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Indian software professionals seem to have dominated the world in providing software development and support services. Bangalore became the highest employer of IT talent overtaking the Silicon Valley. Outsourcing has become a topic of hot debate in countries like US and therefore it should be w

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

ise to contemplate how it will fare as we move on in time. In this article we shall discuss the specialized area of architectural outsourcing.

Architectural and engineering outsourcing comprises of producing drawings where the designers are sitting in countries thousands of miles away and the

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

Examples of combination products may in

drawings are produced remotely in a country like India. In this scenario the design base is called On-site and the production site is called Off-shore. As far as acceptability towards this new idea is concerned, the US seems open on condition of quality and reliability in drawing production. Ma

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

rkets like Europe are emerging from a rather conservative attitude. Australia seems slow in reaction but the advantages of this scheme might soon be realized in that part of the world too.

Architectural outsourcing might prove to be successful due to the following reasons:

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

trong>1.More talent: Architectural/Engineering work is bound by delivery schedules set and marked by promoters of a project. The amount of work required to be done in preparation of drawings seems never enough until the last time of dispatching them. Since amount of work depends on the

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

Combination pro

man-hours put into a project, there is an insatiable need for accumulating more man-hours into the project limited only by the available human resources and the financial budget for engaging them. If quality and talented human resources are available at a lesser cost, then the designers attemp

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 to utilize them to the maximum capacity.

2.More Motivation: There is a significant difference between cost of engaging talented human resources in the onsite area (ex. US/Canada) and the offshore area where the production team is located (ex. India). Therefore, the rewards o

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

fered to architects working in the outsourcing agency are higher than those working in traditional architectural/engineering offices. This result in higher motivation levels, even as compared to theirs peers in the on-site country because the employee receive a higher remuneration relative to t

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

he local settings, resulting in higher productivity.

3.Standardization: Architectural outsourcing was unheard of before the software boom happened in India. That’s when the world got to know about the talent of Indian professional in diverse areas. With this field being in 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

process of attaining its due recognition, several standards of offering this service are being drawn by companies. With standardization comes higher professionalism in production and delivery. Therefore, the designers get better quality architectural drawings with a more prompt service, and at

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

a cost which they can bargain either for more work, or for more economy.

4.Competitive pricing: There shall be an increasing trend for more international architecture in countries like India and other parts of the developing world. If we assume that a majority of internationa

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

Following aspects would a

lly reputed architects are of western origin; their clientele might increasingly be also in developing countries like China, Malaysia, and India etc. Therefore, in order to be competitive in pricing that suits the region, the designers would offload work of cost at least upto the production of

dd to the challenges in developing combination products:

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

drawings, that is incurred by them in their own setup.

5.Transformation from Support to Design firms: The agencies providing architectural/engineering support services will eventually become development partners with the designers as their competency, nexus and synergies with

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

them increases. Their increased exposure to international architecture will help them render not only support services but design services as well- at a cost much lesser than that charged by western architects. This shall be their transformation from Support to Design firms.

6.Attracti

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

g talent: Currently a country like India suffers from ‘Brain Drain’ of talented architects/engineers to the developed countries. With professional agencies that will provide outsourced services- there will be more opportunities available for architects to apply themselves on a diverse

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

range of international projects without having to leave their mother land. The candidates will also have opportunity to travel and examine diverse architecture from all parts of the world that will add substantially to their expertise. Also, the candidates will be made upto-date (and trained) o

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

Professional from academic institutions, pharmaceutical industries, health care indust

n the best engineering and design platforms/software in the world. With these advantages, the outsourcing agency will attract the best of talent.

7.Resource Management: An outsourcing agency would be able to manage the human resources better because it can dynamically shuffle

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

them across different jobs resulting in minimum idle time of employees. Also, the infrastructure required for graphic and CAD related jobs are specialized. Wide screen color monitors, fast computers, uninterrupted power supply, broadband internet, networking etc. are features that can be mainta

.

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

ined well by an outsourcing agency.

Architectural and engineering outsourcing- being in a nascent stage requires much to be done to achieve the vision discussed above. A few points below discuss what efforts may be put in by agencies offering these services:

1.Attracting top quality human res

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

Companies that provide selfless information through particip

ources and making more Leaders than Workers. Constantly upgrading the skill level of development staff to match that of the designers.

2.Team building with designers and sharing their vision. In the longer run becoming their development partners

3.Inventing better methodologies for production

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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