Healthcare · Life Sciences · MedTech Advisory
Intent Venture Management
®
Trusted Regulatory, Quality, Healthcare Economics, Reimbursement Consulting
for Investment, Commercialization, Manufacturing and Regulatory Execution
Our Practice
Intent Venture Management® provides a breadth of commercialization support and deep healthcare economic/reimbursement, regulatory and quality consulting structured for investors, manufacturers, and healthcare innovators who need clear, actionable pathways to funding, market access, and payment. We combine regulatory, quality and reimbursement consulting with hands-on commercialization support, so your product’s regulatory strategy and reimbursement strategy are integrated, not tackled as separate afterthoughts.
As a trusted life sciences investment, growth an acquisition 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 insurance and other CPT code consulting. She has created and directed multi-million dollar, private technology gap funding initiatives and secured competitive capital for and was paid by FDA/Congressional Funding to manage a sponsored device and diagnostics consortium. She privately assists teams and companies working toward product milestones, revenue growth, licensing and acquisitions, reimbursement, coding, coverage, funding, with Centers for Medicare and Medicaid Services (CMS) and private payors, quality compliance, clinical studies/trials and FDA and Outside the U.S. (OUS) developments, EU MDR, MHRA, Health Canada and other regulatory consulting submissions and compliance.
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 entities, manufacturers, life science and med tech, and healthcare clients nationally. Her consulting practice focuses heavily on Intent®'s Integrated Regulatory and Economic/Reimbursement Consulting, quality, audits, 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 regulatory acceptance and new insurance coding, coverage, and payment pathways for services and technologies, offering hands-on insurance coverage consulting and coding-related support such as for CPT code consulting. She has created and directed multi-million dollar, private technology gap funding initiatives, and secured competitive capital for and was paid by FDA/Congressional Funding to manage a sponsored device and diagnostics consortium. She privately assists teams and companies working toward product milestones, revenue growth, reimbursement, coding, coverage, funding, quality compliance, clinical studies/trials and FDA and Outside the U.S. (OUS) 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 customized-delivery and execution alongside Intent®‘s Integrated Reimbursement & Regulatory Planning & Execution Services. She also has longstanding focus on 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 providing services related to 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.
“
Your product’s regulatory and reimbursement strategies should be
built and implemented together, not executed as disjointed or disconnected afterthoughts.
— Intent®’s Integrated Approach
Services
Whether you are preparing a new medical device, diagnostic, biologic or drug for market, navigating FDA regulatory consulting requirements for submissions such as IND, NDA, BLA, PMA, De Novo, and HUD, building a Quality Management System (QMS), diversifying a manufacturing base to biomanufacturing, preparing for an audit, 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 looking to expand market access through 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.
Practice Areas
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, Quality, Healthcare Economics & Reimbursement
Intent®’s regulatory, quality, healthcare economics, and reimbursement consulting includes healthcare economics, reimbursement and revenue growth planning and execution, achieving coding, coverage, and payment, supporting manufacturer compliance 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 ISO 13485:2016 and 19011:2018 Exemplar Global Lead Auditor Certified, offering QMS consulting and regulatory preparations adjacent to product development and market launch stage initiatives.
Frequently Asked Questions
Reimbursement pathways are best delineated starting with a broader healthcare economic evaluation and often require securing a billing code, demonstrating medical necessity to payors, and aligning your regulatory submission timeline with your reimbursement strategy, often before or adjacent to FDA clearance. For drugs, reimbursement also depends on coding, payor coverage policy, and pricing strategy working together. Intent® helps clients plan coverage and payment pathways early so reimbursement is not 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® utilizes specialized knowledge and works directly with manufacturers and investors to build coverage strategies.”
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.’
FDA approval and reimbursement planning work best when run in parallel or when integrated, 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. Value means different things at different times to regulatory bodies like FDA and CMS and outcomes measures considered may vary depending upon the agency, private insurer or national/local coverage determination.
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 or years apart. This is the core of Intent®’s Integrated Reimbursement & Regulatory Planning & Execution Services and helps elevate revenue potential at earlier stages post regulatory acceptance.
Building a compliant QMS cost-efficiently is possible but requires care and planning. A QMS needs to be custom, not AI-designed or templated – and should be human-populated also ensuring additional ISO compliance is met. Intent® supports companies to achieve these goals and ensure the system evolves to support ongoing regulatory monitoring and compliance.”
Contact us to learn more as often the testing requirements and mandates from FDA are quite different than those from insurance, and can also vary from what acquirers/licensees and investors want to see. Intent® has deep experience in defining outcomes measures and ensuring the definition of quality is meeting the standards of the appropriate regulatory and/or reimbursement body.”
Contact
Preparing a submission, planning a raise, or scoping a reimbursement pathway? Send a note we respond personally.