Oak Biomedical is a boutique consulting firm specialized in heart valve technologies.

We partner with leaders globally at startups of all sizes and Fortune 500 companies developing TAVR, TMVR, TTVR, surgical valves, and structural heart products.

Accelerating Next Generation Heart Valves from Concept to Market

STRATEGY

Bringing a new heart valve to market is demanding and complex. With experience across 16 unique heart valve products at all stages of the product lifecycle, we are distinctly qualified to understand the delicate balance between technical rigor, manufacturability, regulatory, and clinical to take your product to market. Let’s talk strategy, and we’ll help you accelerate timelines, maximize ROI, and mitigate risk.

  • ISO 5840 Design V&V Strategy

  • Modular Design and Development Strategy

  • Operations Scaling and Commercialization

  • Gap Analyses and Remediation Planning

  • Due Diligence Technical Review

DESIGN AND DEVELOPMENT

From FIH (first-in-human) and EFS through IDE and CE Mark, we understand the complex process of bringing a new heart valve to market and the unique challenges at each milestone. We bring extensive hands-on product development experience, including analyzing clinical imaging, optimizing leaflet and suture patterns, setting up valve testing labs, market analysis, and requirements decomposition.

  • Medical Imaging Analysis (CT, TEE, and TTE)

  • Leaflet, Cloth, and Suture Pattern Optimization

  • Establish Coaptation and Tissue Specifications

  • ISO 5840 Valve Testing (Hydrodynamic, AWT, DFM, Migration, and Custom Test Methods)

  • ISO 22442 Tissue Processing and Viral Inactivation

  • ISO 11607 Packaging Validation

  • ISO 14160 Sterilization Validation

  • Market Analysis and Statistical Modelling

  • Independent Reviewer

PROCESS DEVELOPMENT

Whether you run a 2 valve/wk pilot line, a 1,500 valve/wk global operations, or anywhere in between, we’ve been there. We’ve led manufacturing teams, executed yield and capacity improvement projects, implemented best practices for bioburden control, and overseen lean transformations. If you’re looking to scale your operations, select new vendors, or plan process development projects, let us develop a tailored solution based on your business objectives, scale, and quality system.

  • Tissue Processing, Fixation, Valve Assembly, Packaging, and Sterilization

  • Contract Manufacturer and Vendor Selection

  • Yield, Lead Time, and Capacity Improvement

  • Bioburden Control

  • Root Cause Analysis for CAPA and NCMR

PROGRAM MANAGEMENT

Valve projects are never simple. There are always too many interrelated aspects to juggle: parallel workstreams, competing priorities, critical paths, contingency planning, vendor management, stakeholder management, scope creep, etc. We’re experienced at managing and organizing projects of increasing complexity. If a project has become unwieldy, let us help bring focus to the critical path, and let us handle the daily, behind-the-scenes coordination, so that your team can focus on executing efficiently.

  • Product Development and Design Verification Projects

  • Market Expansion and Regulatory Projects

  • Facility Transfer Projects

  • Remediation Projects

REGULATORY WRITING

Regulatory writing requires striking the right balance between being concise yet highlighting critical data and rationale. In addition to executing technical projects, we excel at quickly reviewing extensive documentation, and then delivering a focused summary that addresses the reviewer’s question directly without introducing distracting data or information. Bring us onboard to quickly reduce the burden on your regulatory team before and during a submission.

  • Submission Summaries

  • Regulatory Responses

Let’s work together!

We take pride in having contributed to 16 distinct valve products over the past decade by expertly balancing business acumen and technical rigor to solve complex business challenges.

We welcome the opportunity to learn about your organization and technology, and to partner with you in optimizing designs, accelerating timelines, maximizing ROI, and reducing risk.