Subjects - Business

Traditionally, many large service businesses, have focused narrowly on direct operational needs like order handling & invoicing, when designing their information architecture. This way they h

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

ave developed account-centric data structures. A real Customer could have more than one accounts, the records of which were unlinked in the customer database. In this case, more than one Custo

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

Examples of combination products may in

er records, would exist for the same real Customer. This data model would not reflect accurately the relationship of the Customer to the Business. Moreover this information architecture woul

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

d often involve loosely coupled or isolated databases, thus developing departmental ‘information silos’. For example the faults call center database, would not integrate to the order handling

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

atabase. Therefore the Customer interaction history would be fragmented in various isolated systems, serving specific Customer touch points (CTPs). The information architecture described abov

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

Combination pro

e, does not support the Customer holistic view, which is needed in order to provide quality Customer service or analyze efficiently the Customer behavior.

Any analysis on Customer data which

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

re stored in an account-centric structure is problematic. For example, one might want to calculate a simple Customer value ranking based on the last quarter invoiced amounts. However, this wou

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

ld rather be an account value ranking, than a Customer value ranking, since the analysis would probably not aggregate all accounts related to a specific Customer. Business wise, it is erroneou

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

to carry out Customer analysis on the account level, since this analysis may give an incomplete picture about a Customer. Furthermore, one might want to perform a recency analysis based on C

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

ustomer interaction history. This analysis won’t be effective, if the Customer interaction history cannot be consolidated in a single database. Any CRM intera

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

tion which is not based on the Customer holistic view, cannot be optimised. For example a CTP handling sales inquiries and orders, cannot perform efficient cross & up selling without the Cust

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

Following aspects would a

mer holistic view, which allows the call agent to assess the profile of the Customer and handle the case accordingly. Businesses active in highly competitive environments cann

dd to the challenges in developing combination products:

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

ot afford not to develop Customer insight. CRM systems have been developed in order to efficiently manage the Customer interface and capture & exploit Customer contact history. However CRM sys

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

ems integrate with other operational systems in order to support end-to-end processes. These operational systems have to align to a Customer-centric information architecture, in order to achie

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

ve the Customer holistic view. Having realized the paramount need to develop Customer insight, Businesses have started reorganizing their information architecture and gradually developing 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

r Customer-centric information assets.

The process is gradual because legacy data structures and account-centric data, inherit their properties to the new systems, during migration projects.

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

Professional from academic institutions, pharmaceutical industries, health care indust

In order to avoid the inheritance of the undesirable properties, records of the same Customer should be identified, if possible, and merged in order to realize the new customer-centric structu

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

e. The resulting ‘Customer tree’ is a structure which incorporates all accounts and products, related to the same real Customer. This business need has been identified by vendors active in the

.

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

data quality niche market. They started offering record ‘matching & merging’ functionality, in order to develop and maintain customer-centric information assets (such products are Trillium, F

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

Companies that provide selfless information through particip

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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