Useful Advices - Business

Navigating the process of gathering business requirements and creating the business requirements can be hard e

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

nough without adding the issue of stakeholder management to the equation. Nevertheless, fulfilling the needs o

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

Examples of combination products may in

the stakeholders is what the project is all about, so it is critical that the analyst keep them on his or her

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

side throughout the project.

Tips for Gaining Stakeholder Trust

It is critical that all of the stakeholders

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

rust the business analyst to complete the business requirements phase of the project accurately and profession

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

Combination pro

ally. Loss of stakeholder trust is a critical issue that must be addressed by the Project Manager the moment t

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

at any trust concern is raised.

Here is one key method for managing stakeholders during the requirements gath

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

ring process:

Conduct One-on-One Interviews - One-on-One meetings enable the analyst to create a strong relat

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

onship with each individual stakeholder in these ways:

· Draw out Concerns from Hesitant Stakeholders

Some s

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

takeholders do not like to convey their concerns in group meetings, especially if very senior stakeholders are

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

present or if he or she holds opinions or concerns that are contrary to the group's. These stakeholders are mo

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

Following aspects would a

e likely to communicate freely during one-on-one sessions.

· Better Manage Troublesome Stakeholders

Very oft

dd to the challenges in developing combination products:

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

n group meetings will be dominated by one or two stakeholders who are either disruptive or exhibit some other

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

type of behavioral symptoms which affect the other meeting attendees in a negative way. Meeting with these pe

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

ple in a one-on-one environment gives the analyst the opportunity to gently bring the stakeholder's attention

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

o the disruption issues and, ideally, foster better participation in future meetings.

· Build Rapport - Build

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

Professional from academic institutions, pharmaceutical industries, health care indust

ng rapport by fostering personal relationships is crucial

Other Tips for Managing Stakeholders in the Require

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

ments Process

· Never argue with any stakeholders, disagree in a diplomatic way.

· Never embarrass a stakeho

.

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

der in a group meeting.

· Remember that some stakeholders may work against your goals because they fear that

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

Companies that provide selfless information through particip

he project will eliminate or affect their job.

· Always communicate bad news the moment that it is discovered

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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