Main Subject - Business

According to Gartner research, growing number of European businesses seeks possibilities to benefit from global sourcing of software development services. In the recent years, more and more companies are getting involved in nearshore outsourcing partnerships – contracting vendor

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

s from lower-wage countries, which are relatively close in distance and time zone. They prefer nearshoring over offshoring mainly for benefits associated with cultural, geographic, time and linguistic dimensions of proximity.

Companies that are interested in long

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

Examples of combination products may in

term outsourcing for satisfying their growing software development needs may consider the following three alternative models: project-based, dedicated center and captive operations.

Some businesses that find typical project-based outsourcing to be unsuitable to their needs may decide to establis

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

captive facilities in attractive nearshore locations (namely Eastern European countries) and conduct work there as a part of their own operations. However, this model has tangible disadvantages in terms of risk, investment, operational efficiency and organizational issues. Thus, it can

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

e applied mostly by large companies and multinational corporations that are ready to invest heavily, take calculated risks and allocate necessary management resources. In this respect, nearshore dedicated development center (DDC) engagement appears to be a viable alternative for business

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

Combination pro

s with expected long-term need for software outsourcing.

Project-based model is regarded as the most appropriate for development of rather big and well-defined applications or their modules. Alternatively, dedicated center caters for software with changing requirements, maintenance 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

upport of large systems, research and development, testing as well as other types of complex tasks. DDC is about having full-time cost-effective developer resources allocated to work exclusively on client’s projects for a prolonged period of time. It serves as an extension of customer’s

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

rganization in the nearshore country.

In DDC type of engagement, vendor is responsible for providing necessary facilities and setting up a software development team that correspond to client’s methodologies, practices, management style and even business culture. Nearshore partner also undertakes

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

administrative functions, support of technical and office infrastructure, staffing, human resources management and ensures service delivery standards.

Advantages of nearshore dedicated center model

Cultural and geographical proximity
No or insignificant time zone differe

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

No long-term initial investments

Full operational control

Mitigation of business risks

Quick return on investment

Consistent and flexible team

Competitive rates and flexible pricing

Readily available technical and office infrastructure

Accumulation of custo

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

er-specific business process knowledge

Joint venture and Build-Operate-Transfer options

Strong service delivery and methodology practices

There are several types of DDC engagement options catering for different needs of the customers.

Staff-based dedicated team model is

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

Following aspects would a

probably the most common for clients that possess outsourcing experience and utilize solid offshore/nearshore delivery practices. In this case vendor only provides necessary facilities and allocates a team that works only on account’s projects (client has full operational control).

Cert

dd to the challenges in developing combination products:

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

in types of dedicated centers address more specific needs associated with technology and vertical expertise as well as the purpose of the project. They are tailored to custom business models. Term "tailored DDC" covers the following: product development center, product

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

ompetence center, project center, research and development center, software maintenance and support center, application reengineering center, quality assurance center etc.

Joint venture DDC may be considered as a transitional stage to establishing captive operations in the nears

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

ore location. Since it is funded by both vendor and customer, this contributes to risk sharing and improved performance tracking/reporting.

"Build-Operate-Transfer" option basically means that vendor sets up necessary infrastructure, hires people, establishes and operat

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

s dedicated center for a predefined period of time. Afterwards this facility is fully transferred to the client. At the initial stage vendor assigns technical experts and managers who become the core of the future organization, adopt and implement customer-specific processes and practice

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

Professional from academic institutions, pharmaceutical industries, health care indust

, conduct staffing and training of the personnel. At the transfer stage client becomes the owner of a stable captive software development facility staffed with appropriate specialists and operating with minimal supervision by parent company. Benefits of this type of engagement are lower

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

verall infrastructure costs and having turnkey captive operations staffed with well-established team of developers.

Methodology of establishing a nearshore dedicated development center Outlined below are steps that most of software development vendors generally follow to set up ne

.

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

rshore dedicated center and ensure its optimal performance in accordance with customer’s existing practices and project objectives.

Definition of cooperation model
Negotiating formal Service Level Agreement (SLA)
Building a dedicated team
Setting up technological and office infrast

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

Companies that provide selfless information through particip

ucture

Definition of communication mechanisms

Knowledge transfer (onsite to nearshore/offshore)

Alignment with customer's objectives/requirements

Training of the dedicated team

Project execution

Review of DDC performance and SLA

Implementation of the feedback

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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