top of page

CONSULTING

In addition to developing solutions for internal programs, BioScience Innovations also provides consulting services to the medical device industry.  Our vast network of experts in R&D, intellectual property, M&A, operations, clinical, regulatory, marketing and strategy are ready to meet your needs.  Contact us for more details.

Business Meeting

EXPERTISE:

  • Technical Excellence – R&D experience and credibility; ability to translate technical to business and business to technical.  Apply ISO 13485, 14971 and FDA 21 CFR to new product development.

  • Strategic and Tactical – balance both perspectives with companies ranging from start-up to Fortune 100.

  • Product Lifecycle Management – product road mapping & strategic planning.

  • Subject Matter Expert – technical expertise in areas of ablation, heart failure management and neuromodulation.

 

CONSULTING SERVICES:

  • Special Technical Projects – independent perspective for design reviews, product feasibility, audits and market readiness.

  • Pre-Clinical Studies – ranging from benchtop feasibility to GLP studies.

  • Clinical Trials – study strategy, design, execution, analysis and submissions.

  • Technical / Scientific Diligence – advising venture capitalists and investors in the medical device space.  Additionally, support organizations preparing for investment & acquisition.

  • Innovation / Brainstorming – IP strategy, coordination of team brainstorming, documentation and legal liaison.

  • Contract Development/Manufacturing – act as liaison / project manager with vendors and internal design teams.

  • Litigation – advise legal council and act as expert witness in matters involving medical device R&D, clinical studies and intellectual property.

  • Project Management - advance key strategies forward through project leadership, oversight, and execution.

  • Voice of the Customer – gather customer inputs, prioritize and translate to product needs and design requirements.

  • Scientific Publications – analyze scientific data, create technical abstracts, manuscripts, white papers and marketing materials.

  • Interim / Fractional Support – full/part time short/long term R&D leadership.

bottom of page