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Advice Pool - The 4 Basic Steps to Successful Outsourcing
If you are not experienced in outsourcing, consider hiring an experienced outsourcing consulting firm to help you through the process. Generally the large accounting firms and outsourcing vendors provide excellent support for large scale p
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
rojects, and there are a number of smaller firms that can help the small and mid-size companies. If you want to manage the process on your own, even the most sophisticated project management techniques can be broken down into four simple p
; 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
oject management stages:
Analysis
Evaluation
Implementation
Review
After you have identified potential outsourcing candidates try stepping through these steps to see if outsourcing makes sense for your organization.
Analysis.
Analysis
Evaluation
Implementation
Review
After you have identified potential outsourcing candidates try stepping through these steps to see if outsourcing makes sense for your organization.
Analysis.
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
he goal of this stage is to determine your company’s core business and to identify expensive or low performance supporting functions.
Make a list of your mission critical products and services and all supporting functions. Then determine
Make a list of your mission critical products and services and all supporting functions. Then determine
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ow these sectors must perform to keep you competitive or to place you ahead of the completion. Any department or function that is not your core business, is a large cost center and is not particularly effective in delivering results is a p
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ime candidate for outsourcing. In computing your “costs” do not forget to factor in the time that a problem area may take from your executive and support teams.
Evaluation.
The goal of this stage is to identify and match the needs
Evaluation.
The goal of this stage is to identify and match the needs
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
of your targeted department with an outsourcing provider.
First break down the key functions of the department into its major component structural parts and major functions. A simple analysis can be performed by writing down the departme
First break down the key functions of the department into its major component structural parts and major functions. A simple analysis can be performed by writing down the departme
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
t name or function, the work product produced and the information/materials needed to produce that work product. Perform this exercise for the current operations and then for the “how it should be done” case. This chart will be a simple wr
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
tten expression of what is needed from the targeted department or function.
Now it is time to identify local and offshore outsourcing sources, get them to sign a non-disclosure agreement and send them your basic analysis. The outsourcing
Now it is time to identify local and offshore outsourcing sources, get them to sign a non-disclosure agreement and send them your basic analysis. The outsourcing
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
rovider will have many more questions but you will have a simple, basic guide to make sure the provider is on course. You will likely send out a Request for Quote or a Request For Proposal which will contain your “needs” contained in your
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
hart with a request for a solution. It is also a good idea to ask your potential outsourcing partners to send you a proposed contract for you to review at this stage.
You will want to score each provider based on price, service, quality a
You will want to score each provider based on price, service, quality a
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
nd terms. Do a simple net present value analysis to see if the project makes sense. Above all, do not loose your sense of reality in the sea of numbers. Select the service provider that best fits your needs.
Implementation.
The g
Implementation.
The g
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
al of this step is to transfer knowledge and data from your internal department to your outsourcing partner, implement best practices and commence operations.
Implementing a new outsourcing program can be as simple as logging into a new pa
Implementing a new outsourcing program can be as simple as logging into a new pa
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
roll provider’s system and entering data or as complicated as divesting a major division of your company and coordinating a multi-man year conversion process. Regardless of the complexity, you need to work with your outsourcing provider t
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
create a clear step-by-step project plan with clear actions, deliverables and due dates and have a weekly review process that quickly identifies and resolves any problems or delays. Make sure that your outsourcing partner provides you wit
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
some method to clearly track the progress of your project and have contingency plans, testing plans and reasonable penalties if key milestones are not reached. You will also need to create a transition plan for any planned staff reductions
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
.
Review.
The goal of this step is to set up an ongoing system that maximizes the performance of both your internal staff and your outsourcing partner to make sure you get the results you need.
“If it does not get measured it does
Review.
The goal of this step is to set up an ongoing system that maximizes the performance of both your internal staff and your outsourcing partner to make sure you get the results you need.
“If it does not get measured it does
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
not get managed.” This must be a mantra for the team if any outsourcing project is going to be successful. Make sure that you have set up specific service level agreements (SLAs) in your agreements that have specific, measurable results.
.
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
Identify project managers on your staff and with your outsourcing provider and give them targets. If you tie a compensation plan to results you will be amazed at the improvement in quality.
During my years as a business consultant and IT e
During my years as a business consultant and IT e
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
ecutive, I developed a simple checklist to evaluate vendors and manage outsourcing projects. If you are interested in receiving a free copy feel free to send me an e-mail at the address below with information about your project and company
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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