Tags |
|
|
Links |
|
|
Advice You - Get the Right Partner - Recipe of Offshore Vendor Evaluation
Future of business is very intricate with shorter life of any business model. Last three decades have observed the shriveling life cycle of products. The reason certainly is the competition. The appetite for larger market share has resulted in continuous innovation on both business model and its offerings. This century has seen the transitioning of supply oriented to demand in
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
tensive business model. Over the last two decades cost has been very critical driver of business, negative pressure of cost has been active topic of discussion for modern management thinkers and executives. The first wave in this direction was through implementing rationalized processes.
Next wave indeed has been integrating quality tools and scales to the processes. Deming’s
Next wave indeed has been integrating quality tools and scales to the processes. Deming’s
; 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
PDCA cycle, Juran’s Quality trilogy, Feigenbaum’s total quality control, Dr Kaoru Ishikawa’s tool kit, Shigeo Shingo’s Just in Time, Philip Crosby’s zero defect, has been effectual contributions towards process excellence.
General Electric, one of the most successful companies implementing Six Sigma (quality tool), has estimated benefits on the order of $10 billion during the
General Electric, one of the most successful companies implementing Six Sigma (quality tool), has estimated benefits on the order of $10 billion during the
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
first five years of implementation. GE first began Six Sigma in 1995 after Motorola and Allied Signal blazed the Six Sigma trail. General Electric’s revenue soared by 11%, profits by 13% and operating margins increased by 17% during 1996-1998.
The Process automation and information technology became the core to any business strategy; last two decades of the last century saw
The Process automation and information technology became the core to any business strategy; last two decades of the last century saw
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ignificant development in field of IT. Automating and integrating processes indeed changed the way business was done. Most of the management principles related to cost advantage has been process driven. Last decade was the metamorphosis of the cost advantage theory, paradigm shift from process to people has successfully evolved most controversial management tool called “Outsou
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
cing”. The theory to attain cost advantage through low cost labor and concentrate on core competency became the drivers of outsourcing. Outsourcing involved into offshoring to further capitalize on the geographic traits of labor arbitrage and time zones. India, China, Philippines became hot destinations for offshoring.
Outsourcing is the migration of process or processes to a
Outsourcing is the migration of process or processes to a
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
n external entity which excels in performing that process. Offshoring refers to migrating the process to another country taking advantage of lower-cost labor. Offshore outsourcing encompasses manufacturing, IT, and back-office services. GE has been instrumental in success of outsourcing and offshoring. In the early 1990s, Jack Welch, the former CEO of GE, introduced a new rule
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
that governed GE's offshore actions. It is called the 70:70:70 rule. In an e-mail to GE employees, Welch mandated that 70% of GE's work would be outsourced. Out of this, 70% of that work would be completed from offshore development centers. And out of this, about 70% would be sent to India. This comes out to about 30% of GE's work being outsourced to India. Recent market surve
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
s show that almost 80 percent of companies expect to increase their investment in outsourcing both IT operations and business processes. As every business has its risks, outsourcing has its share too.
One of the most critical risks is the failure to deliver apart from Data security, cost advantage and knowledge transfer. The success of the outsourcing project depends upon the
One of the most critical risks is the failure to deliver apart from Data security, cost advantage and knowledge transfer. The success of the outsourcing project depends upon the
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
vendor that you select. Vendor evaluation should be done in a very scientific and methodological manner. Equally important is the selection of geography.
• Evaluate the vendor country:
Analyze the political, cultural and economic climate of the vendor country. Look at the future of offshore outsourcing in the country where the offshore unit is located. One should refer fede
• Evaluate the vendor country:
Analyze the political, cultural and economic climate of the vendor country. Look at the future of offshore outsourcing in the country where the offshore unit is located. One should refer fede
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
al regulations and the stability of economic policies. One of the critical aspects which we forget in evaluating the geography is evaluation of its higher education framework and supply of skilled labor. Infrastructure especially in terms of communication is very important.
• SWOT and Competitive analysis:
A detailed analysis of labor skill sets, technology infrastructure, d
• SWOT and Competitive analysis:
A detailed analysis of labor skill sets, technology infrastructure, d
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
ta security, quality control processes, Intellectual property and other systems as per your requirements. Factors like Business Continuity planning and redundancy plans of the vendor are critical for your business continuity. At this stage do visit the potential vendor, and verify the credentials. A vendor check list should always be prepared and the entire vendor should be ra
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
ted on the common requirements scale. The scalability of the vendor both in terms of labor and infrastructure should also be evaluated. Understand the objectives and vision of the offshore vendor. Be convinced of the vendor’s short-term, medium-term and long term business goals. Evaluate their willingness to implement your standards and processes.
• Is the partner right?
• Is the partner right?
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
It is the most vital question that should be asked; in vendor selection process a questionnaire should be made which should address the following concerns:
• Are they a workable vendor/partner?
• capabilities and services, location, political stability, culture, size, financials, references
• Do they have required delivery capabilities?
• staff skills and e
• Are they a workable vendor/partner?
• capabilities and services, location, political stability, culture, size, financials, references
• Do they have required delivery capabilities?
• staff skills and e
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
perience, resources availability and retention, ability to ramp up, software development process, infrastructure, knowledge management, quality focus
• Selecting the offshore vendor:
For effective offshore vendor management, a contract should clearly define the roles and responsibilities, timelines, financial details, payment modes, quality standards and other details ne
• Selecting the offshore vendor:
For effective offshore vendor management, a contract should clearly define the roles and responsibilities, timelines, financial details, payment modes, quality standards and other details ne
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
cessary for better offshore vendor management. Clearly defined SLA (Service Level Agreement) and a termination clause are also an integral part of the contract. Vendor should be selected on the basis of three year time horizon.
These questions should form a document generally known as RFP (Request for Proposal), RFP should be meticulously written. It should clearly indicate t
These questions should form a document generally known as RFP (Request for Proposal), RFP should be meticulously written. It should clearly indicate t
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 requirements both in terms of processes and facilitators. Companies can hire professional advisory firms like TPI, Everest Group & NeoIT which can assist them in not only writing RFP but also in vendor evaluation and carving the outsourcing/ offshoring road map.
A matrix to scale vendors always helps in evaluation process. Vendors should be given waitage scores is the best
A matrix to scale vendors always helps in evaluation process. Vendors should be given waitage scores is the best
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ay of first round of elimination. The following parameters should be counted on the scale of 1 to 4, according to the criticality of the parameters waitage in terms of percentage should be assigned to them. The scale then multiplied by the waitage and its total sum will give the vendor points. Few parameters can be- Offshore Process/ Methodologies, Cost, Quality of Resources,
.
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
Project Management Capabilities, Certifications, Multi Vendor Capabilities, Domain Expertise, Delivery Capabilities, Infrastructure and human resource rating.
It’s always advisable to select 2-3 vendors and run a pilot with each of them as a proof of concept. Their delivery should be evaluated on a time frame to select a vendor. We have seen a trend over last three years wher
It’s always advisable to select 2-3 vendors and run a pilot with each of them as a proof of concept. Their delivery should be evaluated on a time frame to select a vendor. We have seen a trend over last three years wher
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
in companies select two vendors to de-risk their project of outsourcing and offshoring. It’s a very successful model and it imbibes sense of competition amongst the vendors.
Success of your marriage depends upon how compatible your partner is, the same theory is applied in marriage of businesses. Select the right partner for your business continuity and achieve business goals
Success of your marriage depends upon how compatible your partner is, the same theory is applied in marriage of businesses. Select the right partner for your business continuity and achieve business goals
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.adviceyou.org.ua/article/32447/adviceyou-Get-the-Right-Partner--Recipe-of-Offshore-Vendor-Evaluation.html">Get the Right Partner - Recipe of Offshore Vendor Evaluation</a>
BB link (for phorums):
[url=http://www.adviceyou.org.ua/article/32447/adviceyou-Get-the-Right-Partner--Recipe-of-Offshore-Vendor-Evaluation.html]Get the Right Partner - Recipe of Offshore Vendor Evaluation[/url]
Related Articles:
Compliance Jobs Interview Tips - Insurance Recruitment Advice
Scratch and Win, How Both The Contestant and Retailer Win Big!
Bookmark it:
|