Toll Manufacturing vs. Contract Manufacturing: What is the Difference

Medical devices are in high demand and companies who provide them often compare the efficiencies of toll vs contract manufacturing for the best output of their equipment.

With an increasing frequency of chronic illnesses and continuing novel technological discoveries in medical and life sciences fields, the medical device manufacturing industry is rapidly growing. For every Medtronic or DuPuy Synthes, there are countless smaller and startup medical device manufacturers (MDMs) who often lack the deeper pockets needed to underwrite manufacturing costs. Outsourcing these costs has long been used to help turn ideas into reality.

That’s where companies look to farm out this manufacturing process and need to decide if toll vs contract manufacturing is right for them. There are benefits to each, depending on circumstances such as timing, budget and demand, so it is important to explore the differences to understand the right approach for the particular need.

The main difference between toll vs contract manufacturing lies in the process, and often there is confusion between the two. Both manufacturing arrangements involve outsourcing of production with the intent of easing the burden and cost associated with manufacturing while reaping the benefits of state-of-the-art facilities, technologically advanced machinery, and skilled workforces. These on-demand service models are ideal for new product development, seasonal projects, and testing products by utilizing a variable-cost operation.

Toll Manufacturing

With toll manufacturing (AKA “toll processing”):

  • an original equipment manufacturer (OEM) provides a third-party manufacturer with raw materials or semi-finished products in order to complete a manufacturing process.
  • the manufacturer is fully equipped with the necessary production equipment and specialists.
  • the toll manufacturer charges the company a fee (a toll) to complete a job.

Drake Medical Plastics acts as a toll manufacturer when we receive customer owned and sourced materials such as high performance, specialty polymer resin and convert these materials into desired shapes such as rod, tube, plate or film. Our customers are thereby able to develop the exact product they envision, without the time and capital investment required to build their own manufacturing operation.

This option not only saves the customer in capital expenses, but they can rely on us to ensure that there is the kind of quality control that they require. We have state-of-the art capabilities and stay plugged into the latest technology and processing procedures, so our customers don’t have to concern themselves with outdated production techniques. We also ensure the highest quality additives to give polymers the peak performance that our customers demand.

Contract Manufacturing

With contract manufacturing:

  • companies outsource the entire production process to the third-party.
  • the contract manufacturer selects the vendors for all supplies, purchases all the materials for the production process and, finally, produces the final product to the source company’s specifications.
  • a contract manufacturer quotes the final price at which he will supply the product, and the source company is concerned only with this price. Any variations in the prices of the raw materials are the concern of the manufacturer only.

Drake Medical Plastics acts as a contract manufacturer when injection-molding and machining our FDA registered, implantable PEEK orthopedic anchor screws to the MDM’s specifications.

What to look for in a Contract Manufacturer

If you are an OEM in the medical field, you know that demand is greater than ever to provide medical facilities with the most state-of-the-art equipment possible. It has to be reliable, built to perform and long lasting. In the medical industry, annual estimates expect total revenue of medical equipment to reach $208 billion by the year 2023 and over $612 billion globally by 2025.

For this reason, a number of smaller companies have entered into the manufacturing marketplace. Understanding the criteria for sourcing the most reliable toll and contract manufacturers is imperative to keeping an OEM’s supply chain on track to meet industry needs…and requirements.

The most important factors that an OEM should look for in a contract manufacturer are:

years of experience in sourcing, competitive pricing and assembly of top-quality components

reputation for staying on top of trends, new techniques, and equipment

partnering with OEMs to provide more vertical resources to integrate competencies for better efficiency

keeping tabs on upstream product design and offering new solutions to evolving needs and requirements

Why Many Choose “American Made”

So many companies think that if they want to save money, they should outsource their manufacturing to companies in Mexico or the Far East. There are many reasons why, whether a company wants toll vs contract manufacturing, it is best to keep the process in this country.

While the labor is cheaper in other countries, the quality may be too. Technology changes are rapid and the workers in other countries are not trained often enough to keep up. The equipment used for manufacturing is expensive to maintain, and the rigorous QA that most manufacturers in the United States live by is far superior to the environment elsewhere.

Finally, the cycle time of offshore production can be a huge issue. Most OEM’s want their equipment ready in record time and waiting for shipments to arrive and go through the customs process can create unwanted delays. If the goods are received on one coast and must be shipped, that extra step can also create headaches for an OEM.

No matter the size of the medical device manufacturer or their stage of production, contract and toll manufacturers allow companies more flexibility while easing the burden and cost of in-house manufacturing.

A Guide To FDA Registered vs Approved Medical Devices

The US Food & Drug Administration (FDA) is the primary regulatory body for medical plastics and the devices they are used to create. According to the administration’s own data, it regulates more than 6,000 medical devices, but it does not regulate them all the same. Medical devices are split into three regulatory categories, termed Class I, Class II and Class III. The devices are regulated depending their assigned class. This also determines whether the device is considered FDA Registered, FDA Listed, FDA Cleared, or FDA Approved.

 

How Medical Devices are Classified

Medical devices are placed into one of three classification buckets, depending on how much potential for harm the device possesses should it produce complications or not work properly.  Here is a closer look at each classification:

  1. Class I – Class I devices are those with little or modest risk to the user or patient. About half of all medical devices are in this category. Of Class I devices, only five percent go through a premarket notification process. The other 95 percent can be marketed and sold without a premarket notification to the FDA. Examples of Class I devices include bedpans, manual stethoscopes and elastic bandages.
  2. Class II – Class II devices possess more potential risk for users than Class I devices. Slightly more than 40 percent of medical devices are placed in this category, and include things like infusion pumps, powered wheelchairs, and air purifiers. Most Class II devices require a premarket notification to the FDA. However, the regulatory process is not as demanding as it is for Class III devices.
  3. Class III – Class III devices often sustain or support human life, are implanted, or present high levels of risk to a person if they do not work properly or break. So, they carry substantial risk of serious injury or death should they fail. Only about 10 percent of devices are placed in the Class III category, and examples include replacement heart valves, cochlear implants, and many implanted electrical stimulation devices such as implanted cerebellar stimulators. The FDA regulates Class III devices to a degree it reserves for nothing else, so Class III devices must be proven to be safe, with supporting research data.

 

What FDA Listed, Registered, Cleared, and Approved Mean

Only a small portion of all medical devices go through an extensive regulatory process. Of the remaining devices, some proceed through a shorter, expedited process, while many do not require any premarket approval. The FDA uses words like listed, registered, cleared, and approved to differentiate between these processes and communicate the FDA’s involvement in the product’s approval. Here is what the terms actually mean:

  1. FDA Listed or FDA Registered – These synonymous terms are normally reserved for Class I devices that do not go through a premarket notification process. However, manufacturers are still required to list or register their product with the FDA, so if users or patients do experience adverse effects, the FDA can track the manufacturer down. That’s it, though, so when a device manufacturer states that their product is FDA listed or registered, that does not necessarily mean the product was tested. It just means that the manufacturer has informed the FDA of their product’s existence. In short, these terms do not say much about the product’s safety or effectiveness.
  2. FDA Cleared – If a manufacturer claims that their product has been cleared by the FDA, they are likely referring to a Class II device. Although some innovative Class II devices must go through the same tough premarket approval as Class III devices, this is not necessary in most instances.
    Usually, a Class II device can be shown the same as a Class II device that already exists.  In these cases, a manufacturer submits a premarket approval package to the FDA proving that the new product is the same as the previous product in form, fit, and function.  The FDA reviews the application and clears the device to be marketed.
  3. FDA Approved – This term is reserved for devices that pass through the FDA’s most stringent reviews and analysis. As such, it is only seen on some Class II devices and any Class III device that has shown to be safe and effective. If a medical device has been FDA approved, that means it has been extensively tested for safety and effectiveness.

 

How the FDA Regulates Class III Devices

Bringing a Class I device to market is fairly quick, often taking less than a month. Class II devices normally take between six and nine months to clear. Class III devices, though, may be tested for a couple of years before the FDA approves them. Why does it take so long to approve a Class III device? It has to do with the regulatory process, which looks like this for Class III devices:

  • Implement a Quality Management System, or QMS – Under the FDA’s 21 CFR Part 820, medical device manufacturers are required to implement a QMS before making a device. A QMS concerns the manufacturer’s processes, and not the product itself (or at least not directly). The QMS outlines things like design controls, material controls, equipment and facility controls, production controls, record keeping and how to implement corrective or preventative actions.
  • Approval of an Investigational Device Exemption, or IDE – Before medical devices with significant potential safety risks are studied, the manufacturer has to get approval from the FDA to be able to use the device in a clinical study. The approved IDE limits the use of the device for the agreed upon clinical trials.
  • Design clinical trial protocols and execute a study – This is the longest and perhaps the most difficult part of the regulatory process, but it is critical. How the clinical trials are designed and conducted are very important so that the people who are part of the clinical studies have limited risk from the device. Also, the information gathered during the trials has to show that the device is safe and effective for the device to get approved by the FDA.
  • The FDA inspects the manufacturer’s facilities – The FDA will send regulators to the manufacturer and any of the manufacturer’s suppliers to verify that Quality Systems Regulations (QSR) are fully implemented at every facility.
  • Premarket approval is granted or denied – After reviewing the available trial data and inspecting the manufacturer’s facilities, the FDA will either approve the product or deny approval. If approval is given, the manufacturer must register their company and list the device before selling the product.

 

FDA regulation of medical devices is regularly updated. Always refer directly to the FDA’s website and publications for their most up-to-date regulatory policies and information.

DRAKE MEDICAL PLASTICS AND FOSTER CORPORATION TEAM UP TO PROVIDE CUSTOMERS WITH ONE -STOP SHOPPING FOR MACHINABLE SHAPES

Cypress, TX (May 13, 2021) – Drake Medical Plastics Ltd, experts in medical polymer manufacturing, and Foster Corporation, a leading producer of medical polymer compounds have announced a sales cooperation to provide customers with machinable shapes from Foster’s full range of polymer compounds on a global basis.

Drake Medical Plastics provides resin-to-shape polymer extrusion of rod, plate, and tube for machined medical and life science components. Depending on volume, machined parts can be a flexible platform for production parts with little to no capital investment.

“We are very excited to be working with Foster, a world class company that shares our passion for customer success,” said Steven Quance, President of Drake Medical Plastics. “This agreement streamlines customer access to the medical polymer shapes they require.”

Foster Corporation, based in Putnam, CT, is the recognized leader in medical polymer compounding. Drake Medical Plastics extrudes medical grade polymers into stock shapes, and machines and injection molds precision parts. This collaboration facilitates a quick and economical route for prototypes and scaling up to commercial manufacturing.

“We are extremely happy to enter into this agreement with Drake Medical Plastics. Our focus on problem-solving with highly engineered polymer solutions in the medical market segment is in direct alignment with Drake’s strategy,” said Larry Johnson, Vice President of Business Development at Foster. “Both of our companies focus heavily on great customer service and meeting critical customer expectations.”

Visit www.drakemedicalplastics.com and www.fostercomp.com

 

About Drake Medical Plastics, Ltd.
Drake Medical Plastics delivers lean solutions for prototype to production needs including material selection assistance, state of the art conversion services and exceptional customer service. This includes resin-to-component and resin-to-shape medical polymer solutions for medical and life science customers. DMP is an ISO 13485: 2016 certified device manufacturing facility and an FDA registered device contract manufacturer. For more information, visit www.drakemedicalplastics.com.

About Foster Corporation
For over twenty-five years, Foster Corporation has been serving medical device and pharmaceutical manufacturers with industry leading technology and service in biomedical materials. These include custom medical compounds, implantable materials, drug/polymer blends and polymer distribution. Within ISO 13485:2003 and ISO 9001:2008 facilities, Foster offers comprehensive support to customers from formulation development through production. For more information, visit www.fostercomp.com.

 

Media Contact:
Susan Racca, Drake Medical Plastics
Marketing and Communications Manager
281-255-6848

Injection Molding and Plastics for Medical Devices

What to Consider When Injection Molding PEEK for Medical Devices

The injection molding process allows device manufacturers to quickly convert PEEK into complex component designs. This means injection molding is effective for an array of medical devices, whether they are used inside or outside the body. Many of those devices are used in cardiovascular, trauma fixation, dental, spinal and arthroscopic applications. PEEK can also be injection molded into components for surgical instrumentation and laboratory equipment.

There are several advantages to injection molding medical plastics like PEEK. These advantages include:

  1. High production volumes – The injection molding process only takes seconds, and most of that is dedicated to cooling the material. This quick conversion time means larger production runs are possible, and this is a major reason why medical plastics are replacing metal components in single-use instruments.In some cases, the device’s design is such that it can only be produced by adhering multiple molded components together. These components can be molded in tandem, though, so the process remains time-efficient.
  2. Cost efficiency – Injection molding is also very cost efficient, especially when used for larger production runs. The process requires the production of a mold, which makes up the bulk of initial costs, but the cost to produce each part is much lower compared to machining and other component production techniques. If the production run exceeds a few hundred components, then injection molding is usually the cost-effective choice.

Injection molding is especially useful for surgical instruments and equipment, as medical facilities are tasked with controlling hospital-acquired infections, or HAIs. According to the CDC, HAIs account for nearly 100,000 deaths every year, and 22 percent of them start at the surgical site. Single-use devices help hospitals control infections by switching in a new, sterile instrument every time a different patient is treated. The cost effectiveness of injection molding medical plastics makes this possible.

There are, however, challenges that must be solved when injection molding medical plastics, including PEEK. For example:

  1. Process safety – Medical plastics and the processes they are subjected to must be verified as safe and biocompatible. PEEK’s biocompatibility has been proven using the testing protocols outlines in ISO 10993. However, it’s not enough for a polymer converter to utilize medical grade plastic because the converter’s processes must also be verified.This is done through a number of standards, but one of the most relevant is ISO 13485, which is widely considered to be the standard for medical device manufacturers and the processes they use. The ISO 13485 standard, like the ISO 9001 standard it is based on, is focused on the manufacturer’s quality management system (QMS), but it adds important language on risk management, design controls, inspections and traceability. The converter’s QMS is a critical document, formalizing its procedures and policies for achieving its quality and safety goals. With a QMS, manufacturers can quickly and reliably modify their processes to improve output.ISO 13485, being specific to the medical industry, also contains standards on proper sterilization and device handling to prevent contamination. If adhesives or other materials are needed to produce the final component, these must also be accounted for.

    Among the most important parts of ISO 13485, though, is process validation. Process validation is needed to ensure the medical plastic remains safe even after manufacturing.  A validated process, then, is one that reliably produces a safe, quality component. This is a critical part of the ISO 13485 standard because it’s generally not possible to test a manufactured medical component without destroying it.

    Patient safety is paramount, so medical device manufacturers are expected to attain and maintain ISO 13485 certification.

  2. Process control – PEEK is a high-performance polymer that possesses excellent thermal resistance. Compared to other medical plastics, then, it must be subjected to extremely high temperatures to allow for proper processing. Depending on the size and shape of the injection molding barrel and the grade of PEEK being converted, temperatures inside the barrel may range between 650- and 750-degrees Fahrenheit. That’s a large range to cover, so it may take some time for a converter to find the temperature that works best for their production needs.Further, temperature control is also needed inside the mold, usually between 170 and 400 degrees Fahrenheit, and this includes the surface temperature of the mold. This elevated temperature prevents sudden cooling, which can result in the PEEK transitioning to an amorphous state and thereby affecting the physical properties of the component.Pressure control is also an important processing variable during the injection molding process that is essential for consistent, high quality components.  Advanced molding technology utilizing in mold cavity pressure transducers are an important capability to address consistent processing of high intricate components and devices.

    Experienced polymer converters are experts at controlling multiple processing conditions, which ensures consistent output quality and reduced waste.

  3. Equipment cleanliness – PEEK is processed at temperatures that cause other medical plastics to degrade, so the injection barrel must be meticulously cleaned to prevent this contamination from affecting the finished component. Any contamination could lead to hundreds of pounds of useless PEEK – which would be an expensive mistake. If that contamination makes it to the final product, it may compromise its properties and potentially be a safety concern.To prevent this, the injection equipment must be cleaned thoroughly before PEEK is injection molded. This usually requires personnel to remove the screw and be thorough with all cleaning processes. Further, any other surface that comes in contact with the PEEK, like hoppers and drying ovens, must also be kept clean to minimize the risk of contamination.

There are several advantages and challenges associated with injection molding of medical plastics like PEEK. An expert converter is familiar with all of them, so they can make the most of the process.

 

FAQ

Q. Is injection molding or machining better for medical plastic?

A. Injection molding offers significant cost and time efficiency benefits when used in large production runs. Machining is cost-effective for small production runs (usually a few hundred components or less) and offers superior tolerances.

Q. What certification is important for medical device manufacturers?

A. ISO 13485 is built on the ISO 9001 framework but adds industry-specific language for medical device manufacturers. ISO 13485 compliance can help a medical device manufacturer to be in compliance with FDA and European medical device quality standards.

Q. What advantages does PEEK bring to medical devices?

A. As a high performance polymer, PEEK possesses several advantages. It is biocompatible, radiolucent and has excellent material and mechanical properties. When implanted, it can provide a flexural modulus similar to the body’s cortical bone, which makes the material a frontline choice for spinal implants.