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Companies continue throwing money at IT projects and accept a pathetic 30% success rate. The IT field is filled with complexity and the

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

fast pace seems overwhelming at times, yet we as professionals should adapt to the changing environment and use available best practic

; 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 to increase the success rate of IT projects. IT professionals need to understand best practice guidelines, processes, templates and h

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

ow to deploy them in different situations.

Following these best practices is not a silver bullet. They also will not guarantee success

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

everytime. They will however, provide you with the necessary tools that provide you the greatest chance for success.

Today we will rev

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

Combination pro

iew a few best practice IT management techniques.

Align IT and Business
Align IT projects to specific business strategy goals and

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

objectives. Do not start or continue IT projects that are not aligned with the business strategy.

Qualified Leadership
Make sure

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

that each project has a full time leader with overall responsibility and authority for the project. The project leader should be qualif

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

ed to manage the project size and complexity.

Be Competitive
Use information technology to improve your business competitive adva

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

ntage.

Define Metrics
Define and track measurable objectives that are necessary for the success of the project. Review these metr

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

cs monthly and adjust the project as needed.

Leverage Current Technology
Leverage the investment of your current systems when dev

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

Following aspects would a

eloping a new system.

Project Organization
Project teams or sub-teams should contain 2 to 7 team members with a mix of technical

dd to the challenges in developing combination products:

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

nd business specialists. Keep the project team organization small and agile.

Keep It Simple
Use the simplest possible combination

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

of business processes and technology to achieve your goals.

Work In Small Units
Project work should be broken down into small un

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

ts. A task should not exceed 80 hours and should not be less than 8 hours. The project should produce workable systems every 30 to 90 d

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

ays.

Keep It Small
Break the development of big IT system projects into smaller functional projects to reduce the complexity and

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

Professional from academic institutions, pharmaceutical industries, health care indust

ower the overall risk of a big system project.

Project Administration
Provide each project team with a coordinator or administrat

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

or that help project managers and leads keep project plans and budgets up to date and accurate.

Understand Your Capabilities
Don'

.

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

take on an IT project when the complexity exceeds the companies capabilities.

Start From Scratch
When restarting failed projects

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

Companies that provide selfless information through particip

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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