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- SU Biodesign
- Glossary
- 4
- 5
- A
- Acquisition
- Administrative detention
- AdvaMed (Advanced Medical Technology Ass
- AHA (American Hospital Association)
- AHRQ (Agency for Healthcare Research and
- AIMDD (Active Implantable Medical Device
- AMA (American Medical Association)
- Angel investor
- ANSI (American National Standards Instit
- APC (Ambulatory Payment Classification)
- Arm
- ASIC (Application Specific Integrated Ci
- ASQ (American Society of Quality)
- B
- C
- CAB (Conformity Assessment Body)
- CAC (Carrier Advisory Committees)
- CAF (contracting administration fee)
- CAGR (compound annual growth rate)
- CAPA (Corrective and Preventive Actions)
- Capability-based advantages
- Case controlled study
- Cash flow Statement
- CBER (Center for Biologics Evaluation &
- CDER (Center for Drug Evaluation & Resea
- CDRH (Center for Device and Radiological
- CE Mark
- Citation
- Civil Penalties
- Class I
- Class II
- Class III
- Clinical investigator
- Clinical Study Protocol
- Clinical Trial
- CME (Continuing Medical Education)
- CMS (Centers for Medicare and Medicaid S
- Coding
- COGS (cost of goods sold)
- Common stock
- Comparables analysis
- Competitive benchmarks
- Conditions precedent
- Controlled trial
- Conversion, Automatic conversion
- Convertible bonds
- Core laboratory
- Corporate investment
- Correction
- Cost-effectiveness model
- Cost-utility analysis
- Cost/benefit analysis
- CPT (Common Procedural Terminology) code
- CRO (Contract Research Organization)
- Cycle of care
- D
- Debt funding
- Design creep
- Design controls
- Design validation
- Design verification
- Determination meeting
- Diagnostic trials
- Differential pricing
- Dilution
- Direct sales model
- Discounted cash flow analysis
- Distribution play
- Dividend provisions
- Divisional
- DRG (Diagnosis Related Group)
- DSMB (Data Safety and Monitoring Board)
- DSP (Digital Signal Processor)
- DTC (Direct-to-Consumer)
- DTP (Direct-to-Patient)
- Due diligence
- E
- Earn out acquisition
- Efficacy endpoints
- Eligibility criteria
- Empirical
- Epidemiology
- EPO (European Patent Office)
- Equipment & facility controls
- Equity ownership
- Ethnographic research
- Evergreening
- Evidence-based
- ESD (Examination Support Document)
- Exclusion criteria
- Exclusionary rights
- Exclusive agreement
- Exclusive license
- Exit event
- Expansion funding
- F
- G
- H
- I
- IACUC (Institutional Animal Care and Use
- ICD-9-CM (International Classification o
- ICD-9 (International Classification of D
- IDE (Investigational Device Exemption)
- IDN (Integrated Delivery Networks)
- IFU (Indications for Use)
- Illiquid
- Indirect sales model
- Information rights
- Informed consent
- Injunction
- Innovation notebook
- Intention to treat
- IRB (Institutional Review Board)
- ISO (International Organization for Stan
- Intrapreneur
- IPO (initial public offering)
- ISA (International Searching Authority)
- ISO 13485(International Standards Organi
- ISO 9001
- IVDMD (In Vitro Diagnostic Med Dev Dir)
- J
- K
- L
- M
- Management controls
- Manufacturing costs
- Market segmentation
- Market withdrawal
- Marquee physicians
- Materials controls
- MAUDE
- MDD (Medical Device Directives)
- MDR (Medical Device Reporting)
- MDUFMA (Medical Device User Fee and Mode
- Me-too products
- Mechanism of action
- Medtech
- MEPS (Medical Expenditures Panel Survey)
- Mezzanine funding
- Mixed need
- Morbidity
- N
- O
- P
- P&PC (Production & Process Controls)
- Partnering strategy
- Pass-through code; c-code
- Pathophysiology
- Patient " Towers"
- Pay-for-Performance
- Payer advisory board
- PCT (Patent Cooperation Treaty)
- PDP (Product Development Protocol)
- Peer review
- PHI (Protected Health Information)
- PI (Principal Investigator)
- PIC (Programmable Intelligent Computer)
- Piggybacking
- Pilot trial
- Pivotal trial
- PMA (Pre-market Approval)
- POC (Point of care)
- Porter's five forces
- Post-marketing trial
- Post-money valuation
- Power
- Power calculation
- Pre-money valuation
- Preferred stock
- Primary endpoints
- Primary prevention patients
- Prior art
- Priority date
- Protective provisions
- Provisional patent
- Proxy companies
- Proxy material
- Public Disclosure
- Public Investment
- PubMed
- Q
- R
- Randomization
- Randomized trial
- Recall
- Records, Documents & Change Controls
- Redemption
- Reduction to practice
- Reference pricing
- Registration rights
- Registry
- Reimbursement
- Reimbursement dossier
- Revenue ramp
- Right of First Refusal
- ROI (Return on Investment)
- Royalties
- Royalty anti-stacking provisions
- RVU (Relative Value Units)
- S
- SE (Substantial equivalence)
- Secondary endpoint
- Secondary prevention patients
- Seed funding
- Seizure
- Sherman Act
- Significant risk
- Significant risk device
- SMDA (Safe Medical Devices Act)
- SRR (Suggested Restriction Requirement)
- Stakeholders
- Standard of care
- Standard treatment
- Stark Law
- Start-up funding
- Statistical significance
- Subject
- Surrogate endpoint
- Switching costs
- SWOT analysis
- Syndicate
- T
- U
- V
- W