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Articles Tagged "product development"

Essential Steps to Proactively Improve Your Product Development Process

by Kathie Zipp | Nov 2020

In a perfect world, product development goes smoothly. However, we don’t live in a perfect world. Our imperfection is why a focus on process improvement to enhance our work product is worth R&D teams pursuing.... Read more »

How to Create a Product Development Roadmap

by Kathie Zipp | Jul 2020

Product portfolio roadmapping is like taking a trip. Companies must decide where they're going and how they're going to get there in order to be successful.... Read more »

Why You Should Engage Suppliers in DFMEAs

by BONEZONE | Jul 2020

This practice not only benefits the OEM, but the supplier as well. By partnering in the early stages of development, OEMs can launch a product at a lower risk of encountering manufacturing challenges once released.... Read more »

How to Implement a Solid Approach to Materials Intelligence

Understanding how materials move through each aspect of the product development process can significantly shorten time-to-market, reduce the risk of compliance issues, fine-tune manufacturing processes and improve overall device quality.... Read more »

Tiger Buford Makes COVID-19 Predictions for Technology and You

by Carolyn LaWell | Apr 2020

 COVID-19 has the potential to affect the work of orthopedic professionals profoundly—both how work is conducted and the end product that is created. ... Read more »

6 Best Practices for Successful Product Commercialization

by Heather Tunstall | Apr 2020

You've settled on a concept for your next orthopedic device. Great! These critical steps will assist you through your feasibility, development and commercialization actions. ... Read more »

This is What it Takes to be Competitive in Today's Medical Device Market

by Heather Tunstall | Feb 2020

Findings from a new survey of 524 medical device professionals can help you benchmark yourself against best-in-class companies in the areas of product and quality management.... Read more »

Design Planning with Your Manufacturer May Save Time and Cost

by BONEZONE | Jan 2020

Device companies should encourage their engineers to work with manufacturers even during the concept phase of design. This relationship allows teams to identify the design inputs that affect manufacturing and inspection methods and costs, and together ensure the best design for the product.... Read more »

How to Control Project Scope Creep

by Kathie Zipp | Jan 2020

Directional change and scope creep are inevitable in product development. However, their effects can be minimized through a systematic approach.... Read more »

9 Rules for Orthopedic Product Development

by Dale Tempco | Jan 2020

Rule #1 for successful product development is to tie design outputs to user needs. Dale Tempco shares how this step and eight others helped him decrease product development setbacks throughout his career. ... Read more »

Pristine Surgical Enters Sports Med Market with Single-Use Surgical Imaging System

by Heather Tunstall | Nov 2019

Pristine Surgical is expected to launch to market an arthroscope that includes a single-use digital imaging platform in the first half of 2020. The company's technology includes inventory management capabilities, patient engagement tools, pre- and post-op communications and training compon... Read more »

NASS Review: Spinal Robotics, Enabling Technologies, 3D Printing and Biologics

by Mike Evers | Oct 2019

Enabling technologies were the story of the North American Spine Society 2019 Annual Meeting, with the top spine players prominently featuring an array of robotic-assisted surgery ecosystems.   ... Read more »

Viant Acquires Meraqi Medical

by BONEZONE | Sep 2019

This represents the fourth acquisition that Viant has completed in two years.   ... Read more »

How Good Project Management Can Reduce Production Delays

by Hal Conick | Jun 2019

Good project managers know how to effectively outline a process and assess risk in order to stay on time and budget.... Read more »

Unlock DFM Benefits: A Guide for Product Development Leadership

by Dale Tempco | May 2019

Device companies focus on DFM is shortsighted. DF(x) allows companies to account for designing for manufacturability, as well as design for inspection, assembly, low cost, manufacturing efficiency, business needs, manufacturing throughput, packaging/transportation, etc.... Read more »

FDA's Pre-Submission Process Allows You to Minimize Risk and Decrease Cost

by BONEZONE | May 2019

Utilizing FDA's Pre-Submission Process provides an opportunity to address potential concerns early in the regulatory process, and it can significantly reduce the risk of delays once a 510(k) is under review.... Read more »

OEMs Continue Focus on Reducing Instruments in Operating Rooms

by BONEZONE | Oct 2018

Several device companies within the last two years have capitalized on the shift toward simpler surgeries with fewer instruments in the forms of recent product launches or revisions, process initiatives and 510(k) clearances.... Read more »

Year-to-Date Funding Recap: Robotics, Imaging, ACL Implant, Cervical Disc and More

by BONEZONE | Jul 2018

These funding announcements feature technologies related to each of the market segments: spine, trauma, arthroscopy/soft tissue, joint reconstruction and orthobiologics.... Read more »

Design Validation: More than Just User Testing

by BONEZONE | Aug 2017

EduQuest, a global team of FDA compliance experts, answers industry’s pressing questions. In this round, Denise Dion, Vice President of Regulatory & Quality Services for EduQuest, corrects a common misconception.... Read more »

Arthroscopy/Soft Tissue Technologies to Watch: 1H17 Funding Recap

by BONEZONE | Jul 2017

Funding announcements that we tracked from orthopaedic companies in 1H17 included eight arthroscopy/soft tissue-related technologies we’d like to highlight because of their novelty and early-stage backing.... Read more »

R&D Recap: Leading Orthopaedic Device Company Product Initiatives

by BONEZONE | Jun 2017

Acquisitions, divestitures, market entries and exits have contributed to the shaping of product portfolios of the orthopaedic industry’s larger players, in recent years. We review their product development initiatives over the last 18 months to offer a good look at your competitors’ strateg... Read more »

Proving Your New Design is Production Equivalent

by BONEZONE | Jun 2017

Design validation is essential to new product development, especially when using multiple suppliers to manufacture your device. Our experts weigh in on how to determine your product is production equivalent.... Read more »

Pareto Analysis: Tools for New Product Testing

by BONEZONE | May 2017

Testing is, of course, a critical component to product development. To better understand how it can be proactively employed to help ensure product quality and longevity, we reached out to John McCloy, Founder & President of Engineered Assurance and author of the article on the industry’s 1% fa... Read more »

Suppliers Prioritize Additive Manufacturing Initiatives to Start 2017

by BONEZONE | Mar 2017

Carpenter, GE, Materialise and Siemens announce collaborations, acquisitions to address additive technology.... Read more »

What Great Product Managers Can Teach Us About Our Work

by Carolyn LaWell | Jan 2017

What is your individual product? What do you create, day in and day out, for your colleagues and your customers? Applying lessons in communication, decision making and strategy from great product managers may spur new ideas for ways to think in an even bigger picture.... Read more »

Positioned for Growth: Exactech, Others Move Surgical Assistance Forward

by BONEZONE | Oct 2016

First total shoulder procedures and the first U.S. knee revision procedure have now been performed using ExactechGPS, a Guided Personalized Surgery system combining pre-op planning with intra-op real-time computer assistance.... Read more »

Spine Company 510(k)s from 1H16

by Julie Vetalice | Oct 2016

Not all spine companies attend NASS! Get to know ten recipients of their first FDA 510(k) clearances to see what technologies they’re offering.... Read more »

Spinal Fusion Device in Development Eliminates Bone Graft and Pedicle Screws

by Hannah Corcoran | Oct 2016

Researchers at The University of New South Wales developed a fusion device designed to stabilize the spine without bone graft or pedicle screws in single-level posterolateral fusion.... Read more »

Resubmitting a 510(k) is More Than a Regulatory Decision

by John Gagliardi | Sep 2016

Do changes to your device warrant a 510(k) submission? There are several elements to consider: design controls compliance, risk analysis and postmarket surveillance data, among them.... Read more »

When to Contract Your Device Testing

by Chris Mosby | Aug 2016

All medical devices must be tested. However, the varied aspects of device testing can be unfamiliar ground, and standards are often vague guidelines, open to interpretation.... Read more »

The Advantage of Adverse Event Wear Testing

by Gemma Budd | Aug 2016

Advances in the development of prosthetic joints and materials have led to a need for more effective testing solutions to drive the development of new and improved implants.... Read more »

Medtronic, Zimmer Biomet Enter 2-level Cervical Disc and Robotic Markets

by Carolyn LaWell | Aug 2016

In efforts to invigorate revenue growth, Medtronic and Zimmer Biomet have focused on niche technologies that expand their portfolios—but have yet to prove wide scale adoption.... Read more »

TA Instruments Announces Move of the Electroforce Group

by BONEZONE | Jan 2016

TA Instruments, manufacturer of analytical instruments for thermal analysis, rheology and microcalorimetry, announced that ElectroForce Systems Group has moved to a new facility in Eden Prairie, Minnesota. The ElectroForce Systems Group manufactures mechanical testing systems that are used to chara... Read more »

How to Build the R&D and Marketing Relationship for a Successful Product Launch

by Tim Jeavons | Dec 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Harvesting Engineers’ Ideas through Invention Disclosure

by John W. Boger, Esq. | Dec 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

8 Design Control Issues Found During FDA Inspections

by John Gagliardi | Nov 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Product Development and IP Considerations: A Marriage Made in Heaven?

by John W. Boger, Esq. | Sep 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Surgeon Seeks to Market 3D Printed Implants on Demand

by Hannah Corcoran | Sep 2015

Richard Hurley, M.D., pictures a world where surgeons actually design and 3D print implants in their office. To achieve this, he started Conceptualiz Inc. in 2012.... Read more »

Oberg Breaks Ground on Expansion Project

by BONEZONE | Aug 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Executives Warn of Paradigm Shift in R&D Spend

by Carolyn LaWell | Aug 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Regulatory Expert Builds Web Tool to Assist Companies with 510(k)s

by Hannah Corcoran | Jul 2015

Frustrated with FDA’s 510(k) search function, Eric Eggers created kBLASTER to help companies simplify and speed their 510(k) submissions.... Read more »

AAOS Recap: CAS and Robotic Technology Popular Product Launches

by Carolyn LaWell | Apr 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

STD Med Changes Name To Primo Medical Group

by BONEZONE | Jan 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Teleflex Medical OEM Launches Redesigned Website

by BONEZONE | Jan 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

The Fallacy of Profit as a Percentage of Sales: Part II

by Doug Hicks | May 2014

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Zoning In with Robert Weigle

by BONEZONE | May 2014

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Design Controls: A 17-Year Learning Curve

by John Gagliardi | May 2014

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Synergetic Dissimilarity: Design Validation/Verification and Process Validation

by John Gagliardi | Mar 2014

Verification and validation are commonly confused. John Gagliardi defines the intertwined engineering tools and outlines how they are practiced.... Read more »

The Fallacy of Profit as a Percentage of Sales: Part I

by Doug Hicks | Mar 2014

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

J-Pac Medical: New Name, Expanded Resources to Support Medical Product Innovation

by BONEZONE | Feb 2014

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Risk Management: The Science of Minimizing Uncertainties

by John Gagliardi | Oct 2013

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

How to Choose a Notified Body

by BONEZONE | Sep 2013

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

FDA Releases New Requirements for Combination Products

by BONEZONE | Mar 2013

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

OEM/Supplier Issues Roundtable: Orthopaedic Industry Leaders Weigh in on Commercialization Challenges

by The Advisory Panel | Dec 2012

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Suppliers and Service Providers Offer Innovative Solutions

by BONEZONE | Nov 2012

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Polymer Composite May Eliminate Bone Formation in Soft Tissue

by BONEZONE | Oct 2012

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Histogenics Selects ImageIQ to Provide Imaging Analysis for Phase 3 Clinical Trial

by BONEZONE | Jul 2012

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Trends in Innovation and R&D Investment - OMTEC 2012 Opening Panel Discussion

by BONEZONE | Jul 2012

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Objet Now Offers Customers 100+ Digital Materials for 3D Printing

by BONEZONE | Jun 2012

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Imaging Analytics: Optimizing Time Efficiencies

by BONEZONE | Dec 2011

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Innovation, Advanced Development, IP & Competency: Four Inescapable Product Development Trends

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

A Framework for Evaluating Opportunities in a Dynamic Market

by BONEZONE | Sep 2011

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

The View from Washington: What Device Makers Need to Know about FDA’s Latest Strategic Priorities and Initiatives

by BONEZONE | Aug 2011

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Integrating Internal Strategies to Impact a Successful Product Launch

by BONEZONE | Aug 2011

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Forrest R. Whittaker, Chief Executive Officer, Avalign Technologies, Inc.

by BONEZONE | Jun 2010

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »