Main Subject - Business

Many companies choose outsourcing and offshoring of their software development to cut their costs. Although there

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

is nothing wrong with the idea, it is rarely executed correctly to realize the expected results.

After listenin

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

Examples of combination products may in

g to well-delivered sales spiels, some managers tend to look at the offshore costs and come to some interesting c

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

nclusions. “Hmmm! I could have four software developers for the cost of one”“ or even ““Cheaper, better

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

and faster!”“

All true, however, this gain is not fully realizable as there are several costly and time-con

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

Combination pro

uming obstacles that need to be overcome. For a small flavor, here are a few examples -

1. Ramp-up time or kn

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

owledge transfer time – it often takes projects weeks or even months to be able to teach a newcomer the detai

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

s of a system.

2. Management and the offshoring overhead – outsourcing often needs an intermediate level

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

of management or coordination that may not have been required in your classic organization.

3. Proximity

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

there is an overhead that is generated when teams are not working face to face.

4. Time zones – working

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

with people in different time zones can add on a set of constraints to a working environment. The time window for

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

Following aspects would a

collaboration is often very small and simple issues might require multiple days to resolve.

5. Travel costs<

dd to the challenges in developing combination products:

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

b> – travel to and from the offshore location can be both costly and very time consuming.

6. Process changes<

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

/b> – Bridging the process gap between organizations is not a trivial task. Outsourcing is process intensive by n

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

ture.

7. Cultural changes – often seen as a minor adaptation; nevertheless, requires time to be able to w

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

ork with another culture.

Outsourcing should be seen as a strategic long-term investment; where the investment p

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

Professional from academic institutions, pharmaceutical industries, health care indust

riod itself could span several years. Then, it could be several years before the investment on outsourcing actual

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

ly starts to pay off.

Offshoring for the short-term gain could end up costing more than conventional in-house de

.

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

elopment. Those who choose outsourcing need to have a clear strategic plan. My book “IT, Software and Services

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

Companies that provide selfless information through particip

: Outsourcing and Offshoring” is aimed at helping you develop a tailored strategic plan for your organization

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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Main Subject - Are You Outsourcing Software Development for Cost Savings? Watch Out!

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