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Digg It - Making a Decision to Outsource: Driving Factors
Most executives view offshore outsourcing most of all as a source of cost reducing. The greatest savings are expected to come from lower labor cost and reduced project timelines. However offshore outsourcing also creates new challenges
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
and expenses for the organization involved. Those may include vendor selection costs, legal costs, costs of transition and many others. That is why despite the evidence of possible major up-front cost savings many outsourcing vendors
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
ave yet to prove that they are able to provide positive ROI in a complex project.
Yet businesses have to perform deep analysis of its strategic program and goals before making a strategic decision to outsource part of their activities
Yet businesses have to perform deep analysis of its strategic program and goals before making a strategic decision to outsource part of their activities
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
The main driving factors are as follows:
Lack of special expertise/knowledge. This is probably one of the most important factors that force companies to outsource. Many projects require technical expertise that is not present
Lack of special expertise/knowledge. This is probably one of the most important factors that force companies to outsource. Many projects require technical expertise that is not present
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
within the company. Moreover, very often the company can not hire employees with required expertise, or it is not reasonable to employ them full-time. As Outsourcing Institute has suggested “outsourcing is a clever alternative to hirin
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
”.
Floating demand for personnel. Often a company that engages itself into a large project is reluctant to search for new skilled employees, because it estimates that upon its completion it will be forced to discharge them (say
Floating demand for personnel. Often a company that engages itself into a large project is reluctant to search for new skilled employees, because it estimates that upon its completion it will be forced to discharge them (say
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
in a year or two). It is wise in such case to outsource part of the project to an offshore vendor acquiring also the possibility to reduce costs.
High risk level. Companies working in high risk spheres often prefer to reduce t
High risk level. Companies working in high risk spheres often prefer to reduce t
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
hem by finding an offshore vendor with advanced expertise in the same domain. Also it is not reasonable to shift all responsibility to outsourcing partner, attracting mature specialists with needed skills and technical knowledge in mos
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
cases allows reducing risks.
Process management perfection. Outsourcing vendors earn their profits in many respects because they have standardized their internal processes. Take the example of software developers who integrate
Process management perfection. Outsourcing vendors earn their profits in many respects because they have standardized their internal processes. Take the example of software developers who integrate
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
Capability Maturity Model raising their processes from ad hoc, chaotic level to mature, disciplined software processes. Partnering with such mature organization may allow for transfer of best practices across project boundaries, thus
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
roviding some standardization for the outsourcing organization as well.
Reduction of time spending on management. Transferring secondary functions and processes to outsourcing vendor will allow management of the company to con
Reduction of time spending on management. Transferring secondary functions and processes to outsourcing vendor will allow management of the company to con
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
centrate on core processes and projects that have maximum priority.
Achieving objectivity. Often companies fall into the trap of inertness of its workers. The reason is that people minds can not manage with rapid technological
Achieving objectivity. Often companies fall into the trap of inertness of its workers. The reason is that people minds can not manage with rapid technological
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
hanges and employees are reluctant to refuse “old approved techniques and methods” thus being not able to find and apply optimal solutions. Internal obstacles may delay or even block new initiatives. That is why it is worth recruiting
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ndependent expert company that will suggest the most appropriate solution for particular business needs.
The company shall clearly recognize all possible reasons for outsourcing and rank their priority. A coordinated approach of manag
The company shall clearly recognize all possible reasons for outsourcing and rank their priority. A coordinated approach of manag
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
ement must be formed, in other case valuable time and resources may be spent on finding a vendor whose effectiveness will not satisfy one of the managers. As practical experience shows main reasons for resorting to outsourcing are:
-
-
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
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
ncreasing the overall company effectiveness;
- expanding technological advantages and manufacturing capabilities;
- cutting managerial costs;
- improving technical support and customer service;
- concentration on co
- expanding technological advantages and manufacturing capabilities;
- cutting managerial costs;
- improving technical support and customer service;
- concentration on co
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
e activities;
- lack of qualified personnel;
- etc.
Probably the most important point to keep in mind while making decision whether to outsource or not is that outsourcing is not the means to solve all company’s problems. Al
- lack of qualified personnel;
- etc.
Probably the most important point to keep in mind while making decision whether to outsource or not is that outsourcing is not the means to solve all company’s problems. Al
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
l problems arising within the company require careful examination. If their cause is badly defined strategic aims, outsourcing is likely to worsen the situation, not improve it. If a company does not realize its needs, it will neither
.
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
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
e able to explain them to exterior vendor nor gain success.
Will outsourcing be really profitable for your business? It depends. In first place it depends on you and how much effort you put into pre-outsourcing preparation and analysi
Will outsourcing be really profitable for your business? It depends. In first place it depends on you and how much effort you put into pre-outsourcing preparation and analysi
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
. We hope that this article will help you to identify your needs and acquire more clear vision of possible reasons for outsourcing. If you are still not sure and hesitating, you may contact us, and our analysts will definitely help you
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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