Tag Archive for: Healthcare and IT

Troy Tazbaz joins the FDA to lead the Digital Health Division and Center of Excellence

Former Oracle SVP, Troy Tazbaz will lead the effort to advance AI and ML for healthcare and help orchestrate a new regulatory environment for digital healthcare.

Life Science Partner announces the recruitment of the FDA’s new Division Director for Digital Health and Director for the Digital Health Center of Excellence to prepare the agency to partner with innovators and create regulatory guidance for the application of Artificial Intelligence within the convergence of healthcare IT and medical devices.

Formerly, the Senior Vice President, Industry Business Unit for Oracle, Troy Tazbaz will step into this new critical role created within the Office of Strategic Partnerships and Technology Innovation in the FDA’s Center for Devices and Radiological Health (CDRH).

Troy Tazbaz

“A thought-leader within the integrated world of cloud-based AI technology, Tazbaz is a thoughtful problem solver with a track record of successfully bridging multiple constituencies to accelerate AI adoption to improve efficiencies including patient care outcomes”

Tom Callaway, MD, Founder of Life Science Partner

Tazbaz will partner with a broad range of national and global government agencies, institutions, academia, and various organizations representing patients, consumers, and healthcare professionals. Tazbaz will be responsible for building the FDA’s key resources for establishing digital health guidelines and efficient regulatory pathways for the integration of digital and cloud-based technologies.

Tazbaz joins the FDA after recently serving as Senior Vice President of Strategy and Operations for Industry Business Unit responsible for developing Oracle’s industry-specific operating technologies. Earlier in his tenure at Oracle, he led various strategic initiatives such as global cloud data center expansion planning, developing Oracle’s industry strategy, and the launching of Healthcare Business Unit.  

Life Science Partner is pleased to continue their partnership with the Center for Devices and Radiological Health at the FDA on leadership projects underway for the Office of Product Evaluation and Quality.

About Life Science Partner

Life Science Partner is a specialized executive search firm that recruits transformational leaders for healthcare and life sciences companies. Our high-touch, partner-led process ensures an exceptional level of service, while our backgrounds as physicians and industry executives enable us to efficiently deliver the brightest candidates in the medical device, biopharmaceuticals, diagnostics, and healthcare information technology fields.

Learn More About Chief Medical or Regulatory Leaders

Read More About Life Science Partner’s Recruitment for the FDA

Here are some of featured Press Releases that describe our executive placements and involvement with the FDA:

FDA Regulatory Leadership For Medtech/IT Convergence

Life Science Partner has partnered with the FDA to recruit leaders that can create innovative pathways for early-stage companies to be better prepared for the regulatory review and clearance process. In close collaboration with Jeff Shuren, MD, JD, Head of the Center for Devices and Radiological Health (CDRH) for the FDA, Life Science Partner recruited Doug…

Read More

Something went wrong. Please refresh the page and/or try again.

/0 Comments/by

FDA Regulatory Leadership For Medtech/IT Convergence

Life Science Partner has partnered with the FDA to recruit leaders that can create innovative pathways for early-stage companies to be better prepared for the regulatory review and clearance process.

In close collaboration with Jeff Shuren, MD, JD, Head of the Center for Devices and Radiological Health (CDRH) for the FDA, Life Science Partner recruited Doug Kelly, MD, MBA as Deputy Director for Science to the FDA’s CDRH Office.

Since the creation of his role in August 2020, Dr. Kelly has already made a significant impact on improving FDA/innovator communication and accelerating patient access to high-quality, safe, and effective medical devices.

Doug Kelly, MD, Deputy Director for Science, FDA, CDRH
Doug Kelly, MD, Deputy Director for Science, FDA, CDRH

Dr. Kelly has been instrumental in partnering with top leaders from industry and academia to expedite the regulatory clearance process to assure consumer confidence and advance innovative technologies.

“Through his serial entrepreneurship experience, Dr. Kelly understands the regulatory pathway obstacles that innovators face.”

Tom Callaway, MD, Founder of Life Science Partner

In May 2022, Dr. Kelly spoke as the key note speaker at the AdvanSE Conference in Atlanta, GA where he presented CDRH’s role in the COVID-19 response, the future of the Medical Device User Fee Act and its introduction to TPLC TAP (Total Product Life Cycle Advisory Program); a new team of experts focused on providing strategic advice actively coordinated with FDA review teams and across the MedTech ecosystem.

Doug Kelly, MD, and Tom Callaway, MD, at AdvanSE 2022

Most recently, Life Science Partner recruited David McMullen, MD, to serve as Director, Office of Neurological and Physical Medicine Devices (OHT5) for the CDRH where Dr. McMullen is the technical authority and principal advisor for ninety individuals responsible for the total product life cycle (TPLC) review of neurological, neurointerventional and neurodiagnostics devices, as well as responsible for a separate group focused on neuromodulation and physical medicine devices.

“Co-leading The BRAIN Initiative at NIH, McMullen has demonstrated the leadership to oversee various multi-faceted programs simultaneously and evaluating cutting-edge technologies such as computer-brain interfaces.”

Tom Callaway, MD, Founder of Life Science Partner

McMullen’s team will oversee premarket evaluations, compliance and quality parameters, and surveillance programs for all neurological products and devices and be engaged in the decision-making process on device submissions, classifications, petitions, 501(k)s, PMAs, IDEs and all supplements and amendments to submissions.

Life Science Partner is pleased to have recruited Dr. Kelly and Dr. McMullen as transformative leaders contributing to the FDA CDRH ’s mission to accelerate the adoption of innovative technologies to improve the healthcare of patients.

David McMulen

About Life Science Partner

Life Science Partner is a specialized executive search firm that recruits transformational leaders for healthcare and life sciences companies. Our high-touch, partner-led process ensures an exceptional level of service, while our backgrounds as physicians and industry executives enable us to efficiently deliver the brightest candidates in the medical device, biopharmaceuticals, diagnostics, and healthcare technology fields.

Learn More About Chief Medical or Regulatory Leaders

Read More About Life Science Partner’s Recruitment for the FDA

Here are some of featured Press Releases that describe our executive placements and involvement with the FDA:

David McMullen, MD, Recruited as Director, Office of Neurological and Physical Medicine Devices (OHT5), FDA Center for Devices and Radiological Health (CDRH)

Life Science Partner has recruited David McMullen, MD, to serve as Director for The Office of Neurological and Physical Medicine Devices (OHT5), Center for Devices and Radiological Health (CDRH) at the Federal Drug Administration.  The CDRH facilitates medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring…

Read More
/0 Comments/by

Life Science Partner Builds Canary’s Research and Development Team

Canary Research and Development Team

­­Life Science Partner is pleased to announce the successful placements of Canary Medical’s Senior Research & Development team.

Canary Medical is an innovative MedTech company modernizing smart implants in the orthopedic, cardiovascular, and aesthetic markets. The company integrates a sensor and microprocessor system into FDA-cleared implantable medical devices to remotely gather biometric data and transmit it back to physicians via the cloud to give real-time insights about the performance and safety of these products.

Partnering with Canary at its very inception, Life Science Partner recruited Chief Technology Officer Jeff Gross, VP of Technology Development Mark Phelps, VP of Research and Development Peter Schiller, VP of Operations Balakrishnan Shankar, and Senior Director of Regulatory Affairs & Quality Assurance Nora York. In turn, we worked with these leaders to recruit their technical teams who have been superstars in the fields of electronics, medical devices, and cloud software. These 7 talented, senior R&D engineers will help propel the company’s platform in telemedicine and medical devices.

The recruitment of Lan Herrington as Senior Quality Manager, Luis Dogue as Manager of Data Software, Kevin Gemmell as Senior Biomedical Engineer, David Mejia as Senior Manufacturing Engineer, Matthew Sturtevant as Senior Electromechanical Engineer, Ryan Peck as Senior Quality Engineer, and Reghu Rajan, MBA as Senior Systems Engineer will drive Canary Medical toward commercialization while pursuing their technology’s vast array of potential applications beyond the orthopedic space. They each bring to the company a track record of success and a combined expertise in the orthopedic and cardiovascular space with a broad range of experience from the medical device, healthcare, and information technology industries.

About Life Science Partner

Life Science Partner is a specialized executive search firm that recruits transformational leaders for healthcare and life sciences companies. Our high-touch, partner-led process ensures an exceptional level of service, while our backgrounds as physicians and industry executives enable us to efficiently deliver the brightest candidates in the medical device, biopharmaceuticals, diagnostics, and healthcare technology fields.

/0 Comments/by

Nora York Joins Canary Medical as Senior Director, Regulatory & Quality Assurance

Life Science Partner is pleased to announce the recruitment of Nora York to join Canary Medical as Senior Director of Regulatory & Quality Assurance.

Canary Medical is an innovative medical technology company commercializing smart implants in the orthopedic, cardiovascular, and aesthetic markets. The company integrates a sensor and microprocessor system into FDA-cleared implantable medical devices to generate real-time insights about the performance and safety of these products.

York will be responsible for developing Canary’s regulatory strategy in concert with the other leaders of the team. Her role will involve implementation, oversight, and maintenance of Canary’s regulatory affairs organization.

Nora York

Before joining Canary, York was the Director of Regulatory Affairs & Quality Assurance for SynergEyes, an advanced technology specialist company for hybrid contact lenses. She also spent two years as the Head of Regulatory Affairs for Philips Volcano Corporation in San Diego, where she was in charge of the development and execution of regulatory strategy and submission of several 510(k) applications for the company’s Image-Guided Therapy systems.

“York is a proven performer in quality and regulatory circles in Southern California” notes Tom Callaway, President of Life Science Partner. “Her recruitment to this emerging team will ensure the processes and rigor required in innovative implantable devices.”

York earned her bachelor’s degree in Biology at the University of Texas in Dallas.

About Life Science Partner

Life Science Partner is a specialized executive search firm that recruits transformational leaders for healthcare and life sciences companies. Our high-touch, partner-led process ensures an exceptional level of service, while our backgrounds as physicians and industry executives enable us to efficiently deliver the brightest candidates in the medical device, biopharmaceuticals, diagnostics, and healthcare technology fields.

Learn More About Chief Medical or Regulatory Leaders
/0 Comments/by

Mark Adler, MBA Joins Canary Medical as Vice President of Product Development

Life Science Partner is pleased to announce the recruitment of Mark Adler, MBA to Canary Medical, where he will serve as Vice President of Product Development.

Canary Medical is an innovative medical technology company commercializing smart implants in the orthopedic, cardiovascular, and aesthetic markets. The company integrates a sensor and microprocessor system into FDA-cleared implantable medical devices to generate real-time insights about the performance and safety of these products.

Canary Medical logo

Adler will be driving further miniaturization and reduction of power for Canary’s implantable technology, advancing commercialization efforts in the orthopedic space, and providing technical support and management direction for the company’s cross function leadership to support its business objectives.

Mark was previously the Vice President at JenaValve Technologies, where he managed the development of the company’s next-gen aortic valve delivery system. He has consulted for companies such as Glucovation, Aortica, Nano-Structures, Medina Medical, Proteus Digital Health, and Micell Technologies. Among his many leadership positions, he was the Director of Sensor Engineering at Medtronic Diabetes, where he focused on the company’s glucose sensor. Also notable was his role at Dexcom as the Senior Director of Developmental Engineering and Operations, where he worked on their Class III continuous glucose monitoring system.

“Adler is well-versed in the transformation of early-stage to commercial ready technology,” notes Tom Callaway, Founder and President of Life Science Partner. “He has managed large and small research and development teams, with a heavy emphasis on later stage product development and manufacturing.”

Mark Adler earned a Bachelor of Technology Degree in Mechanical Engineering from Rochester Institute of Technology and an MBA from Argosy University in Seattle, WA.

About Life Science Partner

Life Science Partner is a specialized executive search firm that recruits transformational leaders for healthcare and life sciences companies. Our high-touch, partner-led process ensures an exceptional level of service, while our backgrounds as physicians and industry executives enable us to efficiently deliver the brightest candidates in the medical device, biopharmaceuticals, diagnostics, and healthcare technology fields.

/0 Comments/by

Mark Phelps, PhD Joins Canary Medical as Vice President of Technology Development

Life Science Partner is pleased to announce the recruitment of Mark Phelps, PhD to Canary Medical, where he will serve as Vice President of Technology Development.

Canary Medical is an innovative medical technology company commercializing smart implants in the orthopedic, cardiovascular, and aesthetic markets. The company integrates a sensor and microprocessor system into FDA-cleared implantable medical devices to generate real-time insights about the performance and safety of these products.

Canary Medical logo

Phelps will be driving technology reduction to practice for Canary’s cardiovascular applications, delineating smart implant technologic and business opportunities, providing technical leadership to the Canary Management team, and providing strategic input into building Canary’s infrastructure and business.

Mark Phelps

Previously at Medtronic, Phelps managed the Research and Development team as the Vice President of R&D for Patient Monitoring & Diagnostics. Before that, he was the Senior Program Director for Diagnostics & Monitoring where he worked on a new product line for Medtronic’s wireless implantable cardiac monitor.

“Phelps has shown his ability to be a technology innovator and forward-thinker,” notes Tom Callaway, Founder and President of Life Science Partner. “Given his background at companies such as Medtronic, TASER and LifeSync, Phelps has a proven track record of building innovative technologies to enable future improvements in healthcare.”

Phelps earned his Bachelor of Science, Masters, and PhD in Electrical Engineering from Florida Institute of Technology (FIT) in Melbourne, Florida.

About Life Science Partner

Life Science Partner is a specialized executive search firm that recruits transformational leaders for healthcare and life sciences companies. Our high-touch, partner-led process ensures an exceptional level of service, while our backgrounds as physicians and industry executives enable us to efficiently deliver the brightest candidates in the medical device, biopharmaceuticals, diagnostics, and healthcare technology fields.

Learn More About Chief Scientific and Technology Leader Recruitment
/0 Comments/by

Balakrishnan Shankar Joins Canary Medical as Vice President, Operations

Life Science Partner is pleased to announce the recruitment of Balakrishnan Shankar to Canary Medical, where he will serve as Vice President of Operations.

Canary Medical is an innovative medical technology company commercializing smart implants in the orthopedic, cardiovascular, and aesthetic markets. The company integrates a sensor and microprocessor system into FDA-cleared implantable medical devices to generate real-time insights about the performance and safety of these products.

In his new role, Shankar will lead all operational aspects including manufacturing and supply chain for Canary Medical’s smart medical implants.

Balakrishnan Shankar

Shankar’s 20+ years of leadership in the development and commercialization of active implantable devices as well as their associated software will be an invaluable asset as Canary Medical prepares for the launch of the company’s connected devices.

Shankar previously served as Vice President of Software Development for Medtronic’s Cardiac Rhythm and Heart Failure division, where he led software development across all product lines, including the CareLink patient monitoring system. He was previously at Nevro and St. Jude Medical where he led software product development, operations, and technology development, and systems engineering.

“Shankar has seen the entire spectrum of implantable, electronic medical devices – from concept and design to manufacturing/operations and systems integration,” notes Tom Callaway, Founder of Life Science Partner. “He is the world’s expert for taking connected medical devices from concept to commercialization. His deep technological and operational expertise will be a tremendous asset to Canary Medical as the company continues to develop and commercialize connected implantable devices.”

Shankar earned his MS in Biomedical Engineering from John Hopkins University and his BS in Electrical Engineering from the Indian Institute of Technology.

About Life Science Partner Executive Search

Life Science Partner is a specialized executive search firm that recruits transformational leaders for healthcare and life sciences companies. Our high-touch, partner-led process ensures an exceptional level of service, while our backgrounds as physicians and industry executives enable us to efficiently deliver the brightest candidates in the medical device, biopharmaceuticals, diagnostics, and healthcare technology fields.

Learn More About Chief Executive Functions
/0 Comments/by

Peter Schiller, PhD Joins Canary Medical as Vice President, Research & Development

Life Science Partner Executive Search is pleased to announce the recruitment of Peter Schiller, PhD to Canary Medical, where he will serve as Vice President of Research and Development.

Canary Medical is an innovative medical technology company commercializing smart implants in the orthopedic, cardiovascular, and aesthetic markets.

The company integrates a sensor and microprocessor system into FDA-cleared implantable medical devices to generate real-time insights about the performance and safety of these products.

Peter Schiller, PhD

In his new role, Schiller will spearhead continued product development and commercialization, provide scientific and strategic leadership for this growing team, and serve as the face of the research and development organization to internal and external audiences.

An engineer with a PhD focused on smart sensor systems, Schiller has spent 20 years developing and commercializing novel medical technologies, including a MEMS sensor company he founded and led as CEO.

Schiller previously served as Director of Device Development at San Diego-based Progenity, where he led the design and development of a combination device and connected drug delivery system for gastrointestinal health.

“Peter has well-demonstrated his ability to design and develop novel, forward-thinking electromechanical solutions to complex medical problems,” notes Tom Callaway, Founder and President of Life Science Partner. “His decades in young companies speaks to his entrepreneurial spirit, risk tolerance, and real-world education in the challenges facing implantable medical device startups and how to best navigate them.”

Schiller earned his PhD in Electrical engineering from the University of Minnesota – Twin Cities, and his Masters and Bachelors degrees in Electrical Engineering from the same.

About Life Science Partner Executive Search

Life Science Partner is a specialized executive search firm that recruits transformational leaders for healthcare and life sciences companies. Our high-touch, partner-led process ensures an exceptional level of service, while our backgrounds as physicians and industry executives enable us to efficiently deliver the brightest candidates in the medical device, biopharmaceuticals, diagnostics, and healthcare technology fields.

Learn More About Chief Medical or Regulatory Leaders
/0 Comments/by

Carl Spear, OD, MBA Joins Luxottica as Senior Vice President, Eyecare

Life Science Partner is pleased to announce the recruitment of Carl Spear, OD, MBA, to serve as Senior Vice President, Eyecare for Luxottica, the world’s largest eyeware company.

Luxottica is a leader in the design, manufacture and distribution of fashion, luxury, sports and performance eyewear. Of Luxottica’s 80,000 employees, more than 5,000 are US-based Doctors of Optometry providing patient care and business leadership at LensCrafters, Pearle Vision, Sears Optical, and Target Optical retail stores across the nation.

Carl Spear, OD, MBA

Luxottica is the world’s leading consumer eyecare group, with proprietary brands such as Ray-Ban, Oakley, Persol, Oliver Peoples, Alain Mikli and Arnette, as well as licensed brands including Giorgio Armani, Burberry, Bulgari, Chanel, Dolce&Gabbana, Michael Kors, Prada, Ralph Lauren, Tiffany & Co., and Versace.

A merger is underway between Luxottica and Essilor, the world’s leading manufacturer of ophthalmic lenses.

Dr. Spear will report directly to the Chief Executive Officer and will be responsible for the strategic recruitment, development, and retention of Luxottica’s optometrist community while maximizing the economic return of resources allocated among the Company’s retail brands.

Previously, Spear served as Senior Director, Professional Services for Vision Group Holdings, where he recruited and managed the contracting of ophthalmologists and optometrists to staff their 75 refractory and cataract surgery centers. In parallel, he held a consulting role overseeing the professional affairs strategy for Alcon, the eyecare subsidiary of Novartis.

Before joining industry, Spear spent more than 20 years in private optometry practice. He also served in the United States Air Force as Company Commander for a special operations team in Iraq.

“Carl brings the clinical and industry insights to help Luxottica shape how consumer Eyecare is delivered in the years to come,” said Tom Callway, MD, MBA, President of Life Science Partner. “His tremendous network and deep experience in the space will serve him well as he develops strategies to ensure Luxottica attracts and retains best-in-class clinical talent during this critical period for the company.”

Spear earned his Doctorate of Optometry from the University of Alabama School of Optometry with a residency in Primary Care and Ocular Disease from Northeastern State University College of Optometry. He also earned an MBA from Auburn University and a bachelor’s degree in Biology from Western Kentucky University.

About Life Science Partner Executive Search

Life Science Partner is a specialized executive search firm that recruits transformational leaders for healthcare and life sciences companies. Our high-touch, partner-led process ensures an exceptional level of service, while our backgrounds as physicians and industry executives enable us to efficiently deliver the brightest candidates in the medical device, biopharmaceuticals, diagnostics, and healthcare technology fields.

Learn More About Chief Executive Functions
/0 Comments/by

Barbara Benedict Joins Notal Vision as Director, Patient Engagement

Life Science Partner is pleased to announce the recruitment of Barbara Benedict to Notal Vision as Director of Patient Engagement.

Notal Vision is a tele-health company offering the first patient-initiated, home-based monitoring system to prevent the progression of macular degeneration through early detection and intervention. The technology combines a physical device with a data management infrastructure and a cloud-based physician monitoring system.

In her new role, Benedict will have broad responsibility over all operational aspects of the customer experience, developing key patient engagement strategies and ensuring an exceptional experience for patients and their caregivers.

Previously, Benedict led customer engagement and marketing at Conifer Health, the healthcare management services subsidiary of Tenet Health. Prior to joining Conifer Health Solutions, Benedict spent 4 years in enterprise physician marketing and communications for BayCare Health System, a health care system connecting patients to a wide range of services at 14 hospitals throughout central Florida. She also spent three years as Director, Customer Relations, Marketing and Operations at Healthcare Partners, which manages and administers healthcare products for contracted health plans. Here she led operations for a large multi-specialty medical clinic including a comprehensive customer relations program and community engagement program.

“Barbara has demonstrated she knows how to use remote monitoring technologies to keep patients well, and that she can build and enact a strategy for ensuring these patients are engaged and supported throughout the entire patient journey,” notes Tom Callaway, MD, MBA, President of Life Science Partner. “Her blend of patient-centered empathy and healthcare operations rigor make her a great match for this important role.”

Benedict earned a degree in Marketing and Business Development from the University of South Florida.

About Life Science Partner Executive Search

Life Science Partner is a specialized executive search firm that recruits transformational leaders for healthcare and life sciences companies. Our high-touch, partner-led process ensures an exceptional level of service, while our backgrounds as physicians and industry executives enable us to efficiently deliver the brightest candidates in the medical device, biopharmaceuticals, diagnostics, and healthcare technology fields.

Learn More About Chief Executive Functions
/0 Comments/by