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Digg It - Developing Global Manufacturing Operations - Issues, Challenges and Potential Solutions
Introduction
Manufacturing companies have started venturing globally to take advantage of low cost manufacturing, geographical location, resource availability and so forth. Developing and managing global manufacturing operations have continuously been a challenging task for company’s world wide. This article attempts to explore 10 most significant issues of concern, challenges faced, and potential solutions
Manufacturing companies have started venturing globally to take advantage of low cost manufacturing, geographical location, resource availability and so forth. Developing and managing global manufacturing operations have continuously been a challenging task for company’s world wide. This article attempts to explore 10 most significant issues of concern, challenges faced, and potential solutions
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
for multi-national manufacturing organizations as they start operating globally.
1. Management Philosophy
Management philosophy guides the stakeholders of the organization in providing an understanding of what the Company’s operations are, where they are heading towards, and why they are in business. Companies need to provide a clear statement of their vision, mission and values to the stake holders. It b
1. Management Philosophy
Management philosophy guides the stakeholders of the organization in providing an understanding of what the Company’s operations are, where they are heading towards, and why they are in business. Companies need to provide a clear statement of their vision, mission and values to the stake holders. It b
; 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
comes vital especially in a global company to dedicate thought and efforts in framing this philosophy, as individual companies may have slightly different focus, but the group as such should sail towards a focused destination. Equally important are the business policies and strategies by which the Company targets to achieve its vision. As the company’s grow and become multi-national, it becomes imperative to
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
have a clear organizational structure at entity level and individual level. This would form the basis for better communication, development of collaborative operations, and effective decision making. Notably, organizations should adopt ways of proving its commitment to the strategies and philosophies, link their operational and tactical activities towards their vision, and continuously communicate them to t
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
eir stakeholders.
2. Systems and Systems Thinking
Systems are procedural approach that channels the individuals, departments and the management in effective operations at all levels. An organization operating in different countries need to have a common system by which they deal with operations at same level in their entities. This provides a visibility for individuals from different entities in collaborat
2. Systems and Systems Thinking
Systems are procedural approach that channels the individuals, departments and the management in effective operations at all levels. An organization operating in different countries need to have a common system by which they deal with operations at same level in their entities. This provides a visibility for individuals from different entities in collaborat
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ing their work with each other. Also, a system gives the Company less dependency on a particular individual or group of individuals, which growing organizations will realize to be important in the long run. A system provides the multi-national organization a dynamic work culture, and easier adaptability to working procedure.
The concept of Systems Thinking evolved with the development of supply chain integr
The concept of Systems Thinking evolved with the development of supply chain integr
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
tion. Organizations that concentrate on the individual development of the entities often fail to notice the integrated links and the advantages they can extract off them. Systems Thinking would help look the whole network of entities as one organization, with one business and one objective, and focus on overall development across the supply chain.
3. Collaborative Operations
Collaborative operations help o
3. Collaborative Operations
Collaborative operations help o
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
rganizations take advantage in areas such as utilization of low operations cost, skilled labor, material availability, and so forth though it poses high demands on seamless business processes, interoperability, supply chain visibility, demand forecasting, and customer integration.
As the individual entities of the organization grow, they tend to develop functional expertise in specific disciplines. Often th
As the individual entities of the organization grow, they tend to develop functional expertise in specific disciplines. Often th
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
companies that operate at multi national level concentrate less on getting trained in this expertise from their fellow entities, but involve in sourcing the specific activity to this expert entity of the group. This approach has to be assessed on case to case basis. In a typical organization where the entities do similar activities at different locations, it may not be suitable to source a particular activi
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
ty to a location. Also an imbalance in a specific functional expertise level among the entities might grow to be a barrier in overall growth.
4. Branding
As companies go global, brand management becomes a key aspect. Customer’s perception for a product varies with the country in which it is manufactured. This urges Multi national companies to concentrate on development of brand and strongly commit to their
4. Branding
As companies go global, brand management becomes a key aspect. Customer’s perception for a product varies with the country in which it is manufactured. This urges Multi national companies to concentrate on development of brand and strongly commit to their
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
offerings. This becomes an issue of concern especially for companies that go global before creating a niche brand in the market. Multiple brands and multiple product offerings are to be handled with appropriate concern.
5. Sigma Level
Sigma is a statistical term to express how much a process varies from the target. Sigma level allows comparison of process performance through out the entire organization, pr
5. Sigma Level
Sigma is a statistical term to express how much a process varies from the target. Sigma level allows comparison of process performance through out the entire organization, pr
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
vides figures on overall yield, and DPMO. Though industries have risen to the level of six sigma targeting 3.4DPMO, a lot majority of the companies lie in 3 sigma level where they spend at least 30% of its revenue on defects, corrections, reworks, and rejects. Global companies should have a focused roadmap on improving the sigma level and link them to their business strategies.
6. Global Distribution and lo
6. Global Distribution and lo
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
gistics
With the evolution of global supply chain management, organizations have centralized or decentralized distribution/procurement systems. Applications of appropriate principles of direct shipment, warehousing, or cross docking depending on the Manufacturing/customer locations, customer dispersion and concentration, and transportation involved have saved billions of dollars for multi-national corporati
With the evolution of global supply chain management, organizations have centralized or decentralized distribution/procurement systems. Applications of appropriate principles of direct shipment, warehousing, or cross docking depending on the Manufacturing/customer locations, customer dispersion and concentration, and transportation involved have saved billions of dollars for multi-national corporati
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
ns. Also appropriate push-pull systems are designed to their product and demand requirements. Many companies choose to maintain component level inventory of their standard products and some provide customized parts assembly at the final stages.
7. Human resource & Cultural Impacts in Global scenario
As globalization develops and boundaries shrink, growing economies have started accepting and developing mul
7. Human resource & Cultural Impacts in Global scenario
As globalization develops and boundaries shrink, growing economies have started accepting and developing mul
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
ti-cultural working environments. Companies have already realized the need for greater majority of local employees in their established ventures overseas. These companies spend lot of efforts in understanding and promoting cross cultural communication and motivational activities.
Another vital factor would be the Company’s HR policies, and training and development. HR policies may vary according to the loca
Another vital factor would be the Company’s HR policies, and training and development. HR policies may vary according to the loca
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
human resource standards and their conformance to the international standards. Nevertheless companies must ensure a systematic training structure and curriculum for their employees. This will provide organization’s in maintaining balanced skills among employees multi-nationally.
8. Technology Development
Technology development is the process of research and development of technology. If companies fail to
8. Technology Development
Technology development is the process of research and development of technology. If companies fail to
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
develop innovative technologies, the competitors take a lead. Technology development has become a continuously evolving activity. These technological innovations provide organizations specialization in product centric or process centric areas that help them differentiate in the market place. Growing companies need to concentrate on research and development on key processes that affect their business.
9. Lea
9. Lea
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ing Industry practices
Leading industry practices are methodologies and systems that have evolved over time out of continuous research and development. These industrial practices in technology, application, and service areas are growing in a tremendous pace. Organizations that failed to make efforts to move in tandem with these developments are facing difficulties in moving ahead. On the other hand, practic
Leading industry practices are methodologies and systems that have evolved over time out of continuous research and development. These industrial practices in technology, application, and service areas are growing in a tremendous pace. Organizations that failed to make efforts to move in tandem with these developments are facing difficulties in moving ahead. On the other hand, practic
.
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
ing leading practices provides organizations greater industry recognition, professionalism, cost savings, and also improves employee morale.
10. Exploring market
Companies need to do a market analysis on the trends of the business in their target countries for operations, target market, competitor analysis, government regulations, and so forth. This kind of analysis help companies choose to make an informe
10. Exploring market
Companies need to do a market analysis on the trends of the business in their target countries for operations, target market, competitor analysis, government regulations, and so forth. This kind of analysis help companies choose to make an informe
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
decision on whether to serve the local market or be an Export only Unit.
Conclusion:
These 10 development areas are just part of the extensive list of areas that companies need to concentrate on, nevertheless these would be the most significant ones. The article attempts to highlight some of the modern thoughts and approaches that would help manufacturing industries internationalize in a successful manner
Conclusion:
These 10 development areas are just part of the extensive list of areas that companies need to concentrate on, nevertheless these would be the most significant ones. The article attempts to highlight some of the modern thoughts and approaches that would help manufacturing industries internationalize in a successful manner
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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