Tag Archive for: Medical Devices

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.

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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.

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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.

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Rosalind Fabunmi, PhD Joins Edwards Lifesciences as Senior Director, Medical Affairs

Life Science Partner is pleased to announce the recruitment of Rosalind Fabunmi, PhD as Senior Director, Medical Affairs with Edwards Lifesciences.

Edwards is committed to focusing on the patient journey from diagnosis to treatment to lifetime outcome, and Fabunmi has a rare combination of skills and experiences which make her highly qualified for her new role. With compelling data on the high individual and societal costs of valvular disease, Edwards is seeking to address the significant unmet need for care.

Rosalind Fabunmi, PhD

Fabunmi will lead Edwards’ evidence development and publication strategy in order to call attention to the prevalence and costs of valvular disease. Importantly, she will also serve as the public face of the company on these issues, engaging key opinion leaders to address the broad lack of awareness.

Fabunmi joins Edwards already possessing subject matter expertise in structural heart disease. Earlier in her career, she served in medical affairs roles for transcatheter aortic valve replacement technologies with Medtronic. Notably, she has also served in medical affairs roles in the pharmaceutical industry, working on heart failure products with Merck and Amylin Pharmaceuticals.

Most recently, Fabunmi served as Senior Director, Medical Affairs with the diabetes company Zafgen. The pharmaceutical industry has blazed the trail on burden of disease data and its use, so Fabunmi’s combination of medical device and pharmaceutical experience in Edwards’ disease space makes her exceptionally qualified for this role. In a career primarily focused on medical affairs, Fabunmi’s experience also encompasses health economics and outcomes research, rendering her almost unique in terms of the skills she brings to Edwards.

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.

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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.

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Chie Iwaishi Joins Edwards Lifesciences as Vice President, International Regulatory & Clinical Affairs

Life Science Partner is pleased to announce the recruitment of Chie Iwaishi to Edwards Lifesciences (NYSE:EW) as Vice President, International Regulatory and Clinical Affairs, where she will lead the expansion of this Irvine-based company in the Japan and Asia-Pacific region.

Iwaishi’s three decades of leadership in regulatory and clinical affairs will be an invaluable asset for Edwards Lifesciences, a global leader in in patient-focused medical innovations for structural heart disease, critical care and surgical monitoring. The company’s heart valve offerings encompass both surgical and transcatheter therapies for heart valve replacement and repair.

Chie Iwaishi

In addition, Edwards’ pipeline of future technologies is focused on the less invasive repair or replacement of the mitral and tricuspid valves of the heart, which are more complex and more challenging to treat than the aortic valve that is currently the focus of many of the commercially approved valve technologies.

Iwaishi is a distinguished expert in regulatory and clinical affairs, with particular expertise in Japan, China, and the broader Asia-Pacific region. She possesses keen knowledge of the regulatory and cultural paradigms, launched the first drug eluting stent in China, and has considerable senior global leadership experience and business acumen. In her new role, she will spearhead Edwards Lifesciences’ regulatory and clinical programs in Asia, which the company has identified as a key strategic initiative.

“Iwaishi’s deep understanding of regulatory affairs, with many successful PMAs and 510ks, and her well-practiced leadership of large globally-dispersed teams will be a tremendous asset to Edwards Lifesciences as they continue to expand on a global stage,” notes Tom Callaway, President and Founder of Life Science Partner.

Iwaishi joins Edwards Lifesciences from Abbott (formerly Alere Inc.), a rapid point-of-care diagnostic tests manufacturer, where she served as Vice President, Regulatory Affairs Asia Pacific and led their global strategy development and regulatory compliance in Japan, China, Korea and India. She also led the regulatory diligence for Alere’s $1.3 billion acquisition. Earlier in her career, Iwaishi served in regulatory affairs roles of escalating responsibility, working primarily with Class II and Class III medical devices in the cardiovascular space.

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.

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Megan Eckerman Joins CryoLife as Vice President, Global Marketing

Life Science Partner is pleased to announce the recruitment of Megan Eckerman to CryoLife (NYSE:CRY) as Vice President of Global Marketing.

Eckerman will lead the unification of this Atlanta-based company’s US and European marketing efforts under a common worldwide strategy as CryoLife continues its transformation from an allographic human tissue provider to a global aortic cardiovascular device leader.

CryoLife is a leader in cryogenically preserved human tissues for cardiovascular applications, as well as heart valves and other medical devices for blood vessel repair.

Megan Eckerman

With a focus on aortic technologies, the company has recently expanded their offerings to heart valves and stent grafts with the acquisition of On-X Life Technologies and JOTEC stent graft systems, respectively.

Ms. Eckerman joins CryoLife from Bolton Medical, an aortic stent graft manufacturer, where she served as Vice President of Global Marketing and was instrumental in the merger of Bolton Medical and Terumo’s subsidiary Vascutek under the brand Terumo Aortic following Bolton’s 2017 acquisition by the Japanese medical equipment company. Her earlier career features progressive sales and marketing roles with Medtronic and Intuitive Surgical, as well as service as Chief of Satellite Launch Operations in the United States Air Force.

“Megan’s deep understanding of cardiovascular technologies and their various worldwide customer bases will be a tremendous asset to CryoLife as they continue to reinvent themselves on a global stage,” notes Tom Callaway, MD, MBA, Founder of Life Science Partner. “I am confident her high emotional intelligence and thoughtful leadership philosophy will help her mobilize her team toward this ambitious goal.”

Ms. Eckerman earned her BS in Kinesiology from Indiana University and her MBA from the University of Colorado.

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.

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About CryoLife

Headquartered in suburban Atlanta, Georgia, CryoLife is a leader in the manufacturing, processing, and distribution of medical devices and implantable living tissues used in cardiac and vascular surgical procedures.  CryoLife markets and sells a highly competitive product portfolio focused on treating aortic disease in more than 80 countries worldwide.

Press Release PDF

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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.

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Liz Spurgin Joins the Medical Device Innovation Consortium as Vice President, Health Economics & Patient Value

Life Science Partner is pleased to announce the recruitment of Liz Spurgin to become the first Vice President, Health Economics and Patient Value for the Medical Device Innovation Consortium (MDIC).

The MDIC brings together representatives of the Food and Drug Administration (FDA), National Institutes of Health (NIH), Centers for Medicare and Medicaid Services (CMS), industry, and non-profits and patient organizations to improve the processes for development, assessment and review of new medical technologies. Spurgin will lead the MDIC’s efforts to increase predictability regarding the scientific and clinical evidence to support health economics assessment and the “reasonable and necessary” standard. She will build on the organization’s earlier successes in advancing regulatory science, but with a focus on patient science and economic value.

Prior to assuming her new role, Spurgin was a senior advisor at the prestigious healthcare advisory firm Leavitt Partners. Here and in her earlier roles, Spurgin has extensive experience working with CMS on health economics and coverage matters. Spurgin holds a Master of Business Administration with a specialization in health care management from the University of Connecticut, as well as a Bachelor of Arts from the University of Illinois. Her deep understanding of the CMS coverage process as well as her thoughtful, results-oriented leadership style will make her a valuable addition to the MDIC leadership team.

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.

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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
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