Catheters owe their efficiency to the choice of materials and design used. The inner and outer layers, along with the strategic choice of a middle layer—be it coiling or braiding—allows for optimal catheter performance. In this article, we discuss the differences between coiling and braiding and their outcomes on the final product.

While each layer serves a distinct purpose, the art of catheter engineering lies in the ability to tweak all three layers for optimal performance tailored to user requirements.

The inner layer of a catheter is typically PTFE liner, providing a lubricious Inner Diameter (ID) with great flexibility. Stiff ploymers can be used in the ID as an alternative, at the expense of flexibility, providing the result of increased stiffness.

The outer layer, composed of polymer extrusions, acts as a primary determinant of the catheter’s overall flexibility.

It is in the middle layer where we delve into the complexities of coiling vs braiding. Both processes serve a unique purpose, providing different outcomes to the overall function and output.

Braiding, a common reinforcement technique, introduces a numbers of customisation options, based on the needs of the user. The choice of wire sizes—both flat and round—offers versatility. PPI (Picks per inch) or wires crossing can be varied over the length of the catheter, depending on what the performance requirements are. High PPI gives greater flexibility and low PPI results in increased rigidity and torque transmission.

Pros:

• Better torque transmission
• Reduced radial expansion
• Good pushability and column strength

Cons:

• Less kink resistance
• Potential ovalization in the ID in tight bend radii

– Braider at ICS Medical Deivces

Coiling is another reinforcement method which brings its own set of considerations. Various wire sizes—round and flat—provide flexibility for different catheter sizes. Larger wires e.g. 0.006” x 0.018” stainless steel wire could be used for a large ID catheter, such as structural heart. Small round wires 0.0015” OD is more suitable for high flexibility in small, neuro catheters. The pitch can be adjusted depending on the flexibility required.

Pros:

• Greater flexibility, increased kink resistance
• Maintains a round ID in tight bend radii

Cons:

• Poor torque
• Susceptible to stretching or compression in tension or compression

– Coiler at ICS Medical Deivces

For catheters needing a blend of characteristics, a hybrid approach offers a strategic solution. If wall thickness allows, combining both braid and coil can be particularly useful. This hybridisation caters to large diameter catheters requiring a small bend radius and angle. The proximal end, needing less flexibility, may feature a low PPI braid with a stiff extrusion. Meanwhile, the flexible distal end benefits from a coil and braid combination for better flexibility and kink resistance.

ICS Medical Devices are your flexible partners in the design, develpoment and manufacturing of catheters and delivery systems. To speak with our management and engineering team about your project, send us an email at info@icsmedical.com

• I joined the ICS Medical team in 2023 in the role of ‘Head of Operations’. My responsibilities in this role involve overseeing and coordinating various operational aspects to ensure smooth and efficient business operations.  This involves strategically setting goals and objectives that not only guide our present actions but also enable us to plan for the future. Ultimately, my role is centered around people, technology, quality, delivery and cost, as well as planning for the future to ensure we are scaling and growing with our customers.
• It is imperative that we align our growth trajectory with the evolving needs of our customers, whether it involves enhancing our capabilities or expanding our capacity. I also head the LEAN initiative here at ICS which allows us to improve our efficiency by eliminating waste and ensure continuous improvement.

Can you tell us about an operational program you have introduced at ICS?

• The launch of the ICS ‘Operations Excellence’ program saw the introduction of the tiered management structure. This allows performance to be measured under the pillars of People, Quality, Delivery and Cost at all levels of the oraganisation. This regular measurement allows staff to see if we are going off target and to take the appropriate action or escalate where necessary.
• Having this operation management structure in place is crucial as we scale and grow as an organization. It ensures the engagement of all staff and identifies problems early and at source. When faced with a challenge, this process ensures we, as a team, use structured six sigma problem-solving methods to ensure we are carrying out the most effective solution.

Tell us more about the LEAN practices at ICS Medical.

• LEAN is a process optimization strategy we use here at ICS Medical. A concept which originated from Japan, LEAN processes support the concept of continuous improvement by improving efficiency and effectiveness through the elimination of waste.
• At ICS, we are a 5S LEAN workplace. The 5s’ stand for Sort, Set, Shine, Standardise and Sustain. This practice runs through every vein of the company, from manufacturing processes to work areas to equipment, and all staff members are engaged with this practice at various levels. With this practice in place, customers are assured that they are getting the most efficient service possible from our team.

-Lean 5S boards located around ICS facility to track our monthly progress

-Line-side boards used to track the progress of projects, training and more

Finally, what makes ICS stand out as an industry-leader in the field of catheter design, development and manufacturing?

• ICS stands out in the industry as we have the skills, infrastructure, talent, and technology to bring our customer all the way from an initial idea/ concept right through to commercialisation.
• I believe that ICS’ forte is our flexibility and responsiveness to our customers. We are essentially part of their development team, and we always have one of the team on hand to answer questions, concerns, or challenges that the customer has in their development journey.
• Our business excellence model drives our operations at all levels and customers can rest assured knowing that they are getting the best quality product made and developed at the highest standards.

If you would like to know more about ICS Medical Devices or the services we offer, get in touch today by emailing info@icsmedical.com

-Matt Carty, Head of Operations

Shivani began at ICS Medical in 2022 in the role of Product Builder. Since then she was promoted to Graduate Engineer and now works in the design group. Below, Shivani shares more about her day-to-day at ICS and a little more about herself.

• What is your role at ICS Medical Devices, and how has it changed since you began at ICS?

I started as a Product Builder in August 2022, and within 6 months I was promoted to Graduate Engineer. Currently, I am part of the design group at ICS Medical Devices. As a design engineer, I work on projects in their design phase which involves process development, and process setup, and help bring the design from paper to the physical structure.

• How did you find yourself in this role? What interested you in this field of work?

Ever since high school, I was curious about how medical devices work and was keen on learning about the fundamentals which made me choose biomedical engineering as my career path. In August 2022 I graduated from NUIG with a level 8 in biomedical engineering and I was actively looking for jobs. I was offered the role of Product Builder in ICS and I saw this as an opportunity to grow in and learn about the medical device industry.

• What do you like most about working at ICS?

Working at ICS is a unique experience for me as an engineer. I frequently encounter challenges that help me develop and learn from my mistakes. However, in the end, it is highly rewarding to witness the progress of both myself and the project and to see how we are achieving success. Moreover, I am surrounded by talented and dedicated colleagues who are always willing to lend a helping hand or share their expertise. This sense of teamwork and continuous progress makes it an exciting place to work.

• What skills do you think someone should possess when applying for a job at ICS?

In my opinion, to be part of ICS, the individual should be able to adapt to changes quickly and have a collaborative mindset to bring success to the customer and the company.

• What do you like to do in your free time? Any passions or hobbies?

I am passionate about home cooking and experimenting with new recipes. I enjoy cooking recipes from various cuisines, and I occasionally bake.
Aside from satisfying my taste buds, I enjoy painting, which helps me unwind from my busy schedule.

• As Supply Chain Manager, I’m responsible for shaping the Supply Chain of an extremely dynamic and fast-growing company. 
• Among my responsibilities lie planning for growth and foreseeing future development of the supply chain. Evaluating suppliers and creating Win-Win relationships with them.  
• I’m also currently working on an ERP implementation. The main objective of this implementation is to create a good flow of goods and services while reviewing the process to acquire and manage these goods and services. In other words, the right amount of goods at the right time at the right price. 

What are the key challenges and complexities specific to managing the supply chain in the medical device industry? How do you address these challenges? 

• The typical challenges would vary from company to company and from time to time. However, there are challenges that all companies are facing at the moment. For example, Covid created extremely complex chain reaction and constraints (shortages). When factories re-started production they also had to face a bidding war in order to conquer some shipping space aboard planes and ships. 
• In our case, the biggest challenge is probably forecasting purchases for the long term since we work with growing companies (customers) with growing needs and we must be flexible to move with our customers changing environment and ensure we have the correct goods and materials on time to carry out these projects.

What strategies or initiatives are you currently implementing to enhance sustainability and reduce the environmental impact of the supply chain at ICS Medical Devices? 

• Myself and ICS as a whole are very committed to sustainability. We are constantly exploring new possible ways to reduce our impact. ICS is actively taking action by working with our suppliers to also leverage a change on their side. 
• For example: 
• -ICS is promoting and supporting Active Travel. 
• -ICS is re-using all packaging as much as possible. 
• -We use recyclable packing. 
• -ICS offsets our carbon footprint by working closely with our transport partner. 
• -Recycle all materials appropriately. 
• -Reduce waste internally. 
• -Being energy efficient internally

Looking ahead, what trends or changes do you foresee in the medical device supply chain? How is ICS Medical Devices preparing for these changes? 

• We have already seen over the past 4 years an inversion of trend. Many industry sectors are reversing the outsourcing trends and are bringing sourcing and manufacturing back to Europe. Where possible, companies are insulating themselves against the uncertainties of having suppliers or sub-suppliers all on one continent. In other words, if you solely rely on one supplier based in a different continent you will have very little control over the supply chain. For example, in the news when we again heard about delays at the Panama Canal due to drought, obliging ships to queue for a longer than planned time.  Other disruptions include those coming from the mounting attacks in the Red Sea. These attacks are disrupting maritime trade as leading global freight firms reroute around the Cape of Good Hope to avoid the Suez canal.
• ICS Medical wants and needs to ensure business continuity for its customers. We therefore work with local suppliers (where possible) to meet the highest quality standards and ensure timely communication and responses to our customers’ demands. 

– Enrico Lionello, Supply Chain Manager

Dion Gallagher has worked in ICS Medical since 2022 in the position of Principal Design Engineer. With over 16 years experience in the industry, Dion tells us more about his role.

• What is your role at ICS? What does your day-to- day look like?

As a Principal Engineer at ICS Medical Devices, I play a pivotal role in overseeing the successful completion of ICS Medical Device programs. I serve as the primary liaison between ICS and our customers, providing comprehensive guidance and technical support throughout the entire product development lifecycle. Additionally, I lead customer design input, supporting the advancement of ICS’s technical capabilities to ensure we consistently deliver world-class design solutions to our valued customers. Simultaneously, I mentor and foster the growth of our technical engineering team, nurturing their expertise and contributing to their continuous development.

• How did you find yourself in this role?

After working for approximately 16 years in the contract Design Services department at Creganna Medical, a few of my colleagues from that time established ICS Medical, a company dedicated to developing innovative front-end solutions for their customers. Their commitment to excellence, innovation, and customer focus resonated with me, and I made the decision to join ICS Medical in 2022.

• What do you like about working at ICS?

I like the lively and forward-thinking culture at ICS Medical, providing a platform where I can actively participate in groundbreaking advancements in front-end medical device technologies. From complex structural heart devices to the precision-driven therapy areas of electrophysiology, neurovascular interventions, and innovative smart catheters, the scope of innovation at ICS Medical is inspiring.

• Can you tell us about an interesting or challenging project you have worked on since joining ICS?

At ICS Medical, I was involved in the development of a compelling and intricate device—a Tricuspid Valve Delivery System designed to address Tricuspid Regurgitation (TR). TR is a cardiac valve disorder marked by the reverse flow of blood from the right ventricle to the right atrium during the cardiac cycle. Typically, the tricuspid valve maintains a unidirectional blood flow from the right atrium to the right ventricle, preventing any backward leakage. In cases of severe tricuspid regurgitation, the valve fails to close effectively, leading to the undesired backward flow of blood.

• Outside of work, how do you like to spend your free time?

I’m an outdoor enthusiast, I enjoy spending time travelling around in my self-converted campervan, I enjoy a range of activities, including hiking, kayaking, and paddle surfing. This year, I spent time in Norway, where I did some glacier hikes and hiked to the Trolls Tongue ‘Trolltunga’ Via Ferrata, which was one of my highlights of 2023.

Dainius Zilinskas is Prototype Technical Group Lead at ICS Medical Devices. After four years, he reflects on the early days of ICS Medical and what he has learned since then.

• Give us some information on your career/background. What sparked your interest in a career in medical devices? 

I studied mechanical engineering in university, specialising in Biomedical Engineering in my final year. I found the lectures and projects to be very interesting as there was a huge amount to learn, but it took me a couple of years to get into medical devices after I finished college.  

During my final year and directly after college, I worked with heat recovery ventilation systems and shortly after moved to recycling plant design services for a couple of years, until I got an opportunity to join the ICS team. I always had an interest in medical devices. My decision to join ICS was impulsive and after 4 years, I can still say that it was a good decision as I am still learning every day, using and upgrading my skill set.  

• How long have you been working at ICS Medical? What was it like working in the early stages of a medical device start-up? 

I have been working at ICS for over 4 years. I joined the team a couple of months after ICS opened. Working in the early stages of a medical device startup was an amazing experience as I was able to grow my knowledge and experience together with ICS. I was involved in most of the activities in ICS at the time from prototypes to running manufacturing projects etc. The learning curve in the first couple of years was steep due to the expansion of the company. It would be close to impossible to get an experience like that in bigger companies.  

• How does the prototyping process at ICS Medical work? 

We start communication with the customer to clearly understand project deadlines and desired functionality of the product. After review we have our input into the design outlining possible obstacles and outcomes. We always have design suggestions to improve the product to have fully functional capabilities in the early-stage prototypes.  

Once we agree on the design and materials, we provide a quote to the customer with the quickest possible lead times. Once we receive a purchase order, we order all materials. When materials land we start the prototyping process and work closely with the customers ensuring they are constantly aligned with the progress and give their input if required.  

Once prototypes are complete, we ship them for customer evaluation. Finally, our customers run multiple tests to understand if we need to change/improve some points of the devices. If so, we work on further development until the customer and ICS are confident to move to the next phase of the project. 

• What is the most rewarding part of your job? 

The most rewarding part of the job is receiving very positive feedback from customers with successful functional trials. It‘s very rewarding to see projects moving from the concept of an idea to developing fully functional prototypes right through to the commercialisation of the product.