David M. Hooper, PhD
Austin,TX
Summary
Results-driven leader with strong background in strategic management and organizational growth. Skilled in developing and implementing effective business strategies, optimizing processes, and driving team performance. Known for adaptability, effective collaboration, and delivering measurable outcomes in dynamic environments. Strong communication and problem-solving abilities, coupled with focus on fostering productive and positive team culture.
Overview
26
26
years of professional experience
Work History
Director-Endobariatric Business Operations
Boston Scientific
04.2023 - 07.2025
- Responsible for strategic planning around endobariatrics business, including 3-10 year revenue projections based on patient demographics, reimbursement, physician training and subsequent adoption, patient appeal, and pricing.
- Austin Site Leader with responsibility for supporting morale through the transition to Boston Scientific and selecting a new physical location to function as a hub for R&D and Physician Training.
- Took on analysis around strategic projects, e.g. updating physician locator for endobariatric procedures, pricing strategies, positioning around weight related comorbidities (e.g. Diabetes and Heart Disease).
- Proactively identified potential risks and implemented mitigation strategies to minimize negative impacts on projects or business operations.
VP- Quality and Regulatory
Apollo Endosurgery, Inc. (APEN)
07.2019 - 04.2023
- Managed a quality and regulatory group of 17 people, half of which came to the company within a year of my arrival. The team is responsible for endoscopic and bariatric medical devices, include both Class II endoscopic suturing devices and Class III intragastric balloon devices. These products are sold around the world.
- Creating and implementing the departmental budget, including the costs of worldwide registrations, quality system audits, professional services, salaries, bonus, etc.
- Reporting departmental updates to the CEO and Board of Directors.
- Participate on corporate committees to identify and review business risks, litigation, corporate sponsorships.
- Responsible for compliance of the Quality Management System to 21 CFR Part 820 and ISO 13485, including corporate headquarters and a manufacturing site in Costa Rica.
- Primary liaison with FDA and European Notified body (BSI) for matters involving compliance, product safety and strategic regulatory discussions.
- Successfully transitioned to Quality Management System and products to the EU Medical Device Regulations.
- Ensured that corporate branding and promotional materials are consistent with approved indications.
- Managed the department through the Covid-19 pandemic and made furlough decisions to improve the company’s financial position through this business cycle.
- Primary author of the De Novo application to market the OverStitch device for endoscopic sleeve gastroplasty. FDA Authorized in July 2022.
- Primary participatant in Due Diligence with Boston Scientific, leading to a successful acquisition.
Founder and CEO
Minimus Spine, Inc.
10.2006 - 05.2022
- Entrepreneur. Identified an unmet need for a medical device. Performed due diligence, created business plan and founded a Delaware C-Corp to develop a minimally invasive approach to treat herniated spinal discs using ozone. Negotiated a licensing deal for the international patent portfolio after the company was placed into hibernation.
- Finance and investment. Responsible for all fundraising. Successfully secured angel financing of $2.1M and convertible debt of $1.75M from the state of Texas. Worked with corporate counsel to create convertible notes, stock purchase and investor’s rights agreements. Modeled profit and loss and financial transactions to demonstrate potential return on investment for investors and acquirers.
- Leadership and Project Management. Responsible for creating and maintaining corporate budgets and timelines. Formed a team to develop, build and certify product. Utilized third party vendors when needed. Spearheaded testing and validation of the product through independent laboratories and purchased capital equipment to manufacture product at reduced cost.
- Sales and Marketing. Introduced Triojection to many spine surgeons and pain physicians in the US and abroad, using personal relationships, press-releases, presentations and social media. Represented product at trade shows. These efforts resulted in physician interest in angel investment, clinical studies, and commercial use. Negotiated distribution agreement with European agent. Developed and cultivated relationships many potential acquirers, including some of the largest medical device companies.
- Clinical Affairs. Wrote investigational protocol and led a post-market study at multiple European sites randomizing Triojection to surgical discectomy. Set up the data management system and managed a team of local CRAs to monitor sites. Study randomized 49 patients and demonstrated that Triojection was statistically non-inferior to discectomy. Performed statistical analysis of final data set and authored a manuscript for publication. That paper won an award in 2023.
- Inventor on 8 patents.
Medical Device Consultant
Self-Employed
01.2018 - 07.2019
- Aided Apollo Endosurgery in the transition of the Lap-band portfolio to ReShape Lifesciences, pursuant to a transaction executed in December 2018. Specific focus was on quality, regulatory and clinical issues associated with the deal, including the transfer of the Device History File, Device Master Record, Device History Records, coordinating the transfer of regulatory clearances and the processes around complaint, vigilance reporting and corrective and preventive actions.
- Subcontracted through QA Consulting, Inc to perform supplier quality audits in the US and Mexico. These audits were performed for a public company focused on the use of robotic technology to perform surgery.
- Advised a client on the requirements for technical documentation necessary to apply the CE Mark to a medical device scanner using Bluetooth technology to track implants and inventory.
- ASQ Quality Auditor #69694
Vice President, Clinical Operations
BioSET Inc., acquired by Ferring
11.2009 - 10.2012
- Managed the clinical studies conducted in the US and Canada to evaluate a novel peptide-coated ceramic material intended to enhance boney fusion of the spine or foot. These data drove Ferring to acquire the company.
- Reported to the CEO and participated in Board meetings
- Took a lead role in developing clinical protocols and regulatory submissions
- Was point person with FDA during negotiation for progression to a pivotal study
- Attended surgeries to provide training and support to investigators and medical staff
- Managed outside contract research organizations dedicated to data management, clinical monitoring, blinded review of medical images and data analysis.
- Conducted periodic meetings of a Data Safety Monitoring Board
- Provided significant contributions to the writing of papers accepted for publication.
Divisional Vice President, Emerging Technologies
Spinal Concepts/Abbott Spine
08.1999 - 04.2006
- Member of Executive Team as the company sales grew from $28MM in 2002 to $85M in 2005.
- Was responsible for all clinical and regulatory affairs including departmental budgets and securing adequate resources to meet business objectives within financial restraints.
- Involved in the selection and evaluation of companies being considered for strategic acquisition or partnering, including one strategic investment and one company acquisition.
- Represented clinical, regulatory affairs and quality assurance during Abbott Laboratories’ due diligence process of Spinal Concepts (later Abbott Spine). Resulted in a deal valued at $170MM.
- Represented the company during multiple on-site FDA inspections.
- Built department through successful hires and personnel management.
- Responsible for contracts with physician investigators and outside vendors.
- Responsible for charting U.S. regulatory strategies for Class II and III devices. Introduction of product to foreign markets including European Union, Japan and Canada.
- Design and execution of four IDE studies utilizing three investigational devices and over 40 clinical sites. Coordinated clinical, marketing and engineering efforts for Class III investigational products.
Education
Ph.D. - Biomedical Engineering
University of Iowa
Iowa City, IA01.1996
M.S. - Mathematics
University of Iowa
Iowa City, Iowa01.1995
B.S. - Biomedical Engineering
Case Western Reserve University
Cleveland, OH01.1991
Skills
- Entrepreneurship
- Relationship building
- Strategic planning and goal setting
- Verbal and written communication
- Decision-making
- People management
- Project management
- Statistics
- Public speaking
- Data analysis and Technical Writing
Publications
Refer to pubmed.com and search on "(Hooper_DM and spine) or (Hooper_DM and knee)". Citations and abstracts from 13 of my peer-reviewed papers will be retrieved.
Timeline
Director-Endobariatric Business Operations
Boston Scientific
04.2023 - 07.2025
VP- Quality and Regulatory
Apollo Endosurgery, Inc. (APEN)
07.2019 - 04.2023
Medical Device Consultant
Self-Employed
01.2018 - 07.2019
Vice President, Clinical Operations
BioSET Inc., acquired by Ferring
11.2009 - 10.2012
Founder and CEO
Minimus Spine, Inc.
10.2006 - 05.2022
Divisional Vice President, Emerging Technologies
Spinal Concepts/Abbott Spine
08.1999 - 04.2006
M.S. - Mathematics
University of Iowa
B.S. - Biomedical Engineering
Case Western Reserve University
Ph.D. - Biomedical Engineering
University of Iowa
Similar Profiles
Darragh FoyDarragh Foy
Graduate Scientist at Boston ScientificGraduate Scientist at Boston Scientific
Duane KargesDuane Karges
Facilities Technician III at Boston ScientificFacilities Technician III at Boston Scientific
Selvi BharaniSelvi Bharani
A/P Manager (Epicor to SAP) at Boston Scientific (Baylis Medical)A/P Manager (Epicor to SAP) at Boston Scientific (Baylis Medical)
Dana DialDana Dial
Nanny at Katie and Stan PolinkovskyNanny at Katie and Stan Polinkovsky
Garrett AckardGarrett Ackard
Senior Account Executive at Procore Technologies Inc.Senior Account Executive at Procore Technologies Inc.