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Here’s a scary statistic. According to four prominent research firms, only around 20% of all IT projects are finished in a timely manner. By “timely” the researchers mean without loss of quality or being over budget. They go on to say the average project

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

runs approximately 200 percent late, roughly 200 percent over budget, and contains only 2/3 of the original functionality.

Failure is the norm in the IT industry. But why? And more importantly, how do we fix it?

There must be a way to dissect the problem

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

Examples of combination products may in

and create a solution to the diagnosis of “doomed failure.” Trust me, there is!

Top 7 Problems and Their Solutions

Let’s take a look at the top 7 reasons IT projects are late or over budget. Then I’ll show you some proven solutions taken straight from t

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

he trenches.

1. Not Enough Time

Whether it’s a misunderstanding of the complexity of computer system designs or some other reason, many times little time is devoted to gathering the necessary data. Because this is one of the first steps in the process, wh

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

n adequate time isn’t given to data collection, everything else suffers.

Likewise, enough time is rarely allotted to creating a good design. While the planning stage may not offer the excitement that development does, it is equally, if not more, important.

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

Combination pro

Lack of planning in the design phase almost always leads to ongoing changes during the development phase. When this happens, budget dollars and man-hours are eaten away.

SOLUTION: Give it more time. This vital step must be given due consideration. Adju

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

t your schedule as needed, and you’ll find the rest of the process goes much smoother. Yes, you have to make it to market before your competition. But if you make it to market and your product is filled with bugs, what do you get? A pile of returns and co

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

mplaints, and a bad reputation.

2. Open the Lines of Communication

It sounds like a clich?, but communication is absolutely vital to the success of any project. The communication between the development team and the users, and also the communication insi

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

e the development team must be crystal clear. Does everyone understand you? Do they know exactly what’s expected of them or have you assumed they know? Do they communicate well with each other? With users? With other departments?

SOLUTION: Identify co

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

mmunication breakdowns now. These can only lead to confusion and complications down the road. Never assume that everyone understands. Take just a little extra time to create an environment that is destined to produce a product on time and under budget.

3

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

Testing a New Program in the Production Server

Testing in the production server leads to a breach of security, which can lead to “immediate” release without testing which can ultimately disrupt the production environment.

SOLUTION: There should be specif

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

Following aspects would a

ic protocol setup for security and quality control considerations for new program tests.

4. Inadequate Testing

Experience and studies show that testing is almost always pushed to the end of the development cycle. Since the development is usually bad, the

dd to the challenges in developing combination products:

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

testers run out of time. The result? Running over schedule and over budget. Not to mention the release of an inadequate product.

SOLUTION: Remember problem #1? Ditto! Yes, you have to make it to market before your competition. But if you make it to ma

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

rket and your product is filled with bugs, what do you get? A pile of returns and complaints, and a bad reputation. Test all the way through the process, and you’ll save a lot of time in the end.

5. Pressing the Budget Too Tight

When you have unrealisti

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

goals for a project’s budget to start with, chaos is bound to set in. Departments fall behind, resources are slow to arrive, and - because of budget constraints - the project, once again, runs off the road.

SOLUTION: Create an accurate budget. Also, outl

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

ine ways to develop better upfront planning of the resources.

6. Never/Rarely Checking the Progress of the Project

As the project goes along, the unexpected happens. Various people implement their ideas as to how to fix these challenges and - when launch

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

Professional from academic institutions, pharmaceutical industries, health care indust

day comes - you’re surprised with an entire list of challenges that need your immediate attention.

SOLUTION: Define “checkpoints” throughout the project. Give attention to those things that need to be adjusted along the way, even if they cause minor delay

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

s. Fixing them now, rather than later, will take less time overall.

7. Not Reviewing Existing Standards

Do most or all of your projects run late and over budget? Do you keep the same standards in place time after time? How’s that working for you? If y

.

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

u keep doing what you’re doing, you’ll keep getting what you get. Let’s face it… things change, and if you want to keep pace, you have to change, too.

SOLUTION: Take time to review the standards used for each and every project. Keep a running list of wha

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

Companies that provide selfless information through particip

t worked, what didn’t, and how to do it better next time.

The next time your IT project is late, over budget, and looks like it is never going to work, review this list again. Make the necessary adjustments, and you’ll be downright amazed at the difference

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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At first glance, this question may seem a little silly. Of course I know what my job is. But in my experience, from both sides of the fence, many of us find out the hard way just what is expected of ...

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