INTENT VENTURE MANAGEMENT®
Trusted Healthcare Economics and Reimbursement Consultation for Investment, Commercialization, and & Regulatory Execution
Intent Venture Management® provides healthcare reimbursement and regulatory consulting built for investors, manufacturers, and healthcare innovators who need clear, actionable pathways to funding, market access, and payment. We combine regulatory and reimbursement consulting with hands-on commercialization support, so your product's regulatory strategy and reimbursement strategy are built together, not as separate afterthoughts.
Whether you are preparing a new medical device or drug for market, navigating FDA regulatory consulting requirements for submissions such as IND, NDA, BLA, PMA, De Novo, and HUD, planning your coding, coverage, and payment pathway including CPT and HCPCS codes, pursuing new technology add-on payments (NTAP) or payment status under IPPS, OPPS, and PFS, exploring drug and device pass-through payments or pathways tied to breakthrough device or orphan drug status, or designing your clinical studies, economic evidence, and outcomes measures, our team brings the healthcare economics and regulatory execution expertise to move your project forward. We work with investors, R&D teams, life science and medtech companies, payors, and healthcare organizations nationally, delivering solutions, advisory, and tangible, hands-on support at every stage.
About Intent
Lindsay E. Klee, Founder of Intent Venture Management® LLC, is a consultant advising investors, R&D, life science and med tech, and healthcare clients nationally. Her consulting practice focuses heavily on Intent®’s regulatory and reimbursement consulting, planning and execution work that connects regulatory compliance consulting with reimbursement strategy from day one.
Lindsay has consulted for VC investors, manufacturers, payors, and startups, and has worked as part of the Belle Michigan LP General Partnership. She has consulted with numerous hospitals and served as Executive Director, Managing Director, and healthcare commercialization director for a variety of research institutes, healthcare, and university enterprises. With 20 years of experience in healthcare management consulting and finance, she has worked extensively in innovation focused, technology intensive environments.
As a trusted life sciences investment advisor, Lindsay has helped clients secure new insurance coding, coverage, and payment pathways for services and technologies, offering hands-on insurance coverage consulting and coding-related support such as for obtaining CPT code consulting. She has created and directed multi million dollar, private technology gap funding initiatives, and secured competitive capital for and managed an FDA sponsored device and diagnostics consortium. She privately assists teams and companies working toward product milestones, revenue growth, reimbursement, coding, coverage, funding, and FDA regulatory consulting submissions and compliance.
Lindsay’s prior experience includes consulting for small, medium, and large enterprises, both independently and within the Healthcare and Life Science Divisions of PricewaterhouseCoopers, LLC, on financial, revenue cycle, insurance growth strategy, and M&A consulting healthcare initiatives. Her work has focused heavily on Intent®’s medical device regulatory consulting and reimbursement planning and execution, clinical trial planning and readiness, deal structuring, quality management system consulting preparations, and audit readiness consulting healthcare. Lindsay is an ISO 13485 lead auditor, certified under ISO 13485:2016 and 19011:2018 as an Exemplar Global Lead Auditor. Her background also spans feasibility studies, business and commercial planning, revenue growth planning, clinical evidence and trials, and technology transfer consulting, including her earlier work as a drug discovery scientist with Pfizer Global Research and Development.
Lindsay’s skill set spans multi functional team leadership, technology revenue growth strategy, payor and insurance advocacy, FDA compliance, deal strategy, healthcare operations, healthcare finance consulting, healthcare portfolio management consulting, early stage product development, and inter disciplinary communication involving investors, C suite and fiscal executives, entrepreneurs, scientists, academic administrators, payors, and physicians.
She has strong interests in fundraising and fund strategy, strategy and business planning, portfolio management, philanthropic giving, venture philanthropy, and biomedical and healthcare technology development. She is a public health champion, ethical business and mindfulness advocate, avid bicyclist, swimmer, XC skater, and alpine skier.
Services
Investment & Financial
Our healthcare investment consulting and life sciences investor advisory services cover investor diligence, deal structuring, financial planning, IP evaluation, M&A, and grant writing and fundraising, built for investors and manufacturers who need clear financial and commercialization pathways.
Commercialization
Intent’s life sciences commercialization consulting covers negotiations, business planning, market opportunity assessment, clinical and therapeutic relevance assessment, intellectual property evaluation, licensing and contract negotiation and diligence, and manufacturer selection, supporting medtech market access consulting from early development through launch.
Regulatory & Reimbursement
Intent’s regulatory and reimbursement consulting includes healthcare economics, reimbursement and revenue growth planning and execution, achieving coding, coverage, and payment, and building patient access. We provide medical device reimbursement consulting and drug reimbursement consulting, along with reimbursement strategy consulting for integrated efficiency planning across clinical trials, regulatory submissions, classification, and documentation. Lindsay is ISO13485:2016 and 19011:2018 Exemplar Global Lead Auditor Certified, offering QMS consulting healthcare preparations and product development planning.
Frequently Asked Questions
Reimbursement pathways typically require securing a billing code, demonstrating medical necessity to payors, and aligning your regulatory submission timeline with your reimbursement strategy, often before FDA clearance, not after. Intent Venture Management builds this pathway alongside your product development plan.
Drug reimbursement depends on coding, payor coverage policy, and pricing strategy working together. Intent helps clients plan coverage and payment pathways early so reimbursement isn’t an afterthought once the product reaches market.
Getting a code or CPT code involves identifying the right code category, submitting the appropriate application to the AMA or relevant coding body, and supporting it with clinical and economic evidence. Intent provides hands-on coding-related consulting through this process.
Insurance coverage requires payor engagement, clinical evidence, and a clear value proposition tied to patient outcomes. Intent works directly with manufacturers and investors to build coverage strategy alongside regulatory planning.
FDA approval and reimbursement planning work best when run in parallel, since regulatory classification and clinical evidence decisions directly affect coding and coverage outcomes as well as investment, licensing, adoption, and clinical trial strategy. Intent’s integrated approach plans both tracks together from the start.
Medical device companies get paid through an assigned billing code, a payor coverage determination, and a negotiated or established payment rate. Intent helps clients navigate all three steps as part of its reimbursement strategy consulting.
Integrated regulatory and reimbursement planning means building your FDA regulatory strategy and your healthcare economics, reimbursement, coding, and coverage strategy at the same time, rather than sequentially. This is the core of Intent’s Integrated Reimbursement & Regulatory Planning & Execution Services.