge or care of
to dom

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

nate or influence (a person) by tact, flattery, or artifice

to handle, direct, govern,

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

or control

So while Analysis is about understanding, Management is about control
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
>.

To Engage

to occupy the attention or efforts of a person
to secure for ai
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
, employment, use, etc.
to attract and hold fast
to attract or please

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

Following aspects would a
agement is really about attraction.

In my seminar, The Art and Science of Stakeh
dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod
lder Engagement, I refer to Stakeholder Analysis and Management as the ’science’ – it’s
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
about understanding your stakeholders and communicating with them in an ordered and control
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
ed way.

The ‘art’ is the pure engagement aspect and is very different. This is all about a
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
tracting people to you and your proposition and engaging them emotionally so that their int
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
rest is sustained. This is the part that is often missing from what we do.

Science takes p
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ace in the head, whereas art comes from the heart. We need the science to keep us rational
.

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
nd organised. But, since people operate and communicate at an emotional level most of the t
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
me, we also need to connect with people more deeply and keep their interest. That’s the art

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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Advice You - Stakeholder Analysis - Management and Engagement

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