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The Cisco Technical Assistance Center (TAC) is Cisco's tech support center, and they've got some very talented p

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

eople working there. Before you pick up the phone to call the TAC, though, you should do your best to resolve t

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

Examples of combination products may in

e problem and document each step along the way. One of the first things the TAC will do is ask what you've done

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

so far to resolve the issue, and giving them an accurate answer is a huge step toward getting the problem resolv

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

d.

If you're used to "tech support" where calls are prioritized by the order in which they come in, the TAC wil

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

Combination pro

l open your eyes! Cisco's TAC uses four priority levels to determine which cases should be handled first:

Prio

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

ity 1: The network is down, no workaround available, and business processes are at a critical stage.

Priority

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

: The network is badly degraded, business processes are impacted, and no workaround is possible.

Priority 3:

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

etwork is degraded, but business processes are working for the most part.

Priority 4: Basic support call for i

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

nstallation or configuration, or information on Cisco products.

Once you open a case with the TAC, you can chec

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

the status of your cases online with the Cisco TAC Case Query tool. This is an interactive tool which allows y

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

Following aspects would a

u to update the status of the case from your end without placing additional phone calls to TAC. It's also a fas

dd to the challenges in developing combination products:

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

er way to let your TAC engineer know how your cases are proceeding.

Gather all the information you can BEFORE y

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

ou call tech support. Don't just pick up the phone without investigating the issue.

This goes double for openi

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

g TAC calls. Some good practices to follow before calling TAC:

Document changes made before the issue arose.

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

ocument changes made to configs AFTER the trouble occurred.

Document ping and traceroute results.

Make sure th

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

Professional from academic institutions, pharmaceutical industries, health care indust

log is large enough to keep errors and console messages that are resulting from the issue.

Depending on the te

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

chnology, test everything you can before calling tech support. For Frame Relay, for instance, check everything

.

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

etween your site and the DCE closest to the site. (Trust me, that's the first thing they're going to ask you to

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

Companies that provide selfless information through particip

o.) For ISDN, check the configurations carefully, and again check everything between your site and the provider

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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