Why Bannick LLC?
We are passionately engaged in this industry and thrive on our contribution
to the health and safety of patients around the world!
About Us
Medical Device Consulting Since 1998
Our team of experts at Bannick Primary, including 4 PhD’s on staff, can develop your regulatory strategy, clinical study design and clinical evaluation for the US, EU and beyond. Each of our experts has demonstrated ability to provide strategic clinical, quality, and regulatory and reimbursement guidance to medical companies. When you need guidance working with regulatory agencies to negotiate submission strategy, preparing the quality management systems, clinical protocols and regulatory submissions, and looking ahead to reimbursement, we truly have “been there, done that.”
Why Choose Us
We listen to understand, translating your needs into targeted solutions.
We begin with the end in mind. We re-assess and adapt should challenges arise.
We work strategically, then transactionally.
We practice lean billing practices.
Our Primary Purpose
We are your experienced partner, providing strategic solutions to bring medical technologies to global markets.
Our Core Values
We promote a healthy and balanced live for our team, our clients and patients worldwide.
We act for the greater good of the organization, not our self-interest.
We exemplify integrity and loyalty.
We are mindful of confidentiality.
We deliver high quality, efficient solutions.
Maintaining Our Primary Purpose
We primarily do this by offering companies of all sizes industry-leading regulatory and quality support. And that’s just the beginning…
Industry Experts
PhD's on Staff
CER & PMCF Plans and Reports
Team
Meet Our Team
Karen Bannick McQuoid
Karen is the owner and CEO of Bannick LLC, a primary device group founded in 1998. Her team includes medical device experts that provide clinical (and CER writing), quality, regulatory and reimbursement guidance to medical device companies.
Karen became committed to “returning man to full life” during her first week at Medtronic, when Earl Bakken presented her with her medallion. Driven by that passion to bring technology to patients around the world, Karen has practiced her unique combination of biostatistics, clinical study experience and exceptional regulatory skills in the medical device industry for over 30 years, partnering with Fortune 500 companies, small companies and start up medical device companies bring their Class II and III products to market in the US, Europe and internationally.
Karen’s experience makes her an enthusiastic and insightful advisor. She has prepared multiple US (PMAs, IDEs, and 510(k)s) and European submissions (MDD, AIMDD and MDR). Since MedDev 2.7.1 Rev 3, she has authored over 100 clinical evaluation reports, including 7 to the MDR with no major nonconformities. She excels when tackling a complex project requiring strategic insights from several angles. She and her team at Bannick LLC deliver high quality, efficient and timely results. Her experience encompasses cardiology, neurology, pain management, wound care, urology, chronic pain, sleep apnea and vascular.
She has a BA in biostatistics, MA in Health and Human Services Administration, and an MA in management. Karen is RAC certified and a Fellow of the Regulatory Affairs Professional Society (RAPS). She is Past President of the American Medical Writers Association (AMWA) North Central Chapter and volunteers as a speaker for RAPS, Medical Alley and AMWA.
Getting To Know Us – Karen Bannick McQuoid, M.A., RAC, FRAPS
Location – Marathon, Florida and Isle, Minnesota
What do you like to do when you’re not working?
Riding a new e-bike that I just purchased, scrap booking with friends, and swimming.
Share a personal experience with the medical device industry (how has a device, technology, etc., personally impacted your life).
In 32 years in this industry, there have been many! That’s the beauty of this career path, but I’ll give you 3. Getting to work with Earl Bakken early in my career and experiencing the palpable passion he had for returning man to full life will stay with me always. After our Medtronic team got Deep Brain Stimulation approved, at the Medtronic annual Holiday Party, we watched a man’s tremor STOP when the device was turned ON. My father had many surgeries for PVD using several devices I’d been evaluating. Once, I was even able to convince the physician to use a less invasive approach rather than open surgery on my very sick dad, pushing hard for the physician to consider not the technical “success” of the surgery but the impact on his longevity and quality of life.
Where would you most like to vacation?
For me, it’s not a matter of where, but a matter of how long. I’d love a 10 day vacation away from all phones, social media, and emails.
Who is the most famous person you’ve met?
When I was 10, I met Fran Tarkenton. A few years ago, I got to know Gov. Dayton enough to be his “favorite biostatistician.”
What is your go-to song at karaoke?
I’ve only sung karaoke once, and it was to Shania Twain, “Man, I Feel Like a Woman.”
Stefanie Martinez Koenig
Stefanie is a key member of the Bannick Executive Team. As the Director of Clinical and Regulatory Affairs and Quality Systems, she is tasked with providing overall program leadership and management of our regulatory affairs, including medical writing, and clinical affairs groups. She looks forward to partnering closely with clients to identify their needs, resolve any issues and ensure on time service delivery.Stefanie Martinez Koenig
Stefanie is a results-driven executive with more than 25 years of experience working in quality assurance and regulatory affairs for the device, pharmaceutical, and biopharma sectors. She is a strategic change-agent with proven accomplishments and has been recognized for developing creative and extraordinary partnerships to meet business objectives. She brings to the Bannick team strong experience in quality systems and auditing, MDD to MDR transition, regulatory and clinical affairs.
Stefanie has a BS in Microbiology and MS in Operations and Technology Management. She is an active member of RAPS, an ASQ Certified Quality Engineer (CQE), and a Certified Quality Manager in Operational Excellence.
James (Jim) Moat
Jim joins Bannick LLC as a Principal Advisor. Jim will provide leadership and support in several aspects of the company including audits, clinical, and business development. This role will provide strategic guidance and hands-on execution as needed within our organization.
Jim is an accomplished Clinical Research leader, with extensive expertise with over 32 years in consulting, staff development, and all phases of product development. He has worked for various sized companies including Avania, IMARC Research, NAMSA, Alquest, Inc. and Boston Scientific, Inc.
Jim has a Bachelor of Arts in Biology from Minnesota State University and is a Certified Clinical Research Associate (CCRA) with the Association of Clinical Research Professionals (ACRP).
Hanna is proficient in developing a range of high- quality documents for different target audiences, including Clinical Evaluation Reports in accordance with relevant regulations and peer-reviewed scientific publications
She has an ability to identify, appraise, and analyze data for a variety of technologies, with learning adaptability and aptitude for understanding previously unfamiliar subject areas
she has a history of successful collaboration with cross-functional teams to meet deliverable timelines, including experience managing an external team
Hanna holds a PhD and MS in Chemistry from the University of Minnesota and a BS in Chemistry from the University of Southern California. She is an accredited member of the American Medical Writers Association (AMWA) and American Chemical Society (ACS).
Getting To Know Us – Joahanna Macaranas
Nickname – Hanna
Location – Minnesota
What do you like to do when you’re not working?
Exploring new cuisine and cocktail locations, experimenting with recipes, traveling, cycling, hiking, walking my dogs, and watching the occasional bad horror movie.
Share a personal experience with the medical device industry (how has a device, technology, etc., personally impacted your life).
Extended wear contacts have changed the way I wake up to see the world.
Where would you most like to vacation?
Puerto Vallarta
Who is the most famous person you’ve met?
Nobel Laureate George Olah
What is your go-to song at karaoke?
Free Fallin’ by Tom Petty
Pets – Vivi and Ella
Brad Argue
Brad has been an integral part of Bannick since joining us in August of 2020 as a Medical Writer. Brad quickly adapted to his role here, enthusiastically tackling projects and providing critical support whenever asked. In his new role as Senior Clinical Evaluation Scientist – Team Lead, Brad will mentor junior and entry level writers, helping to ensure future success for a new generation of Clinical Evaluation Scientists. He will also continue to provide great CER writing to clients.
Brad holds a PhD and MS in Fisheries from auburn University and a BS in Fisheries and Wildlife Biology from the University of Minnesota. He is a member of the American Medical Writers Association (AMWA) and Regulatory Affairs Professionals Society (RAPS).
Getting To Know Us – Brad Argue, PhD
Location – St. Paul, Minnesota
What do you like to do when you’re not working?
Hiking, photography, birding, traveling, kids, grand kids.
Where would you most like to vacation?
Philippines
Who is the most famous person you’ve met?
Wayne Brady
What is your go-to song at karaoke?
I have a sore throat- if that does not work, House of the Rising Sun
Pet – I move around too much and like to travel too much to consider caring for a pet.
Tina Mansilla
Tina is a results driven Quality Assurance Leader with 30 years of experience in document control PLM systems, medical device manufacturing and Quality System Management (QMS). She is detail driven as well as an effective communicator, trainer, and team motivator.
Tina has a BS in Management from the National-Louis University in Wheeling, IL. She has received training in many areas including Medical Device Regulation (EU), Code of Federal Regulations Title 21, FDA Device Registration, Listing and Quality System Requirements Medical Device Directive 93/42/EEC Healthcare Fraud, Waste and Abuse and Compliance.
Getting To Know Us – Tina Chapman
Nickname – Bosley, but no one calls me that anymore
Location – Marathon, Florida
What do you like to do when you’re not working?
Fishing, website building, figuring out/fixing things, learning new computer programs and functions, etc.
Share a personal experience with the medical device industry (how has a device, technology, etc., personally impacted your life).
We have a good friend that lost his leg in a car accident. He now has a prosthetic leg which we talk to him about, ask questions, make jokes about it, etc. He thanks us all the time for not being afraid to ask.
Where would you most like to vacation?
I’m more of a home body but we recently moved to the Florida Keys so that’s our vacation land for now.
Who is the most famous person you’ve met?
I’ve met pro-athletes but I’m not a star struck type of person to really ever think about it
What is your go-to song at karaoke?
I NEVER sing karaoke but…When He Cheats by Carrie Underwood
Pets – Jimmy Johnson aka JJ aka Chubby Darter
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