Robot-assisted surgery has firmly cemented its place in the modern operating room. What began as a niche innovation is now a cornerstone of minimally invasive procedures, offering surgeons enhanced dexterity, precision, and visualization.

A few years ago, Springboard, a Sanner Group Company’s Principal Physicist, Joe Batley wrote about the trends he is seeing in the field. Today, we look at what is next and if there is still appetite for his predictions from 2023.

Miniaturization is still enabling incredible innovation

As was the case in 2023, robotic systems like Intuitive’s da Vinci have dominated general and laparoscopic surgery. But the future is getting smaller and more focused. Developers are now racing to miniaturize surgical tools and create systems tailored to specific procedures. Think single-port access, ultra-fine instruments, and robots designed for rigid-endoscopic or microsurgical tasks. One noteworthy surgical device is the Endomag surgical device used in breast cancer detection where the surgical probe is much smaller than originally designed which helps the surgeon using it to precisely pinpoint the cancer cells allowing for a smaller surgical region.

Companies like Virtuoso Surgical and Vicarious Surgical are leading the charge, developing compact systems that can navigate tight anatomical spaces with unprecedented precision. This shift toward specialization not only expands the range of procedures that can be robotically assisted but also makes advanced surgery more accessible in smaller hospitals and outpatient settings.

Surgery with data at your fingertips

What if we could understand the risk of complications (namely infections) from surgery before, during, and after a surgical procedure? That is exactly what startup company, Caresyntax, is doing. By leveraging video, device telemetry, vitals, and historical patient records, Caresyntax’s platform can predict patient risk factors and complications. With millions of past procedures in its database, this platform then alerts surgeons and clinicians to patients at higher risk for surgical site infections or adverse events.

In many cases, surgery is an urgent matter, and hospitals can quickly become overwhelmed when multiple procedures overlap or resources are stretched thin. Surgical Safety Technologies (SST) is a startup creating a black box for the operating room. This platform addresses this challenge by capturing live OR data to predict procedure durations, staffing needs, and potential inefficiencies. This helps hospitals reduce idle time and streamline workflows without adding new resources.

Robots are becoming second nature to surgeons

While the technology behind surgical robots is complex, the user experience is trending in the opposite direction. Intuitive interfaces, haptic feedback, and smarter voice-controlled systems are making it easier for surgeons to adopt and master robotic platforms. Training times are shrinking, and confidence is growing.

On social media platforms like Instagram and TikTok, surgeons are sharing videos showcasing their skill with these multi-million-dollar robotic systems. For example, Dr. Nangeroni, DO, from Southern Ocean Medical Center in New Jersey, demonstrates remarkable precision and control by performing fine motor tasks with the robot. See how intuitive and responsive the technology has become.

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A post shared by James Nangeroni DO Facos (@dr_nange)

For system designers, this focus on usability is critical. As robotic systems become more widespread, they must be accessible not just to elite surgical centers but to community hospitals and ambulatory surgical centers as well.

Distalmotion is a great example of building “usability” or adoption into their system. Dexter’s uniqueness lies in its hybrid design, cost-effectiveness, and compatibility with existing laparoscopic setups, making robotic surgery more accessible and flexible compared to da Vinci’s fully robotic, higher-cost model.

Human-centered design is not just about aesthetics. Instead, human-centered design is about safety, usability, and empathy. By integrating contextual research, task analysis, and iterative usability testing throughout the development process, engineering teams can make intuitive products that are much more likely to be adopted by users.

Looking ahead

The trajectory of robot-assisted surgery is clear. Technological advancements bring greater precision, smarter solutions, and wider accessibility.

As we look to the future, the challenge will be for product innovators to balance these improvements with affordability and proof of impact to the healthcare systems they exist in.

In the United States, roughly 80% of surgeries are considered elective. Because these procedures are planned rather than urgent, hospitals and payors can carefully evaluate which technologies to adopt. This means surgical innovators are competing not only on clinical performance, but also on the value they deliver to all stakeholders: patients, providers, and payors.

About the Author

Michael Denver is a business development professional with over 15 years in the medical device industry and an MBA from the University of Manchester. He currently helps medical device companies at Springboard Pro, a Sanner Group Company, bring innovative technologies from concept to market.

The post New Trends Shaping the Future of Surgical Robotics appeared first on Accola.

As digital technology continues to reshape healthcare, the line between hardware and software in medical devices has blurred. From embedded firmware to AI-powered diagnostics, software now plays a role in nearly every type of smart or connected medical device.

If you’re designing or developing a software-enabled medical device, understanding the distinction between these two categories can help you determine which standards apply and how to plan your product development and submission strategy accordingly.

Defining SaMD and SiMD

Software as a Medical Device (SaMD) refers to standalone software that performs a medical function without needing to be part of a hardware medical device.

Why? The software itself meets the FDA’s definition of a medical device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

By contrast, Software in a Medical Device (SiMD) refers to software that is embedded within or necessary for the operation of a physical medical device.

How do I tell the difference?

To determine whether your product is SaMD or SiMD, regulators typically ask two fundamental questions drawn from FDA and IMDRF guidance:

1. Does the software meet the definition of a medical device?

In other words, is it intended to diagnose, treat, prevent, or mitigate disease, or to affect the structure or function of the body? If yes, it may fall under device regulation.

2. Can the software function independently of a physical device?

If the answer is yes, it’s likely SaMD. If it’s required for the operation of a specific piece of hardware, it’s SiMD.

This framework is widely used by regulatory professionals, even though it’s not codified in FDA law. It reflects how agencies evaluate intended use, functionality, and system dependencies.

Why the difference matters

The distinction between SaMD and SiMD has direct implications for:

• Regulatory submission pathways (510(k), De Novo, PMA, etc.)
• Testing and validation requirements
• Postmarket monitoring and change control
• Cybersecurity and data integrity expectations

SaMD tends to move faster through development cycles, leveraging cloud-based infrastructure and continuous updates. That flexibility also means regulators expect robust processes for risk management, cybersecurity, and real-world performance monitoring.

SiMD, by contrast, is validated as part of the overall device design and typically undergoes full system-level verification to ensure the software and hardware operate safely together.

Here’s where it can get complicated

Imagine you’re developing an intravenous (IV) pump that delivers different medications through interchangeable cartridges. The device’s physical hardware drives the pump mechanism and serves as the main interface for clinicians and patients.
The software controlling the pump’s operation would be classified as SiMD, since it can’t function independently of the hardware and its risk to patients all pertains to the same device function. Potentially, you’d pursue a 510(k) submission on this device and its embedded software.
However, a separate software application that manages the drug library, calculates doses, and tracks patient data could be regulated independently as SaMD if it operates apart from the pump’s hardware and control systems even if later integrated with a pump system. Then, you would pursue another 510(k) submission for this software component.

Applicable standards

Both SaMD and SiMD are subject to rigorous quality and safety expectations — but the applicable standards and validation processes differ slightly.  The following includes a list of FDA consensus standards most commonly used in development of either type of product.

• IEC 62304 defines the software lifecycle requirements for both SaMD and SiMD.
• ISO 13485 and 21 CFR Part 820 establish overall quality system and design control expectations.
• ISO 14971 provides an risk management framework for medical devices including those which are standalone or embedded
• IEC 82304-1 applies specifically to standalone health software (SaMD).
• IEC 60601-1 applies to software used in medical electrical equipment (SiMD).

Artificial Intelligence (AI)

AI-driven software features have their own regulatory challenges for manufacturers because machine-learning elements can make changes in the device performance to improve patient outcomes.  Managing changes so they do not cause the device to depart from the original approved or cleared submission requires planning and FDA coordination.

For AI-driven software, the FDA offers guidance. The FDA’s 2025 draft guidance, “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations” addresses lifecycle management and submission recommendations.   Their guidance,  “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions”, helps to define an approach by which manufacturers can maintain the ability to modify AI functionality on a released product while maintaining the safety and efficacy requirements of a cleared or approved device..

Confused by the regulatory rules around medical device software? We can help.

Accola helps medical device manufacturers design connected systems that are safe, scalable, and regulatory-ready. Whether you’re embedding intelligence into hardware or creating standalone digital health tools, our team can help you bridge the gap between innovation and compliance.

We provide everything under one roof, from software engineering for medical devices to full-scale commercial manufacturing.

About the Author

Jim Fentress brings to Accola more than 20 years of disposable medical device experience, with a strong foundation in device design, manufacturing, process development, validation, and experiment design. In his role as Director of Research & Development and Regulatory Policy at Accola, Jim focuses on novel product development with new technologies, materials, or requirements. Jim also acts as a technical consultant on traditional development products providing guidance for design verification and validation testing, test method development, regulatory submissions, and regulatory body correspondence. Jim holds a degree in Biomedical Engineering from Rensselaer Polytechnic Institute.

The post Understanding the Regulatory Difference Between SiMD and SaMD appeared first on Accola.

Imagine walking through a hospital corridor. What do you hear?

The beeping, ringing, and buzzing of alarms are constant reminders of the complex systems keeping patients alive.

But here’s the problem: up to 85 to 99% of hospital alarm signals don’t require clinical intervention. When nearly every sound demands attention, even the most critical alarm can go unnoticed.

At the same time, patients who receive only intermittent vital sign monitoring are three times more likely to require ICU transfer or experience adverse outcomes than those under continuous monitoring.

Separating noise from important alarms is a matter of life and death for patients in a hospital. With clinicians in short supply, it’s essential to focus human attention where it matters most. That’s where intelligent medical devices come in.

Smarter devices drive better outcomes overall

Next-generation medical devices have evolved from simple tools into intelligent systems that integrate electronics, software, and connectivity. These devices don’t just collect data… they interpret it, act on it, and communicate it seamlessly.

Here are four key ways they’re reshaping care:

1. Internet of Things (IoT) Connectivity

The Internet of Things is transforming how devices interact with clinicians and patients alike. Connected devices are now smaller and more powerful than ever, making real-time monitoring possible across the continuum from hospital to at-home care.

2. Improved User Experience

Technology has turned once-complex devices into intuitive, patient-friendly tools. Think about how blood glucose monitors evolved from bulky, handheld displays to discreet wearables used by people of all ages. Miniaturized electronics mean lighter, more comfortable, and more accessible devices that empower patients to manage their own health.

3. Reduced Regulatory Risk

Medication errors and misuse are still major causes of patient harm. Intelligent devices can help close that gap.

For one Accola customer, we developed a connected syringe that verifies dosage before administration, helping prevent overdoses and ensure compliance.

Connected systems can also self-report maintenance status and performance metrics, simplifying inspections and reducing the administrative burden on healthcare institutions and regulatory bodies.

4. Seamless EHR Integration

Integration with Electronic Health Records (EHRs) means that devices can “speak the same language” as hospital systems.
Standards like HL7 and FHIR allow real-time data to flow directly into a patient’s record, eliminating manual entry and reducing the risk of clerical errors. Clinicians gain access to a complete, always-updated patient story—without ever leaving their EHR.

The Future of Intelligent Care

Looking ahead, medical devices will become even more autonomous—blending integrated electronics, AI, and data interoperability to support fully personalized medicine.

Software as a Medical Device (SaMD) solutions are already leveraging AI to analyze vast datasets, identify early warning signs, and support clinical decision-making. (Check out our recent article on the regulatory distinctions between SiMD and SaMD amid evolving FDA AI guidance.)

Accola is enabling the future of healthcare

At Accola and Sanner Group we help bring intelligent medical devices from concept to commercialization. Whether you’re developing a new device, integrating IoT into your design, or scaling up manufacturing, our team combines deep engineering expertise with regulatory and quality know-how to seamlessly bring your product to market.

About the Author

Michael Marks M.Sc. is a Senior Systems Engineer with deep expertise in complex electromechanical medical device development. His background includes leading more than $4.5 million in funded government contracts, driving advancements in optics, sensors, 3D printing, and polymer chemistry.

The post How AI-Powered Medical Devices Can Save Lives appeared first on Accola.

Understanding and mitigating emissions are essential to creating reliable, compliant electronics. In this blog post, we will introduce the two primary types of emissions and offer practical steps for troubleshooting both conducted and radiated EMC issues.

Understanding Conducted vs. Radiated Emissions

EMC emissions are broadly categorized into two types: conducted and radiated. Conducted emissions are noise currents traveling out of the product back onto the AC mains cable. These emissions can interfere with other equipment connected to the same power source. Typically, the frequencies of concern for this noise range from 150 kHz to 30 MHz. Radiated emissions, on the other hand, are electromagnetic fields that radiate through the air from the product and can interfere with nearby electronics. Typically, the frequencies of concern for this noise range from 30 to 6000 MHz.

Troubleshooting Conducted Emissions

When addressing conducted emissions, the first step is identifying the source within the device. Common culprits include switching power supplies, motor drivers, and high-speed digital circuits. Using a Line Impedance Stabilization Network (LISN) in conjunction with a spectrum analyzer can help isolate the frequency bands causing failures.

Once the frequencies are identified, the next step is to locate the physical origin. A current probe can be used to measure emissions on individual cables to pinpoint noisy lines. Mitigation often involves improving PCB layout—such as minimizing loop areas and ensuring solid return paths—and implementing filtering techniques. Installing differential-mode and common-mode filters at power entry points can significantly reduce emissions. In some cases, re-routing cables or adding ferrite beads may also help.

Troubleshooting Radiated Emissions

Radiated emissions are often more challenging to troubleshoot. Initial testing is typically performed on the complete device under test (DUT) to verify compliance with emissions standards.

If the DUT fails, diagnostic tools such as near-field probes paired with a spectrum analyzer become invaluable for identifying hot spots on the PCB. Focus should be placed on areas with high-speed digital signals, clock lines, and power converters, as these are frequent sources of unwanted radiation.

Shielding is a common solution, but it should be a last resort after addressing fundamental design issues. Improving grounding and ensuring low-impedance paths can reduce emissions at the source. Additionally, managing cable routing to prevent unintentional antennas and using properly terminated signal lines can reduce unwanted radiation. Antenna-like structures, such as long traces or unterminated cables, should be minimized or shielded effectively.

Digital clocks are often a major source of high-frequency radiated emissions; techniques such as improving clock distribution and using spread spectrum clocking can help mitigate these emissions.

An engineer at Accola works with electronics at a test bench

How to Catch Issues Early

By systematically approaching conducted and radiated emissions—starting with measurement, followed by localization and mitigation—a skilled engineer an resolve EMC issues efficiently.

Catching EMC issues early in the design process is key to ensuring both compliance and product reliability. Start by integrating EMC requirements into the design brief, considering relevant standards and potential interference sources. Early use of electromagnetic simulation tools can help predict how your product will behave in its electromagnetic environment, allowing you to adjust designs before physical prototypes are made.

After developing the first prototype, you should perform pre-compliance EMC testing to measure both radiated and conducted emissions. This helps identify major issues early on. Near-field scanning can then pinpoint high-frequency emission sources, allowing for targeted design modifications. Basic mitigation techniques like decoupling capacitors, shielding, and grounding can be applied to prototypes to address issues immediately.

Now, iterative testing is essential… you need to retest with each design revision to ensure that these mitigation strategies work. Use tools like spectrum analyzers and oscilloscopes for real-time feedback. Before finalizing the design, schedule pre-compliance testing at a specialized facility to catch any remaining issues.

Then, once the product is finished, we’ll conduct system-level EMI/EMC certification testing to verify that it does not interfere with other devices in the final product.

For a comprehensive, hands-on guide to EMC troubleshooting, including detailed procedures, equipment setup, and results analysis, I recommend Workbench Troubleshooting EMC Emissions (Volume 2) by Kenneth Wyatt. Drawing on over 30 years of experience at Hewlett-Packard and Agilent Technologies, Wyatt provides clear explanations, real-world examples, and expert tips that are especially valuable for engineers working in design and compliance testing.

Bring Your Project to Accola

If you’re in need of expert assistance in developing or manufacturing medical devices, drug delivery systems, or combination products, Accola is a trusted engineering and manufacturing partner for innovators in the MedTech industry. We help innovators in MedTech bring safe, reliable devices to market by developing and testing products to rigorous medical device standards like IEC 60601. From electrical safety and EMC testing to mechanical, thermal, and performance verification, our team ensures your devices meet regulatory requirements and perform as intended.

To minimize risks and reduce costly delays, we rigorously test products in the early stages of development. We identify and address potential EMC-related issues before they become problems. This proactive approach ensures your product complies with regulatory standards and performs optimally.

With our expertise, you can confidently navigate the challenges of product development and bring your innovations to market. Trust us with your next complex electromechanical project.

About the Author

Noam Sheetrit is an Electrical Engineer at Accola, where he contributes to the design, verification, and compliance of electromechanical systems for medical devices. He holds a Master’s degree in Electrical Engineering and a Bachelor’s in Biomedical Engineering, enabling him to develop integrated systems that prioritize patient safety and usability. His expertise spans circuit design, schematic capture, and system integration, ensuring that devices meet quality standards such as IEC 60601 and IEC 61010.

The post Don’t Fail Your EMC Testing: How to Troubleshoot Emissions Early appeared first on Accola.

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

The post Sanner celebrates grand opening of first U.S. injection molding facility in Greensboro, North Carolina appeared first on Accola.

Our end-to-end capabilities allow us to accelerate time-to-market while ensuring the highest standards of quality for our medical and pharmaceutical customers.

In this blog, we explore the process of bringing injection molded components to life for use in medical devices. First, let’s start with device design and prototyping:

Prototyping and Product Engineering for Injection Molding

Every successful product launch begins with a thorough and well-executed prototyping process. We offer a complete range of prototyping solutions that help customers quickly turn initial concepts into validated, production-ready designs that accelerate development while minimizing risks early on.

First, we start with functional concept prototypes made of materials like PLA, ABS, or resin, using in-house SLA and FDM prototypes. These let our engineers test for failure points that can be designed out before we move on to activities with a higher cost for changing things.

Once a project enters design controls, where regulatory and engineering documentation becomes formalized, prototype activities shift from rapid iteration to production-representative builds. At this stage, parts used for testing or validation must reflect production intent in terms of both design and material.

Our design and development services include:

• 3D printing and digital simulation for concept validation
• Early-stage testing to reduce risk and accelerate time to market
• Aluminum mold tooling for rapid iterations
• In-house Design Transfer team to streamline transition to manufacturing

We move projects through these services to ensure that every design is optimized not just for performance, but also for cost-effective, repeatable production in high volumes.

US-based Injection Molding and Manufacturing

Once the product design is ready to enter production, either for a small clinical batch or a mass production run, we verify and validate the tooling in one of our production facilities.

In the United States, our new Greensboro, NC facility is now operational and equipped to meet the growing demand for medical device injection molding and assembly.

Key highlights of this U.S. facility include:

• White room and ISO class 7 and 8 cleanroom injection molding
• Expansion opportunities for automated and manual assembly
• Close proximity to existing design and manufacturing sites in North Carolina

As part of Sanner Group, Accola operates within an expanded global footprint, leveraging over 300,000 square feet (28,500 sqm) of total production space and more than 115,000 square feet (11,000 sqm) of ISO Class 7 and 8 cleanrooms across North America, Europe, and Asia.

Together, our combined operations bring over 60 years of expertise in molding medical and pharmaceutical components using biocompatible materials such as polycarbonate (PC), polyethylene (PE), high-density polyethylene (HDPE), polypropylene (PP), and glass-reinforced composites (GFRCs).

With these resources and molding experience, we’re able to offer a comprehensive range of injection molding services, including:

• In-house mold toolmaking & high-precision machining
• Injection molding process validation
• Mold flow analysis
• Single-cavity molds to high-cavitation hot runner systems
• Rapid prototyping and quick-turn tooling modifications

In addition to our new facility in Greensboro, our existing manufacturing sites are fully equipped to support end-to-end device manufacturing for finished medical products. These services include:

• Ultrasonic welding, heat staking, curing & annealing
• Pad and screen printing
• First article inspection & real-time process monitoring
• Form fill seal (FFS) packaging

Your One-Stop Shop for Developing Medical Devices

Bringing a medical device from concept to full-scale production is a complex process, but it doesn’t have to be complicated.

At Accola, a Sanner Group Company, we offer everything under one roof, from early prototyping and design validation to precision mold tooling and cleanroom injection molding.

With our new Greensboro, NC facility and our global capabilities as part of the Sanner Group, we’re equipped to support projects of any size, whether it’s a small clinical run or high-volume manufacturing. Our integrated approach helps speed up development, reduce risk, and ensure the highest quality every step of the way, so our customers can focus on delivering better outcomes for patients.

Ready to bring your medical device to market faster and with confidence? Get in touch with our team today to learn we  can support your next project.

The post From Prototype to Injection Molding for Medical Devices appeared first on Accola.

Sanner’s new manufacturing facility in Greensboro has started production according to plan. With a total of 60,500 square feet (5,600 square meters), the facility offers capacities for both CDMO and packaging operations. “We’re thrilled to be opening Sanner Group’s first North American injection molding and pharma desiccant packaging facility. Strategically positioned in North Carolina, this site will be supported by our strong design & development and transfer engineering teams already here in Durham and Pittsboro.” says Ted Mosler, President of Sanner US.

Growth opportunities for CDMO services

The GMP-compliant facility with automated environmental monitoring accommodates both white room and Class 7 and 8 cleanroom space, as well as full laboratory capabilities for testing and metrology. With an additional 20,000 square feet (1,800 square meters) of easily expandable production space, Sanner can quickly adapt to growing customer demands. “We are now able to offer our MedTech and Pharma customers the full CDMO service, including injection molding, from a single source in the US.” says Ted Mosler.

Desiccant packaging solutions made in the USA

The new filling room with automated high-speed desiccant filling lines enables Sanner to provide customers in the North American pharmaceutical and nutraceutical industries with packaging solutions made in the USA. Among the first products manufactured in Greensboro are effervescent containers, the premium DASG-1 desiccant closure, and AdCap^® desiccant canisters; further products will follow.

Set for further growth

Sanner recently acquired the Durham-based CDMO, Accola, a firm specializing in medical design, development, manufacturing, assembly, and packaging. Sanner also opened its second production facility in Kunshan, China, in 2023 and started production at the new state-of-the-art manufacturing site and headquarters in Bensheim, Germany, this year.

“The opening of our new facility in Greensboro, USA, marks a key milestone in Sanner’s long-term growth strategy,” says Christian Classen, Chief Sales Officer of the Sanner Group. “We are strengthening our position as a trusted CDMO partner—bringing together proven expertise, technological excellence, and a strong track record in drug delivery, diagnostics, and medtech devices. At the same time, we are expanding our active primary healthcare packaging business with local production capabilities in the United States. This enables us to serve our North American customers more efficiently, with shorter delivery times and the consistent, high quality they expect from Sanner.”

Building on a company history that spans more than 130 years, Sanner has continuously evolved into a global provider of plastic healthcare packaging and device-related offerings. With decades of experience in desiccant packaging and moisture management solutions for the healthcare industry, and a steadily expanding portfolio that now includes medical device capabilities, Sanner continues to grow its global footprint and deepen its commitment to the U.S. market, where it has been active since 1995.

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

Commha Consulting GmbH & Co. KG

Annette Crowther

Tel. +49 6221 18779-27

sanner@commhaconsulting.com

The post Accola, a Sanner Group Company, starts manufacturing in Greensboro, USA appeared first on Accola.

Almost 4 years ago, I chose to pursue a graduate degree while working a full-time job to grow in my career and to increase the depth and breadth of my technical knowledge. The journey was demanding but it imparted valuable lessons that can broadly apply to any situation where one must balance their day-to-day responsibilities with the effort necessary to grow and develop in a career.

Based on my experience, here are five key lessons that have been most valuable in balancing graduate school with a full-time engineering job:

Communicate Transparently and Often

First is the importance of clear and frequent communication. Whether it is with your manager, colleagues, professors, or classmates, setting expectations and keeping others informed of your availability, workload, and deadlines is essential. Transparency builds trust and can often to lead to support structures that enable your success. A professor allowing an extension of a project presentation deadline because they know you will be traveling for business the same week, a manager encouraging flexible work hours during exam week, and classmates willing to start a group project earlier are all examples of support that was offered to me as a direct result of open communication.

Set Realistic Expectations

Setting expectations with others is just as important as setting realistic expectations for yourself. Taking on more without readjusting what is already on your plate is a tried-and-true recipe for burnout.  One way I learned to avoid this was to write down every reoccurring responsibility/commitment that I had now (include work, school, social, and general life-maintenance), my desired results in an ideal world, and the minimum necessary. Then I removed any items that don’t have that minimum necessity and ranked the priority of the remaining items. This activity can lead to a collection of minor changes that add up to significant impact. For example, it led me to stop folding my t-shirts after doing laundry, lower my expectations for how long a workout needs to be, and start saying no to additional responsibilities when their priority did not rank higher than anything on my list.

Find Synergy

Another powerful strategy is to try and find synergy between work and school where possible. This involved conversations with coworkers to learn whether their projects touched on my course material and conversations with professors to find additional resources that more closely aligned with my career. Not only did this help save time, but it also made my coursework more valuable and helped solidify the material I was learning. I once did a mathematical analysis of a switch mode power supply I was designing into a product to align with a course I was taking, even though this level of analysis was not needed for the design. It helped me understand the formulas I was learning in the course and months later when I needed to troubleshoot issues in a prototype, the in-depth understanding I had of the component allowed me to isolate problems quickly.

Time Management Strategy

Lastly and perhaps most importantly, having a defined strategy for time management is critical. There is no one-size-fits-all approach to this but just as gaps in your own approach tend to be obvious and quickly apparent, so do the right techniques. Personally, I found success in Trello and the pomodoro technique. Trello is one of many available tools that allow you to create cards for individual tasks, sort these cards into lists, rank priorities, and track progress. My personal Trello board had lists titled Backlog, This Week, Today, In Progress, Awaiting Input, and Complete. The pomodoro technique is a method by which you spend 25 minutes of pure focus on a task, followed by a 5-minute break. After four of these sessions or “pomodoros”, the break becomes a 15-minute break. Short breaks are used to reflect on what was accomplished in the last session and what is planned for the next. This technique helped me stay focused and helped me understand how long tasks were taking me.

Find a Company that Cares

Balancing a full-time career with graduate studies is not just about making it out with a degree—it’s about growing as a professional.

A key part of my journey in completing my graduate degree was working at a company that values professional development and growth in their employees.

Accola provides an environment that made balancing hands-on project work with finishing my degree both possible and rewarding. Accola’s culture builds people up through challenging projects, promoting continuous learning and skill development. It makes bright engineers even better equipped to take on complex design work.

Having completed my Master of Science in Electrical Engineering at NC State, I feel that I’m better equipped to design and develop medical devices that change the lives of patients everywhere.

About the Author

Noam Sheetrit is an Electrical Engineer at Accola, where he contributes to the design, verification, and compliance of electromechanical systems for medical devices. He holds a Master’s degree in Electrical Engineering and a Bachelor’s in Biomedical Engineering, enabling him to develop integrated systems that prioritize patient safety and usability. His expertise spans circuit design, schematic capture, and system integration, ensuring that devices meet quality standards such as IEC 60601 and IEC 61010.

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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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