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Just Other Articles - Catalog Management: In-house or Out-sourced?
Many organizations face the dilemma of whether to manage their inventory Catalog in-house or to out-source the function to an external provider. Should you tackle the challenges involved in creating or honing your in-house Catalog team to handle the job? Or should you step back and manage the relationshi
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
p with an external expert who provides those services, tailored to your needs? The decision is not such an obvious one; there are several issues to be considered.
Managing data integrity is a full time job, if it’s done right. Many organizations make the mistake of incorporating catalog responsibilities
Managing data integrity is a full time job, if it’s done right. Many organizations make the mistake of incorporating catalog responsibilities
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
with other duties, so that the resource is neither focused nor dedicated to the task.
Let me illustrate with a real-life example. A multi-site manufacturer had a part-time cataloguer at each of its twelve locations across the corporation. There were no established internal processes to follow, nor templ
Let me illustrate with a real-life example. A multi-site manufacturer had a part-time cataloguer at each of its twelve locations across the corporation. There were no established internal processes to follow, nor templ
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
tes for data entry. Each cataloguer entered data into the free-format description field the way he/she liked to see it. These people came and went and over time and the database grew and grew.
The results showed themselves in the data… spelling errors, inconsistent manufacturer naming, inconsistent abbr
The results showed themselves in the data… spelling errors, inconsistent manufacturer naming, inconsistent abbr
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
viations, inconsistent words/symbols, incomplete description information, and duplicates. System word searches were next to impossible; the data was a mess. Finding a part was a frustrating, challenging, usually unsuccessful experience. They were not alone in their situation. Inventory was viewed as a n
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
cessary evil and rarely got any attention for improvement.
Another common catalog management mistake is to give responsibility to a non-tradesperson. Often we’ve seen cataloguers who lack the basic knowledge to properly identify a part. The item description that is entered into the system is unrecogniza
Another common catalog management mistake is to give responsibility to a non-tradesperson. Often we’ve seen cataloguers who lack the basic knowledge to properly identify a part. The item description that is entered into the system is unrecogniza
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
ble by the maintenance workers who use the part.
The consequences can be expensive for the company. A bin of parts sits on the shelf (already paid for) and each time that unrecognizable part is needed, a maintenance worker fails to find it in the system, so he orders the part directly (and often at a pre
The consequences can be expensive for the company. A bin of parts sits on the shelf (already paid for) and each time that unrecognizable part is needed, a maintenance worker fails to find it in the system, so he orders the part directly (and often at a pre
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
ium “RUSH” price) to complete his job. The end result is that both inventory and spot buy purchases have increased the company’s spend.
Creating an internal catalog team is not as easy as it first sounds, unless you see it as simple data-entry work. Then it really is easy – you just need someone who can
Creating an internal catalog team is not as easy as it first sounds, unless you see it as simple data-entry work. Then it really is easy – you just need someone who can
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
type and spell. But if you see it as the fulcrum that links together your maintenance and procurement teams, you have more of a challenge to find the right skill-set to satisfy the requirements of the job.
Not only should your cataloguers know what the part is and how to describe it so that your maintena
Not only should your cataloguers know what the part is and how to describe it so that your maintena
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
ce workers would recognize it, they also need to know how it is used, and what material quality and specifications are required. And they need to have a process for setting up new item descriptions. Finding someone with all these skills may be a difficult task. And finding several of them (across the com
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
any) to work together may prove next to impossible.
In addition to that, you need to develop internal procedures and processes around the catalog itself -- to establish the standard nomenclature you will use, to develop templates for consistency and completeness, to assign responsibility for the data.
In addition to that, you need to develop internal procedures and processes around the catalog itself -- to establish the standard nomenclature you will use, to develop templates for consistency and completeness, to assign responsibility for the data.
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
That’s a lot to consider for a company that’s not in the Catalog Management business!
An alternative option is to out-source the catalog management function to experts: dedicated, qualified personnel to do the work so that every item description meets manufacturer specifications. The next time a maintena
An alternative option is to out-source the catalog management function to experts: dedicated, qualified personnel to do the work so that every item description meets manufacturer specifications. The next time a maintena
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
ce worker looks through the inventory catalog for the part, he recognizes it immediately and uses it from the Stores inventory shelf.
Catalog Management companies have staff who work with parts data all the time. Many of them are former tradesmen or people who are familiar with manufacturer’s catalogs.
Catalog Management companies have staff who work with parts data all the time. Many of them are former tradesmen or people who are familiar with manufacturer’s catalogs.
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ften they have developed internal software tools to enhance their cataloguers’ efficiencies: pre-defined part templates (with drop-down attribute lists), manufacturer catalogs in electronic format for easy retrieval, data parsing tools, etc.
These resources are available to supply information to you with
These resources are available to supply information to you with
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
n a guaranteed timeframe (hours, not days), and your payment options for these services usually range from a monthly flat fee based on min/max thresholds of catalog activity to a per sku (stock keeping unit) price, where you only pay for the services you use. Either way can prove to be quite cost-effectiv
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
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
for an organization…. a very viable alternative. The challenge then is to find a company with the skill-sets you desire.
Because Catalog Management companies work as an extension of your own organization, it is important that you can easily work with the resources assigned to you developing a good rappo
Because Catalog Management companies work as an extension of your own organization, it is important that you can easily work with the resources assigned to you developing a good rappo
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
rt with them. You need the peace of mind that your data integrity will be maintained according to your usual high standards. Your focus should be: consistent, complete quality work, at a fair price, delivered in a timely manner.
Returning to our real-life example, the company elected to out-source its C
Returning to our real-life example, the company elected to out-source its C
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
talog Management needs. A post-mortem look a year later validated their decision. Although they saw no reduction in personnel, they did see improved Maintenance efficiencies in finding parts. They also documented savings in duplicate avoidance, rationalization of excess stock levels and a narrowing of p
.
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
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
oduct lines. Most importantly, they were able to establish a single Corporate Catalog maintained in synchronicity across all sites (and across several systems)…a goal that they had previously been unable to achieve on their own.
Catalog Management is a challenge that most multi-site manufacturers face da
Catalog Management is a challenge that most multi-site manufacturers face da
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
ly. Each organization must decide for itself whether or not to tackle it in-house or to engage the services of an outside service provider. With each decision comes unique challenges for management. There is no right answer, but failure to address the issue at all will certainly add cost to your company
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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