Brian Bergeron

Brian Bergeron Email and Phone Number

Healthcare Executive Leader / Innovation / Start-Up / Scalability / Commercialization @ Rejoni, Inc
Brian Bergeron's Location
Austin, Texas, United States, United States
Brian Bergeron's Contact Details

Brian Bergeron work email

Brian Bergeron personal email

About Brian Bergeron

Proven ability to take a vast range of innovative medical product types from concept to commercialization. Skilled in directing the development of internal and external programs to further expand platform technologies, software systems (SaaS, PaaS, and IaaS), Software as a Medical Device (SaMD), algorithms, wearables, connected capital equipment, minimally invasive techniques, early intervention, and emerging therapies within the medical arena.Provide operational oversight of 10+ sites with technical leadership and inspiration.Highly experienced in developing product portfolio strategies, product roadmaps, pipeline execution, timely achievement of program milestones and critical launches.Experienced in drafting and maintaining a complete invention disclosure portfolio for patents and communication with internal and external patent counsel.Ability to identify intended uses, human factors, product specifications, and essential design requirements for instrumentation and implantable devices. Led the implementation of Lean Manufacturing, Continuous Flow, and Design For Manufacturability (DFM) processes. Responsible for the planning and budgeting of product and process improvements/cost reduction initiatives in high volume manufacturing settings.Ability to execute rapid analysis of potential investments from commercial, biology and systems perspectives as well as negotiate term sheets.Knowledge of the due diligence and business development process with regard to mergers and acquisitions (M&A), venture capital, fund raising, consolidations, and licenses. Active knowledge of regulatory standards, design controls, and associated documentation as they apply to Pivotal Investigational Device Exemptions (IDE), Breakthrough Technology, De Novo, Food and Drug Administration (FDA), GS1 Standards for U.S. FDA UDI, CE mark, MDD, MDR, MDSAP, 510(k), 522 Postmarket Surveillance Studies - FDA, Pre-Submission, Premarket approval (PMA), Biological Safety Evaluation Plan (BSEP), Technical Filing, Design Dossiers, ISO-13485-2016, ISO-9001, IEC 62366 – Usability of Medical Devices, and Shonin submissions.

Brian Bergeron's Current Company Details
Rejoni, Inc

Rejoni, Inc

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Healthcare Executive Leader / Innovation / Start-Up / Scalability / Commercialization
Brian Bergeron Work Experience Details
  • Rejoni, Inc
    Vice President Of Product Development
    Rejoni, Inc Jun 2020 - Present
    Bedford, Massachusetts, Us
    Rejoni creates products using our proprietary hydrogel technology to improve outcomes in gynecological conditions and disease management.
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  • Clearcam Inc.
    Strategic Advisor
    Clearcam Inc. Jun 2018 - Present
    Austin, Texas, Us
    ClearCam is a company formed from the University of Texas Innovation Center that create products to improve surgical visualization platforms. The first to market device is a simple, mechanical, and efficient disposable in-vivo laparoscopic lens cleaner that eliminates the need for clinicians to continually remove the scope from the patient’s body to clean it during surgery.Provide industry knowledge for product development, fund raising, talent attraction, and regulatory pathways.
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  • Auspine, Llc
    President / Founder
    Auspine, Llc Jan 2010 - Present
    Austin, Tx, Us
    Auspine is an entrepreneurial engineering consultant company created to help medical device companies (small, medium, and large) direct the efforts for all sustaining, in process, and future product development activities.Auspine's mission is to maintain a long-lasting relationship with our clients based on exceptional medical design and cost-effective solutions that meet our client’s medical device business needs:•Design•Development•Regulatory•Clinical •Manufacturing•DistributionWe take all necessary measures to ensure a project’s success by striving to meet and exceed our client’s expectations. We apply the necessary expertise to ensure your project is completed on time and to the highest professional standards.We provide a wide spectrum of service options and configurations:•Software as a Service (SaaS), Platform as a Service (PaaS), and Infrastructure as a Service (IaaS)•Implementation of Quality Management Systems (QMS) and Third Party Internal Audits•Consulting Services for Business Planning and Exit Strategies•Project Management Office (PMO), PMP-certified, and experience managing important implementation, transformation, or execution projects inside major companies.•Experience across pharmaceuticals, biotechnology, medical devices, regulatory, etc. divisions with a focus on market access, product launch/commercialization, and rebranding/integration.Our clients can utilize one or more of our service options to meet their needs. This flexibility allows us to provide everything from offsite project support for short periods of time at our client’s facility to full incubation of their company at our facility from concept through production.
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  • Luminoah
    President And Coo
    Luminoah Jun 2023 - Aug 2023
    Charlottesville, Virginia, Us
    Interim leadership role while Luminoah successfully closed a $6 million Series A funding round, with the mission to enhance the standard of care for patients in need of enteral nutrition. Led by Fry's Path Capital, LLC and joined by Sands Capital, CAV Angels, Virginia Venture Partners, and 757 Angels.
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  • Luminoah
    Board Member
    Luminoah Feb 2021 - Jun 2023
    Charlottesville, Virginia, Us
    Medical device technology company dedicated to improving the lives of people requiring enteral nutrition.
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  • Hologic, Inc.
    Head Of R&D Austin
    Hologic, Inc. Aug 2020 - Jul 2021
    Marlborough, Ma, Us
    • Once Hologic acquired Acessa Heath, acted as the technical visionary for the Business Unit, responsible for understanding global trends impacting the markets served, set the overall technical direction, own the technology roadmaps and provide leadership to the engineering organization.• Cultivate and drive a culture of continuous improvement and innovation across the entire product development organization. Knowledge of state of the art digital engineering tools and systems to reduce product development times and cost whilst improving product quality.• Extensive interaction with customers, partners and suppliers to create relationships with key engineering and executive decision makers and to gain insight into their next generation products and technologies.• Active participant in cross-enterprise organizations such as the Engineering Network, representing the interests of the Business Unit and collaborating with other BU technology leaders to develop fundamental transformational technology.• Ensure a resilient engineering organization is maintained by working with HR to develop key talent to build a robust succession pipeline for engineering leadership and senior individual contributor roles.
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  • Acessa Health Inc. - Acessa Procedure
    Chief Operations Officer (Coo)
    Acessa Health Inc. - Acessa Procedure Feb 2018 - Aug 2020
    • Hologic, Inc. (Nasdaq: HOLX), a global leader in women's health, announced today that it has acquired Acessa Health Inc., a privately-held innovator in minimally invasive treatment for fibroids, for approximately $80 million in cash plus contingent payments based on future revenue growth.• Responsible for the transition from initial beta-launch, manufacturing scalability, and quarter over quarter sales growth.• Strategic and hands-on role within a lean organization. Responsible for P&L, cost control, GM expansion, design improvement/NPD, outsourcing, global supply chain, quality and regulatory.• Member of executive leadership team; trusted partner/advisor to CEO in strategy, long-term planning, exit scenarios, M&A, etc.• Program manage, risk mitigate and problem-solve key initiatives to meet milestone timelines and budget per operating plan. • Develop and report appropriate metrics to track progress towards the achievement of company objectives.• Organizational oversight for all phases of design/development through commercialization of development projects.• Manage global intellectual property strategy and portfolio in collaboration with marketing and legal.• Technology transfer of capital and disposable outsourcing, scale up and cost reduction/process improvement per operating plan.• Maintain robust, digital quality management system and culture of compliance.• Ongoing production excellence: complaint handling, MDR, CAPA, nonconformance, management review and health hazard. • Plan, coordinate and direct regulatory strategies for US and OUS products.• Lead regulatory consultants on project teams, aligning regulatory strategies to operating plan and on-time submissions.
  • Acessa Health Inc. - Acessa Procedure
    Chief Technology Officer (Cto) And Vp Of Operations
    Acessa Health Inc. - Acessa Procedure Feb 2018 - Oct 2018
    • Fully understand and maintain the protectable technologies and core competencies of the company. Staying abreast of cutting-edge research and development, and in adjacent areas of interest that might have an impact on the company’s technical direction.• Provide program management ensuring that the product vision is realized through excellence in execution. Manage the overall program plan that incorporates all inter-dependencies between functional disciplines (e.g. mechanical, electrical, controls, software), which in turn is a part of a company program plan that incorporates inter-dependencies between departments (e.g. engineering, marketing, business development).• Responsible for developing the technical strategy and maintaining a technical roadmap that will continue to innovate from a technical standpoint.
  • Genesys Spine
    Vice President Of Engineering And Operations
    Genesys Spine Sep 2009 - Feb 2018
    Austin, Texas, Us
    • Responsible for the continuous development activities of the revenue generating product lines.• Develop and implement a company strategy for product manufacturing, purchasing, warehousing, distribution, manufacturing engineering, facility maintenance and operations of the company.• Direct responsibility for maintaining high standards of manufacturing operations, design for manufacturability, product quality, reliability, on time delivery, inventory control, and safety to meet established goals. • Industry expertise, intellectual property counsel, product innovation, engineering design, prototype manufacturing, surgeon relationships and technology brokering necessary to efficiently bring products to market.• Establish a network of engineering resources to provide contract engineering support for design, testing, and certification activities.• Lead cross-functional groups charged with executing the various aspects of Medical Development plans and operations to ensure continuity across the entire development cycle.
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  • Apollo Endosurgery
    Program Manager
    Apollo Endosurgery Oct 2008 - Sep 2009
    Austin, Tx, Us
    • Austin medical device maker goes public after completing reverse merger (Nasdaq: APEN).• Led the development and draft of the regulatory submission that resulted in the company’s first FDA clearance and the successful product launches of the FlexShears™ and OverStitch™.• Managed and directed the development of innovative, procedure enabling single patient use devices, which facilitate the adoption of less invasive therapeutic procedures.• Recruitment and management of an engineering team to support the company's expansion into Natural Orifice Translumenal Endoscopic Surgery (NOTES®) and Flexible Endoscopic surgery implants / instrumentation.
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  • Apollo Endosurgery
    Senior Project Engineer
    Apollo Endosurgery Apr 2008 - Oct 2008
    Austin, Tx, Us
    • Create and led the implementation of Lean Manufacturing, Continuous Flow, and first to design and release a product specifically focused on the Design For Manufacturability (DFM) process. Additionally, responsible for the planning and budgeting of product/process improvements/cost reduction initiatives in high volume manufacturing settings.• Foster close cooperative relationships with all functions in the company. Work with Executive Management to develop new product plans and strategies; with manufacturing and quality assurance to ensure new products are of high quality and are readily manufacturable; with clinical research to ensure products are safe and effective.• Implement injection molding capabilities, processes, and personnel in-house to provide for the companies first Human Use components and devices.
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  • Abbott
    Staff Engineer
    Abbott Jun 2006 - Apr 2008
    Abbott Park, Illinois, Us
    Formerly known as Spinal Concepts / Abbott Spine• Led the development of internal and external programs for short and long term business development strategic initiatives to further expand the Emerging Technologies portfolio in motion preservation systems, minimally invasive techniques, fusion / non-fusion systems, and inventive therapies as it pertains to the spine.• Partnered with surgeons and industry thought leaders to identify the intended uses, human factors, and essential design requirements for instrumentation and implantable devices. • Successfully designed, implanted, and published the results of a six (6) month pre-clinical study on an innovative cervical arthroplasty device. • Managed multi-project, multi-site, and cross-functional development teams; effectively led teams; presented updates to executive management on project performance.
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  • Abbott
    Sr. Product Development Engineer
    Abbott Apr 2004 - Jun 2006
    Abbott Park, Illinois, Us
    • Responsible for working closely with internal resources (i.e. Marketing, Clinical, Quality, and Regulatory) as well as external resources (i.e. Key Opinion Leaders, Subject Matter Experts, and Consultants) initiated and developed a project proposal to meet market requirements.• Created an invention disclosure program; designed the invention disclosure form, provided a company wide training course, and instituted an inventor incentive program for each disclosure and patent filing.• Responsible for developing a program that realized an increase of 230% in the patent disclosures and filings from previous years.• Developed departmental and research expenditure budgets to co-develop programs with universities, independent laboratories, and/or other institutions.
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  • Covidien (Medtronic Minimally Invasive Therapies Group)
    Product Development Engineer
    Covidien (Medtronic Minimally Invasive Therapies Group) May 2002 - Jun 2004
    Fridley, Minnesota, Us
    Formerly known as Confluent Surgical / Covidien• FDA Highlights Accomplishments: The FDA's Center for Devices and Radiological Health (CDRH) released that the DuraSeal Dural Sealant System was one of the most innovative products submitted for Investigational Device Exemptions (IDE).• Led the research and development functions used in the evolution of new hydrogel products and improvements to existing systems for discectomies, spinal fusions, craniotomies, laparotomies, ENT (i.e. endoscopic transphenoidal surgery), and laparoscopic procedures.• Performed as the technical and surgical lead of pre-clinical studies to test innovative concepts, conducted failure analysis, and proposed corrective actions or changes to design, processes or procedures to achieve desired results.• Developed and marketed new products and solutions based on existing company strengths and assets. Ensured future product releases reflect experience gained from external market activities, customer discussions, usage analysis, competitive response, and market research.• Designed and tested the DuraSeal Xact™ Sealant System and SprayGel® Adhesion Barrier product lines.
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  • Boston Scientific
    Development Engineer
    Boston Scientific Dec 1998 - Jun 2002
    Marlborough, Ma, Us
    • Designed, prototyped, and constructed minimally invasive vascular, non-vascular, and cardiology medical devices. • Designed products in the Vaxcel® Peripherally Inserted Central Catheters with PASV® Valve Technology and Monorail™ and Over-the-Wire Coronary Stent Systems.• Generated qualification protocols for equipment (IQ/OQ), design & manufacturing processes (PQ), and for final and sub-assembly product performance (PPQ).• Internal Lead Auditor: Coordinate, led, and scheduled internal audits to the ISO-9001 & EN-46001 quality standards.BOSTON SCIENTIFIC IRELAND LTD. Galway, Ireland• Relocated to Ireland Facility for a six-month assignment to develop and implement catheter based technology. Participate in the development and validation of the delivery system for the TAXUS® Express² Paclitaxel-Eluting Coronary Stent program.BOSTON SCIENTIFIC - SCHNEIDER / PFIZER (Europe) AG. Bülach, Switzerland• Relocated to Switzerland Facility for a six-month assignment to transfer of Rapid Exchange and Over-The-Wire catheter based technology.
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Brian Bergeron Skills

Medical Devices Product Development Design Control Fda Iso 13485 Product Launch Biomedical Engineering Engineering Cross Functional Team Leadership R&d U.s. Food And Drug Administration Market Development Design For Manufacturing Spine Commercialization Surgical Instruments Orthopedics Capa Orthopedic Capital Equipment Quality System Research And Development Business Strategy Brand Development Start Ups Technology Transfer Validation Manufacturing Manufacturing Engineering Lean Manufacturing Surgeons Design Of Experiments Surgery Healthcare Business Development Management Quality Assurance Strategic Planning Leadership Operating Room Iec 60601 Iec 62304 Software Project Management Software Development Life Cycle Software Quality Assurance Strategy Cardiology Testing Injection Molding Medical Ultrasound

Brian Bergeron Education Details

  • The University Of Texas At Austin
    The University Of Texas At Austin
    Engineering
  • Worcester Polytechnic Institute
    Worcester Polytechnic Institute
    Biomedical Engineering

Frequently Asked Questions about Brian Bergeron

What company does Brian Bergeron work for?

Brian Bergeron works for Rejoni, Inc

What is Brian Bergeron's role at the current company?

Brian Bergeron's current role is Healthcare Executive Leader / Innovation / Start-Up / Scalability / Commercialization.

What is Brian Bergeron's email address?

Brian Bergeron's email address is be****@****hoo.com

What is Brian Bergeron's direct phone number?

Brian Bergeron's direct phone number is +150875*****

What schools did Brian Bergeron attend?

Brian Bergeron attended The University Of Texas At Austin, Worcester Polytechnic Institute.

What skills is Brian Bergeron known for?

Brian Bergeron has skills like Medical Devices, Product Development, Design Control, Fda, Iso 13485, Product Launch, Biomedical Engineering, Engineering, Cross Functional Team Leadership, R&d, U.s. Food And Drug Administration, Market Development.

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