Advice Pool - Business

Out-sourcing your Catalog Management is a big step for any organization. It sounds great in theory, but the execution is not always clear. What exactly can you expect from the service provider? How d

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

oes it really work? …and most importantly: Is it the right thing to do?

Often the decision to out-source your Catalog Management function can turn out to be more advantageous than you had ever imagin

; 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. Not only is your data integrity maintained, but some additional unexpected side benefits may also be realized.

Catalog Management companies have dedicated staff who are constantly working with part

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

data and manufacturers’ catalogs all the time. Many of them are former tradespeople with the expertise to also know part applications. In other words, they truly are knowledgeable experts in inventor

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

parts. And when you out-source, they start to work for you. Not too many organizations can boast that they man their Catalog team with such expertise.

Complementing this are software tools that have

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

Combination pro

been developed to allow the cataloguers to work quickly and efficiently. These tools ensure consistency in layout, structure, and nomenclature. Pre-defined part templates provide the cataloguers with

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

ttribute lists from which to choose the appropriate selection. Links to electronic versions of manufacturers’ catalogs allow easy retrieval of additional information to enhance item descriptions.

Of c

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

urse, the cataloguers should not work in isolation. For example, attribute order should be dictated by you, based on your maintenance workers’ needs. In fact, at the onset of the transition, all your

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

ompany requirements should be discussed and documented for use by the external Catalog team.

And because this team will work as an extension of your own organization, it is important that you are able

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

o easily work with them, and that you develop a good rapport together. After all, this team is dedicated to you and your Catalog needs.

Delivery or turnaround time is also a reliable, guaranteed featu

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

e from Catalog Management providers. An expectation of one to two days is quite reasonable. However, companies repeatedly find that although the guarantee falls within that threshold, the actual respo

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

Following aspects would a

nse times are much better. Quick turnaround times of less than 5 hours can be quite dependable. This is usually seen as significant improvement over internal turnaround times…especially for centraliz

dd to the challenges in developing combination products:

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

d catalog groups.

Another unexpected benefit of out-sourcing Catalog Management activities is fostering the use of product lines. That is, increasing volume purchases of the existing product lines. F

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

r example, when someone attempts to add an item that is the equivalent of an existing item, the Catalog Management provider will often point the client back to the existing item. In this way, they avoi

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

entering duplicates into the database.

The most obvious benefit of out-sourcing is often cost savings. Catalog Management providers specialize in this service. They are experts and are more efficien

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

at providing the service than you could ever be. It’s what they do and they can price the service lower than what it costs a company to manage the function internally.

That being said, when you out-s

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

Professional from academic institutions, pharmaceutical industries, health care indust

urce, you should still expect to have pricing options available to you. Services can be offered at a monthly flat fee for a maximum threshold of activity to the catalog. Alternatively, you may be offe

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

ed a per sku (stock keeping unit) price, which charges you for the services you have used.

Choosing to out-source inventory Catalog Management services can be the source of unexpected benefits. Saving

.

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

show themselves in many numbers of ways, from avoiding duplicates, improving turnaround times, and reducing overall service costs to fostering internal usage of existing product lines. Added to that,

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

Companies that provide selfless information through particip

he out-sourced provider works as an extension of your own organization and enhances your parts knowledge database beyond what your company could achieve on its own.

Sounds like a true win-win situation

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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