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市場調查報告書

醫療設備的開發:美國的早期產品管理、推銷的基準

Medical Device Development: Benchmarking US Early-Stage Product Management and Promotion

出版商 Cutting Edge Information 商品編碼 332703
出版日期 內容資訊 英文 120 Pages
商品交期: 最快1-2個工作天內
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醫療設備的開發:美國的早期產品管理、推銷的基準 Medical Device Development: Benchmarking US Early-Stage Product Management and Promotion
出版日期: 2015年05月29日 內容資訊: 英文 120 Pages
簡介

在競爭性日益加強的商業市場上掌舵的醫療設備廠商,必須適當準備必要的資金、人力資源以使產品成功。與概念及原型開發相同,必需早期著手商業化。

本報告提供著手新產品計劃的醫療設備廠商等有用的指南、11家醫療設備廠商的初期商業化簡介、產品成功最大化的主要策略。

摘要整理

  • 初期設備的商業化:朝向成功的主要建議

成功的醫療設備商業化的配合措施、資源的分析

  • 醫療設備商業形勢的調查
  • 醫療設備商業化簡介

商業職員的組織及產品開發期間中的支出

朝向產品銷售成功的開發、商業化策略

  • 最適合的調節途徑、支援資料的選擇
  • 關注促進開發、商業化的合作、收購
  • 商業策略、潛在課題的導航
目錄
Product Code: PH210

THE BOTTOM LINE:

As medical device manufacturers navigate an increasingly competitive commercial market, they must ensure they are adequately prepared with the financial and human resources necessary for product success. It is imperative that these companies get an early start on commercialization - some as early as concept and prototype development.

Medical Device Development serves as a guide to medical device organizations that are undertaking new product planning and early commercialization initiatives for US-based launches. The report presents early commercialization profiles for 11 medical devices. Profiles span all company sizes, product classifications product type and novelty, as well as a range of therapeutic areas and focuses. This study also highlights key strategies for maximizing product success, including selecting best-fit regulatory pathways, determining the appropriate laboratory and clinical trials to support submissions, identifying the viability of partnering deals to promote product success, and gathering health economics and market data to build device value.

KEY QUESTIONS

ANSWERING CRITICAL QUESTIONS FOR OUR CLIENTS

Medical Device Development showcases benchmarks, best practices, and case studies to improve device product resource allocation, product development planning and early commercialization strategies for US-based launches. Data are broken down by device company size, device class (Class 2 and 3) or therapeutic area. Additionally, profiles of device manufacturers and their individual products allow for comparisons and provide guidelines for companies and products with a similar background. The report will answer these critical questions about medical device new product planning and commercialization:

  • What key factors influence medical device commercial investments?
  • How much time and money should be allocated for Class 2 and Class 3 products at each development stage?
  • Why is it important to establish a commercial board and a dedicated marketing group early in development?
  • Based on my product's novelty, class or therapeutic area, what kind of competition did similar devices face in the US market?
  • Which regulatory pathway is most appropriate for my device?
  • Why might it be advantageous to run clinical trials even if they are not required for medical device approval?
  • How do partnerships and acquisitions expand company/product support and commercialization capabilities?
  • How can medical device companies meet payer demands for health economics data and proof of product value?

KEY BENEFITS

CRITICAL FINDINGS FOR MEDICAL SCIENCE LIAISON EXECUTIVES

These principles are signposts to help improve your medical device product commercialization in the US. These points emphasize central and critical recommendations contained within this study.

  • 1. PREPARE FOR VARYING LEVELS OF COMPETITION BASED ON PRODUCT NOVELTY.
  • 2. DRIVE PRODUCT DEVELOPMENT THROUGH NEW TECHNOLOGY AND ACCESS TO EXTERNAL PLATFORMS.
  • 3. BENCHMARK COMMERCIAL BOARD STAFFING AND COMMERCIAL INVESTMENTS PER DEVELOPMENT PHASE.
  • 4. ESTABLISH MARKETING GROUPS EARLY IN DEVELOPMENT TO MAXIMIZE COMMERCIAL OUTPUT.

Percentage of Companies Using Specific Regulatory Pathways,
by Medical Device Product Novelty and Classification

  • 5. LOOK TO 510(K) CLEARANCE TO SUPPORT CLASS 2 DEVICES AND PRE-MARKET APPROVAL FOR CLASS 3 PRODUCTS.
  • 6. USE CLINICAL TRIALS TO SUPPORT FDA SUBMISSIONS AND ENHANCE COMMERCIAL MESSAGES.
  • 7. CLEARLY ASSESS COMPANY NEEDS - PERSONNEL, BUDGETS OR CAPABILITIES - TO SELECT BEST-FIT PARTNERS.

Table of Contents

EXECUTIVE SUMMARY

  • Early Device Commercialization: Key Recommendations for Success

PROFILING SUCCESSFUL MEDICAL DEVICE COMMERCIALIZATION EFFORTS AND RESOURCES

  • Surveying the Medical Device Commercial Landscape
  • Medical Device Commercialization Profiles

ORGANIZING COMMERCIAL STAFF AND SPENDING DURING PRODUCT DEVELOPMENT

DEVELOPMENT AND COMMERCIALIZATION STRATEGIES FOR PRODUCT LAUNCH SUCCESS

  • Choosing the Best-Fit Regulatory Pathways and Supporting Data
  • Looking to Collboration and Acquisitions to Drive Development and Commerialization
  • Navigating Commercial Strategy and Potential Challenges
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