Main Subject - Business

Today, IT departments are strained. Internal IT staff are generally tied up working on low-level system mai

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

ntenance, hit by wave after wave of patches and upgrades that are critical to keeping systems current and s

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

Examples of combination products may in

ecure. They have too much to do, too few resources, and pressure from management to do more with less. But

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

while the staff spends precious hours reacting to urgent demands, critical planning and evaluation work is

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

eglected. It’s the classic example of spending 80% of resources on efforts that only return 20% of the valu

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

Combination pro

e.

For these reasons and others, many executives have come to view IT as a necessary evil, rather than a s

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

trategic partner. They struggle with the following issues:

•Limited resources ($, Skills, Time)

•Inabilit

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

to keep current with IT technologies and best practices

•70% of IT budget spent maintaining and operating

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

older products

•IT is chaotic, reactive to problems, and not aligned to Business

•Desire to automate the

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

routine maintenance.

Successful organizations are turning to managed service providers (MSP) for of the f

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

llowing benifits:

•Peace of Mind – because seasoned professionals are using advanced tools to predict and

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

Following aspects would a

prevent any risk as soon as it is visible.

•Increased Productivity – Key network elements are more reliabl

dd to the challenges in developing combination products:

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

e and available.

•Faster & cheaper issue resolution – we notify the service people in real-time, with the

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

exact location and cause of a real or developing problem.

•Reduce time spent on maintenance – we manage th

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

exceptions to a library of internationally accepted standards, so you can focus on your core.

•Predictabl

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

e & lower costs – we take the surprises out of IT planning and execution.

Bottom line, managed services of

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

Professional from academic institutions, pharmaceutical industries, health care indust

fers a business model that aligns IT with the goals and objectives of the organization. Network problems d

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

rectly control the profitability of the managed service provider. Therefore, a MSP is motivated to predict

.

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

and prevent problems instead of the traditional consulting model where service providers receive more compe

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

Companies that provide selfless information through particip

nsation for more problems. And isn’t that what everyone would like in the first place… No network problems

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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If you take a look at the features that different survey softwares offer, you will quickly realize that understanding all of them is no mean task. But it is very important that you do because only th...

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