Manufacturing
Columns
- All
- 3-D Printing/Additive Mfg.
- Assembly & Automation
- Biocompatibility & Testing
- Clean Room
- Coatings/Surface Modification
- Contract Manufacturing
- Design
- Extrusion
- Finishing
- Forging & Casting
- Instruments, Cases & Trays
- International/Offshoring
- Laser Processing
- Machining & Tooling
- Materials
- Molding
- Packaging & Sterilization
- Prototyping
- Research & Development
- Software & Quality
- Staffing, Training & Prof. Dev.
- Supply Chain
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Extremities | Large Joint | Materials | Spine/Neurology
Recycling Implanted Metals From Beyond the Grave
Ever wonder what happens to devices implanted in the body after their users pass away? Probably not, because the thought of it tends to make most people who aren’t ODT editors cringe. But as medical implants become more common, people are dy…Sam Brusco, Associate Editor 09.19.18
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Design
Coming Clean: Developing Standards for Cleaning Reusable Devices and Instruments
Five years ago, I shuddered to read the headlines about “dirty” endoscopes being used in colonoscopies and the speculation that followed. Are colonoscopies really safe? Is this what’s creating new superbugs? Why weren’t hospit…Dawn A. Lissy, President & Founder, Empirical 08.15.18
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Design | Research & Development
Tips to Help Ensure a Successful Surgeon Design Team
Design surgeons and surgeon design times have been at the core of the significant advances that have occurred in the medical device market in the last few decades. Working with surgeon design teams is inspirational, mentally demanding, and exciting.…David C. Kelman, President, Kelman & Company Consulting LLC 08.15.18
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Assembly & Automation | Coatings/Surface Modification | Contract Manufacturing | Design | Extrusion | Machining & Tooling | Molding | Prototyping
The Right Vendors Foster Growth: Why Firms of All Sizes Need to Outsource
I was working as a product development engineer at AcroMed (a spinal implants manufacturer that was acquired by DePuy in 1998), when I noticed a gap in the medical device industry. There were plenty of companies coming up with great ideas for d…Dawn A. Lissy, President & Founder, Empirical 05.29.18
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Extremities | Materials | Spine/Neurology
In Situ Cured Silicone Could Enable Personalized Implants
Medical-grade silicone is a highly valued, versatile biomaterial widely used for medical implants. Often associated with applications such as cardiovascular pacemakers, cochlear implants, hydrocephalus shunts, implantable infusion pumps, and even int…Brian Reilly and Jim Lambert, Ph.D., NuSil, an Avantor brand 05.29.18
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Design | Research & Development
The Hidden Costs of Clinical Trial Agreement Negotiations
Negotiating can be a daunting task, often inducing anxiety in those without much practice. For many, it’s not a skill that develops naturally or easily. Graduate programs offer numerous courses aimed at preparing students for the necessary evil…Megan Florez, Compliance and Reimbursement Associate, Musculoskeletal Clinical Regulatory Advisors 05.29.18
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Design | Research & Development
Product Development in the Changing Healthcare Environment
The healthcare market has been changing over the past 30 years and the speed of change is increasing significantly. During this timeframe, great advances have been made to patient care through new surgical interventions and medical devices. Early on…David C. Kelman, President, Kelman & Company Consulting LLC 05.29.18
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3-D Printing/Additive Mfg.
Will Additive Manufacturing Revolutionize Orthopedic Product Manufacture?
Additive manufacturing is a disruptive fabrication process impacting an array of industry sectors, including healthcare. As such, members of this industry have made bold claims and predictions on the potential for this innovation. How much of this, h…Ali Madani, CEO, Avicenne Medical 05.29.18
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Materials
Material World: Is Titanium the New PEEK?
The fanny pack is back. Give that a minute to sink in. According to Harper’s Bazaar, that’s one of 12 trends we all need to know about for 2018. I don’t spend much time thumbing through fashion tomes, but the occasional doctor&rs…Dawn A. Lissy, President & Founder, Empirical 03.21.18
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Packaging & Sterilization
The Role of Purified Water in Critical Cleaning Applications
High purity water is an absolute essential ingredient to a medical device and biases surgical outcomes toward success.James Dwyer, VP of Technical Operations, Millstone Medical Outsourcing LLC 03.21.18
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Software & Quality
Medical Device Quality: Why Software Is More Challenging Than Hardware
The U.S. Food and Drug Administration’s (FDA) Quality System Regulation 21 CFR Part 820.30(g) states, “Design validation shall include software validation and risk analysis, where appropriate.” The words, “where appropriate,&r…Dan Goldstein, Manager, Quality Assurance, Musculoskeletal Clinical Regulatory Advisors 03.21.18
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Design | Research & Development
Innovation and the Development Engineer
Developing new products is not an easy task to accomplish. It takes a tremendous amount of creativity, fortitude, and sheer dogged determination. And that is just to travel from concept to a final form for commercial sale. Then the true gut wrenching…David C. Kelman, President, Kelman & Company Consulting LLC 03.21.18
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Design | Prototyping
Shop Smart: How to Make the Most of the Prototype Phase
There are two basic types of people: Those who make sweeping generalizations, and those who don’t. (Actually, there’s a third type—one who opens columns with corny jokes and strains to hear the laugh track over the lonely cricket in…Dawn A. Lissy, President & Founder, Empirical 02.12.18
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Software & Quality
Managing Deviations and Adequately Recording Failures
According to the ECA Academy, managing deviations and Corrective and Preventive Actions (CAPAs) are still the focus of inspectorates. The summaries of their observations show deficiencies relating to quality systems are by far the most frequently obs…Emily Ysaguirre, Content Marketing Writer, EtQ 11.21.17
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Software & Quality
Honesty Is the Best Policy: Data Integrity in the Life Sciences
Very few industries see an overlap in big data and ethics like the life sciences. Manufacturers often face the decision between reporting honest test results and those that are favorable. Consequently, altering data is an increasing issue in the life…Alexa Sussman, Content Marketing Writer, EtQ 10.02.17
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3-D Printing/Additive Mfg. | Prototyping
Pro Tips for Prototypes: The Smart Way to Manage Device Iterations
There’s something about hitting the prototype stage of the development cycle that makes everything finally seem real. This is the point at which there is finally an object to hold in your hands—a physical representation of the vision, inv…Dawn A. Lissy, President & Founder, Empirical 08.15.17
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Software & Quality
4 FAQs: Medical Device Single Audit Programs
Audits and inspections are essential parts of medical device manufacturing. Yes, they can be a pain point for many organizations since they require a lot of preparation and may happen unexpectedly. But they are an essential way to keep manufacturers…Alexa Sussman, Content Marketing Writer, EtQ 08.15.17
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Software & Quality
The Importance of an Integrated QMS Within Regulatory Industries
The life sciences market is constantly evolving, and automated quality and compliance solutions must follow suit. The ability to interact, collaborate, and coordinate across the board is key to uncovering gaps in processes and creates visibility betw…Emily Ysaguirre, Content Marketing Writer, VERSE Solutions 05.19.17
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Software & Quality
Three Places for Risk Management in Life Science Organizations
By now, the concept of risk probably isn’t a brand new one—it has entered into many regulations, standards, and best practices. Risk-based thinking has become a cornerstone in many industries, especially those as critical as the life scie…Alexa Sussman, Content Marketing Writer, EtQ 03.22.17
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Biocompatibility & Testing
Testing…Testing…Is This Thing On? Should You Outsource Device Testing or Keep it In-House?
When people ask me what I do, I often reply, “I break things for a living.” Yes, I say it with tongue firmly in cheek. That’s a gross oversimplification of a business I’ve been in for almost 20 years: mechanical testing for…Dawn A. Lissy, President & Founder, Empirical 03.22.17
