Formal Capabilities Statement

Dr. Gene Weinstein is a board-certified diagnostic neuroradiologist at Mass General Brigham, specializing in advanced brain, spine, and head and neck imaging. A respected clinician, educator, and consultant, Dr. Weinstein brings more than a decade of expertise for one of the nation's leading academic medical centers. His work spans tertiary referral centers, multidisciplinary neurologic programs, and 

cross-functional care teams supporting both acute and longitudinal patient management.

Beyond academia, Dr Weinstein is the founder of Weinstein Consulting, providing neuroradiology expertise and expert-witness consultation in personal injury and medical malpractice cases.

His background in teaching and- medicolegal communication allows him to bridge technical rigor with clarity and accessibility.

Dr Weinstein is deeply aligned with Synera's mission of pairing clinician expertise with operational commercialization support. 

 He brings a multidimensional perspective across deep clinician perspective, rigorous evidence-based practice and consulting engagements in clinical and academic domains that strengthen Synera's physician-led approach.

Jonathan Chasper is a transformative technology and product leader with over twenty years of architecting category defining platforms, scaling global engineering organizations, and accelerating enterprise growth access SaaS, AI, digital health, and deep tech. 

A founder, operator, and visionary strategist, Jonathan has guided companies from concept to commercialization, launched more than 20 enterprise platforms, and shaped product ecosystems that support millions of users.

As CEO of Product Savvy and a former CTO/CPTO, Jonathan has led high-performance engineering and product teams internationally. Hisl leadership consistently delivers measurable outcomes including more than $40M in capital rasies. Jonathan excels at aligning technology, business imperatives, and product execution to create scalable, durable market advantage.

Jonathan's approach blends hands-on engineering depth with strategic  foresight, commercial rigor, and a belief in purposeful innovation. He is known for building cultures defined by autonomy, transparency, and accountability-enabling organizations to move faster, think smarter, and execute with discipline. His role as mentor, advisor, and author reflects a long-standing commitment to developing leaders and elevating the next generation of founders to product executives.

Jonathan's strategic partnership with Synera Advisory strengthens the firm's ability to drive founder-led product strategy, enterprise platform design, commercial readiness, and technology enabled scale. His cross-sector perspective-spanning digital health, aerospace, and enterprise SaaS-supports Synera clients in navigating platform architecture, AI integration, product roadmap strategy, and technical due diligence with unmatched clarity.

Jonathan works with leadership teams who are building what is next, organizations seeking to accelerate innovation, crystallize product vision, and unlock scalable growth.

Paul Tilyaev is a seasoned accounting and finance leader with deep expertise in tax strategy, SEC reporting, internal controls, and financing modeling. 

As Managing Partner of Perpetual CPA, Paul brings nearly two decades of industry, advisory, and Big 4 experience to high growth organizations seeking clarity, efficiency, and long-term financial health.

As Managing Partner of Perpetual CPA, Paul brings nearly two decades of industry, advisory, and Big 4 experience to high growth organizations seeking clarity, efficiency, and long-term financial health. 

His background spans Fortune-level operational finance roles with Nike and Zebra technologies, senior advisory work with Deloitte, and extensive tax and regulatory expertise supporting small and midsize companies nationwide. Paul specializes in building defensible reporting systems, streamlining accounting operations, optimizing tax outcomes, and strengthening decision making through advanced analytics and data management.

Paul's advisory approach aligns with Synera's physician-led philosophy: trusted partnership, operational transparency, and actionable insight. He supports founders, clinicians, and innovators with fractional CFO leadership helping them improve cash flow, and legally reduce tax burden while preparing for scalable growth.

Craig Coombs is a seasoned regulatory strategist and commercialization advisor with more than three decades of leadership driving FDA-aligned product development and market entry for medical devices, digital health, and AI-enabled clinical technologies. As a senor strategic partner with Synera Advisory, Craig amplifies our capability to advance early-stage innovations with robust regulatory design, practical execution frameworks, and investor-ready submission strategies. 

As part of Synera's integrated commercialization platform, he identifies optimal FDA pathways and predicate strategy, Craig helps founders align product design and evidence plans to both clinical and commercial milestones. Craig integrates regulatory planning with real-world reimburrsement and clinical adoption frameworks ensuring that pathway decisions support scalable revenue potential. Craig's pragmatic regulatory intelligence strengthens diligence packages, supports board-level discussions, and enhances investor confidence by translating complex requirements into clear risk-adjusted decisions.

Craig combines rigorous regulatory judgement with real-world execution experience. His ability to clarity the FDA landscape and link it directly to clinical and commercial outcomes accelerate progress and mitigates risk for emerging Ahealth technologies. In partnership with Snyera Advisory's physician-led commercialization model, Craig reinforces our commitment to operational excellence, evidence-based strategy, and breakthrough innovation.

David Pudwill is a seasoned leader and regulatory expert who helps companies get medical devices and combination products to market.

David has served in senior leadership roles at AscentX Medical and ConvaTec, and previously worked at the U.S. Food and Drug Administration (FDA), and St. Jude Medical. He is a founding member of the Kidney Health Initiative, and has helped several startups acquire funding and successfully interact with FDA and the Department of Defense. While at FDA, David was a lead medical device reviewer and branch chief, worked on DARPA projects and consulted with CBER and CDER regarding regulatory submissions.

David holds a Master of Mechanical Engineering from Johns Hopkins University, a BSE in Biomedical Engineering from Case Western Reserve University, and a Certificate from HBX, now Harvard Business School Online.

Synera and Ova Solutions, led by Lisa Voronkova, form a full stack physician backed medical technology commercialization alliance designed to take medical devices from clinical insight and market validation through engineering execution, regulatory readiness, and US market entry.

This alliance eliminates the most common failure points for medtech startups including

-misaligned product market fit, under engineered regulatory strategy, disconnected research and development vs commercialization and premature scaling.

Lisa is a seasoned medical device operator with over a decade of experience leading hardware development teams and bringing regulated medical and wellness devices from concept through commercialization. She has overseen more than 200 projects spanning early stage innovation, FDA and CE readiness, and manufacturing scale.

Lisa brings the engineering rigor and hardware leadership that ensures Synera guided innovations are built not only to pass regulatory review but to succeed in the real clinical and commercial world.

Sevan Balian who is the Managing Partner of Balian Strategic Partners provides international institutional grade market entry intelligence and fiduciary-level readiness assessments for International medtech companies.

Through this partnership, Synera extends its physician led clinical, regulatory, and commercialization framework with board level market entry rigor, ensuring that US expansion decisions are grounded in clinical reality, regulatory certainty, and capital protection.

Sevan serves as a Strategic Partner to Synera, advising on US market entry strategy, board level decision frameworks, and international commercialization risk for medtech innovators.

Sevan's partnership strengthens this ecosystem by introducing a fiduciary grade decision lens, tailored specifically to European boards and founders navigating the structural, economic and cultural complexity of the US Healthcare system.

This alignment ensures that strategic amhbition is matched with execution reality.

Ashley Elsner serves as a strategic legal and operational partner to early and growth stage companies navigating fundraising, scaling, regulatory complexity and founder risk. As a two-time fintech founder and seasoned startup attorney, Ashley brings a rare-operator level perspective to legal strategy bridging law, business execution, and venture dynamics.

Through a strategic partnership with Synera Advisory, Ashley supports founders and leadership teams in building investor-ready, defensible, and scalable corporate foundations that align legal infrastructure with commercialization and growth strategy.

David Pennington is a seasoned MedTech and biologics executive with more than 20 years of experience leading commercialization, sales strategy, and global business growth across medical devices, human tissue / biologics, and healthcare SaaS. He brings a rare combination of clinical training, executive leadership, and P&L ownership, enabling companies, to successfully bridge the gap between clinical innovation and scalable commercial execution.

David has built and led high-performing sales and commercial organizations across opthamalogy, orthopedics, sports medicine,  uro-gynecology, cardiology, and regenerative medicine, consistently delivering measurable outcomes. His track record includes 150% year over year revenue growth, multimillion dollar strategic partnerships, full P&L responsibility, and five successful exits spanning venture-backed startups and growth stage enterprises.

• Dr. Erica Kreismann brings more than two decades of frontline emergency medicine leadership, global clinical impact, and physician executive coaching expertise to Synera Advisory. As a Certified Emergency Medicine Specialist and Executive Medical Director, she has led complex medical teams through high-pressure environments, clinical transformation, and system-level change globally.

Today Dr. Kreismann serves as a Synera Medical Advisor with a focus on clinician-centered leadership, workforce sustainability, and healthcare human performance. Her work bridges medicine, behavioral science, and organizational leadership helping clinicians, hospitals, and health systems build cultures that elevate care delivery, reduce burnout, and strengthen professional fulfillment.

Dr. Kreismann is the Founder of OneWild Coaching, where she works with women in healthcare to rediscover purpose, authenticity, and joy in their careers. She is widely recognized for her ability to guide physicians and healthcare executives through burnout recovery, narrative reframing, and values-based leadership development.

At Synera Advisory, Dr. Kreismann helps shape clinician-centered strategy, advisory services, and program development across burnout navigation, leadership evolution, and care model redesign ensuring every solution we build advances the health of the workforce behind the science. At Synera, we believe healthcare transformaton begins with clinicians who feel supported, connected and valued. 

Lucas is the Founder and Managing Director of Gradical, a Switzerland based consultancy specializing in sustainable, regulatory compliant plastics for medical technology.  Through Gradient's  proprietary Gradematch Framework, Lucas supports Medtech companies in reducing CO2 emissions without compromising device performance, regulatory compliance, or cost efficiency.

Lucas is widely recognized as a thought leader in sustainable materials strategy for medical devices, frequently contributing through speaking engagements, podcasts, and industry forums.