Main Subject - Business

Voice of the Customer

The ‘Voice of the customer’ is a tool or process of gathering customer input about the proposed or existing services or products

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

depending on the situation. If a company’s success depends on knowing what the customer wants, then it should develop products and services based on cus

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

Examples of combination products may in

tomer feedback, and this should be done sooner rather than later.

Focus Groups

The focus groups may be thought of as special purpose vehicles or mecha

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

nisms to facilitate understand the voice of customer better, organize the gathered data, evaluate the evolved feedbacks and channelize them in concise f

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

ashion to the developers for deliberation and further action. In a way, focus groups can serve as live links between the customer and the development de

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

Combination pro

partment.

Going a step further, we understand that there is a need for two focus groups with different missions. The first one focuses on exploring the

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

collective needs of customers, develop and evaluate concepts for new product development as sensed or demanded by the voice of the customer. This group

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

is generally called an explorative focus group. The other one is an experiential focus group, used to observe the usage of products in the market and st

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

udy what the customers feel and experience about the products, learning their reasons and motivations to use the product.

How Do Focus Groups Conduct V

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

oice Of the Customer Sessions?

The voice of customer sessions are conducted for long periods of 1 to 3 hours with typically 8 to 10 participants from t

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

he customer side. The objectives of the session are defined and clear in the minds of the participants. To begin with, it requires an experienced facili

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

Following aspects would a

tator to organize the session from initiating to inviting everyone who is designated to participate.

The customers are identified from the group which

dd to the challenges in developing combination products:

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

has expressed interest and been invited. The agenda, presentation and procedures for the session are developed and honed by the facilitator as a precurs

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

or. The facilitator may decide to do a rehearsal of the session beforehand, in order to fine-tune the actual session.

The actual session may be comme

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

ced by a moderator who presents the idea, the purpose and the product description and a group of observers oversee the session. The overseers watch the

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

session from a separate room without the knowledge of the participants and record the outcomes on video and audiotapes.

Member Participants Are Not Sta

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

Professional from academic institutions, pharmaceutical industries, health care indust

tistical Representatives of Customers

Owing to the small number of ‘representative customers’ at each session, the outcome of the session (the comments

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

and feedback) can’t be directly taken as the representation of the customers’ voice as a whole. The session must be punctuated by careful selection of

.

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

participants and increasing the number of sessions conducted does give validity to these sessions.

The results from these sessions can be generalized f

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

Companies that provide selfless information through particip

or acceptance after deliberating over against a comprehensive backdrop. The same theory applies to both explorative as well as experiential focus groups

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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