Class 5 Capabilities & Services

Class 5 Inc. specializes in commercialization solutions for the global life science industry, including medical manufacturers, healthcare providers and distributors. We offer concrete solutions to established medical companies, as well as emerging growth companies and startups. Class 5 has worked with companies seeking to expand their market share, US companies seeking to distribute internationally, and international companies launching products in the US. From development to global launch, we have the skills to help your company optimize its competitive advantage and enhance its bottom line.

Class 5 International Focus

The US is the largest medical and healthcare market in the world, accounting for $2.2 trillion in annual expenditures or nearly 50% of the global market. The US medical industry consists of more than 750,000 physicians and 5,200 hospitals, accounting for 3.8 million inpatient visits and 20 million outpatient visits daily. The process of commercializing a new medical device for the US market is becoming more complex. Class 5 has the experience to navigate the numerous milestones of a successful US product launch, ranging from obtaining the appropriate regulatory clearances, to conducting engineering design review and assessment and to establishing and managing a US sales and distribution team. We have the personal contacts, business networks and expertise to facilitate rapid market access, mitigate risk and meet your product launch objectives.

market sizing and segmentation, survey research, competitive analysis, user interface research, due diligence, financial modeling

business plan development, market and financial modeling, strategic analysis, funding strategies

strategic planning, global product launch, pricing strategy development, marketing trials, engineering design review

distribution strategy development, dealer and distributor management, manufacturer's representative recruitment and management, sales training, national account management

new product introduction and launch, tactical planning, trade show and association management

sales and marketing collateral, operator and user manuals, product and service guides, proposals

New Product Development Process (NPDP), design control audits, project review and management, UL, CSA and CE management

Quality Management System (QMS) development, optimization, auditing, and training for medical and in vitro diagnostic devices; strategic regulatory planning; regulatory submission development and filing; interpretation and application of national and international standards

payer trends and industry requirements, strategies to maximize reimbursement and avoid payment problems, coding and coverage strategies, HIPPA compliance

clinical support, product trials, training, in-services, clinical white papers

business-to-business lead follow-up for vacant sales territories, trade show leads, and hard-to-reach markets

• Acute Care
• Homecare
• Extended Care
• Group Practice
• Emergency Medical Services
• Nephrology
• Cardiology

• Surgery (ENT, Neuro, Plastic,
  Ortho, Spine)
• Dental & Facial Surgery
• Industrial Medicine
• Rehabilitation
• Radiology
• Respiratory Care

• Anesthesia Systems
• Multi-Parameter Monitors
• Handheld Monitors
• Respiratory & Sleep Products
• Orthopaedic Implants
• Surgical Instruments
• Single-Use Disposable Devices
• Patient Aids
• Hemodialysis Systems
• Cardiopulmonary Bypass Systems

• Cosmetic & Reconstructive Implants
• Therapeutic Drug Monitors
• Wound Care Products
• X-Ray & Laser Systems
• Pacemakers & Defibrillators
• Digital Image Systems
• Geriatric Products
• Diagnostic & Ultrasound Systems
• Infusion Systems
• Diabetic Products