Services
MedPanel Innovation Services are designed to meet the knowledge requirements for a medical device or diagnostic idea to be proven commercially viable and to maximize value for the innovator. MedPanel leverages its global network of healthcare experts and Innovation Preferred Providers to generate robust assessment of new ideas, as well as reduce costs and the time to accelerate the development of new ideas.
MedPanel wants to be the single point of contact as various services are needed along the path of innovation. The following provides a brief review of MedPanel services available for each step of the Innovation process.
Legal Services
- Intellectual Property (IP) landscape review (US only)
- IP landscape review (US & EU only)
- In depth IP review / Freedom to Operate (US & EU only)
- Freedom to operate clearance / risk assessment
- Patent preparation and filing
- Trademark, Copyright & advertising guidance
- Compliance Program / Code of Ethics guidance
- Licensing and distribution agreements
- Joint Venture / Strategic Alliance agreements
- Merger & Acquisition agreements
Market Services
- Preliminary Market Assessment
- Voice of Customer / Customer Needs
- Customer Attitude / Usage
- Product Feature/Benefit definition
- Product Concept / Value Proposition Testing
- Sales / Market Potential
- Competitive Analysis
- Market Segmentation
- Pricing
- Brand
Technical Services
- Preliminary Technical Assessment
- Product & Technical Design
- Rapid Prototyping
- Usability Testing
- Manufacturing/Operations feassibility
- Operations benchmark & roadmap
- Product Support & Service Level requirements
Regulatory Services
- Preliminary Regulatory Assessment
- Preparation & submission of pre-market notification : 510(k), investigational device exemption : IDE and pre-market approval : PMA
- Product labeling and Instructions for Use (IFU)
- Registration, Listing & Reporting requirements
- Import & Export requirements
- Quality System & Compliance; GLP, cGMP, cGTP & ISO
- Medical Device Reporting (MDR) & complaint handling
- Audits and Inspection Preparation
Clinical Services
- Clinical trial design & management
- Clinical site selection, initiation & training
- Data management: 21 CFR Part 11 compliant
- Data base design, development & support
- Statistical programming and support
- Publication strategy & execution including white papers, journal articles, abstracts & posters, tech assessments & materials
Reimbursement Services
- Coverage, Coding and Payment Assessment
- Local Coverage Decision Review
- Data base design, development & support
- Health Economic support
- Reimbursement support information
- Reimbursement hotline support
Planning Services
- Business plan
- Financial planning services
- Marketing plan
- Launch plan
- Manufacturing/Operations feassibility
- Operations / Production planning
- Post-Launch Review