Craig Berky

Consultant at 1315 Capital
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Contact Information
us****@****om
(386) 825-5501
Location
Fort Lauderdale, Florida, United States, US

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Experience

    • United States
    • Venture Capital and Private Equity Principals
    • 1 - 100 Employee
    • Consultant
      • Jul 2022 - Present

      We focus on key areas in the healthcare industry and invest in companies that we believe are positioned to scale. 1315 Capital manages over $1 billion and provides expansion and growth capital to commercial-stage healthcare services, medical technology, medtech & pharma outsourcing, and health & wellness companies. The team believes that these investment areas are attractive largely due to numerous niche market sub-segments and business models where high-quality management teams can rapidly… Show more We focus on key areas in the healthcare industry and invest in companies that we believe are positioned to scale. 1315 Capital manages over $1 billion and provides expansion and growth capital to commercial-stage healthcare services, medical technology, medtech & pharma outsourcing, and health & wellness companies. The team believes that these investment areas are attractive largely due to numerous niche market sub-segments and business models where high-quality management teams can rapidly grow small platform companies, in a capital efficient way, into large and important businesses that positively impact patients, physicians, and the broader healthcare system. The firm targets $10 to $40 million investments in commercial healthcare businesses that have the potential to scale to $50 million to $150 million of revenue, a level we believe is highly attractive for acquisition or to access the public markets. In addition to experienced investing partners, 1315 Capital leverages an Operating Team model of CEO and longtime executive partner that work together to navigate diligence, drive decisions, and seek to achieve premium exits. Three operating teams contribute their collective experience across subsectors to 1315 Capital. These three teams have built companies from expansion and growth phases to businesses with revenues in excess of $100 million. Show less We focus on key areas in the healthcare industry and invest in companies that we believe are positioned to scale. 1315 Capital manages over $1 billion and provides expansion and growth capital to commercial-stage healthcare services, medical technology, medtech & pharma outsourcing, and health & wellness companies. The team believes that these investment areas are attractive largely due to numerous niche market sub-segments and business models where high-quality management teams can rapidly… Show more We focus on key areas in the healthcare industry and invest in companies that we believe are positioned to scale. 1315 Capital manages over $1 billion and provides expansion and growth capital to commercial-stage healthcare services, medical technology, medtech & pharma outsourcing, and health & wellness companies. The team believes that these investment areas are attractive largely due to numerous niche market sub-segments and business models where high-quality management teams can rapidly grow small platform companies, in a capital efficient way, into large and important businesses that positively impact patients, physicians, and the broader healthcare system. The firm targets $10 to $40 million investments in commercial healthcare businesses that have the potential to scale to $50 million to $150 million of revenue, a level we believe is highly attractive for acquisition or to access the public markets. In addition to experienced investing partners, 1315 Capital leverages an Operating Team model of CEO and longtime executive partner that work together to navigate diligence, drive decisions, and seek to achieve premium exits. Three operating teams contribute their collective experience across subsectors to 1315 Capital. These three teams have built companies from expansion and growth phases to businesses with revenues in excess of $100 million. Show less

    • United States
    • Higher Education
    • 700 & Above Employee
    • Executive In Residence
      • Feb 2022 - Present

      Advisor to activities of the Coulter Translational Research Partnership Program at the University of Michigan. The Mission of this program is to translate biomedical innovations from faculty at the University of Michigan Medical School and the Department of Biomedical Engineering to commercialization. The Michigan Coulter Program is funded through a $20M endowment. Proceeds from the endowment support collaborative translational research projects that address unmet health care needs, and lead to… Show more Advisor to activities of the Coulter Translational Research Partnership Program at the University of Michigan. The Mission of this program is to translate biomedical innovations from faculty at the University of Michigan Medical School and the Department of Biomedical Engineering to commercialization. The Michigan Coulter Program is funded through a $20M endowment. Proceeds from the endowment support collaborative translational research projects that address unmet health care needs, and lead to new biomedical product concepts designed to improve the diagnosis and treatment of disease. Significant goals for this program include working to identify and fund promising translational research projects, improving the effectiveness of collaborations between biomedical engineers and clinicians, and facilitating business development efforts that lead to additional outside funding, licensing deals, and venture backed start-up companies. Show less Advisor to activities of the Coulter Translational Research Partnership Program at the University of Michigan. The Mission of this program is to translate biomedical innovations from faculty at the University of Michigan Medical School and the Department of Biomedical Engineering to commercialization. The Michigan Coulter Program is funded through a $20M endowment. Proceeds from the endowment support collaborative translational research projects that address unmet health care needs, and lead to… Show more Advisor to activities of the Coulter Translational Research Partnership Program at the University of Michigan. The Mission of this program is to translate biomedical innovations from faculty at the University of Michigan Medical School and the Department of Biomedical Engineering to commercialization. The Michigan Coulter Program is funded through a $20M endowment. Proceeds from the endowment support collaborative translational research projects that address unmet health care needs, and lead to new biomedical product concepts designed to improve the diagnosis and treatment of disease. Significant goals for this program include working to identify and fund promising translational research projects, improving the effectiveness of collaborations between biomedical engineers and clinicians, and facilitating business development efforts that lead to additional outside funding, licensing deals, and venture backed start-up companies. Show less

    • United States
    • Medical Equipment Manufacturing
    • Chief Operating Officer
      • Oct 2019 - Present

      Arterial and venous disease of the lower limbs affects millions of patients, has significant mortality rates, and has an enormous economic impact to our health care system. Patients often wait until symptoms are near irreversible, which is a primary reason why amputations rates are so high—globally more than 200,000 amputations per year are related to peripheral arterial disease (PAD). In addition, it is estimated that more than 400,000 lower limbs are treated for deep vein thrombosis (DVT)… Show more Arterial and venous disease of the lower limbs affects millions of patients, has significant mortality rates, and has an enormous economic impact to our health care system. Patients often wait until symptoms are near irreversible, which is a primary reason why amputations rates are so high—globally more than 200,000 amputations per year are related to peripheral arterial disease (PAD). In addition, it is estimated that more than 400,000 lower limbs are treated for deep vein thrombosis (DVT) annually and are responsible for 60,000 to 100,000 deaths per year. Of the DVT patient population, 10% to 30% will die within 1 month of diagnosis and one-third of all people with DVT will have recurrence within 10 years. At iCHOR, we want to make scientific contributions that improve outcomes and make a difference for patients. Specifically, our aim is to give vascular interventionalists versatile tools to treat a wide range of peripheral vascular occlusions while addressing the shortcomings of today’s drug, surgical, and mechanical treatment options. iCHOR was founded by Interventional Radiologist Dr. Troy Long and industry veteran Tim Blair. They identified an opportunity to develop new technologies to address these large unmet needs in treating peripheral vascular occlusions. This collaboration has lead to the development of the iSWEEP platform technology that has converted the tried and true Fogarty balloon sweep technique from an open surgery to a simple, minimally-invasive endovascular procedure. Show less Arterial and venous disease of the lower limbs affects millions of patients, has significant mortality rates, and has an enormous economic impact to our health care system. Patients often wait until symptoms are near irreversible, which is a primary reason why amputations rates are so high—globally more than 200,000 amputations per year are related to peripheral arterial disease (PAD). In addition, it is estimated that more than 400,000 lower limbs are treated for deep vein thrombosis (DVT)… Show more Arterial and venous disease of the lower limbs affects millions of patients, has significant mortality rates, and has an enormous economic impact to our health care system. Patients often wait until symptoms are near irreversible, which is a primary reason why amputations rates are so high—globally more than 200,000 amputations per year are related to peripheral arterial disease (PAD). In addition, it is estimated that more than 400,000 lower limbs are treated for deep vein thrombosis (DVT) annually and are responsible for 60,000 to 100,000 deaths per year. Of the DVT patient population, 10% to 30% will die within 1 month of diagnosis and one-third of all people with DVT will have recurrence within 10 years. At iCHOR, we want to make scientific contributions that improve outcomes and make a difference for patients. Specifically, our aim is to give vascular interventionalists versatile tools to treat a wide range of peripheral vascular occlusions while addressing the shortcomings of today’s drug, surgical, and mechanical treatment options. iCHOR was founded by Interventional Radiologist Dr. Troy Long and industry veteran Tim Blair. They identified an opportunity to develop new technologies to address these large unmet needs in treating peripheral vascular occlusions. This collaboration has lead to the development of the iSWEEP platform technology that has converted the tried and true Fogarty balloon sweep technique from an open surgery to a simple, minimally-invasive endovascular procedure. Show less

    • Managing Partner
      • Oct 2019 - Present
    • United States
    • Medical Device
    • 1 - 100 Employee
    • VP of Research & Development
      • Nov 2019 - Dec 2021

      Dalent Medical was launched in 2017 by ENT surgeon Dr. Agustin Arrieta and engineer Peter Flores who saw the opportunity to develop an innovative, versatile and lower cost instrument to help surgeons treat patients with chronic sinusitis. The SinusleeveTM Balloon is the world’s first balloon sinus dilation sleeve in the ENT field that offers a unique, universal design that provides surgeons the ability to use the same device on multiple sinuses and to use existing suction instruments and… Show more Dalent Medical was launched in 2017 by ENT surgeon Dr. Agustin Arrieta and engineer Peter Flores who saw the opportunity to develop an innovative, versatile and lower cost instrument to help surgeons treat patients with chronic sinusitis. The SinusleeveTM Balloon is the world’s first balloon sinus dilation sleeve in the ENT field that offers a unique, universal design that provides surgeons the ability to use the same device on multiple sinuses and to use existing suction instruments and other rigid instruments to access the frontal, maxillary and sphenoid sinuses. The ability to use one device such as the SinusleeveTM balloon with a wide array of surgeon-familiar instruments, while also increasing functionality at a lower cost, is a true breakthrough for ENT doctors and their patients. Show less Dalent Medical was launched in 2017 by ENT surgeon Dr. Agustin Arrieta and engineer Peter Flores who saw the opportunity to develop an innovative, versatile and lower cost instrument to help surgeons treat patients with chronic sinusitis. The SinusleeveTM Balloon is the world’s first balloon sinus dilation sleeve in the ENT field that offers a unique, universal design that provides surgeons the ability to use the same device on multiple sinuses and to use existing suction instruments and… Show more Dalent Medical was launched in 2017 by ENT surgeon Dr. Agustin Arrieta and engineer Peter Flores who saw the opportunity to develop an innovative, versatile and lower cost instrument to help surgeons treat patients with chronic sinusitis. The SinusleeveTM Balloon is the world’s first balloon sinus dilation sleeve in the ENT field that offers a unique, universal design that provides surgeons the ability to use the same device on multiple sinuses and to use existing suction instruments and other rigid instruments to access the frontal, maxillary and sphenoid sinuses. The ability to use one device such as the SinusleeveTM balloon with a wide array of surgeon-familiar instruments, while also increasing functionality at a lower cost, is a true breakthrough for ENT doctors and their patients. Show less

    • Chief Operating Officer
      • Oct 2019 - May 2021

      Oversight of Project Lifecycle Management responsible for the resourcing, performance, and overall customer satisfaction for all client programs including client company management and fundraising, client product specification development, client contract manufacturing, and general client consulting services. Leading efforts to identify and create synergistic relationships with supply chain and commercialization partners. Responsible for the alignment of sales, marketing and product development… Show more Oversight of Project Lifecycle Management responsible for the resourcing, performance, and overall customer satisfaction for all client programs including client company management and fundraising, client product specification development, client contract manufacturing, and general client consulting services. Leading efforts to identify and create synergistic relationships with supply chain and commercialization partners. Responsible for the alignment of sales, marketing and product development ensuring a recognized value proposition within the medical device contract engineering and manufacturing industry. Show less Oversight of Project Lifecycle Management responsible for the resourcing, performance, and overall customer satisfaction for all client programs including client company management and fundraising, client product specification development, client contract manufacturing, and general client consulting services. Leading efforts to identify and create synergistic relationships with supply chain and commercialization partners. Responsible for the alignment of sales, marketing and product development… Show more Oversight of Project Lifecycle Management responsible for the resourcing, performance, and overall customer satisfaction for all client programs including client company management and fundraising, client product specification development, client contract manufacturing, and general client consulting services. Leading efforts to identify and create synergistic relationships with supply chain and commercialization partners. Responsible for the alignment of sales, marketing and product development ensuring a recognized value proposition within the medical device contract engineering and manufacturing industry. Show less

    • United States
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • Chief Operating Officer
      • Dec 2018 - Oct 2019

      Responsible for the overall operations of a startup neurovascular device company by providing the strategic plan and leadership required to provide interventional ischemic thrombectomy devices to Stryker Neurovascular. Realignment of New Product Development to enhance efficiencies and accountability of Program Managers as well as the Quality Department to address the gaps as defined in FDA inspections and customer site audits. Complete reorganization of the Operations Group to a metric based… Show more Responsible for the overall operations of a startup neurovascular device company by providing the strategic plan and leadership required to provide interventional ischemic thrombectomy devices to Stryker Neurovascular. Realignment of New Product Development to enhance efficiencies and accountability of Program Managers as well as the Quality Department to address the gaps as defined in FDA inspections and customer site audits. Complete reorganization of the Operations Group to a metric based operation with the implementation of lean manufacturing principles to meet customer demand and quality objectives. Show less Responsible for the overall operations of a startup neurovascular device company by providing the strategic plan and leadership required to provide interventional ischemic thrombectomy devices to Stryker Neurovascular. Realignment of New Product Development to enhance efficiencies and accountability of Program Managers as well as the Quality Department to address the gaps as defined in FDA inspections and customer site audits. Complete reorganization of the Operations Group to a metric based… Show more Responsible for the overall operations of a startup neurovascular device company by providing the strategic plan and leadership required to provide interventional ischemic thrombectomy devices to Stryker Neurovascular. Realignment of New Product Development to enhance efficiencies and accountability of Program Managers as well as the Quality Department to address the gaps as defined in FDA inspections and customer site audits. Complete reorganization of the Operations Group to a metric based operation with the implementation of lean manufacturing principles to meet customer demand and quality objectives. Show less

    • United Kingdom
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • Founder and General Manager
      • Aug 2004 - Dec 2018

      Responsible for the overall financial reporting and management of all daily operations of a full service Medical Device Contract Manufacturer including Cleanroom Manufacturing, Product Development, Engineering and Complex Catheter Manufacturing. Other responsibilities include Sales and Marketing and the implementation of Key Strategies to meet core company KPIs. • Grew customer base from zero to over 126 customers • Responsible for a CAGR growth over the last 5 years of… Show more Responsible for the overall financial reporting and management of all daily operations of a full service Medical Device Contract Manufacturer including Cleanroom Manufacturing, Product Development, Engineering and Complex Catheter Manufacturing. Other responsibilities include Sales and Marketing and the implementation of Key Strategies to meet core company KPIs. • Grew customer base from zero to over 126 customers • Responsible for a CAGR growth over the last 5 years of 14.8% • Functional Leader of $36M Medical Business Unit • Analyze and Optimize Operational Efficiency • Develop on-site Budget • Manage site’s Profit and Loss • Develop and Meet Long Range Planning • Define and Manage Expansion Plans • Identify Required CAPEX for Growth Initiatives • Define and Drive Sales Activities • Set and Achieve Quality Metrics • Define and Maintain a Culture of Quality and Integrity

    • Vice President Research & Development
      • Dec 2004 - Aug 2012

      Responsible for all Engineering Services including definition of Program Scope, Early Stage Conceptual Activities, Product Design and Development, Product Verification and Process Validation Testing resulting in over 18 successful product launches. • Create a Successful Billable Engineering Business Model • Build and Lead Product Development Team • Transfer into Manufacturing • Define and Maintain Supply Chain

    • United States
    • Managing Director
      • Sep 1998 - Dec 2004

      Being the catalyst of transitioning from early stage concepts into commercializable technologies within a medical technology incubator. Invent and commercialize innovative new products by solving problems in both finished goods and processes. • Equity Based Business Model • Early Stage Analysis of Ideas and Patentability Assessments • Cost of Goods and Manufacturing Analysis • Market Trending Analysis • Licensees of Various Technologies include:  Sakura Finetek  Tyco… Show more Being the catalyst of transitioning from early stage concepts into commercializable technologies within a medical technology incubator. Invent and commercialize innovative new products by solving problems in both finished goods and processes. • Equity Based Business Model • Early Stage Analysis of Ideas and Patentability Assessments • Cost of Goods and Manufacturing Analysis • Market Trending Analysis • Licensees of Various Technologies include:  Sakura Finetek  Tyco Healthcare  Guidant  Cardio Thoracic Systems  Ortheon Medical  AtriCure  Cleveland Clinic Show less Being the catalyst of transitioning from early stage concepts into commercializable technologies within a medical technology incubator. Invent and commercialize innovative new products by solving problems in both finished goods and processes. • Equity Based Business Model • Early Stage Analysis of Ideas and Patentability Assessments • Cost of Goods and Manufacturing Analysis • Market Trending Analysis • Licensees of Various Technologies include:  Sakura Finetek  Tyco… Show more Being the catalyst of transitioning from early stage concepts into commercializable technologies within a medical technology incubator. Invent and commercialize innovative new products by solving problems in both finished goods and processes. • Equity Based Business Model • Early Stage Analysis of Ideas and Patentability Assessments • Cost of Goods and Manufacturing Analysis • Market Trending Analysis • Licensees of Various Technologies include:  Sakura Finetek  Tyco Healthcare  Guidant  Cardio Thoracic Systems  Ortheon Medical  AtriCure  Cleveland Clinic Show less

Education

  • University of Pittsburgh
  • Pittsburgh Technical College
  • University of South Florida

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