Sanner, a global leader in high-quality healthcare packaging and drug delivery solutions, officially opened its first U.S.-based injection molding facility in Greensboro, North Carolina, just weeks after commencing initial operations. This marks a strategic milestone in the company’s 134-year history: signaling a new era of innovation, customer proximity, and sustainable growth with localized production to better serve MedTech and pharmaceutical partners across North America.

“This is more than just a new facility,” said Christian Classen, CSO of Sanner Group. “It’s a bold step forward in our global journey, reinforcing our long-term commitment to supporting our customers in North America with local production, cutting-edge technology, and world-class service.”

Key highlights of the new facility:

• 60,500 sq ft site equipped with GMP-certified cleanrooms (ISO Class 7 & 8)
• Advanced injection molding
• High-speed desiccant filling
• State-of-the-art laboratory capabilities
• Designed for the future with 20,000 sq ft of expansion space built into the site.

Sanner’s investment in Greensboro strengthens its position as a trusted supplier of quality-driven primary packaging and as Contract Development and Manufacturing Organization (CDMO) for the healthcare industry — seamlessly integrating global quality standards with local responsiveness.

By combining world-class design expertise with Accola, as Sanner Group’s Design Center of Excellence in the U.S., local and global manufacturing capacity, regulatory insight, and operational excellence, Sanner helps its partners to not only navigate these challenges but to thrive within them. Whether launching a next-generation drug delivery combination device, an innovative diagnostic, a connected health device, or a pharmaceutical packaging to maintain physical and chemical stability, Sanner provides everything pharmaceutical companies need from a single source.

“We’re grateful for the warm welcome and outstanding support from the Greensboro community,” added Classen. “This new site is a testament to what’s possible when global vision meets local partnership. Today, Sanner opens the door to a new chapter: this time, in the U.S.”

With recent expansions in Germany, China, and now the United States, Sanner is well-positioned to support the evolving needs of healthcare customers around the world to bring innovative solutions closer to where they’re needed most.

About Sanner

Sanner GmbH was founded in 1894. Headquartered in Germany with best-in-class manufacturing facilities across Germany, France, Hungary, China, and the U.S., Sanner has successively developed from a global market leader for desiccant closures and effervescent tablet packaging into a sought-after provider of customized solutions in the areas of medical devices and diagnostics, pharmaceuticals, and consumer healthcare. Today, Sanner supplies its products to more than 150 countries globally and has more than 820 employees. In November 2021, GHO Capital, Europe’s leading specialist investor in healthcare, acquired a majority stake in Sanner to partner with the fourth generation of the Sanner family to continue to support the growth of the company with a specific focus on transforming Sanner into a global MedTech CDMO.

Media contact

Dan Webb

Marketing Communications Manager

Tel. +1 (919) 595 8241

dwebb@gilero.com

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Published by the International Standards Organization, ISO 13485 is the global standard for quality management system (QMS) requirements for companies involved in the design, production, installation and servicing of medical devices and related services. A quality management system (QMS) is a set of policies, processes and procedures that help an organization meet the requirements to achieve quality policies and objectives. It can also be used by internal and external parties, such as certifying bodies, to help them with their auditing processes. Many organizations in the medical device industry are expected to demonstrate their quality management processes and ensure best practice in everything they do; therefore, this internationally agreed upon standard sets out the requirements for a quality management system and guidance for common regulatory concepts to ensure those processes are properly maintained and regulated.

The Importance of ISO 13485

When it comes to medical devices, ISO 13485 is an important standard because patient safety greatly depends on the quality and consistency of medical equipment. Ensuring effectiveness, control, and maintenance of your QMS is critical to customers, stakeholders, patients, users, and regulatory agencies. It also ensures that the medical device is consistent when it comes to its design, development, and manufacturing, and that it operates safely and effectively. For instance, medical device labeling requirements are in place to ensure the safety of medical device users. In addition, ISO 13485 can be used as a tool for a thorough audits to test the effectiveness of the QMS and provide an organization with a higher confidence to achieve and maintain compliance with regulatory requirements.

ISO 13485 Requirements

The ISO 13485 standard is organized into 8 sections that a medical device company should follow and abide by.

Section 1: Scope
Describes the purpose and use of the standard.

Section 2: Normative Reference
Provides introductory information and confirms the common nomenclature.

Section 3: Terms and Definitions
Defines the terms and provides the definition of the terminology used throughout the standard.

Section 4: Quality Management System
Outlines the general and documentation of the organization’s QMS. This section talks about the general QMS requirements, and requirements for the Quality Manual, Control of Documents, and Control of Records, all of which are required documents in the QMS. This section also specifies the requirements for controlling documents and records. Document control includes reviewing and approving of documents before use, controlling changes and ensuring that current versions of controlled documents are available where needed for use. Requirements for control of records include maintaining their integrity and establishing procedures for how long documents and records are maintained.

Section 5: Management Responsibility
This section requires management involvement at the level of the person who makes policy and financial decisions and covers the need for top management to be instrumental in the implementation and maintenance of the QMS. This section establishes that the quality policy and objectives, support, and oversight of the QMS and provision of resources are the direct responsibility of upper management.

Section 6: Resource Management
This section requires management to provide the assurance of the facilities such as the space, tools, and equipment used. Buildings, tools, and equipment must be sufficiently maintained to enable production of devices that meet all their requirements. Additionally, the QMS must include processes that ensure all required maintenance activities are performed.

Section 7: Product Realization
This section covers everything that is required to realize a product, from planning to creating (designing and manufacturing) to implementing and supporting a medical device. This section includes requirements on planning, product requirements review, design, purchasing, creating the product or service, and controlling the equipment used to monitor and measure the product or service.

Section 8: Measurement, Analysis, and Improvement
This section provides instruction on how to incorporate feedback and other related information that will enable the management team to sustain the effectiveness of their QMS, such as customer reviews, complaints, internal audits, monitoring and measurement of processes and products, CAPA, non-conformances, and corrective and preventive actions.

Importance of ISO 13485 Certification

Obtaining an ISO 13485 certification is not a requirement for medical device companies, but many organizations find benefits in obtaining third party certification and demonstrating to regulators that they have met the requirements of the standard. “ISO 13485 Certified” means that an organization has implemented an ISO 13485 Quality Management System and has successfully met all of the requirements in ISO 13485.

Certification is important because it allows for organizations to communicate a commitment to its customers and regulators, and many customers believe it gives the organization more credibility when it comes to the safety of medical devices. Getting ISO 13485 certified can also help a company make more positive and permanent quality and process improvements that strengthen the company when it comes to the products and services they provide.

Is Accola ISO 13485 Certified?

Accola is ISO 13485:2016 certified. We operate a Quality Management System which is compliant with the requirements of ISO 13485 for the design, development, manufacture, and packaging of medical devices. If you are looking for an ISO certified company to help with your next medical or drug delivery device project, contact Accola today.

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What are cGMPs?

Current Good Manufacturing Practices (cGMPs) refer to the regulations enforced by the US FDA that direct the design, monitoring, maintenance, and control of manufacturing processes and facilities.  The FDA enforces these regulations for medical devices, pharmaceutical products, food and beverages, and other products that fall under the FDA’s regulatory authority. Following cGMP regulations ensures the identity, quality, strength, and purity of commercial products by requiring that manufacturers adequately control manufacturing operations. Some of these controls include:

• Establishing a strong Quality Management System (QMS)
• Establishing and following robust set of standard operating procedures (SOPs)
• Appropriately documenting, storing, and controlling records of all development, manufacturing, and testing activities
• Ensuring employees are properly qualified and trained
• Using raw materials that meet appropriate quality standards
• Maintaining reliable testing methods
• Keeping manufacturing equipment and facilities clean and well-maintained
• Detecting and investigating product quality deviations

This formal system of controls helps to prevent contamination, mix-ups, deviations, failures, and errors, helping to ensure that products meet the necessary quality standards. CGMP regulations also require that manufacturers use modern technologies and innovative approaches to achieve higher quality through continuous improvement.

Why do cGMPs Matter?

Unless the flaw is obvious, consumers can not usually detect whether or not a drug product or medical device is safe and effective. If a product has passed regulatory clearance and made it on the market, consumers generally assume it is safe for use. CGMP standards set by the FDA exist to ensure that these products meet the government’s standards for safety and effectiveness. The regulatory oversight that comes from employing current Good Manufacturing Practices helps to prevent products that are defective, contaminated, unsafe, or ineffective from getting into the hands of consumers. Testing alone is not adequate enough to ensure quality and safety, therefore it is important that drugs and medical devices are manufactured under the conditions and practices set forth by cGMP regulations. This will ensure that quality is built into the design and manufacturing process of a given product.

Do Medical Device Manufacturers Have to Follow cGMP Regulations?

Medical device manufacturers are required to follow all applicable FDA guidelines, including compliance with current Good Manufacturing Practices. The Code of Federal Regulations Title 21 Part 820 outlines the regulations that medical device companies are required to follow. FDA cGMP guidelines call for manufacturers of medical devices to establish and maintain policies that ensure device design requirements and other decisions are well-documented and adequately justified. These guidelines are broad, allowing them to be applied to a variety of medical devices.  It is up to the manufacturer to determine how to best apply the guidelines in order to achieve compliance.  The FDA conducts regular inspections of medical device manufacturing facilities to make sure they remain in compliance with cGMPs and 21 CFR Part 820.

Current Good Manufacturing Practices at Accola

Accola is FDA registered, ISO 13485 certified, and abides by current Good Manufacturing Practices. We operate under a robust Quality Management System (QMS) to help facilitate our compliance with cGMPs, ensuring we produce products of the utmost quality that meet all safety and efficacy standards. CGMP regulations apply to all of the products manufactured by Accola, including medical devices, drug delivery systems, and combination products.

If you are looking for a cGMP contract manufacturing partner, look no further than Accola. We provide a full suite of manufacturing services, including design transfer, injection molding, complex assembly, packaging, and kitting. With a proven capacity to innovate and scale, our domestic and international manufacturing facilities allow us to service medtech clients across the globe. Contact Accola today to learn more about our medical device manufacturing capabilities.

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All medical devices in the United States go through a review process by the US Food and Drug Administration (FDA) before they can be marketed for patient use. High risk devices such as those implanted into the body are more regulated than those with minimal risk, such as a pair of tweezers or bandages. Therefore, the FDA assigns every medical device a “class” based on its risk profile, which is the potential threat posed to the safety of the patient if something were to go wrong. The three classifications include: Class I, II, and III. Each class is based on the level of control necessary to assure the safety and effectiveness of the device. 

Types of Medical Device Classifications

Class I Medical Devices:

Lowest risk medical devices, these devices present minimal potential harm to the user. Examples include bandages, and handheld surgical instruments. Around 47% of medical devices fall into this category.  

Class II Medical Devices:

Intermediate risk medical devices, examples include CT scanners, catheters, and infusion pumps. 43% of medical devices are Class II.  

Class III Medical Devices:

High risk devices, these devices are especially important to health or sustaining life. Examples include pacemakers, orthopedic implants, and artificial valves. About 10% of medical devices are Class III. 

Why is Medical Device Classification Important?  

A key reason for classifying medical devices is to provide reasonable assurance of their safety and effectiveness for the user. Product classification determines the regulatory rules and requirements you must comply with before you can sell your product. Each class has their own set of regulations, and knowing the class your device falls into is critical to prepare the necessary documentation for FDA approval.  The type of classification of your device also is an important component of how much it will cost and the time it will take to bring your product to market. 

How to Classify your Medical Device

The first step in classifying your device includes establishing the intended use and indications for your medical device. Intended use refers to the general purpose of your device. The device’s indications include the disease or condition that the device is meant to prevent, treat, or diagnose.  

The second step includes specifying the panel that aligns with your device out of the 16 different medical device specialties grouped by the FDA. These panels are listed in CFR Title 21: Parts 862 to 892.  

The third and final step includes finding the FDA product codes that are applicable to your device by searching in the FDA Product Classification Database. The search is conducted through entering the regulation numbers selected from the second step. A detailed listing of information will populate that includes a product code and corresponding device class.  

What types of medical devices qualify for 510(k) exemptions? 

The class to which your device is assigned determines the type of premarketing submission/application required for FDA clearance to market. 

Most Class I and Class II devices are exempt from 510(k) requirements. Devices that may be 510(k) exempt include:  

• Preamendment devices  
• Class I devices specifically exempted by FDA or classified as class I under section 513 (with certain exceptions) 
• Class II devices specifically exempted by the FDA 

A listing of Class I and Class II devices exempt from 510(k) requirements is available on the FDA website.  

For Class III devices, a premarket approval application (PMA) will be required unless your device is a preamendments device (on the market prior to the passage of the medical device amendments in 1976, or substantially equivalent to such a device). In that case, a 510k will be the route to market. 

Medical Device Classification with Accola

Accola’s in-house regulatory experts provide guidance and recommendations for classifying your device while considering the intended use, technology, regulatory landscape, and commercialization strategy. With this assessment in hand, the output of our design and development process provides a complete package for regulatory submissions and transfer into commercial production. Along with preparation and submission, Accola can provide ongoing support for your product throughout every phase of its life cycle. 

Accola follows FDA 21 CFR Part 820 as part of our Quality Management System (QMS), which ensures that all medical devices created and developed within the US market follow satisfactory quality processes at all stages of development. In addition, Accola is ISO 13485 certified, which ensures that your medical device is safe and consistent when it comes to its design, development, and manufacturing processes.  

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At a high level, medical device design and engineering can be broken down into three main categories: electrical, mechanical, and software engineering. Mechanical engineering plays a large part in medical device design and development. Many of the most common types of medical devices are purely mechanical. Equipment such as vial adapters, scalpels, IV tubing, crutches, needles, and so many more have no electrical or software components.

What is Mechanical Engineering?

This is an engineering branch that combines engineering physics and mathematics principles with materials science to design, analyze, manufacture, and maintain mechanical systems. Mechanical engineers analyze their work using the principles of motion, energy, and force to make sure that their designs function safely, efficiently, and reliably. Mechanical engineers design all types of products, from medical devices to automotive parts to consumer goods and more. 

Trending Mechanical Engineering Inventions 

• Nanotechnology- Refers to the study and use of structures between 1 nanometer and 100 nanometers. Mechanical engineers use nanotechnology for synthesis and characterization of nanoscale materials (nanoparticles, carbon nanotubes, graphene) for durability, damage sensing, and structural health monitoring. Flexible electronics and digital displays, along with battery and sensor applications are implemented and created through nanotechnology. Today, nanotechnology sits at the front of many mechanical engineering projects; fluid mechanics, robotics, combustion, bio-medicine, measurements, heat transfer and many more.
• 3D Printing- 3D printing is a complex process where an object’s mode is created using CAD software. The object is saved in a STL (Standard Triangular Language) which allows for the design’s object to be “sliced” in ultra- thin layers. These layers are then printed in a formation of fine plastic layers, each layer bonded to the layer preceding it to create precise shapes. In healthcare, 3D bioprinting is used to create living human cells or tissue for use in regenerative medicine and tissue engineering. Also, 3D printing is used for the development of new surgical cutting and drill guides, prosthetics as well as the creation of patient-specific replicas of bones, organs, and blood vessels. Recent advances of 3D printing in healthcare have led to lighter, stronger and safer products, reduced lead times and lower costs.
• IoT (Internet of Things)- The IoT describes physical objects with sensors, processing ability, software, and other technologies that connect and exchange data with other devices and systems over the Internet or other communications networks. This allows for data to be transferred and shared over a network without requiring human-to human or human-to-computer interaction. 
• Electric Vehicles (EVs)- One of the most popular mechanical inventions includes the movement from internal combustion engines to a cleaner battery-based power system for cars, and other modes of transportation. Electrical vehicles have a battery instead of a gasoline tank and the rise of EVs has led to consumers being able to save money on gas, as well as them being more beneficial to the environment than the standard car. 

What Are Accola’s Mechanical Engineering Capabilities?

Accola has a broad range of in-house engineering talent, including mechanical engineers. Accola engineers have a proven track record of success building everything from consumable medical devices to complex electromechanical drug delivery systems. Our expansive service offerings enable us to provide holistic engineering solutions for medical and drug delivery device design. A few of our capabilities include:

• Mechanical design and testing of components, assemblies, and packaging
• Plastics, elastomers, and metal components
• User-centered design and human factors expertise
• Early concept development
• Detailed 3D CAD and modeling of components
• 2D drawings and drafting
• Engineering analysis using FEA, CFD, and other simulation methods
• Prototyping and pilot builds
• Housings and enclosures for electronic medical devices
• Assembly equipment, fixtures, and process development
• Additive manufacturing, machining fabrication, and assembly

What to Expect for the Future of Mechanical Engineering?

The mechanical engineering industry is projected to grow at 4% annually between now and 2028 according to the U.S. Bureau of Labor Statistics. The demand for mechanical engineers is expected to increase, due to the field’s overlap with other areas of study, such as civil, chemical, and industrial engineering. As a result, mechanical engineers can be found in numerous industries working on a wide range of projects. Employment of mechanical engineers is projected to grow around 7% from 2020 to 2030. The future of mechanical engineering involves advances in electrical vehicles, nanoengineering, biomechatronics, and many more fields. With these fields growing, more technology will be integrated into our modern society to make our lives easier, as well as advances in the healthcare industry for better patient care and life- saving equipment. 

Accola offers end-to-end contract design and development, and manufacturing services for medtech customers around the world. If you need help with your next medical device or combination product, contact our engineering experts today.

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Ocular drug delivery systems are designed to be applied onto the external surface of the eye, administered inside or adjacent to the eye, or used in conjunction with an ophthalmic device. These ocular delivery methods are used to combat against any ailment or disorder involving vision.

What are Different Types of Ocular Drug Delivery Systems?

There are several different types of ophthalmic drug delivery systems including, but not limited to, liquids (such as eyedrops and lotions), ointments, aqueous gels, and suspensions. New advances in ocular drug delivery have required the use of medical devices as a vessel to administer ophthalmic drugs. Some devices that have seen success in ophthalmology are punctum plugs, ocular implants, drug-eluting contact lenses, iontophoresis (mild electric charges to deliver through ocular barriers) devices, electromechanical tear stimulators, and others. 

New Regulatory Guidance with Ocular Drug Delivery Systems

In previous years, products such as eye shields, eye droppers, and other ophthalmic dispensers were regulated as drugs when they were packaged with an ophthalmic drug. In April of 2021, it was determined by the U.S. Court of Appeals for the District of Columbia Circuit that “…devices must be regulated as devices and drugs- if they do not satisfy the device definition- must be regulated as drugs.” The FDA determined that this statement indicated ophthalmic dispensers and devices packaged with ophthalmic drugs can no longer be regulated as “drugs” and must be regulated as “devices.”

In March 2022, the FDA released new guidelines to manage products such as those listed above. The new regulations require products that fall into the “device” category to be regulated separately from the drug they are packaged with. These are considered “combination devices” which have been monitored and categorized by the FDA since 2002 to ensure proper regulation of each product within the combination. The ophthalmic device components now need to comply with either the full 21CFR §820 device quality system regulations or, more typically, a streamlined quality system regulation under 21 CFR §4.4(b)(1) system. In either case, device design controls under 21 CFR §820.30 will apply. This new guidance can significantly impact the ophthalmic drugs market, requiring pharmaceutical companies to understand the depths of combination devices.

Navigating Regulatory Changes in Ocular Drug Delivery

“This aspect of the device quality system regulation is often least familiar to our pharmaceutical clients that do not typically manufacture drug combination devices. We can assist clients with the design control requirements of the device quality system or any other novel elements. Additionally, we can assist with the development of appropriate documentation and/or testing to meet the new requirements.”

-Jim Fentress, Director of R&D and Regulatory Policy

Accola’s Expertise with Ophthalmic Drug Delivery Devices

Accola has worked with many medical device companies to develop market ready ophthalmic devices. Preservative free eye drop applicators, ophthalmic syringes, implant injectors, and electromechanical tear stimulators are some examples of devices we have produced. We achieve high quality results with our established and experienced engineering team who work to ensure your ophthalmic medical device is properly designed and developed to your specifications. Accola also offers human factors engineering and validation studies, prototyping, clinical builds, and contract manufacturing to provide a comprehensive solution for your ophthalmic device needs. 

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Transferring a medical device into manufacturing can be challenging. There is a high demand to manufacture devices efficiently, affordably and with a faster time-to-market than ever before. Medical device manufacturers must find innovative solutions to meet these needs while following best practices and regulatory guidelines to ensure that the finished device meets all critical requirements and will be safe and effective. Based on Accola’s medical device manufacturing expertise, we’ve put together seven tips that will lay the groundwork for successful medical device manufacturing and commercialization.

What is Medical Device Manufacturing?

Medical device manufacturing is a highly regulated process of producing, assembling, and packaging medical devices and combination devices. The whole manufacturing process includes various activities such as engineering, prototyping, testing, regulatory compliance, quality assurance, and precise packaging. Medical device manufacturing typically involves the use of specialized equipment that meet strict regulatory and quality requirements.

Types of Medical Devices in Accola’s Capabilities:

Including but not limited to:

• Ocular and Ophthalmic drug delivery
• Autoinjectors
• Surgical Instruments
• Electromechanical medical devices
• Luer lock syringes
• ENT drug delivery
• Vial access devices
• Vial adapters
• Syringe infusion systems
• Monitoring Devices
• Diagnostic Equipment
• Wound Management
• IV equipment
• Urology devices
• Neuromodulation Devices

See Accola’s Medical Device Manufacturing experience, please visit Our Work

7 Tips for Medical Device Manufacturing

1. Plan for Manufacturing Medical Equipment Early in the Design & Development Process

The method of manufacturing for a medical or drug delivery device must be considered early on in the design and development process. Shortly after basic product requirements have been defined based on user needs, design and manufacturing engineers should be working together to determine what manufacturing method will be used. They will look for critical points in the manufacturing process, consider basic assembly options, and ask questions like ‘How many pieces will make up this device?’ and ‘How complex will each piece need to be?’ Figuring out the method of manufacturing early on can help ensure that the device is designed for manufacturability and will meet the necessary cost and volume targets. As medical device development progresses, the cost to make a design change increases. It may be necessary to modify mold tools or even change materials later in the design cycle if the proper manufacturing requirements are not identified and planned for up front. These changes take time and often result in repeating testing and/or development activities that were previously completed.

2. Understand Cost Targets and Target Markets for Medical Device Production

A poor understanding of product cost targets and price sensitivity within the target market can be detrimental to the success of a medical or drug delivery device. In medical device manufacturing, it can be all too easy to design a device that never meets a cost target and ultimately fails in the market. Market research of competitor products can provide an initial baseline for competitive pricing. However, this should be adjusted based on factors such as whether multiple devices already serve the market space or whether the new product offers specific benefits to improve performance, ease of use, or safety.

In general, the consumable medical device market responds best to products that incorporate enough features to effectively function without being burdened by costly unnecessary features or decorations. Although actual costing of a new device might not be fully understood in the early stages of design, it is wise to begin a cost model as soon as reasonably possible. This can help drive design and manufacturing decisions along the way. Be sure to include reasonable placeholders for items often missed such as shipping of raw materials, sterilization, and manufacturing overheads to ensure that actual margins do not evaporate once product launch is realized.

3. Select the Right Manufacturing Partner

When it comes to medical devices or drug delivery and combination products, a good manufacturing partner will offer more than just technical expertise. Medical device manufacturers need to follow FDA guidance and Good Manufacturing Practices (cGMPs), so choosing a partner with proven experience in the medical device industry is vital. They should work within a quality management system, have established processes in place and understand the critical requirements for manufacturing the device. When evaluating a manufacturing partner, consider industry experience, if they manufacture similar products with similar processes, and whether or not they can meet both small batch and full-scale production needs. Also consider if this manufacturer can provide other services that may be necessary for device commercialization, such as testing, packaging, sterilization management or drug and device kitting. Select a manufacturing partner who is a good fit for your business and can meet your needs now and in the future.

4. Work with a Medical Device Manufacturer who is Vertically Integrated with Design, Development and Manufacturing

Medical and drug delivery device regulations and technologies are constantly evolving. When manufacturing these devices, it helps to have in-house expertise in other areas besides manufacturing. Depending on the device, this could include expertise in product development, packaging design, testing, regulatory, complex assembly, injection molding, machining, software development, and more. When design engineers can engage with experienced assembly technicians and manufacturing engineers, they can better understand the impact that design decisions will have on finished device manufacturing. By understanding the clinical use of the device, a manufacturer is more likely to catch potential problems in the manufacturing process before they become real problems. A medical device manufacturer with a grasp of medical device design can also be an advocate for the design itself, ensuring the design is carried through to manufacturing correctly. When design and manufacturing groups work seamlessly together, technical challenges can be addressed more quickly and the opportunity for errors can be reduced.

5. Rely on a Proven Medical Device Manufacturing Process

When an assembly process lacks clear controls and has ambiguous performance requirements, it’s usually a strong indicator that the engineering work was either glossed over or not done at all. It is better (and less expensive) to recognize an ineffective design element or manufacturing process and fix it as early as possible. Good medical device manufacturers will follow established protocols for design verification and process validation. These processes should be characterized based on risk and ability to identify defects through inspections and subsequently validated where required. Medical and drug delivery device manufacturing is not an area where you can wing it. Following proven a process helps to ensure a robust manufacturing system, which will in turn increase the chances that the products being produced are safe and effective.

6. Evaluate Supply Chain Elements

It can be difficult to remain cost effective when manufacturing a new medical device, especially if the design is complex. The good news is, there are likely efficiencies within the supply chain and manufacturing logistics that can be taken advantage of. On the flip side, there are also likely hidden costs within these areas that may not have been acknowledged. A few things to consider are whether it is necessary for the manufacturer to hold reserve inventory, if products have expiration implications requiring additional management, and if the manufacturer has enough supplier volume to drive preferred pricing. Again, it becomes important to rely on experts who have a thorough understanding of supply chain and logistics for help. Obtaining the best materials at the best price and setting up a supply chain in a way that makes sense will contribute to cost effectiveness and ultimately lead to a greater chance of success in the marketplace.

7. Be Open to New Ways of Doing Things with Medical Product Manufacturing

There is no cookie-cutter formula for commercializing a medical device. Every device is different, and some may require more innovative manufacturing solutions than others. Thinking outside-the-box and being willing to try things like new assembly methods or a different piece of machinery could lead to a more efficient manufacturing process.

Accola provides contract manufacturing services for the medical device and pharmaceutical industries. Our manufacturing expertise ranges from single-use medical devices to complex electromechanical drug delivery systems. In-house service offerings include cleanroom manufacturing, plastic injection molding, injection mold tool building, complex assembly, packaging and kitting. With a proven capacity to innovate, scale and commercialize, our domestic and international facilities are equipped to develop unique manufacturing solutions and accelerate device commercialization timelines. Contact Accola today to learn more about our contract manufacturing services.

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Medical device labeling refers to all of the information that is provided to the consumer with the device itself. This includes symbols, warnings, instructions, and control labels applied to the device or incorporated into the design by color coding, printing, machining, or molding.

Medical device labeling also refers to

• Information display on the device’s user interface
• Information printed on the device’s packaging or point-of-sale displays
• Documents provided with the device, including manuals and instructions

Medical device labeling is not just the label on the device, but rather any labels on the pouch, box, instructions for use, etc. The leading international standard for medical device quality systems, ISO 13485, states that a label is any information related to identification, technical description, intended purpose, and proper use of the device.

What Are Medical Device Labeling Requirements?

Medical devices companies that sell their products in the US must adhere to the FDA’s strict medical device labeling requirements. The purpose of these regulations is to help keep medical device users safe. The requirements for labeling a particular medical device depend on what type of device it is and what level of risk is involved.

All medical device labels must include the name and address of the manufacturer, packer or distributor, and directions for use. Beyond these general requirements, medical device companies must determine the intended use and risk classification of their device to pinpoint their specific requirements. The FDA has published detailed regulations in 21 CFR Part 801. In addition, electromechanical medical devices have labeling requirements defined in IEC 60601-1 Clause 7. The usability of the labeling is addressed in IEC 62366. Canada’s regulations can be found in Canadian Medical Device Regulations clause 21. Refer to Medical Device Directive Annex 1, clause 13 for EU regulations.

The Importance of Proper Medical Device Labeling

A medical device label is intended to educate users, namely patients or healthcare providers, on how a device should be used, what risks are involved, and how to safely operate and maintain the device. Given that many medical devices are used by the patient at home, not under supervision by a medical expert, it’s critical that devices give accurate information about how to use and interpret the device to avoid injury, illness, or death.

For instance, a prefilled syringe allowing a patient to administer a measured dose of medication at home could help treat or prevent a specific disease when used correctly. If used incorrectly, a number of adverse effects could occur, such as injury from improper handling of the needle or an incomplete dose of medication. Because of these scenarios, a thorough analysis of human factors and usability testing is necessary to ensure device labeling covers all bases.

The Do’s and Don’ts of Medical Device Labeling

Given how lengthy and varied medical device labeling requirements can be, the process can be tricky for medical or pharmaceutical companies attempting to create this labeling. Tips for what to do and what to avoid are outlined below. Note that each jurisdiction has its own requirements, so be sure to check regulations for each country or region where you plan to commercialize the device.

What to Do

When labeling medical devices, do:

• Include labeling early on in your design planning
• Identify the device by make, model number, date of manufacture, and batch or serial number
• Provide contact information for the manufacturer and/or the local representative or distributor
• Include the intended use and indications for use and any contraindications or possible side effects
• List the box contents, meaning everything supplied with the device
• Include instructions for correct usage
• Include any warnings or cautions resulting from the risk management process
• Use appropriate symbols where possible in the labeling of the device
• Select label materials that will remain legible for the life of the device and are compatible with cleaning and sterilization methods defined in the instructions for use
• Have someone with regulatory knowledge review the labeling before submitting the device for clearance

What Not to Do

The following should be avoided on medical device labels:

• Including any text which contradicts the intended use or describes or refers to an off label use
• Including any marketing statements that are not supported by data
• Using the certifying body (e.g. CSA, ETL, UL) artwork on the product label without written permission
• Making any labeling changes after the device has gained regulatory clearance

Learn more from Accola in these posts: FDA 510(k) Submission Process: An Introduction & How-To Guide and Combination Products: Definition & Overview.

Accola is a trusted partner for medical and drug delivery devices from start to finish. For more information about our services and capabilities, contact Accola today.

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Medical device patents legally protect inventions and innovations related to the medical field. Having a medical device patent allows the inventor to protect against another person or company from unauthorized use of the invention. Medical devices generally qualify for utility patents protection, given that they are novel, which means the invention is new and different from all prior inventions and cannot have been previously disclosed. The invention must also be non- obvious meaning that someone of ordinary skill in a relevant field could not have easily made that invention. In addition, medical devices can qualify for a design patent, which protects the device’s ornamental design, such as its configuration and shape. Many applicants apply for a provisional patent, which is a low- cost way to gain protection for up to 12 months before the filing date of a full patent. This also gives the inventor time to test and perfect the invention before filing for a full patent, also called a non- provisional patent. Those granted a provisional patent have the term “Patent Pending” associated with their invention. Provisional patents can be issued on utility patents, but not design patents.

How to Patent a Medical Device

Generally, the process to receive a medical device patent in the United States can be broken down into 6 steps.

1. Decide if the Medical Device Meets the Requirements to Receive a Patent
For a US utility patent, the medical device must fall within one of the statutory classes, must be novel, and must not have been used in prior art. The invention must also be non- obvious and works the way in which its inventor claims it does and be clearly useful for a specific purpose.
For a US design patent, the medical device design must be for “an article of manufacture,” which means that it is a tangible object made by man. The design must be original and not obviously derived from other designs, the design must have unique ornamentation, and be different from prior art.

2. Prepare to Apply for Medical Device Patent
If the invention meets all the specified criteria, gather the documents and drawings associated with the invention. It is crucial to do a preliminary search of US patents and published applications to ensure that the invention is not already patented. The Patent and Trademark Resource Centers (PTRCs) provide online access to the PatFT (Patents Full-Text and Image) and AppFT (Applications Full-Text and Image) databases. Search through the database using keywords that describe the invention based on its purpose, composition, and use.

3. Submit Medical Device Patent Application to the United States Patent and Trademark Office (USPTO)
Complete all the necessary forms and follow instructions to submit the application to the USPTO for further review. Necessary application fees will have to be paid at the time of filing.

4. Work with an Examiner
Once the patent application is submitted, an examiner will be assigned to the case and will work with you to determine if your application meets all the criteria for US patent approval consideration.

5. Gain Medical Patent Approval
Once a patent application gets approved, the inventor will be issued a Notice of Allowance, which will list the issue and publication fees to be paid. After that is complete, the patent will be issued to the inventor or inventors and assigned a unique patent number.

6. Maintain Medical Patent Protection
Once patent approval has been granted, make sure to continuously maintain the patent protection and pay all necessary fees. Utility patents generally last for 20 years and design patents generally last for 15 years.

Understanding the Intellectual Property (IP) Landscape for Medical Devices

Knowledge of the intellectual property (IP) landscape is an important consideration for understanding medical device patents. An IP landscape is a thorough overview of the current patents and practices in a technical space. Through references, documentation, etc., an IP landscape can show potential legal validity and provide a competitive analysis of the chosen space, as well as uncover “white space,” which are opportunities and gaps in the market. An IP landscape investigates a wide variety of data, such as documents and other useful information that is taken from computer programs, software and machine learning. Patent landscape analysis and research are beneficial to the field of medical device because innovators can look at previous patents and creations and customize and improve existing designs and devices. The customizations can lead to more avenues for new medical devices and companies can use these devices to differentiate themselves from the competition.

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A combination product is a therapeutic or diagnostic product that combines drugs, medical devices, and/or biological products. A combination product will combine at least two of these product categories and sometimes combines all three. Some of the most common types include traditional drug device combination products, like a syringe prefilled with a drug, and co-packaged or kitted products, like a first-aid kit containing bandages and pain-relieving drugs.

What are Some Examples of Combination Products?

The Code of Federal Regulations (CFR) classifies combination products as three main types: single-entity, co-packaged, and cross-labeled. A single-entity combination product is comprised of two or more components (drug and device, device and biologic, biologic and drug, or all three) that are combined or mixed to produce a single entity. Examples of single-entity combination products include:

Single-Entity Combination Product Examples

• Prefilled drug delivery devices and systems, such as a prefilled syringe, injector pen, insulin pump or metered dose inhaler
• Prefilled biologic delivery devices and systems, such as a vaccine in a prefilled syringe or nasal spray
• Medical device coated with or otherwise combined with a drug or biologic, such as a transdermal patch or antimicrobial wound dressing
• Drug/biologic combination, such as an antibody combined with a therapeutic drug

A co-packaged combination product consists of two or more components that are packaged together as a unit or in a single package. These combination product types are sometimes also called convenience kits. Some common examples of co-packaging are:

Co-Packaged Combination Product Examples

• Drug or vaccine vial packaged with a syringe
• Liquid medication with dose-dispenser
• Surgical tray containing surgical instruments and anesthetic drugs

A cross-labeled combination product is a device, drug, or biological product packaged separately that according to its investigational plan or proposed labeling is intended to be used only with an approved individually specified device, drug, or biological product where both components are required to achieve the intended use, indication or effect. Put simply, these products are sold separately but labeled for use together. A few examples of cross-labeling include:

Cross-Labeled Combination Product Examples

• Photosensitizing drug and activating laser or light source
• Light-activated biological products not co-packaged but labeled for use with a specific light source device

Combination Product Regulatory Requirements

Combination products have unique regulatory requirements, often leading people to ask “what is the right regulatory pathway for my combination product?” In 2002, the FDA Office of Combination Products was established to classify medical products in the US as devices, drugs, biologics, or combination products, and assign them to an FDA center for review and regulation. The lead FDA investigation center is determined by the product’s primary mode of action (PMOA), which is defined as the single mode of action, providing the most important therapeutic action, of the combination product. For example, if a drug is the PMOA in a drug-device combination product, then the lead center would most likely be the Center for Drug Evaluation and Research. The primary mode of action will also help determine what type of regulatory submission will be required. Common regulatory pathways for combination products based on the PMOA include:

• Premarket approval application (PMA), De Novo classification request, or 510(k) submission when the PMOA is a device
• New drug application (NDA) or abbreviated new drug application (ANDA) if the PMOA is a drug
• Biologic license application (BLA) if the PMOA is a biologic

There can still be some ambiguity on how to classify complex combination products. While the Office of Combination Products is not a review center, they do provide guidance on the subject and answer frequently asked questions on the FDA website.

The Future of Combination Products

The combination product market continues to grow as pharmaceutical, medtech, biotech and life science companies continue to innovate. Combination devices and combination drug products can provide more targeted treatment, enable better drug delivery, and improve the efficacy of both the medical device and the drug. The market for drug device combination products in particular has seen tremendous growth. According to data shared in 2018 by Research and Markets, the global market is expected to surpass $177 billion by 2024.

Patients can benefit immensely from these products that simplify drug delivery. For example, drug delivery devices that allow for easier self-dosing, like a single-use prefilled syringe containing one dose of medication, can help to reduce patient dosing errors and increase compliance. Injection systems and pulmonary inhalers currently dominate the drug delivery combination product market.

Because combination products involve components normally regulated under different types of regulatory authorities, they have unique regulatory challenges. The FDA established the Office of Combination Products (OCP) in 2002 to meet increased regulatory demands for combination products and take a holistic approach to evaluating the safety and efficacy of these products. As this technology continues to evolve, and the market grows, regulatory pathways and policies must continue to evolve as well.

Accola’s Comprehensive Approach to Combination Products

Accola has a breadth of experience with combination medical devices and drug delivery products. Combination product design and development is one of our areas of expertise. Our team can also handle elements of the combination product manufacturing process, including device assembly, kitting, and packaging. A few examples we’ve worked on include a lidocaine buffering system, sterile skin anesthetic, topical applicator for antiseptic, metered dose, dry powder and capsule inhalers, prefilled syringes, and an infusion management system. Contact us today to see how Accola can help with your next project!

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