Main Subject - Business

A survey conducted recently by Quint Wellington Redwood, the independent management consultancy dedicated to solving IT-related organizational issues, reveals that for 75% of companies, co

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

st reduction is still the most compelling reason for IT outsourcing. However, outsourcing to reduce costs has a negative impact on commercial innovation. The survey actually shows that too

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

Examples of combination products may in

sharp a focus on cost reduction is a clear impediment to innovation. Other findings are that the outsourcing market is continuing to mature and that companies are tending to become more se

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

lective in their outsourcing.

The major role in outsourcing still played by cost reduction is the most striking outcome of the Quint Wellington Redwood survey. 75% of companies still view

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 as the definitive way of enhancing employee productivity and cutting costs. 50% of the outsourcing suppliers succeed in saving costs through outsourcing as agreed with their cu

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

Combination pro

stomers. Half of this group have severe constraints on their innovative capacity. Outsourcing motivated by cost reduction is often at the expense of commercial innovation, because companie

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

tend to enter into inflexible outsourcing contracts without allowing freedom for innovation, or at least failing to document it.

Most IT outsourcing contracts are still concerned with th

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

e IT infrastructure. The need for cost containment and a focus on core activities is boosting the popularity of this type of outsourcing. The survey also shows the strong growth in the out

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

ourcing market. Compared with 2004, the proportion of companies outsourcing application administration and development has risen from 15% to 32%. Expectations are that this trend will cont

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

inue. Companies would also appear to be becoming more selective in their outsourcing. Rather than opting to outsource all IT, they are choosing only certain items, such as the IT infrastru

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

ture. The partners would appear to assess the most suitable supplier on an item by item basis. This approach demands a more extensive outsourcing policy of companies and a more professiona

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

Following aspects would a

l controlling organization.

"Outsourcing IT applications can make a valuable contribution to commercial innovation", says Arno IJmker, partner at Quint Wellington Redwood. "Properly think

dd to the challenges in developing combination products:

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

ng through and planning outsourcing can lead to a strategic partnership between the supplier and the partner. This partnership stimulates the partners to be innovative, and so to retain th

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

eir distinguishing features, which leads to the constant improvement of business processes."

About the survey

The survey was conducted among 107 people with ultimate responsibility for I

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

(in the business and ICT domains) in companies based in Europe and South America, distributed over all sectors. Several IT outsourcing experts were also interviewed in order to gather mor

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

e qualitative information. The number of employees in the participating organizations varied from 100 to over 10,000, and the IT budgets ranged from 50,000 euros to more than 200 million e

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

Professional from academic institutions, pharmaceutical industries, health care indust

ros.

About Quint Wellington Redwood

Quint Wellington Redwood - or simply 'Quint' - is an independent management consultancy that is devoted exclusively to IT-related organizational chang

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

e. We supply our services in more than 30 countries from fourteen internationally distributed offices. Quint focuses on strategy, sourcing issues and the implementation of processes.

Quin

.

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

's customers are prominent profit-based and non-profit organizations that rely heavily on IT. We help our clients establish integrated management of the business and IT domain and so to ac

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

Companies that provide selfless information through particip

hieve strategic advantage over their competitors. These ideas are captured in our mission, Orchestrating Business Excellence. For additional information: www.quint.nl or www.quintgroup.com

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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