Senior Product Manager Stephanie Poulsen speaks about her role guiding strategies for the development of products used for diagnostic and interventional procedures. And more recently, her focus on products specific to the radial approach, a technique that has grown significantly around the world because it allows patients to get up and return to their lives faster. In her I am Merit video interview, Steph shares why she believes that her work at Merit is truly important and how it has touched her life personally.
Casey Holland, Clinical Operations Manager for Merit Medical, Rockland, Massachusetts, USA.
Perspective. I started working with BioSphere in 2007 in Quality and Regulatory Affairs, which worked closely with Medical Affairs. I worked hard during this period of time. I was really starting to focus and gain perspective on my career, which lead me to make the transition into Clinical Research in 2009. Then Merit acquired BioSphere in 2010 and I became a Merit employee. In 2012, I obtained my Masters degree from Northeastern University in Regulatory Affairs for Drugs, Biologics and Medical Devices. My Masters degree gave me detailed knowledge of all regulations pertaining to the development and commercialization of medical device products. Currently, I oversee all operations for three FDA approved clinical trials using Merit Medical products.
Most Rewarding. I feel that every part of my work is rewarding. Being the Clinical Operations Manager comes with great responsibility and importance. I manage a staff of ten highly specialized individuals here at the Merit office in Rockland, Massachusetts. We run three clinical trials involving hundreds of patients. The importance of clinical trials can’t be understated. All of my efforts are directed towards helping people. The development of innovative new treatments and products are important to the ever changing Healthcare Industry. Clinical trials are a crucial part of the innovation and development. I’m not a doctor. I’m not a nurse. But I am making a difference in the lives of patients through medical research. Having found my way of helping people, is what’s truly rewarding.
My Part in Our Vision. Merit Medical has the vision to “make a difference by understanding our customers needs.” Being the Clinical Operations Manager my work is directed towards understanding and documenting the needs of the patient. Just because a treatment is being used today, doesn’t mean that the treatment should be used tomorrow. Understanding the needs of the customer requires research and the development of new treatments. Clinical research gives us the ability to understand these needs and bring new products to the market.
New York Yankees? Absolutely not. No way. Not ever. I’m from Boston, our sports teams are a way of life here. Being from Boston, it’s not even a question of being a fan of our teams. We just are. We are Boston Strong. I just went to a Patriots game last weekend. It’s hard to explain, it’s just a real big thing and not just for the Red Sox, it’s for all our sports teams.
Brandon Beck, Senior Engineer for Merit Malvern, Pennsylvania, USA
My story here began 20 years ago: I started working here in the now “Merit Malvern” office twenty years ago, right after graduating from Penn State University. When I started it was Thomas Medical and I was a supervisor who worked on the team that built the Classic Sheath, a device for implanting leads for pacemakers and defibrillators. Years later we were acquired by GE Healthcare and then in December 2012, by Merit Medical. Now I’m a Senior Manufacturing Engineer, which means I look after our manufacturing processes to ensure efficiencies and quality, including ECN’s and validations. I review work that others produce and mentor other engineers so they can grow in their professions.
Thomas, then GE, then Merit: The transitions from company to company has been a positive experience. There’s a group of us who have been together for 15-20 years and have gone through these transitions together, making it all feel familiar. However, looking back over the past 20 years, I have been presented with so many varying opportunities and challenges. My goals from day-to-day and year-to-year are never the same. This has made working here feel new, exciting and challenging all the time.
What do you enjoy most about being a Manufacturing Engineer: I love solving problems all day long. Sometimes I feel like a CSI investigator. I love to fix and improve things so I spent many months training to receive my Lean Manufacturing and Six Sigma Black Belt certifications. Several years ago, we found that we were carrying six months of inventory for one of our most popular products. Utilizing lean and six sigma techniques and working with a team to determine how to reduce waste – we reduced the number of people working on that line by half and now only carry a two week inventory. These efficiencies benefit Merit and our customers.
Tell us about a project you feel most proud of: I’m proud of many of the projects I’ve worked on but the first one that comes to mind is the Steerable Sheath. I was the lead manufacturing engineer working with R&D and it was the first new project coming out of R&D Malvern incorporating lean manufacturing techniques. The steerable sheath is the most complex product we’ve built in Malvern because it has the most parts and several new unique processes. We’re already at 98% yield and labor is the smallest portion of the cost of the product.
After work: I married my wife Meredith the same week I was hired by Thomas Medical, 20 years ago, and my marriage and my career here are still going strong! Meredith and I have three teenagers – two sons and a daughter. Matthew is in college and Christopher and Sarah are in high school. I love hockey and played ice hockey at Penn State. But my real hobby passion is disc golf. Disc golf allows me to see beautiful places while playing a competitive and fun sport. I look forward to playing disc golf at the Solitude Mountain Resort in Big Cottonwood Canyon next time I am in Utah to visit HQ.
Tell us about managing Merit Medical’s Customer Service for all of Europe, Middle East and Africa: I manage Merit Medical’s customer service for our distributors, direct customers (hospitals) as well as the tender department for all of Europe, Middle East, Africa and Russia (EMEA). When I started (on November 3, 2008), there were three of us in the Distributor Customer Service department for EMEA and approximately 20 people at our facility. Over the past 7 years the number of employees increased to just over 60 people and I now manage 24 customer service employees, soon to be 25 before the end of this year!
I work from our European Headquarters in beautiful Maastricht in the very southern region of The Netherlands on the border of Belgium and Germany.
Tolerance is Key for EMEA Customer Service: The biggest (and most rewarding) challenge for our EMEA Customer Service team is working with 75 countries that speak 12 different languages. This includes 14 countries that sell direct to hospitals and 61 distributor countries. Our team services 1,830 external customers and 75 Merit EMEA sales representatives! Our team speaks Spanish, Portuguese, Danish, Swedish, Russian, English, French, German, Dutch, Norwegian, Finnish and Italian and at all times we need to make sure that someone who speaks that language is available to speak with customers calling in.
Tolerance is a very important trait to have when you work in EMEA customer service because we must be familiar with and sensitive to so many different cultures. So I’m sensitive to having a team with a good vibe and I look for people who can maintain a sense of humor while managing so many customers and nationalities.
On why it’s all important to Michelle: I once had a job opportunity to work for a company in a different industry. It didn’t feel important to me – medical devices save lives, they are important and that’s why I love this industry. This was confirmed recently when my husband David suddenly had a heart attack at age 39. Products like the ones that Merit manufactures saved his life. We got married this past weekend after 15 years of being together. I would trust Merit products to go into my husband’s body – I know that we make the highest quality and we do everything we can to produce the best we can.
What about Merit do you enjoy: Merit has a family feeling, it’s like a second home. The people in this company give you that second family feeling. And Customer Service feels to me like the center of everything. We provide all of the information to planning so they can ensure products ship on time, to finance, to logistics, to regulatory, to marketing, to the customer, internally and externally. To them we are the face of Merit.
I have especially enjoyed working with Justin Lampropoulos – he helped me move up from distributor customer service representative to my current position as Customer Service Manager for EMEA. He has motivated me all along the way. His vision for Merit to be the most customer-focused company has been my mantra for our EMEA customer service team – give every country what they need – do anything and everything we can for the customer. That’s what makes Merit very unique in our industry.
After work: On the weekends I love to take my two daughters horseback riding. Yadira is 11 and Yuna is 8. Horses really help me to destress from the week and it’s an activity we love doing together.
Justin Lampropoulos, Executive Vice President of Sales, Marketing & Strategy for Merit Medical Systems, recently contributed the article, “The Building Blocks of Sustainable International Growth,” to Business Connect Utah magazine. In his article he shares key insights into growing a business internationally, including finding shared culture and values, developing successful channels and building a brand in a new market.
Merit Medical derives nearly 50% of its business from global markets outside the United States. This global success and Merit’s continued growth stems from smart, forward-thinking tactics as well as the company’s stated vision to deliver the best health care possible. Merit uses this universal foundation to follow through globally on its corporate vision: Each day we are determined to make a difference by understanding our customers’ needs, and innovating and delivering a diverse range of products that improve the lives of people, families, and communities throughout the world.
Above all else, Merit Asia’s third employee, Michelle Xu, Channel Management Supervisor, enjoys working with her dedicated Merit colleagues “who never say never.”
Working for Merit Asia as it continues to grow: I joined Merit Asia five and a half years ago in 2010 as an Administration Assistant. I was the third employee then, and now, as of the end of September, we have 89 employees with Merit Asia! I enjoy working for Merit because it is a friendly, flexible and open environment to present your opinions, share your ideas and discuss better solutions. A good work ethic is always encouraged and outstanding performance is rewarded. Merit provides us with different kinds of opportunities to thrive.
Her responsibilities as Channel Management Supervisor: As Asian Channel Management Supervisor I manage 380 distributors in Mainland China and 30 distributors in Southeast Asia. My key responsibilities include conducting due diligence, legal documentation review, on-line compliance training and Agreement and Letter of Authorization as well as distributor performance evaluation and incentives calculation. In addition to my distributor responsibilities I manage sales promotion control, internal process improvements, data analysis and dealer training. Channel Management is an important function that acts like a “doorkeeper,” to monitor distributors’ qualification and activities, and like a “bridge,” to build up a channel and connect external distributors with internal Merit sales representatives. As the Channel Management Supervisor, I ensure that Merit is receiving maximum benefit from our distributors and contribute to the overall sales organization.
On what she enjoys most about Merit: No doubt, if nothing else, THE PEOPLE! People are precious to Merit. All of our incredible achievements have come from the Merit team’s continuous efforts and amazing creations. I enjoy my colleagues who are professional, dedicated and never say never. I am delighted to work with them and celebrate every milestone moment together.
How she spends her time outside of work: I am an outdoor enthusiast and like swimming, spinning, mountain climbing and hiking. I will travel around the world during my annual holiday. Reading books and cooking are also my favorites during my spare time.
Sales Engineer Sarah Spangler customizes Merit Medical products and devices for Merit’s OEM (Original Equipment Manufacturer) customers. Sarah spends her days collaborating with the OEM sales team, customers and other Merit engineers to ensure that we can provide a product that meets the customers’ needs and procedures. Watch her video interview.
At Merit Medical’s newest facility in Tijuana, Mexico, Manufacturing Manager Ricardo Alvarez does everything he can to ensure his employees feel successful – because his team is what makes Ricardo feel successful.
The path to becoming the 2nd employee at Merit Tijuana: I moved my family to Tijuana in January 2014 when I accepted a position with Integra, a contract manufacturer to Merit for seven years. At Integra I assembled a high performance team to produce Merit products with high standards for Safety, Quality, Delivery and Costs. This April, I had the privilege to become part of the Merit family as the Manufacturing Manager and second employee at the new Merit Tijuana Mexico Plant.
Ricardo’s Hiring Philosophy: I currently have 190 total employees covering Engineering, Facilities, Maintenance and Production. I always try to include my team because my team makes me successful. When I hire I look more at personality and values. I take interviewees to the manufacturing floor to see whether they are passionate and enjoy what they do. Technical skills can be learned, but personality and values is so important because they need to fit well with the team and the company’s vision.
How Ricardo Shapes the Merit Culture in Tijuana: Right now we’re the new kids on the block in Tijuana. But my goal is for employees to stay here a long time because many on our corporate team have 15-20 years seniority! And I believe we can achieve that goal if we follow the Merit culture treating people the best we can and looking after our employees’ personal lives. For example, here at Merit we provide free transportation to and from work, lunch and snacks and life insurance – these benefits are not typical around Tijuana and we want to be the best!
On his Commitment to Work and Family: My passion is Manufacturing Operations and I feel a high degree of responsibility to ensure every single device is manufactured with quality, delivered on time, meets standard costs and exceeds the expectations of our customers, so they can use my products or any other Merit device to improve their quality of life. My best hobby is my family: my wife Alessandra Aranda is my motivation, she supports me in many ways, listening, coaching and living in the manufacturing world with me. We have two children, Constanza age 9, she loves to do yoga, and Andre who is 2 is getting ready to play Soccer! We enjoy biking or simply watching a movie together and the best feeling is to end up the week every Sunday with the work done and the family happy!
At Merit Medical’s Galway facility, Quotes and Samples Analyst, Maeve Harris, enjoys meeting directly with physician customers and helping them find solutions that make their jobs more efficient.
Maeve’s Unique Role at Merit Medical: A Merit sales rep from Europe or a distributor from the Middle East or Asia will come to me if one of their physician customers wants a procedure pack. They’ll tell me what they want in that procedure pack and I’ll price it out and build a non-sterile sample to send to the customer. The procedure pack will include everything the doctor needs for that specific procedure, from devices to accessories that Merit doesn’t manufacture, like drapes. These packs save a lot of time for the hospitals and make the doctor’s job more efficient. Once the doctor orders the pack, my job is done until they want to make a change – then they come back to me.
Why she loves coming to work every day: The doctors come to our Vision Building in Galway to meet with me and pull product from our shelves. We collect it all in the pack work area and I build the pack with the customer. I get to meet many new people all the time – our international sales reps and our customers. Every day is different. I really enjoy being able to find solutions for our customers and seeing their appreciation for the opportunity to visit the beautiful Merit facility and the customized efforts we make on their behalf.
On why she stays settled at Merit: I grew up in the middle of Ireland. I’ve lived in several places, as distant as Australia. I’ve tried a few different careers. I was a bit of a wanderer until I moved to Galway to work for Merit six years ago. I started on the production line and later became team leader, eventually helping to start Merit’s custom packs business in 2012 – the first production lot was very exciting! I feel very lucky to have been moved up from production – Merit has given me opportunities. There’s always something new for me to learn here and it keeps me going.
After work: I love hiking in the mountains and beauty of Ireland. I come from a large family – four sisters and one brother and my nieces keep me very busy!
If you could send one message to our customers: Merit provides a very individually tailored product and experience for our customers. Other companies claim that they customize, but they don’t customize like we truly do.
The ThinkRadial team is grateful to the clinicians who came from around the US and England to join them for the two-day training course hosted at Merit Medical’s beautiful campus in Salt Lake City, Utah. The program was kicked off on Thursday with welcome remarks, a tour of the facility and an enjoyable evening welcome reception with Merit and the course attendees.
Dr. Sandeep Nathan of the University of Chicago, Associate Professor of Medicine and Director, Interventional Cardiology for the University of Chicago Medical Center, was the featured faculty presenter. Beyond his engaging presentations and demonstrations on transradial approach, Dr. Nathan fielded many questions from attendees regarding potential roadblocks, which devices to use and when and how he would approach certain complications that could arise. At the end of the course Dr. Nathan provided his contact info to attendees so they could send him questions once they were back in their own practice.
On Friday evening, the ThinkRadial team organized a trip to the charming mountain town of Park City so the group could see the area. Before heading home on Saturday, attendees participated in a lively review of potential transradial complications and how to address them.
ThinkRadial is looking forward to hosting another group of clinicians at the next course scheduled for September 24-26 at the beautiful Merit Medical Vision Building in Galway, Ireland—then back to Utah October 22-24th. Click here to learn more and to register: https://thinkradial.com/for-clinicians/courses/
Merit Medical’s Production Planning Manager on her approach to Planning, her work/family balance and how she takes her responsibilities “personally.”
Connie’s History with Merit: “I’ve worked with Fred (as in Fred Lampropoulos, Founder, Chairman and CEO of Merit Medical) for more than 32 years, starting in 1983 at Utah Medical. I started on the production line and moved up through several positions to Planning. Fred brought me to Merit Medical’s Planning Department in 1991 as a Planner for our production and molding facilities. In 2011, I was promoted to Manager of Production Planning for all manufacturing out of Merit’s Utah HQ and today I manage seven, soon to be eight Planners.”
Her Loyalty to Merit Medical: “Fred’s dedication, drive and commitment to his employees makes Merit feel like a home away from home. Fred is just as committed to the people here as he is to the business. And that’s why we’ve grown like we have – it’s incredible to see how far we’ve come! Sometimes you just want to say slow down!! But he just keeps going. Fred has inspired my work ethic and set my drive. I’m not sure I could work for someone other than Fred or anywhere other than Merit for these reasons.”
On her Approach to Planning: “I see Planning as the hub of Merit. We could stop a hospital from completing procedures if a product doesn’t get there. Therefore my job is an important step in saving a patient’s life – and I take this responsibility personally. This drives me in everything I do, from my persistent personality to get things done, to hiring Planners who share this same drive. I’m going to do everything in my power to make sure we meet our customers’ needs by getting their orders to them on or ahead of time. We love to beat lead times! We have the strongest planning department we’ve ever had – everyone is proactive and communication flows freely between us and the Customer Service department to ensure our customers have the best experience possible.”
After Work: “When I leave the office my family is my life. I’m married to Rob and we have two kids – Jacob who is 18 and will be leaving for college in the fall, and Kallie, 16, who just got her driver’s license! My kids are my everything to me – we love hanging with our two dogs, camping and 4-wheeling together. At night when I get home I do mom stuff – cook, clean, etc. Late at night I can’t resist reading my Merit emails – but when I’m home – being a wife and a mom is my priority.”
It’s not FedEx. It’s not UPS. It’s not TNT. It’s a global medical device company: Merit Medical. Today Merit Medical opened its recently expanded Europe, the Middle East, and Africa (EMEA) distribution center and corporate office in Maastricht, the Netherlands. This advanced distribution center and the service it provides hospitals, physicians, and nurses in more than 100 countries throughout the EMEA region shows Merit Medical continuing its quest to be the most customer-focused company in healthcare.
Minimizing the number of catheter exchanges is important for transradial interventions in order to reduce the likelihood of spasm.1 Using catheters with radial-specific shapes may help radial operators minimize the number of catheter exchanges that can result in spasm.1
To meet the needs of radial diagnostic and interventional procedures, Merit Medical now offers the Ultimate 1 shape in both diagnostic catheters and ConcierGE® Guiding Excellence catheters with radial-specific shapes.
ConcierGE has approximately 30% more kink resistance2 and better torque response3 than the leading guiding catheter brands.
Cardiologists will now have the ability to match their guiding catheter to the shape of their diagnostic catheters, helping to reduce the need for multiple catheter exchanges.
Merit’s Performa Ultimate™ diagnostic cardiology catheters include four radial–specific shapes including the Ultimate shape, which can be used in both right and left coronary arteries using a single catheter.
ConcierGE and Performa Ultimate–more shapes give radialists more options for successful access.
1 Kwan et al, http://www.ptca.org/radial/optitorque_kwan.html
2 Data on File. Test results are based on 6F guide catheter comparison.
3 Data on file. At ½ hub rotation.
Manipulating diagnostic guide wires through radial vasculature can sometimes be a little more complex than the pathways used during femoral access. To help facilitate radial navigation, Merit offers its InQwire diagnostic guide wire in both the standard J 3.0 mm curved tip as well as a 1.5 mm smaller ”baby” J tip configuration. The smaller, more closed J tip can help you navigate through the vasculature without selecting unwanted branches along the pathway.
The InQwire guide wire is precoated over the entire wire surface for smooth, consistent coverage that resists flaking. Smooth PTFE coating means less friction which improves trackability, lubricity, and durability. InQwire wires also have precise J-tip memory that ensures tip shape retention during utilization.
Having the right tools for your radial procedure provides the efficiency and effectiveness that can help ensure a successful outcome for your patients. Contact your local Merit Sales Representative to learn more about InQwire for radial and our extensive line of products for radial approach.
Senior Product Manager
Merit Medical continues to add to its extensive line of products for Electrophysiology. The HeartSpan Steerable Sheath Introducer offers control, coverage and comfort for Electrophysiologists when navigating cardiac chambers. The 8.5F HeartSpan Steerable Sheath Introducer’s braided construction provides kink resistance and curve durability. The distal tapered tip creates a smooth transition from the dilator to sheath introducer to reduce trauma to the atrial septum.
- Softer, flexible tip
- Smooth transition from dilator
- Responsive curve deflection
- Braided construction for kink resistance
- Bidirectional (180-degree) deflection
- Small curl (16.4 mm)
- Medium curl (22.4 mm)
- Large curl (36.0 mm)
- Ergonomic shape
- Improved grip size
The HeartSpan line of products also includes the HeartSpan® Fixed Curve Braided Transseptal Sheath with braided steel shaft for excellent torqueability and the HeartSpan® Transseptal Needle designed to be exceptionally responsive with enhanced stiffness.
Our EP team is excited to introduce this new steerable sheath designed to help EPs extend their options.
Transradial cardiac catheterization in patients with previous coronary artery bypass graft surgery can be technically challenging.
Since the majority of CABG patients have a left internal mammary artery (LIMA) graft to the left anterior descending artery (LAD), many radial operators choose to perform catheterization procedures in CABG patients from a left radial approach using standard femoral diagnostic catheters. However, other operators have reported success with the right radial access to the LIMA. Right radial access for right radial LIMA angiography provides more comfortable access from the right side of the patient, reduces back strain, and the need to reach over the patient, especially patients who are obese.
For patients with LIMA grafts, Merit Medical now offers a Radial Internal Mammary catheter to facilitate navigation to the left internal mammary from the right transradial approach. The Merit Radial Internal Mammary catheter is available in 4F and 5F, 110 cm lengths. The Impress® material offers a highly torqueable shaft with a soft, tapered atraumatic tip.
Combining Merit’s broad offering of products for radial approach with your clinical expertise can help achieve the improved outcomes you expect from the radial approach including reduced complications, quicker ambulation, and increased patient comfort.
For more information about the Impress Radial Internal Mammary catheter and Merit’s growing portfolio of products for your radial procedures, visit the product page on merit.com.
Senior Product Manager
Dr. Katerina Malagari et al conducted a study of 45 patients with hepatocellular carcinoma (HCC) treated with the new 30-60 µm size HepaSphere Microspheres. The study found that “TACE with HepaSphere was well tolerated with an acceptable safety profile and no 30-day mortality.”1 The overall objective response from the study was “(CR + PR), including patients treated at all dosages of doxorubicin, was seen in 68.9% of cases.”1 The results were published in Cardiovascular Interventional Radiology in February 2014.
HepaSphere 30–60 µm is a new size of a loadable microsphere that has a dry caliber of 30–60 µm that expands to 166–242 (197 ± 31) µm in saline and 145–213 (148 ± 45) µm after loading with doxorubicin. HepaSphere Microspheres’ unique properties offer the following advantages:
Targeted: Flow directed due to spherical shape.
Absorbing: Rapidly absorbs aqueous solutions such as contrast media, saline, or reconstituted doxorubicin HCI.*
Conforming: Compresses in the vessel lumen, providing more surface contact with vessel intima.
Expanding: Expands up to four times the stated dry diameter when hydrated.
HepaSphere Microspheres are indicated for use in embolisation of blood vessels with or without delivery of doxorubicin HCl for therapeutic or preoperative purposes in the following procedures: Embolisation of hepatocellular carcinoma and embolisation of metastases to the liver. For full prescribing information, please refer to the HepaSphere Microspheres Instructions for Use.
Senior Product Manager
1 Malagari K, Pomoni M, Moschouris H, Kelekis A, et al. Chemoembolization of hepatocellular carcinoma with Hepasphere 30-60 . Safety and efficacy study. Cardiovasc Intervent Radiol. 2014 Feb;37:165-175.
HepaSphere Microspheres is a Class III Device, CE 0459, and manufactured for Merit Medical Systems, Inc. by Biosphere Medical, S.A., Parc des Nations-Paris Nord 2, 383 rue de la Belle Etoile, 95700 Roissy en France. HepaSphere Microspheres are not approved or available for sale in the United States.
I am pleased to announce the availability of the next generation Merit Snares for iPad. This app is designed to help customers when selecting the appropriate EN Snare® or ONE Snare® product configuration for use in a desired vessel. The app also provides the technical product code specifications for reference and ordering purposes.
Interested in downloading Merit Snares for iPad? You can download it from the App Store via the following link: https://itunes.apple.com/us/app/merit-snares/id951074703?ls=1&mt=8
Designed with accuracy and reliability in mind, the ONE Snare and the EN Snare Endovascular Snare Systems go hand-in-hand to provide physicians with both single loop and triple loop options to help meet clinically-challenging case that may arise.
Director of Marketing
San Jose, Calif. January 23, 2015 — DFINE, Inc.,announced today that the first two patients have been enrolled in the STARRT Clinical Trial at Providence Sacred Heart Medical Center, Spokane WA. The multi-center trial is the first prospective study to evaluate the treatment of painful metastatic lesions with STAR Targeted Radiofrequency Ablation (t-RFA) and Radiofrequency Targeted Vertebral Augmentation (RF-TVA) prior to or following radiation therapy.