Medical Device Development

Benchmarking U.S. Early-Stage Product Management and Promotion

Medical Device Development

$1,995.00

This report is a guide for medical device development teams undertaking new product planning and early commercialization initiatives for US-based launches. Because each product has different challenges and opportunities, the study profiles 11 devices, including:

  • Product support and investment
  • Unique approaches to product development and commercialization
  • Human and financial resources needed to support these processes

 

  • Description
  • Additional information

REPORT HIGHLIGHTS

This report is a guide for medical device manufacturers that are undertaking new product planning and early commercialization initiatives for US-based launches. Because each product has different opportunities and challenges, the study profiles 11 devices, including product support and investments, unique approaches to product development and commercialization, and the human and financial resources needed to support these processes.

Medical Device Development: Benchmarking U.S. Early-Stage Product Management and Promotion

Publication Date: 2015
Pages: 120
Chapters: 3
Metrics: 400+
Charts/Graphics: 95
Companies Participating: 42

Report data have been split by company size:

  • Top 10 Medical Device Companies
  • Top 50 Medical Device Companies
  • Small Medical Device Companies

Report data are broke down by Product Classification (Class 2 and Class 3) and Product Type:

  • Breakthrough (a new product with new technology)
  • Adjacent (a related market/technology)
  • Line Extension

Brand profiles provide granular detail to match against including:

  • Product Background / Competition Levels
  • Product therapeutic area
  • Product type (biologic, diagnostic, etc.)
  • Approval Process (510K, 510K + clinical trials, PMA)
  • Product Type (breakthrough, adjacent, line extension)
  • Peak US Annual Sales, Peak Market Share
  • Competition at Launch
  • Underlying Technology (new v. pre-existing)
  • Product development (in-house, collaboration, acquisitions)
  • Acquisition types (technology, business, intellectual property)

Product Timelines cover a monthly breakdown for:

  • Concept & Development
  • Development and Final Design
  • Clinical Studies
  • Approval, Manufacturing Ramp Up

The report includes a functional breakdown of Commercialization Spending and Staffing, by phase, for:

  • Marketing
  • Clinical Development
  • Manufacturing (direct labor)
  • Reimbursement / HEOR
  • R&D / Technical
  • Quality / Regulatory
  • Business / Finance
  • Manufacturing (Engineering)

Report data cover Therapeutic Areas including:

  • Spinal
  • Endocrinology
  • Ophthalmic
  • Wound Care
  • Cardiovascular
  • Immunohematology
Report Features

This report serves as a guide to medical device manufacturers that are undertaking new product planning and early commercialization initiatives for US-based launches. Because each medical device product is different, this study profiles 11 companies’ devices, product support and investments. After presenting these unique approaches to product development and commercialization, this study examines the human and financial resources needed to support these processes. Appropriately resourcing commercialization boards allows teams to better support product launches.

Reason To Buy

The report will answer 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?

Target Audience

Medical device manufacturers face a number of challenges — from growing numbers of competitors to attaining the resources needed to support development — moving their products through development and into today’s saturated market. Because the commercial landscape is so competitive, organizations must begin commercialization processes early in the product lifecycle — sometimes as early as concept and prototype development. However, commercialization teams need the human and financial resources — either internal or through partnerships — to support emerging products throughout development.

Chapter Example

From Chapter 1: Leverage clinical trials to supplement FDA submissions and to enhance marketing messages. Although the FDA only requires clinical trials to support Pre-Market Approval (PMA) submissions, both PMA and pre-510(k) submissions can benefit from clinical data by earning more extensive claims than those submissions without clinical trials. Clinical trials may also satisfy anticipated questions from the FDA, thereby expediting regulatory clearance. This report includes medical device companies’ strategies for successful early commercialization for products launching in the US market, including the percentage of companies using specific regulatory pathways.