Tag Archive for: Medical Devices

Life Science Partner has recruited Ross (Rusty) Segan, MD, formerly Chief Medical Officer of Olympus and Integrated Leader, Pre-Clinical, Clinical, and Medical Affairs at DuPuy Synthes, to the FDA to become Director of the Office of Product Evaluation and Quality (OPEQ) in the FDA’s Center for Devices and Radiological Health (CDRH).

Segan’s New Role and Responsibilities at the FDA

In this role, Dr. Segan is responsible for setting the strategy and overseeing Device-Specific Offices, the Office of Clinical Evidence and Analysis, and the Office of Regulatory Programs. His leadership ensures quality end-to-end device evaluation and consistent interpretation and application of regulatory policy and guidance.

Ross "Rusty" Segan, MD, FDA CDRH's Office Director, Product Evaluation & Quality

With his extensive background in medical and scientific affairs, Dr. Segan brings a wealth of experience from his global leadership roles at Olympus, Johnson & Johnson, and Covidien, where he led the development and implementation of clinical and regulatory strategies that significantly improved clinical outcomes and upheld patient safety.

Career Highlights and Contributions to the Medical Device Industry

Before joining the FDA, Dr. Segan held several prominent positions in the medical device industry. As Chief Medical Officer of Olympus, he was pivotal in driving the company’s medical safety initiatives and fostering innovation across the global portfolio. At Johnson & Johnson’s DuPuy Synthes, he led Pre-Clinical, Clinical, and Medical Affairs for the $9 billion orthopedic and medical device division.

His career also includes leadership roles at Covidien, overseeing a diverse portfolio of clinical studies, healthcare economics, and reimbursement strategies. Across these roles, Dr. Segan consistently demonstrated his ability to integrate business strategy with scientific excellence, driving transformation in medical technologies that improved patient care worldwide.

Rusty brings a wealth of experience in science, medicine, and, most importantly, organizational leadership, said Thomas Callaway, MD, Founder of Life Science Partner.  His former colleagues widely praised his management skills, an asset that will help him succeed in leading the teams and infrastructure within the FDA’s CDRH. 

Dr. Segan’s educational background complements his extensive career in the medical technology industry. He earned his Medical Doctor degree from UMDNJ-Robert Wood Johnson Medical School and holds a Master of Business Administration with specializations in Entrepreneurship, Innovation, and Leadership from New York University’s Stern School of Business.

Before his medical education, Dr. Segan earned a Bachelor of Science from Salisbury State University and a Master of Science in Athletic Training from West Virginia University. 

His clinical training includes general surgery residencies at Thomas Jefferson University Hospital and Cooper Hospital/University Medical Center and a clinical fellowship in minimally invasive surgery at the University of Maryland.

This diverse academic background has equipped Dr. Segan with a unique combination of medical, business, and leadership expertise, enabling him to excel in advancing healthcare technology and regulatory practices globally.

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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Former CEO of Solta Medical joins SOLIUS Board of Directors.

Life Science Partner is proud to have recruited Scott Hirsch to join the SOLIUS Board of Directors. With extensive experience leading medical device companies and steering business units to success, Hirsch brings a wealth of regulatory expertise and business acumen to SOLIUS.

In collaboration with newly appointed CEO Chris Kiple, JD, Hirsch will assist in fundraising, scaling operations, and launching SOLIUS’ proprietary UVB light therapy technology, designed to treat patients with low Vitamin D levels, including a groundbreaking at-home therapy device.

Hirsch’s Professional Background

Hirsch was drawn to SOLIUS following Valeant’s $250 million acquisition of Solta Medical, a former division of Bausch Health Companies, where Hirsch spearheaded significant achievements. Solta became a recognized leader in the aesthetics industry with a portfolio of products that included the popular Thermage®, Fraxel®, Clear + Brilliant®, and VASERlipo® systems. Hirsch’s expertise in direct-to-consumer business models will drive SOLIUS’ commercialization and regulatory strategies.

“With an impressive background in financing and a proven track record for executing innovative commercialization plans, Hirsch’s strategic vision and dynamic leadership will play a crucial role in SOLIUS’ success,” says Tom Callaway, MD, Founder of Life Science Partner.

Before his tenure as CEO of Solta, Hirsch held leadership roles across several Bausch business units, including President of the Bausch Foundation, President of Ortho Dermatologics, and OraPharma.

Before that, Hirsch was an investor and portfolio manager on Wall Street at Citadel and was Vice President at Plural Investments. He also held the position of Lead Equity Research Analyst for Specialty Pharmaceuticals and Global Generics at Credit Suisse.

Hirsch holds a Bachelor of Fine Arts from the Rhode Island School of Design and an MBA in Finance and Healthcare Management from The Wharton School.

Life Science Partner is also pleased to announce the recruitment of Chris Kiple, JD, former CEO of Ventec Life Systems, as SOLIUS’s Chief Executive Officer.

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.

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.

Read More About Life Science Partner’s Recruitment for 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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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.

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

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.

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.

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.

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

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.

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.