Advice You - Business

Success of a project when developed by an offshore provider is largely dependent on the way the project is remotely managed from the client’s s

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

ide. If you hope to make a project successful with very little input from your end as a customer, it is unlikely that the project will achieve

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

Examples of combination products may in

success in the long term. The basic reason is very simple: you know your business requirements best. Software services companies working in ano

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

ther part of the world can only develop a solution based on the input provided by you.

Fairly large projects have a dedicated project manager

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

ho interacts with the offshore team and acts as a virtual bridge between the business and the software developers. If your project does not hav

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

Combination pro

e dedicated personnel for it, there is no need to despair. You can follow some simple tips mentioned below and manage your project quite succes

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

sfully.

Define the goal every week: The complete lifecycle of the software development process can be divided into smaller goals which can the

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

be communicated to the team via email or by phone. It is a good idea to have a call with the entire team on Monday morning and run through the

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

list of weekly goals that need to be achieved and then call again at the end of the week to evaluate if they have been achieved or not and wha

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

t type of roadblocks were faced by them.

Manage the time difference: Time difference is one of the factors in offshore software development pr

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

jects which can become a pro or a con depending on how it is managed. It is imperative that a "common" time zone is mutually agreed on by you a

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

Following aspects would a

nd the offshore vendor. This time should be used for communication and ironing out issues faced by the development team. Though it might take s

dd to the challenges in developing combination products:

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

ome time to get used to getting in to the office at 7 AM, it pays good dividends in the long run.

If there are issues, alert everyone in time:

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

It is advisable that you keep a look out for early warning signals and warn the team up front rather than wait for things to correct themselve

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

. Ninety percent of the time, the issue is not self-correcting but goes on to become a real pain to the entire team before additional effort is

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

exerted to get it on track.

If someone in the offshore team is doing well, comment on it: Encouragement and motivation are required even when

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

Professional from academic institutions, pharmaceutical industries, health care indust

you have hired a team with an offshore service provider. Motivating team members with an encouraging email along with occasional gifts sent to

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

them on regional festivals creates camaraderie as well as doing wonders for the project. At the end of the day remember that developers are hum

.

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

an beings and they do need an occasional pat on the back.

Although a number of onsite project managers feel that project management tools are

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

Companies that provide selfless information through particip

advantageous to the flow of a project, the core driver in a successful project will always be good project and human resource management skills

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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