Mark Bogart joins B-Secur – Senior Vice President, US Healthcare

Life Science Partner announces the recruitment of Mark Bogart to serve as Senior Vice President, US Healthcare for B-Secur, a global leader in accelerating the quality of EKG signals to create highly accurate analytics for digital heart health.

Life Science Partner served as a strategic consulting and executive search partner of B-Secur to support their U.S. launch of their signature SaaS technology, HeartKey 2.0®.

Mark Bogart

This cloud-based solution will accelerate the convergence of medical and consumer health devices by offering a proprietary conditioning, FDA-cleared software to improve health algorithms and wellness insights. B-Secur’s innovative biosensing algorithms refine and enhance signal clarity on micro processing chips (implantable or wearable), for consumer technology partner servers providing novel insights. Their technology also serves as an adjunctive tool for accelerating the adoption of medical device company’s proprietary and patient-centric solutions.

With B-Secur’s technology in high demand to improve signal quality, Bogart will secure and expand relationships with US-based medical device and digital health providers. Additionally, Bogart will build and lead the team to grow the US commercialization opportunities with leading cardiac device companies seeking to bring their EKG monitoring solutions to ambulatory and at-home patients.

“With his subject-matter expertise in digital healthcare and remote patient monitoring combined with his exceptional career as a sales leader, Bogart is well-suited to accelerate B-Secur’s growth and establishment within the US market.”

Tom Callaway, MD, Founder of Life Science Partner

Bogart joins B-Secur after serving as Senior Vice President, US Healthcare for AliveCor, a medical device company that produces ECG hardware and software for mobile devices. Bogart led the healthcare division’s go-to-market strategy spear heading critical partnerships and novel acquisitions during his tenure. Earlier in his career, Bogart served in revenue-generating business development leadership roles at companies such as G Medical Innovations, Viterion Corporation, LifeWatch, ZOLL Medical and Boston Scientific.

Bogart holds a Bachelor of Arts degree in Economics and Political Science from Lake Forest College.

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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Stan Harris joins BioTissue – Vice President, Clinical Operations

Life Science Partner is pleased to announce the recruitment of Stan Harris as Vice President, Clinical Operations for BioTissue – the newly unified brand for TissueTech, Amniox, and Bio-Tissue.

BioTissue is an emerging biotechnology leader in utilizing the power of human birth tissue for regenerative healing to treat ocular surface disease and in surgical, chronic wound, and musculoskeletal applications.

Stan Harris

“For years, health care professionals have known our products—regardless of their specific applications—for providing mother nature’s most natural gift of healing so their patients can get back to the lives they love,” said Ted Davis, president, and CEO, BioTissue. “Our new, unified brand supports our entire pipeline of human birth tissue products to aid the treatment of wounds, musculoskeletal conditions, trauma-induced injuries, ocular surface disease, and burns.”

With nearly 40 years dedicated to the medical device industry and a focus on regulatory, quality, and clinical affairs, Harris brings a wealth of knowledge and experience to the clinical operations team at BioTissue. The FDA and other global regulatory agencies are increasing the regulatory oversight of cell-derived therapies.  Harris will be responsible for developing and leading BioTissue’s clinical development with an emphasis in the ophthalmology, orthopedic and pain management indications.

Most recently Harris served as the Vice President, Regulatory, Clinical and Quality Affairs at Lifeline Scientific with previous clinical and regulatory roles at MiMedx, Integra Life Sciences, Ascension Orthopedics, and Wright Medical. “From his previous experience, Harris has direct relationships with key thought leaders in wound healing including excellent relations with the FDA, US, and European regulatory agencies for biological products,” states Tom Callaway, MD, MBA, Founder of Life Science Partner. “His experiences and enthusiasm will be ideal for BioTissue’s continued growth and product development.”

Harris earned a bachelor’s degree in biology from Mercer University. He completed Graduate Studies in Biotechnologies from the Georgia 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 in medicine, science, and industry 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
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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 consumer confidence in devices marketed in the U.S.

David McMullen, MD

The Office of Health Technology 5 (OHT5) is within CDRH’s Office of Product Evaluation and Quality (OPEQ) and is responsible for the total product life cycle review of neurological and physical medicine devices.

As Director for OHT5, McMullen will serve as the technical authority and principal advisor to the OPEQ Director on the total product lifecycle of devices including premarket evaluation, compliance and quality, and surveillance programs for neurological products. 

Career Highlights and Contributions

Since 2016, McMullen has served as the Program Chief for the National Institute of Mental Health (NIMH) within the Neuromodulation and Neurostimulation Program, Division of Translational Research (DTR).

His oversight included device development and biomarker discovery grants as well as clinical trials ranging from first-in-human to critical studies designed to gain FDA regulatory approval. McMullen’s experience includes acting as co-leader for the NIH BRAIN Initiative team and as the NIMH point of contact to the FDA on devices.

“McMullen’s neurovascular and neurostimulation expertise combined with his working relationships within the FDA make him a natural fit for his new leadership role at the Office of Neurological and Physical Medicine Devices,” states Tom Callaway, MD, MBA, Founder of Life Science Partner.

In his new role at OHT5, McMullen will be tasked with navigating the complexities and multiple constituencies of the FDA’s neuroscience device regulatory division and industry agencies while managing a 90 plus person office.

McMullen earned his Bachelor of Science degree in Psychology and Neuroscience from Duke University and his Doctor of Medicine from Rutgers Robert Wood Johnson Medical School.

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 in medicine, science, and industry 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:

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…

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Tom Afzal Joins Novum Medical as Chief Executive Officer (CEO)

Life Science Partner has recruited Tom Afzal to become Chief Executive Officer and Board Member of Novum Medical.

Novum Medical is a private, medical device and orthopedics company developing advanced orthobiomaterials that are structurally sound and compatible to the body. Having shown success with their current applications in extremities, the company is entering the spine industry with their first cervical implant device (currently in FDA IDE clinical trials). The technology has already shown promising and superior results when compared to other implants such as titanium or PEEK plastic.

Tom Afzal

Afzal is a leader in the spine, orthopedic and cardiovascular industries. He will lead Novum in transforming the spine surgery and orthopedic markets, while continuing the growth of the company. As a co-Founder and former Chief Executive Officer of Spinal Kinetics, Afzal brought his company to profitability and led the commercial strategy for their artificial discs. He also gained extensive experience building international businesses across Europe, raising sales to over 60,000 implants in over 20 countries.

Prior to Spinal Kinetics, Afzal was the Chief Executive Officer of Cardiovention. He raised $45 M from venture capital firms, established U.S., German, and Swiss sales organizations, filed his own patents, and helped create a team to develop minimally invasive products for cardiovascular surgery.

Afzal spent the early 90s working overseas in Germany for Life System Medizintechnik and Krauth Medical, achieving annual revenue growth and leading Life System through its acquisition by Krauth Medical. He graduated from San Diego State University majoring in Business Administration and minoring in Finance.

Afzal will play a critical role in raising funds for Novum Medical with his financing background and connections in the spine, cardiovascular and sports medicine industries. As the company completes its FDA IDE clinical trials for their Vitrium cervical interbody spinal fusion device, Afzal will leverage his strengths in commercial and operational leadership to advance the company to its next level of growth.

Novum Medical is a private, medical device and orthopedics company developing advanced orthobiomaterials that are structurally sound and compatible to the body. Having shown success with their current applications in extremities, the company is entering the spine industry with their first cervical implant device (currently in FDA IDE clinical trials). The technology has already shown promising and superior results when compared to other implants such as titanium or PEEK plastic.

Afzal is a leader in the spine, orthopedic and cardiovascular industries. He will lead Novum in transforming the spine surgery and orthopedic markets, while continuing the growth of the company. As a co-Founder and former Chief Executive Officer of Spinal Kinetics, Afzal brought his company to profitability and led the commercial strategy for their artificial discs. He also gained extensive experience building international businesses across Europe, raising sales to over 60,000 implants in over 20 countries.

Prior to Spinal Kinetics, Afzal was the Chief Executive Officer of Cardiovention. He raised $45 M from venture capital firms, established U.S., German, and Swiss sales organizations, filed his own patents, and helped create a team to develop minimally invasive products for cardiovascular surgery.

Afzal spent the early 90s working overseas in Germany for Life System Medizintechnik and Krauth Medical, achieving annual revenue growth and leading Life System through its acquisition by Krauth Medical. He graduated from San Diego State University majoring in Business Administration and minoring in Finance.

Afzal will play a critical role in raising funds for Novum Medical with his financing background and connections in the spine, cardiovascular and sports medicine industries. As the company completes its FDA IDE clinical trials for their Vitrium cervical interbody spinal fusion device, Afzal will leverage his strengths in commercial and operational leadership to advance the company to its next level of growth.

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 in medicine, science, and industry enable us to efficiently deliver the brightest candidates in the medical device, biopharmaceuticals, diagnostics, and healthcare technology fields.

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Jo Carol Hiatt, MD, MBA joins the Medical Device Innovation Consortium as Vice President, Health Economics & Patient Value

Life Science Partner is pleased to announce the recruitment of Jo Carol Hiatt, MD, MBA to become the 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, non-profits, and patient organizations to improve the processes for development, assessment and review of new medical technologies. It is the only public-private partnership developed to work with government and industry stakeholders to advance solutions that promote patient access to innovative medical technologies.

Jo Carol Hiatt

Well-known across multiple industries, Dr. Hiatt 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 act as the critical leader to interface between the MDIC, its members of the board, FDA, CMS, and other payors. In addition, she will manage the Health Economic and Patient Value committee to focus on projects that have a high priority for its members.

Previously, Jo Carol Hiatt was a Chair for the Inter-Regional New Technology Committee for Kaiser Permanente, where she led physicians and executives in reviewing evidence for new technologies. As an Assistant Medical Director, she acted as a liaison and strategist to produce recommendations for quality care based on available evidence and patient supply/demand forecasts. Her deep understanding of coverage processes as well as her connections with various organizations across the industry will make Hiatt a valuable addition to the MDIC leadership team.

Hiatt graduated from Stanford University with a Bachelor of Arts, received her Medical Degree from Duke University, and completed her internship and surgical residency at University of California, Los Angeles. She also earned her MBA from UCLA in 2001.

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 in medicine, science, and industry enable us to efficiently deliver the brightest candidates in the medical device, biopharmaceuticals, diagnostics, and healthcare technology fields.

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David Ramsingh, MD Joins Edwards Lifesciences as Vice President, Clinical & Medical Affairs – Critical Care

Life Science Partner is pleased to announce the recruitment of David Ramsingh as Vice President, Clinical & Medical Affairs – Critical Care at Edwards Lifesciences.

Edwards is a global leader in patient-focused medical innovations. Recently, their Critical Care division has expanded its role in AI-supported predictive software solutions that allow ICU physicians to make better patient care decisions. In doing so, the team sought an integrative leader to oversee clinical research activities, including clinical trials, data management, and systems development to help with future product approval. An anesthesiologist and researcher in hemodynamic monitoring and echocardiology, Ramsingh has a combination of skills which positioned him for this opportunity.

David Ramsingh, MD

Ramsingh will direct multiple functions within clinical and medical affairs, oversee research activities around clinical trials, data management, and system development for future product approvals. In addition, he will oversee Edwards’ high standard of professional education through its Global Professional Development program.

Ramsingh possess valuable skills and experience, having come from Loma Linda University and University of California at Irvine, where he developed an innovative teaching program for anesthesiologists to apply whole-body, point-of-care ultrasound exams. At Loma Linda, his research focused on the use of ultrasound technology to improve perioperative care.

As the Director of Clinical Research and Perioperative Ultrasound at Loma Linda University Medical Center, Ramsingh spent most of his time leading a research team that he developed to focus on hemodynamic monitoring devices, partnering with corporate sponsors such as Edwards, Masimo, and General Electric. Ramsingh earned his medical degree from the Medical College of Georgia. He completed his residency in anesthesiology at Loma Linda University, and he was a cardiothoracic fellow at the University of California in Los Angeles.

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
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Doug Kelly, MD, MBA Joins FDA’s Center for Devices & Radiological Health as Deputy Director for Science

Life Science Partner is pleased to announce the recruitment of Doug Kelly, MD, MBA as Deputy Director for Science to the Food and Drug Administration’s Center for Devices and Radiological Health (FDA, CDRH).

FDA, CDRH is responsible for protecting and promoting public health by assuring that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products.

They provide the community with accessible science-based information about the products they oversee and facilitate medical device innovation by advancing regulatory science.

Doug Kelly, MD, MBA

The CDRH also provides industry with predictable, consistent, and transparent regulatory pathways to assure consumer confidence in the devices marketed in the United States.

With the tremendous advancements in technology and a new age for telemedicine and remote patient monitoring, the CDRH is also focusing on advancing their field of digital health. Housed within the CDRH is the Office of Strategic Partnerships and Technological Innovation.

This unit provides leadership for all scientific collaborative and emerging technology, including the new division of Digital Health, which focuses on providing leadership and oversight in the development, review, and implementation of new software services that are aimed at healthcare.

Career Highlights and Contributions

Doug Kelly is a leader in the field of innovative medical technologies. After earning his medical degree from Albert Einstein College of Medicine and his MBA from Stanford University, Kelly was one of the founding members of Ligand Pharmaceuticals, where he served as the Manager of Business Development and helped recruit their Scientific Advisory Board and manage relationships with corporate partners.

In 1996, he helped create a new venture fund, Alloy Ventures, and identified new opportunities for investments in seed- and later-stage medical device, drug discovery, biotechnology and healthcare IT companies.

Dr. Kelly will play a critical, external-facing role for the CDRH and the Office of Strategic Partnerships and Technological Innovation by collaborating with leaders in industry, academia, and healthcare innovation, leveraging his wealth of experience in the medical device investment community.

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…

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Chris Elliot Joins Tier One as Senior Embedded Software Engineer

Life Science Partner is pleased to announce the recruitment of Chris Elliot to Tier One, where he will be a part of a team of professional design engineers as a Senior Embedded Software Engineer.

Tier One is an engineering design firm consisting of top-tier, professional engineers with exceptional talent. The group provides solutions in product development for custom software and electronics. They have developed their credibility in the industry with their streamlined process in bringing products to market.

Chris Elliot

By having a diverse range of engineers who are highly proficient in their specialty, Tier One is able to fulfill a wide variety of market needs and solve problems quickly.

Elliot will be responsible for creating custom software solutions that target embedded devices for clients. His expertise will be critical for providing technical advice and guidance to internal and external teams, and he will be an integral member of a complete engineering team at Tier One.

Among some of his many notable accomplishments and past careers, Elliot started his own consulting group to design and develop website architecture and solve unique software, firmware, and hardware problems. He also worked for the Weather Channel, where he developed video and audio platforms for the company’s broadcasting services. Previously, he was a Software Task lead for Georgia Tech Research Institute, where he was responsible for software and systems engineering projects for the Department of Defense.

With the recruitment of Elliot to Tier One, the company will be able to meet the needs of their clients and continue to provide exceptional service. Elliot brings a wealth of knowledge and experience to the team, and his role will synergize well with the senior engineers.

Chris Elliot earned his Bachelor of Science, in Electrical Engineering from Georgia Institute of Technology.

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 scientists enable us to efficiently deliver the brightest candidates in the medical device, biopharmaceuticals, diagnostics, and healthcare technology fields.

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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.

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Chad Kolean Joins Vivex Biologics as Chief Financial Officer (CFO)

Life Science Partner is pleased to announce the recruitment of Chad Kolean as Vivex Biologics’ Chief Financial Officer.

Vivex Biologics is a leading regenerative medicine company that markets tissue technology products and cellular therapies focused on orthopaedic applications with an emphasis on spine related therapies. They have a diverse portfolio of current products including cellular bone matrices, amniotic tissue, general orthopaedics, and sports medicine products to meet the therapeutic demand in the areas of spine, dental, sport medicine, and wound care.

Chad Kolean

Vivex is preparing for its next stage of growth with the launch of its new product, VIA Disc. This product will be used for the treatment of Degenerative Disc Disease (DDD). As the company continues to grow in the spine and biologics industry, it sought a seasoned Chief Financial Officer who understood the landscape of this field.

Kolean previously served as the Chief Financial Officer of Titan Spine, a medical device surface technology company. One of his major milestones in preparing Titan for success was controlling and managing inventory and manufacturing challenges. His attitude helped put the company’s financial house in order.

He was also Chief Financial Officer of Cellectar Biosciences, a clinical stage biopharmaceutical company, where he restructured management and raised funds, which led to an uplisting on the NASDAQ Capital Market. Before that, Kolean served for Pioneer Surgical Technologies as their Chief Financial Officer. He was responsible for the financial aspects of leadership restructuring, development and execution, treasury, board support, investor relations, and operations.

Kolean’s arrival will provide tremendous guidance and leadership to Vivex Biologics as it prepares itself for the next stage of growth and development and the launch of a new product in the biologics space. By leveraging Kolean’s experience as a financial leader in the spine and orthopaedic industry, the company hopes for continued growth and preparation for a future financing event.  

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 Our CFO Recruitment
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