Advice You - Business

You have probably heard the stories: Software that does not work. Software that does the wrong thing. Money paid to set up an offshore operation that never produces any software. Can these outsourcing nightmares be avoided

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

?

Of course. The key is how you manage the outsourcing of your software development.

The two biggest fears of outsourcing that I hear from clients are the fear of selecting a bad outsourcing vendor and the fear of not m

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

Examples of combination products may in

anaging their work effectively. Let's assume you pick a great team, perhaps one of the proven Accelerance teams from around the world. Even then you may still have lingering worries about getting your software developed qu

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

ickly. Here are eight ways you can manage your outsourcing to get reliable results.

(1) Milestone tracking - Your plan for outsourcing should include some estimating and scheduling. The outsourced team should commit to da

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

tes for the completion of the milestones. Define your development milestones so they occur frequently and make corrections if they are not being met.

(2) Requirements tracking - Make sure the features you need are being c

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

Combination pro

mpleted properly in each release. You want to make sure your users will be able to gain the maximum benefit from your software. You don't want important details to be lost or forgotten.

(3) Daily monitoring of your outsou

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

rcing progress - No news is NOT good news. You need regular communication with your outsourced team. This should occur almost everyday. You should at least have a regular email or a conference call on specific days to make

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

sure things are going well and that unresolved issues are not blocking progress.

(4) Continuous builds - Put a system in place to re-compile and build your software every time a developer checks in a source file. This al

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

lows you to detect problems as they occur so they can be fixed quickly and do not lead to a delayed software release.

(5) Test-driven development - You should require your outsourced engineers to perform unit tests of 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

ir programming work. Tests should be created first, before the feature is implemented. Writing the test first helps clarify what the software should do. It also builds a set of regression tests that can be performed later

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

o check for basic system functionality.

(6) Integration testing and Quality Assurance - Testing of the individual software modules by the outsourced developers is not enough. You also need to test the entire system to mak

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

Following aspects would a

e sure high levels of functionality and quality will be experienced by your users. Comprehensive testing requires automation to check all paths through the user interface. A full QA process also verifies the software behav

dd to the challenges in developing combination products:

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

es well when users make "mistakes."

(7) Collaboration for design and problem resolution - If the engineers are working in your office then you just meet with them to resolve the issue face-to-face. Of course, this is not

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

possible when the engineers are thousands of miles away across one or more oceans. But with the Internet you can get pretty darn close. An email or instant message conversation can often resolve your issues. Using the tel

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

ephone is also an extremely useful tool and with VOIP software like Skype, Yahoo Messenger or Google Talk the communication cost is zero. The important point is that the tools are available to make long-distance collaborat

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

on a reality and they enable extensive use of outsourcing to be practical.

(8) Knowledge management and retention - You provide a specification to the outsourced team. Issues are resolved and clarifications are made. Then

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

Professional from academic institutions, pharmaceutical industries, health care indust

the software is delivered and it works well. But what if the outsourced team leaves the picture? Will you be able to pick up the software and make changes efficiently? Yes, if you have gained the knowledge of how the soft

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

ware is written. The technical documentation describing the architecture and workings of your software should be created by you or your outsourced team. You don't need a huge tome no one will read. Simple installation ins

.

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

tructions and architectural documents that can facilitate the learning process and enable your US engineers to deploy and support your software are sufficient.

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Believe me. You will gain peace of mind and produce g

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

Companies that provide selfless information through particip

reat software when you apply these powerful techniques to manage your outsourcing. Use of these techniques will quell your fears and help you bravely take advantage of the benefits of outsourcing in the new global economy

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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