Webinars are one hour in length and are live-streamed on our YouTube Channel. They will also be recorded and available for later viewing.
The goal of the MedTech Innovator webinars is to provide the medtech ecosystem and our portfolio companies with feedback from experts and professionals in areas that are specific to the strategic needs outlined in our discussions and surveys. Strategic areas to be covered include: intellectual property, product development, commercialization, reimbursement, healthcare economics, regulatory strategy, clinical trial design and execution, and fundraising.
Our webinars are administered virtually and consist of one or more panelists addressing key questions supplied in advance by the MedTech Innovator Accelerator & Showcase companies, as well as a general discussion on the topic within the context of the evolving healthcare ecosystem.
Co-founder and CEO of ImmersiveTouch, where we are reducing the standard 7-10 day 3D planning delivery down to just minutes. We are a pioneer in VR simulated surgical planning; the next dimension in personalized healthcare. ImmersiveTouch is highly differentiated with a large hospital base and patent portfolio. I’m responsible for running all facets of the business and have a proven executive management track record driving growth and innovation in healthcare. I am driven to improve healthcare economics and patient outcomes. I am an accomplished speaker, and a contributor to publications such as Forbes and Business Insider. Under my leadership ImmersiveTouch was awarded Best Video and Top 4 Finalist by MedTech Innovator, won the Center for Advancing Innovation Global Health Innovation Challenge; awarded Best Simulation Company in North America by Frost & Sullivan; listed in the 34 Virtual Reality Companies to Know by Built In; featured in Healthcare Tech Outlook ‘s Top 10 Medical Imaging Solutions Providers; named one of The 7 Virtual Reality Companies to Innovate Healthcare by Medical Design and Outsourcing; listed as one of The 9 Healthcare Companies Making Innovations in Virtual Reality by Touchstone Research; selected as one of the Top 10 Startups by HealthBox; and awarded Top Simulation Company by MedTech Outlook.
After earning a bachelor’s degree in Mechanical Engineering from Colorado State University, Mike went on to become a Nuclear Refueling Engineer for the Department of Defense’s submarine program.
Then, he and his wife relocated from Seattle, WA to San Diego, CA where he took an engineering position with Invetech, a Danaher company, and his wife, Dr. Leah Gordon, attended medical school.
While with Invetech, Mike worked as a senior mechanical engineer on a variety of projects supporting the development of diagnostic instruments, medical devices, cell and gene therapies, consumer products, and automation systems.
He currently operates his own consulting company, Michael Gordon, Inc, which specializes in the conceptualization, development and integration of novel technologies and biological workflows in the immuno-oncology/immunotherapy space.
I am the CEO and co-founder of Oxford Endovascular Ltd, a spinout from Oxford University.
The company is developing a revolutionary medical device to cure brain aneurysms; a life-threatening disease affecting 1 in 50 persons in a strongly growing market valued over $1 billion. In 2017 it won ‘Best Med-Tech Start-Up’ at the Oxford Bio Network awards, 1st place at the BioTrinity ‘Perfect Pitch’ competition, and an award at the ‘European Health Catapult’ finals.
I have nearly 30 years growing international businesses in large corporations & start-ups.
Experienced in strategic planning, execution, team building, gaining regulatory approvals & fundraising including winning a prestigious Horizon 2020 SME instrument grant amongst several others.
I mentor budding entrepreneurs, am a panelist at industry conferences and sit on the ‘Medfit’ steering committee in Paris, France.
Driven executive with 29+ years experience in VC / private equity medical device start-ups and growth companies. Extensive domestic and international corporate leadership, including marketing, business development, sales, reimbursement, regulatory and operations experience in multiple medical specialties. Successful ventures encompassing significant corporate growth, multiple profitable exit strategies and a successful IPO, and key, central participation in fund-raising efforts.
Led several organizations including founding multiple entities and offices. Nine years living in Europe growing business internationally, 19 years based in the US/San Francisco Bay Area leading corporate functions and global/domestic activities.
Significant business development experience with more than 20 deals achieved including multi-million dollar JDA’s, partnerships, CRADA’s, licensing deals, and grants. Multiple significant corporate, direct-to-surgeon and direct-to-patient marketing initiatives, 19 product introductions, and development of new medical markets and applications.
Experienced new business developer, product manager, engineer, inventor, and innovator with a passion for developing and commercializing new and innovative products that create value, solve real problems, and improve lives. Expertise in turning ideas into viable business solutions through understanding needs, creating concepts, inventing or identifying solutions, making and testing prototypes, engaging with potential customers, forming business models and supply chains, evaluating M&A targets, and leading a cross-functional team to convert on new opportunities.
Passionate, collaborative senior Leader with Marketing, Product Development and Regulatory Affairs experience across multiple divisions and product lines in market-leading global medical technology companies. Proven track record advancing medical device introduction throughout the entire innovation lifecycle from customer insight synthesis and ideation to commercial launch and customer training.
Virginia is an accomplished innovation executive with experience spanning Fortune 500 companies to start-ups. She is focused on accelerating disruptive, early stage innovation in healthcare. She works collaboratively, fostering partnerships to access external innovation, as well as to drive internal innovation by setting and aligning strategy, inspiring team and addressing internal barriers to innovation. She believes in the importance of customer- and patient-centric innovation, and to that end, looks for opportunities to be immersed with clinicians in hospital and other healthcare settings.
She has achieved outstanding results, across a spectrum of R&D leadership roles, resulting in launch of clinically impactful medical device products in the orthopaedic, cardiology, ENT and neurology spaces. She is an accomplished scientist, having authored numerous peer reviewed publications and been a frequent presenter at global healthcare conferences. She is a Fellow of the American Institute of Medical and Biological Engineering, the prestigious honorary society for Medtech Engineers.
Virginia also has significant management experience, having managed a variety of technical teams and projects with significant annual budgetary responsibility. She is sought after for her professional guidance and serves on several Advisory Boards.
Cynthia Yee is a Partner at Vensana Capital. Cynthia brings nearly two decades of investing, operating, and public equities experience to Vensana. Prior to joining Vensana, she served as a Principal at Windham Venture Partners, where she led the firm’s investments in multiple companies, including Cartiva Medical (acquired), ClarVista Medical (acquired), Personal Genome Diagnostics (acquired) and NeuSpera Medical. She was previously an investor at NEA working across its medtech and healthcare services practices, and she spent time in business development and strategic marketing at Epix Therapeutics and medtech incubator D3DC. Cynthia began her career in public equities, covering medical devices at Piper Jaffray and biotechnology at Pacific Growth Equities. Cynthia currently serves on the board of directors of Evident Vascular and SpyGlass Pharma. She graduated from the University of California, Berkeley with a BA in Integrative Biology and a BS in Business Administration at the Haas School of Business.
Elizabeth has 25+ years cross-functional experience in drug development (oncology), regulatory affairs and clinical trials for startups, biotech & academia. She has been an active angel investor for the past decade. She currently serves as a Scientific & Commercialization Advisor to the NIH’s National Cancer Institute’s (NCI) Technology Transfer Office, as a reviewer of NCI SBIR/STTR grants and formerly on the Investment Committee of the Health Innovation Consortium, providing investment recommendations to the VA Commonwealth Health System. Elizabeth also serves on the advisory board of healthcare startups including Playbl, Oxiwear & NuvOx Pharma and as a regulatory affairs consultant to numerous biotech & medical device companies. She received her BA from Johns Hopkins, her MS from Georgetown University, her PhD from Thomas Jefferson School of Medicine and completed her postdoctoral fellowship at Harvard Medical School & NIH.
John Hyung-Jun Kim completed his residency in Internal Medicine at Stanford University Medical Center. Dr. Kim completed his undergraduate studies in biochemistry from Harvard University, and is a graduate of Duke University’s School of Medicine and the Fuqua School of Business, where he concentrated on health sector management. Dr. Kim has worked as a medical consultant in biogenetics, and was previously with Bear Stearns & Company as an Equity Research Associate. Dr. Kim continues to practice part-time as a hospitalist, keeping Aphelion Capital current with medical trends.
Dr. Kim sits on the Board of Directors at Siesta Medical, Zeto, and Moving Analytics.
**By Invite Only
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Jo Carol Hiatt, MD joined the Medical Device Innovation Consortium (MDIC) as Vice President, Health Economics and Patient Value (HEPV) in October 2020. Her portfolio currently includes two workstreams: Patient Perspective/Risk Tolerance Research (PPR) and Real World Evidence (RWE). Current areas of focus include close collaboration with CMS and FDA to support implementation of the new Medicare Coverage for Innovative Technologies.
Prior to MDIC, Dr. Hiatt was a physician with the Southern California Permanente Medical Group for many years. She led the Kaiser Permanente (KP) National Product Council for nearly 16 years, overseeing more than 80 multi-disciplinary teams responsible for selection of equipment, devices, diagnostic tests, and products used to care for members across the entire program. She also chaired KP’s Inter-Regional New Technologies Committee which provides evidence reviews and technology assessments for new procedures, devices, diagnostic testing, and other non-pharmaceutical clinical interventions including mobile applications.
In 1999, Dr. Hiatt launched and chaired KP Southern California’s Medical Technology Deployment Strategy Team until she retired from the Southern California Medical Group (SCPMG) in 2020. This group is responsible for operational and deployment management of the technology assessment conclusions across KP Southern California. Additional responsibilities as regional assistant medical director in SCPMG included development of regional after hours teleradiology service, trauma surgery repatriation program, regional tele-stroke program with significant improvement in speed to appropriate treatment and reduced long term disabilities, and the development of telehealth capabilities which greatly expanded virtual care options from home to ICU.
Dr. Hiatt served as co-chair of KP’s California Benefits, Contracts, and Policy Committee, responsible for determining coverage of new therapies, possible expansion of coverage such as infertility, and potential associated benefits e.g. travel expenses, most requiring regulatory approval and communication to payors and members. She also represented KP Southern California on the Inter Regional Benefits Design Group for national decisions. In addition, she served two terms on the Medicare Evidence Development & Coverage Advisory Committee which conducts evidence reviews and public hearings for some Medicare National Coverage decisions. Low dose CT screening for lung cancer is one example.
Dr. Hiatt has had additional roles which leveraged her KP experience: she serves as a reviewer for NIH Centers for Accelerated Innovation and National Heart Lung Blood Institute Reach Evaluation and Commercialization Hubs (REACH), and chaired EXCITE International’s Payers’ Advisory Committee. She was a member of FDA’s Payor Communication Task Force and KP’s Venture Management Committee. Dr. Hiatt was also a member of the National Medical Device Evaluation System Planning Board.
Dr. Hiatt joined Kaiser Permanente as a general surgeon at Panorama City. She subsequently served as Chief of Surgery at that location and was elected to the SCPMG Board of Directors. Dr. Hiatt was appointed Regional Assistant Medical Director of Clinical Services, and has since assumed a number of regional and program-wide roles. In 2013 she was designated an American College of Surgeons Health Policy Scholar. Dr. Hiatt received her undergraduate degree from Stanford University and her medical degree from Duke University. She trained in general surgery at UCLA. In addition to her clinical degree, Dr. Hiatt received an MBA from UCLA’s Anderson School of Management. She presents frequently on technology assessment integration with value-based decision and implementation processes.
Strategic advisor offering reimbursement strategy, health policy, and health economics strategy development for medical device, digital health, and medical technology organizations.
Consultant who helps Medtech and SaMD companies find their market sweet spot and accelerate adoption with data-driven insights, strategies and implementation support.
30+ years of operating experience with disruptive life-science technologies.
Proven record of leading development and implementation of commercialization, go-to-market and turnaround strategies in successful large businesses and small companies.
Combines the sophistication of multi-nationals with pragmatism of startups.
Robust process demonstrated successfully in broad range of products including office-based procedures, robotic surgery, implantables, and SaMD. Experience with many specialities.
CAREER HIGHLIGHTS
Served as Vice President Marketing for Entellus Medical, a start-up that completed a highly successful IPO with a $400 million valuation and subsequent acquisition by Stryker for $660 million. During three year tenure, Entellus enjoyed an average annual revenue growth of 100%. Led all aspects of downstream and upstream marketing and professional education.
Built Marketing function from inception as Vice President Marketing at Medrobotics, a privately funded start-up that raised over $200 million, launched a first-in-class flexible surgical robotic system, and sold 40+ systems worldwide. Company received $500 million acquisition offer (declined by Board).
Led Marketing team for VC funded medical device start-up, Aerin Medical, to drive adoption of minimally invasive procedures for the treatment of chronic nasal conditions in the office or operating room. Revenue grew over 5X in Company’s second year of commercialization.
Led Medtronic’s global deep brain stimulation marketing as a Director. Business grew from $60 million to $250 million over seven year tenure. Built a high-powered marketing team that was consistently recognized for excellence with awards and promotions.
Background also includes marketing and field clinical experience in cardiac rhythm management, and eight years with Merck in a variety of commercial pharmaceutical roles.
Exceptional marketing skills and the ability to collaboratively lead development and execution of business strategies and activities. Education includes an MBA from the University of Chicago and a BS and MS in Chemical Engineering from the University of Notre Dame and Northwestern University respectively.
Getting a medical device or diagnostic product on the market is not the end of the road. To ensure the largest possible impact, these products should get into as many good hands as possible. This webinar will discuss how to identify appropriate distributors for your medical device or diagnostic product, strategies for maximizing distribution and long-term partnership opportunities, and what terms should be discussed during distribution negotiations. We will hear from panelists with a variety of backgrounds– from startups to large corporations– on how they consider aspects like geographic reach, supply chain, hospital Value Analysis Committees (VACs), direct-to-consumer (DTC) approaches, product platform potential, and more when making important distribution decisions.
Based in Irvine, California, Biren Mehta is the Vice President, Venture Investments – MedTech, where he initiates and manages equity investments to drive business innovation and deliver new and sustainable business for the MedTech sector. He is responsible for existing and new MedTech investments on the West Coast, ensuring targeted strategic options are shaped for success. Biren plays a critical role in building and maintaining networks in the venture capital community, entrepreneurs, startups, incubators and accelerators and other venture organizations that fit the strategic interests of the MedTech sector, sourcing new opportunities for the sector and positioning JJDC as the partner of choice.
Most recently, Biren was Vice President of Business Development for the Cardiovascular & Specialty Solutions (CSS) Group and J&J Vision. This represents a portfolio of six diverse, high-growth businesses within MedTech. In this role, he provided strategic leadership in executing acquisitions, investments, distribution transactions, and other collaborations to support the growth and innovation agenda of these businesses.
Prior to joining Johnson & Johnson, Biren was a medical device analyst at Roth Capital Partners. In that role, he wrote and published recommendations on publicly traded small and midcap medical device companies. Before joining the investment bank, he worked as a project manager and software engineer at Intralase Corporation, now owned by J&J Surgical Vision.
Biren completed his bachelor’s degree in Cybernetics at UCLA. He earned master’s degrees in Biomedical Engineering and Computer Science from the University of Southern California. He also earned his MBA from the UCLA Anderson School of Management.
Mischa Jurkiewicz graduated with dual degrees in Biomedical Engineering (Hons) and Neuroscience from the University of Sydney, Australia. He began his career in the Medical Device industry at Nanosonics™, the inventors of the trophon®. Mischa led the expansion of the Global Services Operations business into North America, the UK and Germany transforming the aftermarket service business into a profit center of $15M recurring revenue. Mischa later received an MBA from Harvard Business School and was awarded the Robert F. Kaplan Fellowship for outstanding credentials in the life sciences. He joined Desktop Metal™ in 2021 following the acquisition of Beacon Bio, a startup founded at Harvard University with the goal of commercializing research into 3D bioprinting. Mischa is now leading the Desktop Health™ dental product group as Director of Product, Medical Solutions, with the goal of advancing the dental industry through the digital transformation of the healthcare ecosystem.
Dr. Shelton is a passionate and motivated business-focused engineer with a profound personal connection to the problem PhotoniCare is solving. He received a B.S. in Electrical Engineering from Oklahoma State University and a Ph.D. in Bioengineering from Texas A&M University, followed by three years of post-doctoral research at the University of Illinois. He has been building optical imaging systems for 20 years and managing engineering teams for 15 years. He leads PhotoniCare as its CEO and drives the company’s long-term vision and strategic plan. He has experience raising private financings, as well as negotiating and executing various research contracts, license agreements, distribution agreements, and other business development activities. He is passionate about his family, mountain biking, and music.
The primary exit strategy for many medical device and diagnostic startups is merger and acquisition (M&A) by a larger company. Following discussions from our distribution panel, often innovative medical products can have a broader reach and impact once in the hands of a larger organization. Our panelists will discuss their stories from startup to M&A, covering discussion topics such as what to look for in a potential M&A partner, appropriate timing and strategies for interacting with potential M&A partners, how to prepare for M&A, at what company stages can M&A happen effectively, how to negotiate the best offer, and how to transition your team into a large organization. The panelists will discuss potential pitfalls of M&A and alternative long-term corporate strategies so that startups can begin to plan their best path for patient impact.
Austin Dirks is an experienced entrepreneur and executive within the healthcare technology and medical device industry, serving as CEO and Founder of GreenLight Medical from 2014 until 2022, growing the company from idea to eventual acquisition by symplr in March of 2022. GreenLight Medical is a cloud software used by hospital supply chain, physicians, medical device representatives and companies alike to assist hospitals with the introduction, evaluation, and decision-making regarding new medical technology. Following acquisition of GreenLight, Austin served as Managing Director, Senior Vice President within symplr helping to integrate GreenLight into the existing symplr technology stack while leading the strategy and product portfolio efforts across the supply chain, access management, and contract management product lines. Austin currently serves as an advisor and Board member for several healthcare technology companies and venture capital firms.
Before founding GreenLight Medical, Austin worked as a cardiac medical device representative for St. Jude Medical, and within the Business Development team at Thoratec Corporation, focusing on merger and acquisition opportunities.
Austin holds an MBA with honors from Harvard Business School and a Bachelor of Biomedical Engineering from Vanderbilt University. Austin, alongside GreenLight Medical, received numerous awards in Nashville during his tenure as CEO including Entrepreneur of the Year, 40 under 40, CEO of the Year, Emerging Leader of the Year, Best in Business, Small Business of the Year, Tech Startup of the Year, and Nashville Entrepreneur Center Startup of the Year.
As a supporter of technology and entrepreneurship in the Nashville community, Austin is a frequent guest lecturer and volunteer at his alma mater, Vanderbilt University, and within the Nashville Entrepreneur Center. At Vanderbilt, Austin competed on the Track and Field team as a pole vaulter and was a member of the Sigma Chi Fraternity. Austin is a native of Lincoln, NE and patiently awaits the next Nebraska college football National Championship.
Amar currently serves Sr Dir for Strategy and Business Development for Zimmer Biomet’s market share leading Hip and Knee Reconstruction Business Unit, Infection Solutions portfolio and Tech & Data Solutions Business Unit where he leads strategy, partnership and M&A activity for the company’s primary businesses. With prior Marketing leadership experience for surgical device, interventional and diagnostic solutions at Zimmer Biomet, Covidien, Medtronic and Cardinal Health as well as several startup med tech companies, Amar also brings extensive experience in New Technology Evaluation and Acquisition, New Product Development, Go to Market Launches and Commercial Execution across numerous procedure spaces and disease states through the lens both of large scale and start up organizations.
Highly collaborative, influential, and accomplished Healthcare Senior Executive with demonstrated ability to drive company growth tightly aligned with corporate strategy. Leadership experience spans all functional areas including M&A, venture investing, business development, corporate strategy, and operations. Smith & Nephew, Olympus and Zimmer Biomet are among the companies where Christos held leadership roles. Harvard MBA, Columbia University MS Mechanical Engineering.
Over the past 10 years, Ken Nelson has led commercial efforts for disruptive technologies in the digital health, wearables, and cardiac remote patient monitoring industries, playing a significant role in building the teams and cultures for 3 of the top 4 market share players, including #1 (BioTelemetry), #2 (iRhythm), and #4 (Bardy Diagnostics).
Overall, he is a 20 year digital health, medical device, and remote monitoring innovator with successful senior leadership experience ranging from a Fortune 500 company (Boston Scientific) to a medium sized #1 market share (Biotelemetry, acquisition by Philips for $2.8 Billion in December ’20) to 3 start-ups, 1 of which eventually led to an extremely successful IPO (iRhythm) and another which was acquired by HillRom (Bardy Diagnostics) in August ’21 for what will end up being $400M+ after milestone payments.
Changing the standard of care in medicine through innovative technologies often requires reshaping the narrative on how these technologies will impact patients, physicians, hospitals, and the healthcare system at-large. The story that you tell through your brand messaging can have a profound impact on how well your product is perceived and adopted. Our expert panelists in marketing and branding will discuss their experiences optimizing medtech/biotools messaging, drawing upon case studies of successful (and unsuccessful) medtech and biotools startups in crafting a branding message. Branding should reflect the heart and mission of the company, and our panelists will discuss strategies for effectively conveying your product and impact beyond just your logo and tagline. Viewers will learn how to turn complex scientific advancements into relatable content that resonates with broad audiences to transform the status quo.
Branden Morris, Senior Director of Marketing, has been telling stories of medical innovation and patient impact for nearly 20 years. He has built brands, launched products, and developed marketing teams at biotech companies large and small, across several therapeutic areas. Branden is passionate about continuing to grow the MedTech Innovator programs as the premiere life science accelerators in the world, so that our member companies can get novel therapies in the hands of clinicians and patients as efficiently and effectively as possible.
U.S. adults alone consume 14+ hours of media per day. Why should they listen to you? My passion is to help healthcare companies use storytelling to exit the all too common “sea of sameness” and make a meaningful mark in an industry that impacts us all.
I love the healthcare industry. It’s a fast moving, exciting and crowded space where traditional tech and medtech have become one, data is the new oil, and consumers increasingly hold the reins. It’s also incredibly complex, with stakeholders that span not only providers and patients but also regulatory, payer and policy audiences. I have years of experience building and sustaining winning brands – for both startups and established companies – with a deep understanding of the industry and how to navigate it.
My company Pazanga Heath Communications is the Navy Seal team of healthcare communications. We are senior led and senior driven. Our staff is steeped in healthcare with experience at the highest agency and in-house and levels, and also includes seasoned healthcare and medtech journalists. Who you see is who you get.
Our services cover a range of communications functions, from brand positioning, messaging and design to campaign execution across traditional and social media, digital marketing, events, KOL programs, patient advocacy and more.
I proudly lead the team as a trusted C suite advisor – offering our clients strategic thinking and communication programming designed to drive market adoption, sales growth and, when appropriate, successful exit strategies.
On a personal note, I am also a member of the board of the Orange County Chapter of the American Cancer Society. I am honored to be co-chairing the upcoming 2024 ASC Orange County gala. My goal is to raise an obscene amount of money for this organization, which has helped an untold number of people including my own family.
Nick Tippmann is a founder/operator turned angel/VC. He is currently the founder & GP of TipTop VC, an early stage firm backing the next generation of vertical SaaS+AI winners. Nick was previously CMO at vSaaS for Medtech, Greenlight Guru, and a judge and mentor for Medtech Innovator for over five years. He is currently based in Austin, TX with his wife and frenchie.
Shyam Natarajan is focused on improving clinical outcomes and patient care in urology and beyond. He leads a clinical-stage AI healthcare startup that is creating a more personalized future of prostate cancer care. Previously he led an NIH-funded lab focusing on image-guided cancer interventions at UCLA with a background in software engineering.
Team dynamic can make or break a startup, regardless of the technology and traction. Additionally, those in startups spend more time with their coworkers than they spend with their families. Thus, building and maintaining a healthy startup team culture is paramount to the success of every other milestone you seek to accomplish. Our panelists with experience working with biotools and medtech startups will share their perspectives on how to ensure that you are building a robust, capable, and diverse team. Topics will include recruitment strategies, best practices for interviewing candidates, onboarding, teambuilding, developing skills, celebrating accomplishments, and more. Panelists will also discuss strategies for how to approach complex and contentious situations with employees, de-escalating conflict, and how to appropriately respond when the only remaining viable solution is to let go of a team member. At the end of the session, viewers will hopefully feel empowered to take an active role in crafting and supporting a strong biotools or medtech team.
John Compton is a former Division-I athlete, member of the military, and entrepreneur with a passion for building high performing teams. After graduating from the US Military Academy in 1994, John worked in the Academy’s Center for Enhanced Performance, applying peak performance principles and subsequently serving in the U.S. and abroad as a Ranger qualified, Army Military Police Officer. Following time in the military and five years in corporate business development, John founded Agile Search as part of Babson’s Executive MBA program, and for the past 19 years is grateful for the opportunity to help hundreds of companies grow and careers flourish.
Recognized effective leader, focused on achieving exceptional results in the public health sector. Experienced in managing executives, senior scientific staff and resolving complex scientific and regulatory issues. Extensive professional and volunteer experience focused on women’s health issues including rape crisis, risk reduction and contraceptive counselor. Accomplished facilitator with strong oral and written communication skills as demonstrated through national conference presentations and policy publications. Comprehensive knowledge developing regulatory science programs, business processes and project design criteria. Innovative strategic program management and planning experience in capacity and relationship building with diverse stakeholders. Over twenty years of healthcare experience, with high evaluations and performance awards.
A change catalyst and innovative problem solver, Karen Walker Johnson has a 35-year track record of driving organizational transformation in the healthcare industry. Having worked with Fortune 50 companies, her experience encompasses P&L management, market share growth, product development, hospital administration, health plan operations, and sales serving Medicare, Medicaid, Long Term Care, and Commercial populations.
As an established strategic leader, she pursues her passion for leadership development and positively impacting and improving the health status of vulnerable populations. She has consistently demonstrated the ability to drive innovation, market share growth (double-digit year over year), and superior quality outcomes as evidenced by achieving the coveted Medicare 5-star rating. While working as an executive at a private equity-backed company, she was responsible for developing innovative clinical care models and end-of-life programs.
Currently serving on public and private boards, she aspires to find additional board governance opportunities that leverage her expertise in growth, innovative transformation, health equity, and diversity and inclusion.
Reza Khorasaninejad (PhD) is the CEO and Founder of LEADOPTIK, a deep-tech startup based in San Jose, CA, pioneering next-generation imaging technology for accessing and diagnosing early-stage lung cancer. Prior to that, he was CTO and Co-founder at BRELYON Inc. and a former Research Scientist at Harvard, where he invented the first efficient meta-lens across the visible range, which was featured on the cover of Science Magazine and selected as a “Top Ten Breakthrough of the Year” by Science Magazine. Reza has over 110 scientific publications in flagship journals such as Science, Nature Photonics, and Nature Nanotechnology, and holds more than 30 patents.
Boards are vital for life science startups as they provide strategic guidance, industry expertise, and access to networks, while ensuring governance and risk management. A strong board enhances credibility and supports fundraising, helping startups navigate complex business and operational challenges. This webinar will focus on the key elements of building, structuring, and managing a board for medtech and life science tools startups. The discussion topics include; board structure and composition, compensation, roles and responsibilities, and management and communications. The panel will address common challenges such as navigating investor expectations, balancing insider versus outsider influence, and ensuring the board’s active contribution to company success.
Brandon Bendes is co-founder and President of Woven Orthopedics and has dedicated his career to building businesses and guiding them through their evolving lifecycle stages. A former management consultant and venture investor, Mr. Bendes designs and implements strategies that drive growth as well as identifies, structures, and executes transactions to generate returns for shareholders.
Prior to co-founding Woven, Mr. Bendes was part of a family office that specializes in acquiring and managing businesses within the neuromusculoskeletal industry as well as a member of a large, public management consulting firm that advised healthcare companies and institutions on growth activities to prepare for subsequent exit. Throughout his career, Mr. Bendes has helped sell businesses to corporations such as Stryker, Zimmer, Stanley, Olympus, and Time Warner as well as middle-market firms seeking to acquire small tuck-ins. Mr. Bendes is also a former ice hockey referee for NCAA, the National Women’s Hockey League, and USA Hockey.
Mr. Bendes received his degree from the Kelley School of Business at Indiana University.
Dan brings over 40 years of leadership experience in Life and Health Sciences. He is currently President and Chief Executive Officer of seqWell, Inc, an NGS library kit company in the Boston area, where he joined in April 2021. Prior to seqWell Dan served as President and CEO of Gyros Protein Technologies AB from 2013 through its acquisition by Mesa Labs in 2019. Earlier CEO roles, all of which lead to successful exits, include Oncimmune (USA) LLC, a leading early cancer detection company along with Cellomics, Inc. and Assay Designs, Inc., having led both companies through acquisition by Fisher Scientific and Enzo Biochem, respectively.
Dan had a 17-year career at Perkin Elmer (now Revvity) and the Dupont Company in various commercial, operational, and business roles. He has degrees from Princeton University (A.B. in Biochemistry), The Johns Hopkins University School of Hygiene and Public Health (M.H.S in Environmental Engineering) and Bellarmine University (M.B.A).
With over 25 years of experience in investing and leading in the healthcare sector, Renee Ryan is a passionate supporter of innovation and entrepreneurship that advances human health and well-being. Most recently, she was the CEO of Cala Health, a bioelectronic medicine company that develops wearable therapies for chronic diseases. She was responsible for setting the vision, strategy, and execution of the company’s mission to transform the standard of care for patients worldwide. Frequently, she stepped in to run key operational departments such as Manufacturing, Sales & Marketing and Customer Success.
She has a strong track record of finding and fueling innovation, both as an investor and as an executive. She has led or participated in many M&A transactions, venture capital investments, and strategic partnerships, creating value for the companies and the patients they serve. She has also built and managed high-performing teams, fostered a culture of collaboration and excellence, and established a reputation for integrity and leadership in the industry. She holds an MBA from Columbia Business School and a bachelor’s degree in economics from Georgetown University.
Innovative and strategic results-oriented leader with a demonstrated history developing emergent technologies and commercializing disruptive revolutionary life science and medical device products. 20+ years of executive and leadership experience developing solutions that allow customers to meet their research and commercial objectives. Dynamic team builder and leader for teams spanning multiple functions and locations including R&D, Innovation, Business Development, Corporate Strategy, Product Development, Intellectual Property Development, Program Management, Angel Investing, Fundraising, Startups, Expert Witness and Advocacy.
The journey of a medical device from conception to market often takes many years of iteration in design, component identification, material sourcing, and potential transfer to contract manufacturing organizations (CMOs). In this panel, we will discuss the medical device manufacturing process end-to-end, from ensuring your designs can be easily scaled up for final production to implementing a robust supply chain. Our panelists, with expertise in a variety of manufacturing methods, will provide tips for early-stage prototyping and performing verification testing to confirm your device is appropriately manufactured to specifications. The importance of your quality management system (QMS) in these stages will also be discussed, including ensuring traceability in your design history file (DHF) and managing appropriate risks in the manufacturing process. Additional manufacturing considerations for medical devices, such as clean room environments, sterilization processes, labeling, packaging, and shipping will also be discussed. We hope to provide a “supply” of manufacturing knowledge that will “mold” your organization in creating an efficient and cost-effective manufacturing workflow for your medtech innovation.
Rev.1 Engineering is an ISO 13485:2016 Certified medical device design and development firm that has been serving medtech businesses since 2007. We support our customers’ innovative devices with an integrated engineering team, in-house prototyping, and early stage manufacturing capabilities. Our team at Rev.1 Engineering understands how important it is to have a medical device development company you can trust. From concept to manufacturing, we guide you through every step of the process, providing unparalleled support and expertise along the way. Strategic Manufacturing is at the core of our approach. We define it as manufacturing that directly contributes to your company’s continuous, competitive advantage. For startups, this advantage impacts the acceleration of your company’s valuation. Our team leverages strategic manufacturing principles to provide a strong foundation for long-term success.
As a mechanical engineer, Adam Alexander’s passion is to solve problems and achieve results that positively impact the way people interact with the world. He believes this is accomplished with effective leadership and creative innovation. His experience working within a team and as an individual contributor in a fast paced, changing environment, has developed his ability to influence across boundaries, drive collaboration, and motivate productivity. He is a self starter and continuously seeks new challenges. He is eager to learn hands on and explore new products, applications, and processes designed to exceed customer expectations.
Adam obtained his Masters in Materials Science & Engineering at the University of Connecticut in 2011, starting his AM journey by advising the university 3D printing club. At MIT, Adam developed early stage medical devices for sustained drug delivery. His prototypes have landed in the hands of Bill Gates and have been exhibited in the Smithsonian design museum. At Mayo Clinic, Adam designed patient-specific anatomic models and surgical guides and lead design automation initiatives. At Ricoh, Adam co-develops additively manufactured medical devices. He is a proponent of extending the reach of patient-specific medical devices, and enabling mass customization through workflow development and automation. He is also passionate about educating the next generation of engineers in the field which brings him here today.
Soniya Patel holds both a Master of Science in Product Design and Manufacture and a Bachelor of Science in Mechanical Engineering from Boston University. Her professional journey spans impactful roles, including Product Marketing Manager at Desktop Metal and Additive Applications Engineer at Stryker, where she led multiple R&D projects involving additive processes across metals and polymers. As a co-founder of a direct-to-consumer assistive aid company, Soniya combined her passion for technology and healthcare to create innovative solutions that improve everyday lives. Currently, she is involved in a stealth startup focused on leveraging technology to address critical needs in Women’s health. Soniya’s career reflects her dedication to engineering and technology, showcasing her ability to bridge technical expertise and market strategies, particularly in the realm of medical devices and patient-focused innovations.
MedTech innovations take many different pathways to reach the market and impact patients. During this panel, we will hear from panelists with a diverse array of experiences helping these innovations get to market from both sides of the table– from the FDA perspective and from the startup perspective. We will discuss what factors determine the regulatory route for a medical device, including special attention to the Premarket Approval (PMA) vs. 510(k) vs. De Novo pathways, the Breakthrough Devices Program, and drug/device combinations. As startups often need to be lean, the right time to hire in-house regulatory experts will be covered. Additionally, we will discuss the preparation of testing plans, including designing a biological evaluation plan and an effective clinical trial strategy. As part of this discussion, we will hear about the Investigational Device Exemption (IDE) process and when this submission may or may not be needed. The importance of clarifying your regulatory route and testing plan via Q-Sub meetings with the FDA will be discussed. Finally, our panel will discuss how to bridge from approval in the US to additional global markets, recent trends emerging in the regulatory environment, and what resources the FDA has in place to support startups. Don’t miss the opportunity to learn from industry professionals on this important topic so you can become more clear on clearance requirements for your innovation.
Doug Kelly, MD became Deputy Director and Chief Scientist at the FDA’s device, diagnostics and digital health branch in 2020 after a 30-year seed and early-stage life sciences venture capital career starting, financing, growing and exiting companies spanning biotech, medical devices, robotics, laboratory tools, healthcare IT, ADME/Tox simulation and clinical trial software. At CDRH, Doug is the interface between the FDA and patient and physician groups, payors, industry, academia, innovators, investors, and other agencies and governments. His focus is on creating a more vibrant and sustainable MedTech ecosystem, to bring new innovations to patients faster to relieve suffering, especially in unserved and underserved populations. Doug received his BA in Biochemistry and Cell Biology with honors from University of California, San Diego, his MD from the Albert Einstein College of Medicine, and his MBA at the Stanford University Graduate School of Business. In addition to lecturing at the GSB and Stanford Medical School, he conceived of and taught the class “Financing The Start-up”, for over a decade the Stanford’s Department of Continuing Education biggest and most popular class.
Christy Foreman is a biomedical engineer that has worked in the medical device space for the last 30+ years. She recently joined Drive DeVilbiss Healthcare as the SVP, QARA in 2024. She is also an affiliate Senior Consultant at Biologics Consulting where she supports a wide range of clients from start-ups to established global medical device companies with premarket strategies and quality compliance. She joined Biologics Consulting in 2018 after spending 28 years working for the federal government with 22 of those years spent at the FDA. While at FDA she served in many capacities in both premarket and postmarket roles, including as a reviewer, Deputy Office Director and Director of the Office of Device Evaluation, as well as a Branch Chief and Deputy Division Director in the Office of Compliance, CDRH. She also spent time as the Associate Director for Regulatory Programs in the Office of Compliance and Enforcement in the Center for Tobacco Products.
Miriam Provost has over 24 years of experience in Medical Device Regulatory Affairs, including 13 years at the Food and Drug Administration. Prior to joining TransMedics, Dr. Provost was an internationally recognized expert in Regulatory Affairs and provided strategic guidance and tactical support for large and small medical device companies as medical device regulatory consultant. Her expertise stems from 13 years as a reviewer and manager at the Food and Drug Administration where she served in a variety of roles across the Agency, gaining broad knowledge and familiarity with all matters related to FDA policies, procedures and decision-making. Dr. Provost earned a Bachelor’s degree in Chemical Engineering from the University of Dayton and M.S. and Ph.D. degrees in Chemical Engineering from the University of Pennsylvania.
Monica Ferrante is a Regulatory and Quality executive who has worked for and consulted with medical device companies to include start-ups and large multi-national corporations. The first 10 years of her career involved commercial mechanical engineering design and software development. Upon earning a Masters, she became a scientific reviewer of device submissions with the FDA. For more than 30 years she has worked in various positions in the areas of worldwide regulatory affairs, quality systems, and clinical studies over a broad range of medical devices and market authorization processes. Her current position is VP of Regulatory, Quality and Clinical for Vitara Biomedical, a start-up company developing new technology for the care of premature babies. She has significant experience in working with the FDA, Health Ministries, Notified Bodies and Technical Standards organizations. Her education includes a BS in Biomedical Engineering from Catholic University, MS in Physiology from Georgetown, and MPA and DPA in Public Policy from USC.
When is a medical innovation ready for testing in a human clinical study, and how should you approach this important milestone? Our last MTI LIVE of 2024 will guide attendees through the critical steps of planning and executing a successful clinical trial. Whether your company is navigating a PMA pathway or simply looking to gather clinical data for marketing and adoption purposes, we will address key considerations for timing, strategy, and execution. During this session, we will explore scenarios where clinical data may be required or be beneficial, even if not mandated, to bolster your device’s market positioning. We will also discuss what level of pre-clinical data is necessary before proceeding to the clinical trial phase, especially for different device risk profile devices. The pros and cons of partnering with a Contract Research Organizations (CROs) for your clinical trial will be discussed, as well as tips for deciding between single-site and multi-site trials. Additionally, panelists will discuss how to approach patient enrollment, trial duration, control groups, and outcome measures to maximize the impact and efficiency of your study. Finally, panelists will share their advice for startups, including creative ways of funding trials. Fill your Halloween season with clinical study “tricks for treat–ments”!
Bibaswan Ghoshal is a seasoned executive who guides early-stage healthcare companies in getting their products into the market. Bibaswan has ushered 120+ startups to obtain $30M+ in sales and $15M+ in investments. Bibaswan has a background in informatics and digital health and has been involved in developing and commercializing health technologies. He completed his graduate studies in neuroscience, bioinformatics and animal sciences at the University of Alberta. He has worked in the hospital sector on developing informatics tools and later on in technology transfer, intellectual property protection, and commercialization of early-stage technologies. Bibaswan also runs a not-for-profit organization in the arts and culture industry.
He leverages expertise in business strategy, regulatory affairs, technology adoption, and intellectual property to:
1. Develop & execute winning business plans through mentorship and strategic guidance.
2. Secure dilutive and non-dilutive funding with compelling pitch decks and proposals for investors & government grants.
3. Navigate market access in Canada and develop effective go-to-market strategies.
4. Draft & negotiate complex agreements including licenses, NDAs, and collaborations.
5. Creating a comprehensive intellectual property strategy through patents, copyrights and trademarks.
He is skilled in public procurement, stakeholder negotiation, market research, business model development, VC/Angel fundraising, project management, licensing and commercialization. This comprehensive skill set makes him a valuable asset to medical device and digital health start-ups seeking growth and success.
Dr. Jason McKeown is a UK trained Medical Doctor and started his career in the NHS. Through his work in the field of neuroscience and a combined intrigue and passion for technology, Jason believed that there was a better way to treat many of the diseases he had seen affecting the daily lives of his patients. After successfully completing multiple pivotal clinical trials, Jason then achieved FDA Clearance in October 2023 for Modius Sleep, a treatment for Chronic Insomnia. Just a few months later, in March 2024, Neurovalens also received FDA clearance for Modius Stress, a treatment for Generalised Anxiety Disorder.
Senior executive with 15+ years of diverse and extensive leadership experience across industry and academic medical centers. Valued as a strategic thinker with a proven ability to lead cross-functional teams, develop talent and influence and inspire team members at all levels of the organization. Expert in building team consensus for strategic direction, evaluating and executing challenging decisions in crisis situations, and developing new paradigms for clinical research. Strong healthcare services professional skilled in Pelvic Reconstructive Surgery, Healthcare Management, Healthcare, Clinical Research, and Medical Education.
Innovator, problem-solver, and all around implementation guru! Responsibilities include the development and implementation of the Life Sciences Research Enterprise at the Center for Discovery and Innovation as well as the development and implementation of a network wide innovation strategy. Our efforts include fostering new ideas and opportunities internally and leveraging external innovation to drive new care processes and improve outcomes.
Date | Topic |
---|---|
JUN 27 | Perfecting Your Pitch Video |
JUL 25 | Pushing Partnerships |
AUG 1 | Finding Funds: Raising from Venture Capital and Angel Investors |
AUG 8 | Negotiating Term Sheets & Deal Structuring; Key Considerations in Contracts and Negotiations; Cap Table **By Invite Only |
AUG 15 | Route to Revenue: Healthcare Economics, Payers, & Reimbursement in MedTech |
AUG 22 | Distribution Decisions: Getting Products in Good Hands |
AUG 29 | Q&A for M&A: Mergers and Acquisitions in MedTech |
SEPT 5 | Telling Your Story: Brand Management & Marketing |
SEPT 12 | HR: Hiring, Firing and Inspiring |
SEPT 18 | Building Better Boards: How to Prevent a Bored Room |
SEPT 26 | Manufacturing MedTech: Supply Chain to Final Product |
OCT 3 | Regulatory Routes: Bringing MedTech Innovations to Market |
OCT 10 | Dealing and Healing: How to Engage with Hospitals & Large Health Systems for Clinical Studies & Beyond |