Main Subject - Business

In today’s day and age companies can ill afford to take on full time equivalent employees to manage functions which can be easily outsou

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

rced. In fact most businesses today, particularly in marketing, can not afford to keep a large marketing staff, but they still need to

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

Examples of combination products may in

complete those vital marketing functions. Companies are going to a much more of a virtualized model and the fundamental relationship be

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

ween employees and employer has changed. Companies are often using a make or buy criteria to decide what they outsource to other compan

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

ies, and what are core competencies that they need to retain inside their own walls with their own employees.

The trend is towards stro

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

Combination pro

g rethinking of maintaining a large headcount in the face of stiffer competition, tightened margins and higher specialization of particu

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

lar skills that are required in order to be effective in the sales and marketing mix. This is where a relationship with an outsourcing

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

ompany becomes valuable. Today most companies can’t afford to keep positions like product marketing manager or product manager full tim

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

e or they can’t afford to have a full time person doing search engine optimization on their staff, but they still need access to those f

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

nctions. Outsourcing those functions to an outsourcing or inter-management company like ours is a perfect solution.

Many companies now

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

look for employing sales or marketing specialists on a fractional basis. And so the term “fractional management” is now becoming more

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

Following aspects would a

common as part of the lexicon of companies as they think about how to make sure that they’ve got the right skill mix in their company wi

dd to the challenges in developing combination products:

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

hout necessarily having to employ those resources full time. Another perfect example of outsourcing is when companies need to do a prod

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

uct launch, or they need to do product management duties but they can’t afford to have a full time product manager that would cost seven

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

y or eighty thousand dollars a year. A great solution to that problem is employing a fractional product manager for perhaps one quarter

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

or one fifth of that cost and still making sure that vital product management duties are getting done inside your company.

These are j

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

Professional from academic institutions, pharmaceutical industries, health care indust

st some of the examples of how companies can use fractional sales and marketing management and specialty skills to make sure that they h

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

ave a complete capability inside their company without spending on individual full time equivalents or FTE’s in order to have those capa

.

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

ilities in their company. As virtualization of companies continue we see that this trend is going to continue to accelerate and Cube Ma

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

Companies that provide selfless information through particip

nagement is optimally positioned to provide those fractional sales and marketing management services to companies that need to outsource

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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