Cases - Business

Every enterprise and business organization thrives for effective strategies in order to maximize the returns on thei

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

r assets. They do this by reducing operating costs, managing capital expenditures, and improving asset maintenance a

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

Examples of combination products may in

d utilization. Enterprise asset management solutions provide high-end, integrated, and complete capabilities to mana

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

ge the assets of the entire business enterprise. These solutions provide updated information and maintain data that

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

elp in decision-making. Enterprise asset management solutions also support the strategic plans and operating procedu

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

Combination pro

es, which prove to be an effective tool to increase productivity and reduce costs.

The novel approach of EAM, Enter

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

prise Asset Management, optimizes the business process by yielding significant savings and increasing the life cycle

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

of the assets. This new approach may help in improving the entire life cycle, taking care of all the relevant phases

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

starting from planning the right investments, specifications and designing to asset constructions, operations and ma

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

intenance procedures, finally moving towards the disposal and decommissioning of the assets.

An Enterprise Asset Ma

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

agement solution can be particularly helpful for asset intensive sectors such as the chemical, automotive, aerospace

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

Following aspects would a

defense, petroleum, and mining industries. Other industries that may benefit from the EAM solution include transpor

dd to the challenges in developing combination products:

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

tation, management, high-tech, government, and public sectors.

Various EAM solution providers sell solutions that a

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

e based on different architectures to support individual enterprise needs and business plans. The detailed PDF files

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

about Enterprise Asset Management can be downloaded directly from the websites put up for the very purpose of provid

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

ing an idea of how the specific solution works and help in managing assets and serving the business purposes.

EAM s

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

Professional from academic institutions, pharmaceutical industries, health care indust

lutions support different platforms and applications and can be employed according to the specific requirements of t

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

e organization. Amongst many such examples is the SAP Net Weaver platform that allows a competitive edge and busines

.

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

s flexibility and supports collaboration among the stakeholders within the network. The benefits of this EAM solutio

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

Companies that provide selfless information through particip

also include uninterrupted, complete, and real-time awareness of the assets, including real-time network visibility

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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