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Contract Manufacture Quotation Process Work and its Requirements

Posted by Joe Pignotti on May 22, 2018 10:15:00 AM

To put any medical device design into actual production, the device company needs to obtain quotes from prospective contract manufacturers like Sanbor Medical. While different sources may offer different prices, the process of completing the quote can be similar with different manufacturers requiring comparable pieces of information from the OEM.

The quotation process at Sanbor Medical starts with an RFQ (Request for Quotation) or as some call it, an IFB (Invitation for Bid) from the OEM. Once a non-disclosure agreement is in place the quoting process can get underway.

The contract manufacturer will produce a more efficient and accurate quotation if the OEM provides comprehensive information. This should include files such as:

  • Bill of Materials (BoM)
  • 3D/2D drawings (e.g. Solidworks/Illustrator)
  • Gerber file for PCB
  • Assembly Work instruction
  • Inspection/testing instruction

OEM should have comprehensive design files

Once the information is passed onto the CM, it will be reviewed by operations, engineers, a project manager, and a manufacturing rep. if one is involved. This is the time when the CM and OEM can go back and forth requesting and providing additional supplementary materials. To expedite this step, before submitting your package, ask yourself questions similar to the following:

Do the drawings provide enough information to complete an estimate on tooling costs? Does the product have to meet any certification requirements? Do different components have approved vendors and part #’s included? Are details such as tolerance and power included? What kind of environment will the product be exposed to (harsh climate, biohazards, chemicals, etc.)?

The less additional information the CM must request, the faster and more accurate the quote will be. Our US based project manager can raise some technical questions for the design team at this point.

At Sanbor Medical we try to deliver a low-cost solution plan to our valued customers. It’s important for both the CM and OEM to look at cost drivers and understand how a quote is estimated. Reviewing these factors helps the OEM to ensure they know exactly which services they are receiving within the quote and keeps the final amount down.

Main cost drivers are:

  • Materials
  • Tooling
  • Overhead/margin
  • Labor
  • Packaging
  • Freight/duty
  • Quality control
  • Compliance

Not every CM will offer all the above services like Sanbor Medical. We like to be our customers’ one-stop-shop from the original BoM all the way through getting the product packaged and shipped to our US warehouse. All OEMs filing RFQs should clarify with potential CMs what is included in their quotes to avoid surprise costs being incurred such as duty and/or compliance fees.We aim to provide fast and accurate services

Once everything has been calculated and the final internal review has taken place (typically 1 – 2-week turnaround time depending on project complexity and information completeness) the results will be shared with the customer.

If you are an OEM interested in obtaining a quote for any upcoming projects, please contact us HERE. We would love to hear from you!

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Topics: class III, new product development, medical device turnkey, usa headquarters, global logistics, class ii medical devices, class I medical devices, electronic manufacturing services, off shore outsourcing, off shore manufacture, medical outsourcing, OEM, electro mechanical, contract manufacture, outsource, oversea outsourcing, medical equipment, finished medical device, medical devices, healthcare, medical, quotation process

How to Choose from Different Medical Contract Manufacturers?

Posted by Joe Pignotti on May 8, 2018 9:40:00 AM

Sanbor Medical, as a highly experienced (28 years in operation, 17 years in medical) CM (contract manufacturer), receive lots of inquiries; mostly on Class I & II electronic and electro-mechanical medical devices and high level sub-assemblies.

Our readers may find this topic familiar, as a few months back, we did a Q&A post to address our most frequently asked questions. They can be read right here.

Image of man scientist working in laboratory with microscope

The difference of this particular post, is that we are delving into a specific question related to working with CMs: When is the right time to bring in your CM partner? Many OEMs (Original Equipment Manufacturer), whose wish is to make their design vision a reality, have different requirements. Some will claim that the CM should be involved as early as possible, so they are knowledgeable about all the specifics of the project and the CM may have personal stakes in the product whether it be financial or emotional.

This approach works the best with CMs with a built-in design house. Not every company sees the need to keep engineers on the payroll due to uncertainty of whether or not their abilities would continuously be needed. On top of that, there are multitude of engineers: software, hardware, mechanical, and electrical. Slightly complex medical device may call for all of these capabilities, which is why some CMs, like Sanbor Medical, choose to work closely with a trustworthy design firm For 20+ years. Our design group locates less than an hour away, taking logistics and communication out of the equation.

Now what are the advantages of not keeping the design in-house? Of course one can see the fact that the more hands the design goes through the higher chance of an IP (intellectual property) incident. In Sanbor Medical’s 20+ years of history, we have taken every precaution to protect our clients’ designs and thus never had an issue.

Composite image of doctor looking at xray on tablet

At Sanbor Medical, we are happy to see our clients walk through the door with their innovative designs and are eager to see how we can produce the product as possible while offering significant cost downs. Sanbor Medical’s method of operation a.k.a. with an out-of-house design team provides more security to every project that passes through our hands.

Comparing these two types of CMs, the entry point of a project naturally will be different. A CM with an in-house design team would likely become part of the medical device project group early on, so they can work with the OEM on every change to the design, and the OEM would have moderate control over their project, and have to share much information. 

On the other hand, CMs like Sanbor Medical are engaged when the design is finished their job is to build it to its specifications and make sure it functions properly. In this case, the OEM definitely has full control of the design until they’re satisfied.

Medical contract manufacturing has become a booming industry. According to estimates, the market will expand to $41 billion in the next 5 years. As more and more competition enters the emerging market, naturally an increasing amount of potentially confusing decisions arise for medical OEMs. We at Sanbor Medical hope this blog can help some of you navigate through the tough terrain of not just choosing a CM but determining the right timing to bring them on as your partner.

Workers in motion at modern drug factory-1

Please feel free to check back for our future updates, maybe the next blog will be the exact information you are looking for! Tune in for more insider knowledge, market trends, new technology… etc.

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Topics: FDA, new product development, transfer product, new product introduction, medical device turnkey, vertically integrated, usa based, usa headquarters, global logistics, supply chain consolidation, class ii medical devices, class I medical devices, electronic manufacturing services, finished medical device, off shore outsourcing, off shore manufacture, medical outsourcing, OEM, electro mechanical, oversea outsourcing, contract manufacture, outsource, medical equipment, medical devices, healthcare, medical

The Importance of DHF, DMR, and DHR

Posted by Joe Pignotti on Apr 24, 2018 9:45:00 AM

We’ve mentioned the three Ds of medical device manufacturing previously on this blog; they play a significant role in bringing any device to the market and they each need to be carefully managed throughout the entire design and manufacturing processes. In simple terms, a DHF (Design History File) marks the start of a particular device and how an OEM arrived at the final design, followed by a DMR (Design Master Record) which details the specific material, equipment, and environment requirements for production, and the manufacturer maintains a DHR (Design History Record) which has all the documentations during the production process such as date produced, quantity, and labels of the final products.

 

Many files need to be documented through out the entire design and manufacturing processes.

 

Let us take a closer look at what each of them entail:

Medical Device Companies (OEMs) will design and develop their product either internally or with the aid of an outside engineering firm. The process will be recorded in a DHF maintained by the OEM.

DHF (Design History File): the collection of documentations created as you go through the design and development processes that documents the evolution of the design including user needs, design inputs, reviews, risk assessment, a plan for making the device which could include manufacturing processes, verification, validation protocols and reports etc. It should contain or reference the records needed to demonstrate that the design developed is in accordance with the approved design plan and the requirements of 21 CFR Part 820.30. Any future changes on the original design will also need to be reflected by updating relevant files.

The DHF will need to be submitted to the FDA at this point, along with its documents, for either a 510k (Class II) or Pre-Market Approval or PMA (Class III). The FDA reviews the design and product for safety and efficacy, and has the final say on whether or not the product is approved for market.

After obtaining FDA approval, the OEM can move forward and start manufacturing the product in-house or entrust an experienced contract manufacturer like Sanbor Medical. We will work with the OEM during the process to ensure the next set of records are managed in accordance with FDA requirements.

DMR (Device Master Record): a compilation of the procedures and specifications for making the finished device and testing it, including design specifications (drawings, composition, formulation, component and software specifications), process documents, tools and tooling specifications, production methods, environment specifications, inspection procedures, quality assurance (acceptance criteria, QA equipment), labeling and packaging, and service details. Many of these files should be already available if a proper DHF was created, and they can be simply referenced here. The focus is to ensure that the manufacturer has all of the necessary items to build, test, package, and maintain the device.

DHR (Device History Record): the production history of a finished device. Includes: lot #s or UPCs (important for complaint investigations), manufacturing dates, quantity manufactured and distributed, acceptance records that shows the design followed the DMR, and labeling for each unit. If the OEM gets audited, the investigator may wish to see a DHR and compare it to the corresponding DMR to check for compliance. If a contract manufacturer is used during this process, the DHR has to specify who reviews and releases the product.

 

The OEM and the contract manufacturer of their choosing need to work together to be compliant in accordance to FDA.

Efficiently managing the three Ds is crucial for regulatory compliance. An OEM will start with a DHF for each type of their devices, collecting documents as the design process moves along. Then for the manufacturer comes the DMR which is essentially all the procedures and specifications on how to actually build the device, according to all the design inputs in the DHF. When the device is actually put into production, the DHR is maintained to show that everything follows the DMR. Since each of these collections of files and records relies on the completeness of the previous files, if any necessary documents were missing, it would greatly affect later documentations and references. If the OEM provides all the necessary documents, Sanbor Medical can deliver the exact same product as the OEM would if they were building it in their in-house facility.

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Topics: new product development, transfer product, new product introduction, medical device turnkey, vertically integrated, usa based, usa headquarters, global logistics, supply chain consolidation, class ii medical devices, class I medical devices, ems, electronic manufacturing services, finished medical device, off shore outsourcing, off shore manufacture, medical outsourcing, OEM, electro mechanical, oversea outsourcing, contract manufacture, outsource, medical equipment, medical devices, healthcare, medical, DHR, DMR, DHF, FDA, compliance, class III, pre-market approval, PMA, 510k, regulatory

What's the Importance of Medical Patents & How Do We Protect Your IP?

Posted by Joe Pignotti on Apr 10, 2018 9:45:00 AM

 

Patent application itself involves countless documentation

 The development cycle for a new medical device is extremely taxing on its OEM; there are many questions which the OEM must ask themselves before delving into the lengthy process from research and development to having a marketable product.

Some important examples are: Is the medical device using any new technology? Are there third parties who are already marketing a similar product? Do they hold a patent on the device technology? If yes, when will it expire?

To understand the importance of medical patent filing and how challenging applications may be, we should look at some statistics first.

In 2017, out of all the patents filed in the US, the EU, China, and a few other prominent regions combined, the medical technology category had the most applications received for patent approval, and the number is only growing each year. Just in 2017 there was a 6.3% increase in medical patents filed when compared to the year before, and the trend only seems to be continuing.

 

So why are companies so concerned about filing patents on their new products?

 

The process involves lawyers, design engineers, process engineers... etc.

Medical research and development is a very demanding process. On average, it takes 10-15 years and $1.6 billion to apply and complete all the necessary trials to prove the safety and effectiveness of a new technology or pharmaceutical, which is a huge investment for any organization.

Along with high development costs, the need for patent application and later FDA approval results in an even longer lead time to market. For the device to be able to reach its market, OEMs also have to ensure it is high quality and performs perfectly. With all of these barriers, there must be good enough incentives for the private sector to provide the funding needed to advance current medical technology. Without proper intellectual property protection at the fruition of years of hard work and investments, any other company could easily copy their research results and put out a competitive device without putting in any of the work or funding.

Patents complete a circle of supporting the researchers and investors for sacrificing years and millions if not billions of dollars. They allow the companies to recoup what they’ve spent during the long R & D process while the patent is active, so they can re-invest the profit that comes from keeping their new technology exclusive. Essentially, patent protection makes developing new technologies attractive for investors and possible for researchers, and moves the industry forward.

 

What does Sanbor Medical, as a contract manufacturer, do to give your medical intellectual property the maximum protection?

 

Our staff will ensure the confidentiality of your product design and technology.
  1. Sanbor Medical owns its factory in China.  All of the production work is done by our own employees, who have signed a confidentiality and non-compete statement. We do not contract out orders to uncontrolled factories.
  2. All product documentation from clients is reviewed and then made anonymous by our US project management engineers before being sent to the factory. All identifiers such as name or address are removed and the project itself will be code named.
  3. Clients place orders with Sanbor Medical’s HQ office in Allentown, PA. We then act as a secondary barrier and place the order with our factory.
  4. No single employee has full access to all documents at the factory.
  5. Sanbor Medical is a U.S. company, thus providing legal recourse should any problem arise.
  6. In the 20+ years since the factory was incorporated in China and wholly owned and operated from the U.S. since 1993, we have never had an IP incident.
  7. IP protection laws are catching up in China and becoming stricter as Chinese firms are now developing their own products.

With our impeccable record with keeping our customers’ intellectual property confidential, Sanbor Medical is a great choice to trust your new product with. We are always thrilled at the opportunity to work with new designs. April 26th is World Intellectual Property Day, we hope you celebrate it by choosing a reliable strategic partner like us!

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Topics: new product development, transfer product, new product introduction, medical device turnkey, vertically integrated, usa based, usa headquarters, global logistics, supply chain consolidation, class ii medical devices, class I medical devices, ems, electronic manufacturing services, finished medical device, off shore outsourcing, off shore manufacture, medical outsourcing, OEM, electro mechanical, oversea outsourcing, contract manufacture, outsource, medical equipment, medical devices, healthcare, medical

Is Your Contract Manufacturer Efficient and Knowledgeable To Help You Through the FDA Process?

Posted by Joe Pignotti on Mar 27, 2018 9:45:00 AM

 

Red Ring Binder with Inscription Compliance on Background of Working Table with Office Supplies, Laptop, Reports. Toned Illustration. Business Concept on Blurred Background.

We have discussed the various aspects of choosing a contract manufacturer before, some of the past topics can be read here, here, and here. In this post, we are going to examine what it takes for an OEM (Original Equipment Manufacturer) and their partner CM (Contract Manufacturer) to get the seal of approval from the FDA, and get that finished device onto the market.

One of the big barriers of enabling the product to enter the market is having to meet government regulations. Any medical device must reach regulatory compliance under the FDA’s standards, and depending on the type of device and the complexity of its regulations, this process can turn out to be quite time and resource consuming.

On the OEM’s side, after they have chosen an efficient and trustworthy contract manufacturer like Sanbor Medical, they will need to have a DHF (Design History File), which is a compilation of their new device’s full record of design history. It is then submitted, along with other countless documents, to the FDA for approval. If everything meets the FDA’s requirements, Class I devices will obtain a 510k approval and Class II will have a Pre-Market Approval (PMA).

 

close up of conference meeting microphones and businessman writing

 

With protecting the consumers in mind, the FDA then reviews the device’s design for its safety and efficacy. The final product needs to fulfill all of its claims while remaining absolutely safe to use for the user.

After obtaining the FDA’s approval, things move on into the hands of your trusted contract manufacturer. During Sanbor Medical’s production cycle of your device, we maintain records in strict accordance to the FDA’s regulation 21 CFR part 820, which mainly consists of two sets of records:

  • Device Master Record (DMR) includes: device specification, production process specifications, quality assurance procedures and specifications, packaging & labeling specifications and installation, maintenance and servicing procedures and methods.
  • Device History Record (DHR) includes: dates of manufacture, quantity manufactured, quantity released for distribution, acceptance records, primary identification label, and any unique device identifier (UDI).

 

On top of the impeccable record keeping, as the manufacturer Sanbor Medical must also validate all of the manufacturing methods and processes. Validation means confirmation by examination and provision of objective evidence, that the particular requirements for a specific intended use can be consistently fulfilled. Then comes process validation, which means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.

Without any of the aforementioned records, a finished product will not be allowed on the market. These records are not collected at the end of the design or manufacturing cycles, but instead, need to be carefully and thoroughly documented as each step of the processes moves along. Record keeping should be one of the most essential parts of designing and making a medical device. Sanbor Medical is always following every requirement of the FDA’s 21 CFR part 820, so when it comes to trusting your Class I & II devices and sub-systems to an experienced contract manufacturer that will adhere to all of the necessary government standards, Sanbor Medical will be an excellent choice for you.

 

Our facility is also ISO 13485 certified and QSR compliant, but that will be a topic for another day. You can look forward to future articles on more subjects by subscribing to our email updates and checking back with us for our bi-weekly blog posts.

Don’t forget Sanbor Medical is always here for your comments or questions, and we are eager to help you with your next exciting project. Simply contact us here or click on any of our contact links at your convenience!

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Topics: new product introduction, finished medical device

FAQs - What questions does Sanbor Medical receive the most

Posted by Joe Pignotti on Mar 13, 2018 1:55:00 PM

Now that you have some excellent background knowledge from our last four blogs of Sanbor Medical’s history, capabilities and quality standards for the Medical Device market, we would like to fill in some further details in the form of FAQs we receive when speaking to potential new customers. We selected four of the 15 or so FAQs to share with you here. The balance can be viewed in our content offer.
So, here you go, please enjoy and we hope this whets your appetite to review all of our FAQs:

1) Risk mitigation for disasters/ emergencies:
    The following are emergencies that our company may encounter:

a) fire

b) natural disasters (typhoon, heavy rain, and earthquake)

c) power and water blackout

d) occupational injuries, infectious diseases, food poisoning

e) labor shortage

f) material shortage

g) critical equipment failure

h) after-sale returns

All of these emergencies are defined in detail in our Quality Manual for your review. Production recovery and unplanned material shortages which I’m sure are of most relevance to our customers are outlined in sections 4G and 4.7 respectively.

2) What are the typical lead times for an initial order?
    Since we are a custom contract manufacturer there are no specific lead times.
    Based on the documentation provided and our experience with various devices, including the complexity we estimate the              product to be in mass production within 12-16 weeks after receipt of order, including ocean freight, which is the standard              shipping method.

a. Ocean Shipments are consolidated and sent on a regular basis to the LA warehouse. Transit time is approximately 3-4 weeks for ocean transit and importation, and up to one week for US ground delivery to the customer site.
b. Air shipments are typically done via the customer’s preferred carrier or FedEx. Transit time for air shipments is approximately 3 to 5 days following shipment from the factory through customs clearance.

    The following are typical tasks that are included for a device:
a) Sanbor Internal tasks such as creating part numbers, BOMs, inspection standards and work instructions
b) Material lead time
c) Drawing creation
d) Tooling (including Molding)
e) If there is sterilization required that can add time as well dependent on the type IE, ETO, Gamma etc.
f) Creating F/A’s
g) Production


3) What are the most complex products you produce?
    a) Product with 150+ parts, 4 PCBs and a large aluminum frame.
    b) System with 100+ parts, 2 PCBAs, 17 molded parts, with EPS shipping container.


4) What are the differentials that separate you from competitors?

    Of the nine value propositions we reference below the value props that resonate with our customer base are as follows:

    a) Sanbor Medical provides Manufacturing Outsourcing EXCLUSIVELY for the Medical Device Market- NO General Industrial Products
    b) We are vertically integrated- we produce plastic molding and stuff the printed circuit boards in house.
    c) We have all of the quality credentials you would expect for a Contract Manufacturer marketing to the Medical and Life Science              markets; FDA registered factory, ISO 13485 and QSR compliant.
    d) And finally the factory is wholly owned and operated from our Allentown, PA corporate office with USA based contacts for all                 your communications throughout the life span of your products.

Value Prop Chart

 

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Topics: off shore outsourcing, electro mechanical, medical, medical device turnkey, usa headquarters

Looking to Outsource Your Medical Device? Sanbor Medical is THE Choice.

Posted by Joe Pignotti on Feb 27, 2018 9:30:00 AM

 

Tech working on a machine in a medical facility.

One of the major trends currently in the medical device industry is the increase in medical device outsourcing. Globally, the outsourcing market is forecasted to grow 11.5% over the next seven year period, while the U.S. market is steadily growing at 1.5% annually. The reason a medical OEM would choose to have their production carried out overseas, instead of close to home in the US, is very straightforward: cost cutting.  By outsourcing their devices’ production offshore, to where the factories can offer lower total costs, these OEMs accomplish their cost cutting goals.

        New taxes and regulations, eroding price margins and the pressure on shorter production cycles have also made outsourcing offshore quite an enticing option. A new industry tax was introduced as part of the Affordable Care Act in 2013 and came into effect recently, on Jan. 1, 2018. In addition to hospitals having tighter budgets, faster production cycles, and other regulations that are already pushing medical device manufacturers to further squeeze their profit margins, the medical device excise tax forced medical OEMs to cut even more costs in order to stay competitive.

        Every company looks for advantages over their competitors, who are trying to appeal to the same group of consumers as they are. Just like these medical OEMs, their consumers are also making their purchasing choices based on price, as long as it still meets all of their standards.

        Since consumer choice dictates the direction of the market, and they want cheaper products, so too the medical device OEMs want cheaper products.

        OEMs faced with this cost dilemma, even after staff cutbacks and reduced R&D spending, find their answer in offshore manufacturing.

 

Two techs working on the monitor of a medical machine.

Once they shift their production offshore, the question becomes how to choose the right contract manufacturing partner. It’s a strategic decision as important as choosing to outsource rather than produce in-house. With a massive and still growing contract manufacturing industry, making the right choice becomes harder and harder. It only makes sense for medical device manufacturers to choose to work with contract manufacturers who can offer low shipping costs, or, like Sanbor Medical, those that include shipping as part of their service. Our customers only have to worry about picking up their finished device from our California warehouse. When we quote our customers, we include even the soft costs in the manufacturing process so they know exactly what they will be paying for. (Our blog on consolidation has a handy chart to help you visualize this.)

        Another consideration medical OEMs have is what some refer to as “Asia Fatigue”. Many offshoring companies did not consider the time difference between the overseas factory and the US’s time zones when they decided to go offshore. We at Sanbor Medical made it our priority to eliminate this issue for our clients by having a fully functional headquarters in the US. We work at the same time as our clients and speak the same language as them thereby completely eliminating the 12-hour time difference and language barrier. Sanbor Medical’s service and staff are available whenever you need them.

        In our last blog we addressed that Sanbor Medical possesses a FDA registered, QSR compliant manufacturing space with a clean room and all of the credentials an offshore factory can offer to make sure the finished products shipped to the US adhere to all quality and regulatory standards.

        With such high demand for outsourcing coming from countless medical device OEMs in need of competitive prices, there exists many offshore factories trying to offer their low prices with quality devices. When choosing the right strategic partner as your contract manufacturer, price is only one factor to consider. Sanbor Medical has over 17 years of experience in this field, has all the qualifying certifications, and has a US Headquarters to provide timely service. These are qualities that are very rare to find consolidated into one single medical device manufacturer.

         If our expertise has piqued your interest, please contact us either through the form below or directly through email or phone at sales@sanbormedical.com or 484-664-2673.

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Topics: new product development, transfer product, new product introduction, medical device turnkey, vertically integrated, usa based, usa headquarters, global logistics, supply chain consolidation, class ii medical devices, class I medical devices, ems, electronic manufacturing services, finished medical device, off shore outsourcing, off shore manufacture, medical outsourcing, electro mechanical, OEM, oversea outsourcing, contract manufacture, outsource, medical equipment, medical devices, healthcare, medical

Medical Production & Regulatory Compliance: Are You Meeting Them ALL?

Posted by Joe Pignotti on Feb 1, 2018 9:00:00 AM

                Among the many strategic partners with which a medical device company can choose to work with to help them take their product(s) from design to reality, there is a myriad of criteria that sets each of them apart. Some only provide specialties such as tubing or metal components, some can have a range of capabilities to serve general industrial needs; and some, like Sanbor Medical, choose to exclusively focus on the medical market and offer our contract manufacturing services only to companies in the medical industry. 

Products made by Sanbor Medical

        At Sanbor Medical, we make the conscious choice to exclusively serve medical device businesses for a few reasons: First, we believe by focusing our training, production and quality assurance on this single, innovative market, our team of dedicated personnel has the chance to elevate their expertise in this field while accumulating hands-on experience in an industry that exists to improve lives. 

       Second, we are more than equipped to handle the required necessities to produce the advanced designs our clients bring to us. Sanbor Medical has been in the medical industry for more than 17 years, and throughout the almost two decades, we have accumulated invaluable experience that only comes from being a steady participant in the medical market for such a long time. We have worked with many big name corporations and manufactured their designs not only to their exacting standards, but to the  FDA's as well. 

          Third, we trust that only by exclusively serving the medical industry, can we enable ourselves specific capabilities and compliance knowledge that a general contractor may never have the chance to encounter. Sanbor Medical prefers Class I and II devices, and higher-level assemblies which are manufactured in our FDA registered facility. Our production facility, which is located offshore in Xiamen, China, maintains and remains QSR compliant. We are proud to say that Sanbor Medical built its first ISO system in 1998. In 2005, we became ISO 13485 certified and FDA registered. Our factory is complete with a white room environment and we fully adhere to the 21 CFR Part 820 Regulations for DHR and DMR maintenance. 

 

 Medical staff needs to be very careful when inside a clean room. With our high standards Sanbor Medical and its qualified, dedicated team are more than excited to see what our next project will be. If you're a medical device OEM and are ready to team up with Sanbor Medical to produce your next high-quality device, contact us to learn more! 

Our helpful US HQ, located in Allentown, PA, would be happy to connect you to our Xiamen facility. Potential clients are more than welcome to tour our factory, confirm that all of our certifications are up to date and see our passionate employees that thrive on being a part of something that can help a great deal of people. 

                Sanbor Medical believes in the quality of our top-notch services and our past customers can definitely testify that they were more than  satisfied with our thorough services throughout the entire manufacturing process. Our dedicated team is always excited to hear from you about any potential design(s) and is eager to let you know how we can help in turning your design into a finished product. We are ready to help people who have been desperately waiting for such a device! Don't hesitate to click any numbers or Contact Us links on the page or just press the button below to get in touch with our team, and let us see how we can best assist you! 

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Topics: medical outsourcing, new product development, new product introduction, transfer product, medical device turnkey, vertically integrated, usa based, usa headquarters, global logistics, supply chain consolidation, class ii medical devices, ems, electronic manufacturing services, class I medical devices, off shore outsourcing, off shore manufacture, finished medical device, electro mechanical, OEM, contract manufacture, oversea outsourcing, medical equipment, outsource, medical devices

Why Medical OEMs Are Consolidating within and Across Commodities

Posted by Joe Pignotti on Jan 23, 2018 9:51:43 AM

Medical technology is advancing everyday.                 This is a problem that we Sanbor Medical are sure that medical device and equipment makers have faced at one point or another: having to find, deal, and coordinate multiple suppliers just to produce a single finished product. We set out to solve this problem for makers in the industry, by helping our customer consolidate their supply base by commodity.

                To achieve this, Sanbor Medical has made our production capabilities varied and consolidated so our customers no longer have to look for multiple vendors to get one job done. We can handle printed circuit board assemblies, cable assemblies, injection molded plastic parts, etc. But most importantly, Sanbor Medical will gladly further consolidate all the different components into higher level assemblies.

A flowchart showing what Sanbor Medical's commodity consolidation can do.

                Our goal is for our clients to be able to come to us with their design, and through working with our professional team, to have a completely finished product ready for the market or a sub-assembly ready to integrate into a larger assembly, without the customer having to seek out any additional suppliers during the process themselves.

                Currently for many OEMs, the typical process involves dealing with several commodities each with its own supplier. To reduce costs, which is the ability Sanbor Medical is offering by having vertically integrated production, these OEMs are going to consolidate their suppliers down as much as they possibly can with their vendors.

                Sanbor Medical can come in during any of the steps while OEMs are trying to cut down vendor cost, but we aim to offer the best price reduction by being the single supplier for cables, PCBAs, and plastics, and we are not stopping here. We have the capabilities of combining multiple commodities and take over assembling them or finished products.

                To recap, many OEMs have to endure the process of first finding necessary commodities from multiple suppliers, then try to consolidate the process, and finally work with a production house to have their product finished. At Sanbor Medical, the difference we offer is we take away all the work for OEMs to find and consolidate commodities or finding that right manufacturer.

A chart comparison of using multiple vendors and only Sanbor Medical

                We do it all here at Sanbor Medical. We help our customer consolidate their supply base by commodity, have the capabilities of assembling cable assemblies, PCBAs, injection molding plastic etc. and most importantly, we can assemble your whole finished product or sub-assemblies.

                By choosing Sanbor Medical, it’s not just about cost cutting, we also save you the headache and time with our vertically integrated capabilities by consolidating the customer’s supply chain. Our stateside HQ is excited to see medical OEMs’ innovative designs and bring them into reality. Contact us anytime and we are ready to save you money while delivering high quality finished devices!

 Request an outsourcing assessment

Topics: new product development, transfer product, new product introduction, medical device turnkey, vertically integrated, usa based, usa headquarters, global logistics, supply chain consolidation, class ii medical devices, class I medical devices, ems, electronic manufacturing services, finished medical device, off shore outsourcing, off shore manufacture, medical outsourcing, OEM, electro mechanical, contract manufacture, oversea outsourcing, outsource, medical equipment, medical devices, healthcare, medical

Buy or Build – Outsourcing Healthcare Equipment and Devices

Posted by Joe Pignotti on Nov 14, 2017 2:26:06 PM

Front of Sanbor Medical's Xiamen, China Factory

               The healthcare industry is constantly expanding while companies are outputting complex equipment and devices made with cutting-edge technology.  The current trend manifests itself in increasingly complex solutions entering the market, often involving many high level electro / electro-mechanical sub-assemblies. On top of the demanding manufacturing capabilities required to create proficient equipment and devices, quality control and regulatory compliance will continue to drive up total costs.

                Eventually all manufacturers run into a crucial decision: should you BUY or BUILD? The costly production can either be held in-house after meeting the necessary capital/material/labor standards, or can be contracted out to an outsourcing partner

Comparing manufacturing in house, outsource to contract manufacture, and by Sanbor Medical.

 

                Build In-House

                The biggest reason a manufacturer would decide to undertake their own fabrication is the advantage of maintaining full control over all of the individual aspects. The maker will be in charge of overseeing the entirety of the production cycle, but also fully liable for tackling any delays or mistakes encountered on the way.

                Although building new capabilities means accepting more risks, keeping staff directly involved in the manufacturing procedures builds experienced, loyal, and dedicated individuals who will become more knowledgeable and dependable than contracted services.

                Device producers may shy away from contracting out complicated processes due to intellectual property (IP) issues. Contract manufacturers, such as Sanbor Medical, take every preventative measure to alleviate potential concerns. To ensure maximum protection of sensitive proprietary information, serious care is taken to never share important documents within the organization, erase all company and product name mentions, and distribute design files of components among different teams, just to name a few. IP may be considered safer if the equipment or device stays within the OEM from start to finish, but vulnerability can still be present within a business' own employees

               

                Buy Finished Products from a Third Party

                The best argument for outsourcing a product is cost efficiency. Contract manufacturers often divert resources to concentrate in particular areas of their choosing, and through this specialization they are able to offer prices sometimes far below what an OEM can manage in-house.

                Offloading the production lets equipment and device OEMs avoid having to make huge, long term commitments. Smart companies choose a single contract manufacturer instead of investing finite resources and time into setting up the space, equipment, hiring and training new staff, packaging, testing, and logistics. Additionally, when industry trends and consumer tastes inevitably change, companies who did not tie themselves down with pre-existing infrastructure have an upper-hand over their competitors in the form of flexibility. They can now more easily adapt to market shifts.

 

Should you build in house or outsource?

                The Decision

                With each new project comes the choice of trusting a strategic outsourcing partner or doing-it-yourself, and both methods have their pros and cons. Certain manufacturers are unsure about not having all of the control over the production and potential IP worries, while others carefully identify a dependable third party to handle the fabrication for the sake of versatility, cost efficiency and a timely turnaround.

Each participant of the healthcare market has the freedom to do either but for those who are ready to start selecting a reliable electro mechanical contract manufacturer, Sanbor Medical is HERE to help every step of the way! Request to speak to one of our experts on outsourcing your medical devices. 

Request an outsourcing assessment

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Welcome to Sanbor Medical's home for the latest in Contract Manufacturing news, solutions, products with a leading medical device CM for electronic and electro-mechanical handheld, desk top devices and subsystems.

This is place to learn from the experts who can assist you if you don’t have the intensive manufacturing infrastructure for your devices.

Please partner with Sanbor Medical to build your entire device or improve the manufacturability of your device.

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