Subjects - Business

One of the great challenges facing senior executives today is whether or not to outsource the delivery of some of their services. The financial services sector wa

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 an early adopter of outsourcing in the US and UK and many institutions have outsourced their IT functions for several years. In other sectors, such as telecoms,

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

Examples of combination products may in

outsourcing is in its infancy. In these sectors key questions are being asked about what functions should be outsourced; various criteria are used to inform these

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

decisions – are these functions core? Are they critical? Whole industry norms are being challenged in the telecommunications industry with big players such as 3

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

outsourcing their entire mobile networks.

Outsourcing in the telecoms sector has raised one specific interesting regulatory issue. Licenses governing spectrum al

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

Combination pro

ocation in the mobile space usually stipulate that mobile operators must retain ‘functional control’ of their network. The telecoms sector is highly regulated; ne

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

twork operators cannot evade this regulatory responsibility – it cannot be shifted to service providers. Indeed this issue raises interesting questions for the do

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

inant outsourcing providers – no doubt some caution may need to be exercised in the future to ensure they are not perceived to have de facto control of any network

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

More broadly speaking all companies should retain strategic control over the direction of all outsourced functions. All aspects of your core business will have k

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

ey dependencies on the functions you have outsourced – this means you need to be in a position to control the outsourced operation at a strategic, governance and o

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

erational level (up to and including termination where the outsource is no longer aligned to corporate strategy) This requires three key elements to be present in

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

Following aspects would a

our outsourcing framework:

* A Strong Internal Service Management Team responsible for the day to day management of the Service Provider. (commonly referred to as

dd to the challenges in developing combination products:

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

the ‘Retained Layer’.

* A specific and enforceable Service Level Agreement between you and your Outsourcing Service Provider.

* Ongoing review of the strategic

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

usiness drivers for outsourcing.

Frequently companies spend so much time during the analysis, design and implementation phase of an outsourcing project that they

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

eglect to dedicate time to the importance of ongoing management of the deal. It is only through consistent management of the service provider that the client orga

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

nisation will retain a high level of understanding and expertise in the outsourced function. (This needs to be achieved whilst allowing the Service Provider to ge

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

Professional from academic institutions, pharmaceutical industries, health care indust

on with managing the delivery of the service whilst the client focuses on the governance).

It is important to ensure that specific service levels are agreed betw

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

en you and your service provider. Service levels should be as precise and business relevant as possible – avoid ambiguity and use a small number of significant me

.

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

asures. Where possible try to ensure the numbers are baselined against the industry norm.

A carefully designed and implemented Service Model will ensure that you

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

Companies that provide selfless information through particip

remain in control of your business – a well trained management layer and a clear, Business-relevant Service Level Agreement are key components of the Service Model

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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National economic development is pivoted on the availability of good infrastructure. As path-breaking concepts, frameworks and methodologies are being evolved, at the national, state and local levels, especially in the critical facets of infrastructure management such as financing, contracting and regulation, an Infrastructure Manager today needs to have a variety of skills. The immediate requirement of the Indian economy is, therefore, a pool of holistically trained domain-ready infrastructure managers. The comprehensive Post-Graduate Diploma in Infrastructure Management (PGDIM) Programme offered by Karnataka's prestigious Visvesvaraya Technological University (VTU), through the School of Management for Infrastructure and Development Strategies - India (MINDS), at Bangalore, is a timely response to this crying need and the first-ever initiative of its kind. From this academic year, the PGDIM is being offered in an innovative format whereby a student will receive the PGDIM on successfully completing the first year and also an MBA Degree in Infrastructure Management, after the second year.

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