medical device product development

get it done right. now. since 1998.

Bannick, LLC – a primary device group

An Alliance of Medical Device Experts!

Call for Consultation

Don’t Settle For Less

Optimize Your Goals and Objectives

  • Clinical Evaluation Reports and manuscript development.
  • Clinical protocol design, statistical planning and study analysis
  • Regulatory strategy development and submissions, including q-sub submissions and FDA meetings
  • Preparation of PMA, 510(k) and IDE submissions in the US and Design Dossiers and Technical Files in the European Community.
  • Quality Systems: gap analysis of 13485 to 2016, development and enhancement of quality systems.
  • Reimbursement strategy development.

Charge Forward

Strategies Built Exactly To Your Needs

Bannick Primary Devices is a network of subject matter experts ready to tackle any aspect of medical device product development, including advising development teams on strategy, clinical study design, reimbursement strategy and market approval in the US and EU. Each of our experts has demonstrated ability to provide strategic clinical, quality, 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.” We are passionately engaged in this industry and thrive on our contribution to the health and safety of patients around the world.

Our Specialties

We Can Do It All. Get In Touch For a Free Consultation

Clinical Evaluation Reports and manuscript development.

Clinical protocol design, statistical planning and study analysis.

Regulatory strategy development and submissions, including q-sub submissions and FDA meetings.

Preparation of PMA, 510(k) and IDE submissions in the US and Design Dossiers and Technical Files in the European Community.

Quality Systems: gap analysis of 13485 to 2016, development and enhancement of quality systems.

Reimbursement strategy development.

Services

What We Can Do For You

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CLINICAL & STATISTICAL SERVICES

Clinical study design: premarket, safety, efficacy, postmarket.

Literature search and summary.

Clinical Evaluation Reports (Meddev 2.7.1 Rev 4).

Protocol and CRF development.

Investigator meetings, site training and monitoring.

Statistical Analysis

REGULATORY PLANNING SERVICES

Development and execution of domestic & international regulatory strategies.

Preparation and approval of US (PMAs, IDEs, and 510(k)s) and EU (design dossier, tech files) submissions.

FDA Meeting planning and leadership.

QUALITY SYSTEMS

Establish and maintain Quality Systems compliant with FDA QSR and ISO 13485:2016.

Create and implement Quality System procedures: documentation control, design control, CAPA, complaint handling, management review, purchasing, receiving, calibration, internal and external auditing, and inspection.

Quality Auditing: internal (FDA QSR and ISO 13485:2016), supplier, ISO 13485:2016 and MDSAP GAP assessment.

ISO 13485:2016 transition.

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PROFESSIONAL WRITING SERVICES

Preparation of clinical evaluation reports (CERs), manuscripts, clinical study reports, regulatory submissions and annual reports for many topic areas, including: cardiology, neurology, urology, brain stimulation, neurostimulation, and urinary incontinence.

Analysis & summariziation of results, culminating in preparation of a manuscript ready for publication. We are skilled at report & table generation for many types of documents–both internal reports and external publications, including FDA submissions, abstracts for specialty congresses and marketing pieces as well as technical manuals & labeling.

Our team’s extensive clinical and regulatory background coupled with excellent writing skills results in having a talented professional medical writers on your team!

REIMBURSEMENT SERVICES

Providing personalized reimbursement services to the medical-device industry is accomplished by determining the product-specific coverage, coding and payment requirements necessary for: clinical trial reimbursement, market access, and market sustainability; and executing to fulfill those requirements. It also supports potential investments or acquisitions and companies looking for investment or to be acquired. Our service offerings include:

  • Reimbursement due diligence, strategic reimbursement planning, and execution; with business-process integration.
  • Multi-stakeholder value proposition/business case development, including hospitals.
  • Cross-functional evidence creation, including health economics.
  • Reimbursement sales support and materials creation.
  • Reimbursement negotiation and advocacy throughout the product life cycle, including reimbursement under the clinical trial.
  • Reimbursement department creation and evaluation.

About Our President & Founder

Karen Bannick

For over 25 years, Ms. Bannick has worked with device companies to bring Class II and III products to market in the US and internationally.
Ms. Bannick brings a broad base of expertise to each project, working with clinical and regulatory and medical writing groups alike.  She has prepared PMAs, IDEs, and 510(k)s; clinical protocols, data collection forms and data managements systems; and manuscripts, white papers and statistical analysis reports.  She has prepared over 70 clinical evaluation reports per MedDev 2.7.1.  She has completed projects in many fields, including cardiovascular, neurological, pain management, wound care, urological, chronic pain, and sleep apnea.    She has a BA in biostatistics, MA in Health and Human Services Administration, and an MA in management.
She 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.

Get In Touch

+1 320 630 5171
karen@bannickprimary.com
Offices in FL and MN