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Main Subject - Attributes of a Good Outsource Manufacturing Partner
Careful consideration must be given when choosing and working with an outsource manufacturing partner. Although each situation is unique, there are common characteristics that make for a reliable outsource partner.
One company that caref
One company that caref
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
ully analyzed the determining factors of a successful outsource partnership is VIASYS Healthcare, a global leader in health care technology. VIASYS manufacturers, markets, and services medical devices, instruments, and medical/surgical pr
; 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
oducts for use in respiratory care, neurocare, medical systems, and orthopedics. VIASYS is known for its solid history of innovation, superior product performance, and a commitment to customer service, yet they achieved this success while
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
outsourcing more than 75 % of the assembly of each of its product lines. To complicate matters even more, VIASYS currently outsources to Canada, Mexico, the United Kingdom, Germany, Italy, China, and Thailand. Their two biggest outsourcin
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
g facilities are in China and Guadalajara, Mexico.
Managing this many outsource relationships is a huge task and required them to create a criterion matrix to choose and measure their different outsource partners. After careful considera
Managing this many outsource relationships is a huge task and required them to create a criterion matrix to choose and measure their different outsource partners. After careful considera
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
tion, they focused on four major criterions: Quality (the most important), Cost Savings, Work Relationships, and Geography (the least important). Specifically, the criterion is defined as follows:
Quality: Within each outsourcing facilit
Quality: Within each outsourcing facilit
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
quality and control tests are done for each product by the team of Operations and a team of Supply and Quality engineers. If the products do not pass the control tests, the product is discharged. Product testing and inspection is very cr
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
itical for VIASYS since they provide health care products that consumers rely on for life support.
Cost Savings: VIASYS studies the total cost of ownership when making a decision whether to outsource a product or not. For example, one h
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
igh-volume consumable cost $5 to produce in California and in China it only costs $.50. In this case a 90% percent savings justifies the significant investment and risk of sourcing from a geographically remote supplier.
Work Relationshi
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
: VIASYS chooses to outsource with reputable companies. In addition, they maintain continuous communication with the outsourcing facilities through weekly program management and conference calls in addition to one on one telephone convers
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ations, all of which are facilitated after hours to accommodate the different time zones.
Geography: VIASYS looks at the current economy of the country as well as the politics in order to give them an idea of the current status of the
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
local health of the geography. In addition, they look at the local environment where prospective outsource supplier’s facilities are located to confirm not only that it is in good condition but also to be assured the location is safe.
A
A
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
ditionally, VIASYS chooses their facilities based on how well their manufacturing practices are, such as higher quality, faster lead time; whether or not they comply with Good Manufacturing Practices (GMP) and the ISO standards, company r
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
ating, profit capability, and last but not least, the employee-turnover rate. Also, VIASYS supply chain group outsources for a minimum of two years within each country for the longevity of each product. They feel that two years gives the
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
m a good idea of the type of service and quality they receive.
Still risk exists for VIASYS and they must mitigate this risk with vigilant measurement and management involvement. There are risks involved in all the industries, be it poli
Still risk exists for VIASYS and they must mitigate this risk with vigilant measurement and management involvement. There are risks involved in all the industries, be it poli
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
ical, social, or economical. VIASYS follows various practices to mitigate their risks from unforeseeable factors. They carry safety stock for most of their products. For example, they store three-month inventory instead of one-month suppl
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
y. VIASYS also carefully segments their market, which protects them by not assigning too much control to a supplier. VIASYS maintains frequent communication with their suppliers, and employs various methods to audit the facilities weekly
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
to ensure appropriate internal control.
Additionally, VIASYS has a very open mind and is well aware of their social responsibilities. They work with the outsourcing facility to ensure that the workers are working under good working condi
Additionally, VIASYS has a very open mind and is well aware of their social responsibilities. They work with the outsourcing facility to ensure that the workers are working under good working condi
.
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
ions and there is no child labor involved. VIASYS oversees the whole process; however, local customs vary from region to region.
This example of successful outsourcing is not necessarily unique but it is definitely a Best Practice. Outso
This example of successful outsourcing is not necessarily unique but it is definitely a Best Practice. Outso
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
urcing is a trend that continuously evolves and is driven by the relentless push for low cost, quality, and improved profitability. To this end choosing and managing your outsource partner is a critical element of a successful partnership
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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