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Medical Device + Diagnostic Industry
Volume 34
- Inside Look—Startup Sees Need for Autism, Mental Illness Devices
- Limited Effectiveness Reported on Hip Bearing Combinations
- All Malfunctions are ‘Reportable’ to FDA
- The Growing Reduction of FDA
- Medtech Attorney Pilot Urges Third Party Device Reviews
- Bill Would Boost FDA Role in Recalls
- Light Curing Adhesives with Confidence
- All Your Product Design and Life Cycle Management Questions Answered
- Blue Skies or Clouds Ahead for Medtech Industry? Experts Make Their 2012 Predictions
- Theoretical Physicist Michio Kaku Predicts the Future of Healthcare
- FDA: Computational Modeling Could Lead to Big Gains in Device Safety
- Medical Device Gets Regulatory Nod in 17 Days
- In Study, Hospital Executives Weigh In on Health IT and Medical Device Integration
- As Medical Technology Evolves, So Does Intellectual Property Law
- Ultrafast Laser Research Could Lead to New Diagnostic Applications
- FDA Needs to Examine Its Institutional Culture
- CDRH Report Includes Promises to Improve Culture
- Kay Hagan Backs Legislation for Management Review Board at FDA
- Consumers Union Seeks Stronger Device Law
- Future Medical Device Regulation in the European Union: Prospects for Reform
- Reimbursement and Coverage Strategies Matter, Here’s Why
- An MD+DI Exclusive Interview with Medtech Pioneer Thomas Fogarty, MD
- Partnership: The Ultimate Expression of Supplier Control
- Toxicology and Biocompatibility Testing of Ophthalmic Drug-Device Combination Products
- Negotiate for Value: Reengineer Your Purchasing
- How to Deal with a Supply Chain that Is Growing Ever More Complex and Global
- Fight Diabetes and Obesity without Surgery
Volume 33
- State of Medtech 2011 and Beyond: A SWOT Analysis
- Inside Look: AdvaMed Pursuing a Six-Point Plan for Success
- The 510(k) Program Should Be Saved, Not Scorned
- CDRH Director Shuren to Speak at LifeScience Alley
- Democrats Want Hearings to Examine Device Safety
- Taking a Firmer Hand, Shuren Works to Make CDRH More Consistent, Predictable
- Industry Rejects Funding FDA Bonuses with User Fees
- Approval Granted to Mela Sciences
- MDDI 2011 Salary Survey: Research and Development
- MDDI 2011 Salary Survey: Regulatory and Legal Affairs
- MDDI 2011 Salary Survey: Quality Assurance and Quality Control
- MDDI 2011 Salary Survey: Production and Manufacturing
- MDDI 2011 Salary Survey: Product Design Engineering
- MDDI 2011 Salary Survey: General and Corporate Management
- A Tough Year for U.S. Medical Device Manufacturing
- Many Medtech Companies Struggled to Find Funding in 2011
- Though 510(k) Program Faced Heavy Criticism, Numbers Showed It to Fared Better than PMAs
- MedTech Snapshot International: Are the Next Eleven the Next Frontier?
- Mergers and Acquisitions: Medtech Buyers and Sellers Win
- The Best (and Worst) Thing About Medtech Jobs—An MD+DI Salary Survey Guide
- A Look at Medical Device Numbers in 2011
- AdvaMed Ramps Up Political Spending in Third Quarter
- Inside Look: MDMA to Target Regulatory Process
- FDA Says SCIENCE, But Is the Agency Spin Doctoring?
- FDA Establishes Academic Centers to Study and Improve Drug and Device Review Processes
- Will a Hostile Funding Environment Hurt U.S. Innovation?
- What Thomas Fogarty, MD, Thinks of the U.S. Medtech Industry
- Polymeric Material Could Be Used for Noninvasive Applications
- FDA Is Suffocating the Small Businesses It Should Be Helping
- The Future of Devices is Generic
- MD+DI's Manufacturer of the Year: Johnson & Johnson
- Facilitating the Flow of Content within Medical Device Companies
- Pump Up Balloon Tubing Process
- Five Ways to Control Intellectual Property Costs
- A Big Thumbs Up for a Plan to Rate Medical Devices
- Pressures to Cut Medtech Spending Build
- MD+DI Names Medtech Industry Veteran Bill Betten to EAB
- 'Boston Herald' Sides with Advamed in Push to Repeal Device Tax
- Exclusive Coverage of AdvaMed 2011
- Federal Cuts Could Impact Home Healthcare Device Market
- More Bad News for Cardiac Devices
- Baucus and Hatch Seek to Make R&D Tax Credit Permanent
- FDA, Industry Playing Political Games
- Overcome the Challenges Posed by the RoHS Recast
- Textile Forming Technology Leads Material Future
- Tapes and Drapes: Adhesives and Materials in Surgical Supplies
- Lean Manufacturing and Sustainability for Medical Device Manufacturers
- Policy Predictions and Planning for Accountable Care
- MD&M Minneapolis Conference Session to Focus on Power Design
- Pushing Pills Out of the Picture
- How I Learned to Stop Worrying and Love Digital Healthcare
- Insulin Pump Hacking: Sensationalism or Legitimate Threat?
- IOM Report Not a Public Relations Threat to Industry
- As Supply Chains Grow, So Do Companies’ Worries About Reform, Regulation, and IP Protection
- Venture Capitalists Invest More in Device Industry in Second Quarter
- Washington Wrap-Up: Industry, FDA Continue to Negotiate User Fees, MDUFA
- Washington Wrap-Up: Kalypto Seeks 510(k) Ban for Smith & Nephew's Wound Device
- Patent Validity Challenges in the Medical Device and Diagnostic Industry
- Chart a New Course to Efficiency with Value Stream Mapping
- Getting the Most Out of High-Speed Motors in Medical Device Applications
- Delivering Optimism from Hospital to Home
- Pacific Markets: Growth for Telehealth
- Addressing Catheter Testing Challenges
- Medical Device OEMs Bring Out the Best in Workers
- Generic Orthopedic Devices Change the Game
- Emerging Markets Are Hungry for Aesthetic Devices
- Theft of Boston Scientific Devices Likely an Anomaly
- Tackling the Challenge of Launching a New Medical Device
- The Sustainable Importance of Platinum in Biomedical Applications
- Best Practices for Design and Development of Software Medical Devices
- GAO: FDA Continues to Fall Short on Managing Device Recalls
- MX: Ensuring Effectiveness of Voluntary Medical Device Recalls
- MDUFMA III Won’t Really Solve Review Problems
- Alfred Mann Wins MDEA Lifetime Achievement Award
- Playing a Numbers Game: Studies Conflict Over 510(k) Recall Rates
- FDA to Evaluate Direct-to-Consumer Genetic Tests on Case-by-Case Basis
- Human Error and Quality Control in Medical Devices
- Exporting Medical Devices to Europe and Emerging Markets: A Double-Edged Sword?
- Navigating Through the Mobile Healthcare Revolution
- Example: Following Six Success Principles
- Is the Third Edition of 60601 the End of Objective Evidence?
- Novel Transparent Plastics Offer High Stress Crack Resistance
- Using Nano-TMA to Rapidly Detect Environmental Stress Cracking of Polyurethane
- MD&M East 2011 Preview: Making Devices for the People
- Robotic Radiosurgery: Long R&D Road Pays Off
- May 2011 Contributors
- A Permanent R&D Tax Credit Is a Great Idea. We Can Do More.
- MDEA 2011: Medical Device Design at a Crossroads
- Protecting Microimplants
- Shuren's Remarks Highlight Flashpoints in Broader Debate About Regulatory Approaches of FDA, EU
- Medtech Companies Begin to Rally in Wake of Japan’s Catastrophe
- CDRH Unveils Medical Device Innovation Pathway
- Blazing a Safe Trail to Market
- Patenting for Early-Stage Medtech Companies
- April 2011 Contributors
- A Belated Holiday Present to Industry: Sharfstein Is Out
- A Deeper Look into Lumens
- Meaningful Use: The Door to Innovation
- Robots Doing It for Themselves
- Six Steps to Fix FDA
- MX: Prepare for IP Battles in the Medical Devices Sector
- Medical Device Prototyping for Clinical Trials
- Global Manufacturing Tiptoes Toward Optimism
- Could a Device Predict Which Cancer Cells Spread?
- Is TruBlood on the Horizon?
- Inside Look: Finding a Rhythm in Wireless Telemetry
- February 2011 Contributors
- Experts Tell You What to Expect in 2011
- Mobile Health Devices Require New Strategies for Manufacturers
- CDRH Shows Impatience with Defibrillator Issues
- Looking for a Competitive Advantage in Puerto Rico
- What Happens to Medical Device Reports Once They Reach FDA?
- FDA Addresses Data Harmonization Concerns
- Optimizing Package Design for EtO Sterilization
- Common Mistakes in Medical Sealer Equipment Designs
- The Microsphere of Influence
- Exploring Systems EMC in Medical Devices
- Patient-Centric Human Factors
- InsideLook: Can EnteroMedics Gain Access to the Neural Pathway to Manage Weight?
Volume 32
- 2010: A Year in Review
- 510(k): What Happens When the Fox Guards the Chicken Coop
- MedTech Snapshot
- MedTech Snapshot: Manufacturing
- MedTech Snapshot: Corporate Finance
- MedTech Snapshot: Regulatory
- MedTech Snapshot: International
- Salary Survey: Where Do You Rank?
- Buyer’s Market Prevails for Medtech Firms
- Salary Survey 2010: Methodology
- Salary Survey 2010: General and Corporate Management
- Salary Survey 2010: Product Design Engineering
- Salary Survey 2010: Production and Manufacturing
- Salary Survey 2010: Quality Assurance and Quality Control
- Salary Survey 2010: Regulatory and Legal Affairs
- Salary Survey 2010: Research and Development
- Facing the Long-Term Challenges of Economic Recovery
- Manufacturer of the Year: Siemens—On a Quest for Excellence in Imaging
- Monitoring with Process Signature Analysis
- The MedSun Strategy for Manufacturers
- Accelerating the Product Development Cycle
- More on Concurrent Engineering
- Do GPOs Help Or Hurt? Depends on Who You Ask
- Industry Speaks Out at Town Hall Meeting
- Scarless Option in Brain Surgery Makes the Cut
- Biosensors Bring Possibility to Personalized Medicine
- November 2010 Contributors
- Outstanding OEM: From Garage to Lab, Finding a Path to the Digital Era
- How Early-Stage Device OEMs Can Make It in Uncertain Times
- Improving Diagnosis Times with New Point-of-Care Technology
- A Logical Choice for Medical Device Software
- Unlocking the Power of Coronary CT Angiography
- Implementing Global Location Numbers
- Q&A With David Hatch, Aberdeen Research Group
- A Secretive Agency Makes a Secretive Safety Appointment
- Antimicrobials: The Silver Lining for Infection Control
- A New Era in FDA Recall Authority
- Reduced VC Funds Means New Challenges for Medtech Start-Ups
- MIT Lauds Top Innovators Under 35
- The New Mind Readers: Electrodes Reach for Telepathy
- Can Heart Sensors Keep Their Distance?
- Titanium Foam Mimics Bone Structures
- October 2010 Contributors
- The U.S. Innovation Struggle: One Model to Follow
- So Many Polymers, So Little Time
- Practical Use of FEA for Medical Rubber Components
- Streamlining the Complaint-Handling Process
- Juggling Act: How to Design with Multiple Materials
- Deciphering De Novo Reviews
- A Stricter 510(k) Process Offers Challenges, Promises
- Highlights of Proposed Changes to 510(k)
- Frost & Sullivan Honors Siemens for CT Technology
- User Fee Rates Announced
- Designer Molecules Could Lead to Fast Medical Images
- Device Puts Preterm Labor in Check
- FDA Continues Campaign to Upgrade Quality
- September 2010 Contributors
- Just Say No to FDA’s Idea of Transparency
- Building a Plug-and-Play Future for Healthcare
- Protecting Devices with Silver-Based Antimicrobials
- Analyze This: Device Cleanliness Testing
- Medical Devices Come Home
- Piezo Motors and Actuators: Medical Device Performance
- New Interval Offers Confidence—Without Limits
- Risk Analysis: Beyond Probability and Severity
- Risky Business
- As Social Media Evolves, the Device Industry Must Also
- Device Reviews Not Hostage to Safety Over Efficacy
- FDA Backs Risk-Based Approach for Lab Tests
- FDA's Town Hall Tour Comes to the West Coast
- Investment in Industry Is Leaner, but Still Alluring
- Do Unproven CAD Tools Get the Benefit of Reimbursement?
- Memry: The Virtues of Vertical Integration
- Ohio a Rapidly Growing Hub for Device Innovation
- Dissolving Microneedles Take the Edge Off Sharps Risks
- Thin-Film Nitinol Could Hold Key to Reducing Thrombus
- Night Vision Sees a New Enemy
- Japanese Device Manufacturers Warm to Rapid Heat Molding
- Device Makers Should Respond to Industry Shifts by Going Global
- Outsourcing on the Rise
- Managing Outsourcing for Success
- Top Tips for Scaled Manufacturing
- Manufacturing Medical Devices with Confidence in China
- Science versus Safety: The Future of Regulating Genetic Tests
- Keeping an Eye on Advances in Ophthalmic Technologies
- Where Color Meets Clarity
- Humidity and Microbial Penetration in Porous Materials
- China Cracks Down on Bribery
- Consider This A Warning
- While Listening to Industry, CDRH Flexes Muscle
- Government Gets Competitive with Tax Credit
- Imaging Market: M&As Likely to Further Strengthen Power Players
- Stroke Therapy Project Wins BCI Award
- Students Drive Device Innovation
- Looking Ahead to Heal Wounds
- Antimicrobial Techniques Could Expand Medical Use of Microneedles
- Strong Public Policy Key to Health of U.S. Device Industry
- 50 Companies to Watch
- Wireless Advances Are Afoot
- Feel the Heat: Thermal Design Trends in Medical Devices
- 510(k) Caution Engulfs FDA—Predicate Choices Questioned
- How a 510(k) Submission Can Affect Your Patent
- RAPS Takes Regulations to China
- Orthopedics Industry Needs a Revolution
- Patient Preferences to Shape the Diagnostic Industry
- Breathing Innovation into Breast Cancer Detection
- Monitor Detects Bad VAD Acoustics
- Infusion Pumps in the Hot Seat at FDA
- The Evolution of CRM Power Technology
- No Dirty Devices Allowed
- Iran: A Missing Piece of the Puzzle
- Psst: Your Customer Knows Something You Don’t
- Get with the Program
- A New Perspective on Medical Device Certification
- Predictability Competes with Confidence in 510(k) Revamp
- Caution: V&V May Be Hazardous to Software Quality
- Patent Eligibility for Personalized Medicine
- Let’s Not Forget Innovation
- Healthcare Reform: How the Device Tax Will Work
- Update on China’s Healthcare Reform
- Device Finance Landscape Remains Promising
- Complex Devices Complicate Interconnectivity
- Judge Strikes Down Myriad’s Patents on Genes
- Anchor Driver Could Improve Doctor’s Feel for Skull
- Flex Electronics Get Closer to the Tissue
- Survival of the Smartest
- The Heathcare Reform Tax: It’s Your Job on the Line
- MDEA 2010: Winning Products and Suppliers
- Jurors Turn an Experienced Eye Toward Design
- Getting the Details Right
- Shuren Seeks a “Predictably Adaptive” CDRH
- FDA, Industry Plan Imaging Changes
- AAMI, FDA Focus on Merits of Simulation Testing
- Soft And Strong: A Self-Healing Gel Supports Skin and Bones
- Benign or Malignant? Scanner Can Help
- Fixing the 510(k) Process: Overhaul Would Be Overkill
- Mass Customization in Electrical Connector Design
- Consistency Is King in Silicone Molding
- To Assess or Determine? Unraveling the D-Value
- Mastering the Clinical Investigation
- Will FDA Be Able to Crack the Regulatory Whip on Industry?
- The Need for Compliance as a Business Strategy
- Best Practices: Designers and Patent Attorneys Unite
- Health Reform in 140 Characters
- California’s Biomedical Industry Healthy, but Could Lose Its Edge
- Consultants Get a Voice
- Reform Makes Industry Nervous
- Finding Harmony in a New Auditing Program
- Nanoburrs Get Their Hooks into Damaged Vasculature
- Stronger Collagen Could Aid in Wound Healing
- How Well Do Your Outsourcers Serve You? Hint: They Could Probably Do More.
- Buyer Beware: A Quest for Vendor Qualification
- Looking Beyond Outsourcing to True Partnerships
- Making Connections with Tubing and Suppliers
- Failure Isn’t an Option
- Overcoming Concerns about Outsourcing to Asia
- Better by Design: Seeking a Contract Molder’s Support Up Front
- An Era of Change: New Director, New Direction for FDA?
- Neurostimulation in the New Decade
- 10 Steps to Managing Master Data for Devices
- Detecting Nitinol Surface Inclusions
- Biocompatibility Testing: Tips for Avoiding Pitfalls, Part 2
- When FDA Takes Its Complaints to Your Customers
- Following the Road to Regulation
- Mapping the Regulatory Path of Digital Pathology Systems
- CDRH Launches Probe into Radiation Overdoses
- GHTF Outlines Recommendations for a UDI System
- AAMI Vows More Interaction in 2010
- Making Minimotors with Paper: Just Add Liquid
- Italian Researchers Create Synthetic Bone from Wood
- Great Pretenders: Polymer Creates Blood Cell Mimics for Drug Delivery
- Tough Times Breed Opportunity and Optimism in the New Year
- Laser Welding to the Rescue
- The Smile Goes Digital
- Biocompatibility Testing: Tips for Avoiding Pitfalls, Part 1
- Clinical Evaluation Reports: The New Requirement
- Supply-Base Risk: Three Tools to Take the Edge Off
- A Sneak Preview of FDA's Human Factors Standard
- Changes in Europe: The New Landscape for Existing Medical Devices
- Improving the Product Design Process
- Medical Devices Deserve More Respect
- FDA Sees Dollar Signs in Battle with TMJ Implants
- The Future of Brain Health: Precise and Virtual Biopsies
- Punctal Plugs Take Control of Drug Release
- Device Tax Could Suck the “Start” Out of Start-Ups
- FDA Reform Could Pose a Danger to 510(k) Process
- “Bo-Tax” on Cosmetic Surgery
- HHS Outlines Healthcare Reform Effects
- Industry Bullish in 2010, Says Medtech Survey
- Coding Decision Keeps Options Simple For Manufacturers
- Will Breast Care Guidelines Make OEMs Nervous?
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