Advice You - Business

Todays business environment has changed drastically from just a few years back. Rather than working exclusively with equipment, data, and systems, todays IT managers face issues such as cross tr

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

aining, personnel management, interdepartmental communication, and a widening job scope for all IT employees.

This expansion of the IT job realm has left many IT managers juggling new challenge

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

Examples of combination products may in

s. While the problems, in and of themselves, might appear overwhelming, there are simple, proven ways to rise above them.

Problem #1 - Tough Data Flow

Information often flows irregularly and i

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

s subject to quantitatively strong fluctuations. These fluctuations can become detrimental if not dealt with. The simple solution is to control the information.

Officially, information controll

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

ing is the analysis, evaluation, and importance attached to the electronic data that is collected and provided with the data under various criteria.

To achieve this, start by making employees a

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

Combination pro

ware of the importance of the data they help to gather. Encourage accuracy and demonstrate to employees how their active participation in the process can reap rewards they might not have thought

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

of.

Because your job as IT manager will continue to get more and more hectic, youll want to continually look for ways to improve speed and quality while reducing rising costs.

Problem #2 - Ri

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

sing Costs

Rising costs are a challenge for any manager. They are especially troubling to an IT manager working in the electronic data processing area.

Industry experts show that, despite vari

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

ous "old systems" existing, resources are only used at about 30% of their optimal performance. This leaves room for 70% improvement without an excessive outlay of cash.

To increase ROI using ex

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

isting resources, consider:

Conducting a survey of departments. Ask what their primary challenges are with the existing systems. The majority of the time the solutions lie within unta

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

ped features of existing resources. Search the systems for solutions and provide them.

Getting clear definitions of problems. Oftentimes, employees may not know how to communicate the probl

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

Following aspects would a

ems they face in IT language. This may relate to an ill-suited solution. Take time to work with employees or department heads to clearly outline challenges so you are equipped to find solutions

dd to the challenges in developing combination products:

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

more quickly and accurately.

Looking for ways to integrate. A smooth flow of information always increases productivity. When possible, work to find ways to integrate existing systems. With

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

a little ingenuity on your part, and a little creativity, you can develop solutions without budget increases.

Problem #3 - Insufficient Sensitivity Concerning Data Security

As the compl

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

exity of electronic data processing increases, security often decreases. Not only does this pose problems in the form of breaches, it also has legal ramifications with regard to licenses.

From

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

healthcare companies to financial organizations, the US government is cracking down on lax security. The smart IT manager is taking steps now to not only stress the importance of security to tho

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

Professional from academic institutions, pharmaceutical industries, health care indust

se in his/her company, but to also instill the necessary protective measures.

To help others within your organization understand how sensitive certain data is, create a memo or site page explai

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

ning:

what security measures are currently in place,
why these measures exist,
the consequences (internally and externally) for not following security procedures, and
w

.

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

hom to contact with questions/issues regarding security.

Although an IT managers job is continually evolving and becoming more challenging, there are ways to overcome pressing problems.

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

Companies that provide selfless information through particip

By looking at each situation from a variety of angles, youll be able to define problems quickly and accurately, and then offer solutions that will benefit you, your team, and your entire 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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Raising funds can be really hard especially if your organization is not known or when it is just starting its operations. Face it, with today's rising commodities, people do not part with their money that easily. They need a very good reason to do this.

The pareto-principle is very useful especially if you combine it with a benchmark.

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