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Articles in category: Legal, Clinical & Regulatory

Clinical Data and CE Mark: What are We Doing Wrong?

by Carolyn LaWell | Mar 2017

A reader called saying companies are failing the clinical evaluation portion of the initial CE Mark or audit process and asked what insights could we offer now and at OMTEC? Here's our response....

Read more »

Once an Easy Path, Europe’s Regulatory Approval Toughens

by BONEZONE | Mar 2017

Enactment of the EU's Medical Device Regulations is expected to increase challenges for orthopaedic companies seeking CE Mark Approval.... Read more »

FDA Update: Final Guidance on Medical Device Reporting

by BONEZONE | Jan 2017

FDA has issued final guidance on Medical Device Reporting (MDR) for Manufacturers. The goal of the guidance, says FDA, is to detect and correct device problems in a timely manner.... Read more »

A Watchful Eye on Device Performance can Decrease Postmarket Surveillance Burdens

by John Gagliardi | Jan 2017

Our global industry requires companies to develop harmonized postmarket surveillance systems that minimize inconsistencies in our understanding of product lifecycle risks.... Read more »

One Answer to Your Postmarket Challenge: Planning

by Julie Vetalice | Dec 2016

Planning goes a long way in moving from premarket to postmarket data collection. Vicki Anastasi, an OMTEC 2016 speaker, suggests the best way to start.... Read more »

Building Your Bridge to the Island of ISO 13485:2016

by John Gagliardi | Nov 2016

Medical device companies have until March 1, 2019 to update their quality management systems to the ISO 13485:2016 standard. The simultaneous introduction of the Medical Device Single Audit Program and transitions to ISO 9001:2015 will leave manufacturers busy and certification bodies slammed. There... Read more »

Clinical Data: A Snapshot of Recent Announcements

by BONEZONE | Nov 2016

Your surgeon and hospital customers will continue to demand clinical and economic data, no matter the type of implant or the size of your company. Wherever your responsibilities lie within your company, it’s important to consider how your work contributes to better patient outcomes, and know ... 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 »

Reimbursement in Spine: A NASS Priority

by Julie Vetalice | Sep 2016

In order for commercialization to succeed, everyone needs to be paid. Be proactive for you and your customers by making reimbursement a part of your development timeline.... 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 »

Making the Most of UDI

by Chris Mosby | Aug 2016

UDI regulations have altered your business. Gaining solid ROI from your compliance efforts comes down to internal efficiency, capturing your own master data and learning how to use that data for product development, marketing and logistics.... Read more »

Cartiva Receives FDA PMA for Synthetic Cartilage Implant

by BONEZONE | Jul 2016

Cartiva received FDA Premarket Approval for the Synthetic Cartilage Implant to treat arthritis of the great toe. This is reported to be the first synthetic cartilage device and the first product in the forefoot to gain FDA approval.... Read more »

FDA Guidance Outlines How to Create a Unique Device Identifier

by Carolyn LaWell | Jul 2016

FDA recommends companies reexamine UDI basics with new draft guidance on how to form a proper identifier.... Read more »

How to Register Your Device in Australia

by Chris Mosby | Jul 2016

This article provides a high-level view of how a company can enter the Australian market and leverage their CE Marking in the process.... Read more »

3 Points to Consider from the Long-Awaited EU Medical Device Regulations

by Hannah Corcoran | Jul 2016

The new EU Medical Device Regulations could make it tougher for orthopaedic device manufacturers to do business in Europe.... Read more »

Third Party Reviews – Is This the Real Deal?

by John Gagliardi | Jun 2016

Companies with simpler products like arthroscopes and surgical instruments could consider a regulatory route that doesn't start with FDA and instead utilize the Third Party Review program. The benefits to doing so include speeding time to market and saving time and resources for more complex 510(k) ... Read more »

Trade Secrets Go Federal

by John W. Boger, Esq. | Jun 2016

Passage of the "Defend Trade Secrets Act" (DTSA) federalized the trade secret law. One of the key aspects of DTSA is that companies will now be allowed to file civil lawsuits in Federal court if their trade secrets have been stolen, possibly creating a new level of consistency in how trade secret la... Read more »

Invibio Settles FTC Antitrust Allegations Concerning PEEK Market

by BONEZONE | May 2016

Invibio, the first company to sell implant-grade polyetheretherketone or PEEK, agreed to settle Federal Trade Commission (FTC) charges that it violated antitrust law by using long-term, exclusive contracts to maintain a market monopoly.... Read more »

FDA Issues Draft Guidance on Additive Manufactured Devices

by Carolyn LaWell | May 2016

FDA published draft guidance on technical considerations for additive manufactured devices in response to the technology’s advancements and investments. Among the top concerns of FDA and industry are post-processing, cleaning and sterilizing devices.... Read more »

Supplier Quality Agreements Are Not Just a Handshake Anymore

by John Gagliardi | Apr 2016

Regulatory bodies do not see supplier quality agreements as a new requirement. They also expect medical device manufacturers to require suppliers to conduct remediation where required and within documented timelines. It is appropriate to use a risk management approach to prioritize required focal po... Read more »

FDA Releases UDI Education as Deadline Approaches

by BONEZONE | Apr 2016

FDA released a series of resources to help companies understand GUDID submission, UDI labelling regulations and compliance schedules. The resources include slideshow presentations and video interviews with FDA.... Read more »

FDA Releases Final Guidance on Human Factors and Usability Engineering

by BONEZONE | Apr 2016

The Agency released the final guidance on considerations for human factors data in premarket submissions, as well as two draft guidances on the topic.... Read more »

Proving Medical Necessity: the Need for Evidence in Reimbursement

by BONEZONE | Mar 2016

Providers, OEMs and suppliers all say that they’ve been impacted by complexities in the reimbursement system. For example, bundled payments and an increased burden of evidence have changed the way that products are developed and launched. One theme has arisen from the many conversations—not a ne... Read more »

New Guidance for UHMWPE Submissions

by BONEZONE | Feb 2016

FDA recently released draft guidance outlining new information companies must include when submitting devices with Ultra High Molecular Weight Polyethylene (UHMWPE) for approval. ... Read more »

The Revitalized ISO 13485: Ready for Business

by John Gagliardi | Feb 2016

The ISO 13485:2016 Standard is slated for publication in March 2016. Consider these eight changes when updating your certification.The internationally-recognized medical device industry quality management systems (QMS) standard has been under revision since 2010. The newest version of ISO 13485 (201... Read more »

A Look at FDA’s 2016 Priorities, Status of 2015 Priorities

by BONEZONE | Jan 2016

FDA released its annual priority list for the new year, as well as previously-issued final guidance documents, on which CDRH is accepting feedback as part of its retrospective review.... Read more »

UDI Update: Trays and Kits

by BONEZONE | Jan 2016

FDA released draft guidance for its Convenience Kit exemption, offering orthopaedic device manufacturers more direction on labeling device trays and kits with unique identifiers (UDIs). The proposed change would clarify the definition of convenience kit, reducing the number of accepted exemptions an... Read more »

Adaptive Designs Provide Clinical Trial Flexibility

by Hannah Corcoran | 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 »

UDI Ruled a Requirement for EHRs

by BONEZONE | Dec 2015

A final rule issued by the Office of the National Coordinator for Health IT of the U.S. Department of Health and Human Services will require providers to incorporate UDIs into electronic health records, allowing providers to track devices used by their patients at any point of care.... Read more »

Harvesting Engineers’ Ideas through Invention Disclosure

by John W. Boger, Esq. | Dec 2015

The key precursor to the development step is the “harvesting effort.” Answering specific questions allows inventors to organize their thoughts and give a clear explanation about their invention.... Read more »

Big Data Tops FDA’s 2016 Priorities

by Carolyn LaWell | Nov 2015

FDA’s Center for Devices and Radiological Health (CDRH) plans to embrace the use of big data and patient reported outcomes in regulatory decision making, according to its 2016 Regulatory Scientific Priorities.... Read more »

3D Printing, Cybersecurity Emerging Concerns for Device Manufacturers

by Hannah Corcoran | Nov 2015

Additive manufacturing and the domination of digital communication and information transfer pose new concerns for manufacturers.... Read more »

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

by John W. Boger, Esq. | Sep 2015

This article outlines the stages of the R&D process and the corresponding parallel issues that the legal department would want addressed either prior to or at the same time.... Read more »

FDA Outlines Critical Quality Measures

by BONEZONE | Sep 2015

FDA’s Director of the Division of Manufacturing and Quality discussed recent Agency initiatives that emphasize quality over compliance.... Read more »

CMS Targets Hip and Knee Reimbursement

by BONEZONE | Aug 2015

The U.S. Centers for Medicare & Medicaid Services (CMS) proposed a bundled payments program to accelerate value-based care that, once passed, could impact hip and knee implant pricing.... Read more »

Master Your Sterilization Process

by BONEZONE | Aug 2015

At OMTEC® 2015, Jozef Mastej, Vice President of Operations, Gibraltar Laboratories, Inc. outlined the cleaning and sterilization validation process for reprocessing reusable devices.... Read more »

ISO 9001 Drastically Revised

by Robert Packard | Aug 2015

The ISO 9001:2015 standard is a major revision that will require significant time and resources to determine the best way to implement the revised quality system. Most companies will need all three years of the transition period for compliance.... Read more »

The Dos and Don’ts of Trademark Registration

by John W. Boger, Esq. | Aug 2015

The investment of time and money to obtain trademarks may take a significant hit if the respective trademarks are not properly used and noted. This article serves to suggest best practices regarding a company’s use of its trademarks.... Read more »

New UDI Draft Guidance Addresses Direct Marking of Reprocessed Devices

by BONEZONE | Jul 2015

FDA’s most recent UDI draft guidance, Unique Device Identification: Direct Marking of Devices, addresses common questions posed by labelers preparing for the September 24, 2015 compliance deadline.... 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 »

FDA Outlines Stance on ex-U.S. Clinical Data

by Hannah Corcoran | Jun 2015

In a recent draft guidance, FDA describes what device companies should consider when submitting OUS clinical data for regulatory approval in in the U.S.... Read more »

FDA Launches Searchable UDI Database

by BONEZONE | Jun 2015

FDA recently announced the launch of AccessGUDID, a website that allows users to search and download information on devices that require identification.... Read more »

Mobile Medical Apps Attract OEM, FDA Attention

by Prithul Bom, MBA, RAC | Jun 2015

Mobile communication devices are radically changing the way we think and make decisions about our healthcare. Manufacturers developing medical mobile applications must understand FDA’s regulatory stance.... Read more »

Training Your IP Police Force to Catch Infringement

by John W. Boger, Esq. | May 2015

It is critical for all companies to establish and properly train their own IP police force to enforce their own protected inventive designs.... Read more »

Big Changes in ISO 13485:2015?

by Robert Packard | May 2015

On February 5, 2015, a second draft of ISO 13485 was released to the world for comment. How will new quality system requirements in the latest version of ISO 13485 affect you?... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | May 2015

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space. An asterisk denotes those receiving their first clearance for an orthopaedic product.... Read more »

CDRH Proposes Nationwide Postmarket Surveillance System

by BONEZONE | Apr 2015

The Center for Devices and Radiological Health has proposed a National Medical Device Postmarket Surveillance System expected to serve the needs of patients, clinicians, payors and manufacturers.... Read more »

How to Avoid Risky CAPA Decisions

by John Gagliardi | Mar 2015

When non-conformity is identified, your company must determine the significance, the associated risk and the potential for recurrence. Manufacturers must determine a common denominator that helps with the decision-making.... Read more »

You Secured a Utility Patent; Now What about Your Design Patent?

by John W. Boger, Esq. | Mar 2015

Recent high-profile lawsuits have demonstrated the importance of design patents to protect inventions. Understand the difference between a design and utility patent to ensure that your IP portfolio is appropriately armed against attack.... Read more »

The Basics: Understanding the Medical Device Single Audit Program

by Robert Packard | Feb 2015

MDSAP was launched to leverage resources of regulatory bodies in the U.S., Canada, Brazil and Australia to monitor device manufacturers. Here is a breakdown of how the pilot program works and each country’s participation.... Read more »

CAPA+2, UDI and More: What to Expect from FDA in 2015

by Hannah Corcoran | Feb 2015

Ensure that you’re prepared for FDA’s 2015 plans. Keep your compliance in check with this expert perspective.... Read more »

Actions Underway in a Push to Repeal the Medical Device Tax

by BONEZONE | Jan 2015

With support from both major parties, U.S. legislators have introduced bills in renewed attempts to repeal the medical device tax.... Read more »

Compliance Isn’t Accidental: A Case for Management’s Commitment to Quality

by John Gagliardi | Jan 2015

Leadership must foster a culture of business and quality equilibrium to drive long-term product and company success. That commitment involves proper planning, employee training and performance measurement.... Read more »

FDA Publishes Priorities for 2015

by BONEZONE | Jan 2015

FDA’s Center for Device and Radiological Health issued its list of priorities for 2015, including guidance documents it intends to publish and other initiatives.... Read more »

Why Won’t My CAPA Process Work?

by John Gagliardi | Dec 2014

Having a viable CAPA process in place is critical, in a time of frequent recalls, increased warning letters for repeat offenders and burdensome reporting requirements.... Read more »

Unique Device Identification (UDI): Many Questions Remain

by Karen Conway | Dec 2014

FDA issued its final rule requiring medical device manufacturers to assign and label products with UDIs more than a year ago. However, many questions remain for orthopaedic and spine manufacturers.... Read more »

How to Get the Most Out of Your IP Firm

by John W. Boger, Esq. | Dec 2014

Device companies often mistakenly focus solely on patents to protect their ideas. Taking this narrow approach could hurt the long-term growth of the company.... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Dec 2014

Discover which orthopaedic companies recently received strategic FDA 510(k) clearances to market their products.... Read more »

FDA Extends UDI Compliance Date for Certain Orthopaedic Implants

by BONEZONE | Dec 2014

A variety of fixation screws, plates and spinal devices will not need to meet UDI labeling requirements until 2016.... Read more »

Preparation for Spinal Reclassification Under Way, Despite Pending EU Regulations

by Carolyn LaWell | Nov 2014

While the EU has yet to set a completion or implementation date for spine implant reclassification, manufacturers shouldn’t wait to prepare.... Read more »

FDA Focuses on Properties and Biocompatibility of AM Medical Devices

by Hannah Corcoran | Nov 2014

Understand FDA’s current thinking on the regulatory process for additive manufactured devices.... Read more »

FDA Surveillance Inspections and Warning Letters Decrease

by Hannah Corcoran | Nov 2014

A CDRH quality system data report offers insight into common observations from 2013. Familiarize yourself with these trends and action items to avoid quality issues.... Read more »

FDA Addresses Custom Device Exemptions

by Hannah Corcoran | Nov 2014

FDA clarified changes to the Custom Device Exemption provision through a final guidance document.... Read more »

FDA Seeks 21st Century Agility with 510(k)s

by John Gagliardi | Oct 2014

FDA introduced several changes, including new initiatives to clarify the 510(k) submission process. How will these changes affect your device’s pathway to market clearance?... Read more »

Can I Make, Use and Sell My Patented Invention? The Answer May Surprise You

by John W. Boger, Esq. | Oct 2014

Obtaining a patent does not always guarantee the ability to build and commercialize your invention. Follow these tips to avoid infringement and ensure success.... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Oct 2014

See which orthopaedic companies recently received 510(k) clearances to market their products.... Read more »

FDA Publishes Q&A on UDIs

by BONEZONE | Sep 2014

The deadline for Unique Device Identifier (UDI) implementation for medical devices is September 24, 2014. FDA has issued a 14-page Q&A document to help manufacturers prepare.... Read more »

Experts Offer Strategies for Clinical Trial Execution and Outsourcing

by Hannah Corcoran | Sep 2014

Experts share their insights on best practices and strategies for conducting clinical trials inside and outside of the U.S., as well as ways to manage outsourcing of the process to a partner.... Read more »

FDA Clarifies Substantial Equivalence Requirements for 510(k) Submissions

by Justin Rowland | Sep 2014

FDA attempts to clarify substantial equivalence requirements in its latest 510(k) guidance. What do these changes mean for your next submission?... Read more »

Choosing Materials in a Shifting Global Regulatory Environment

by BONEZONE | Aug 2014

Orthopaedic device manufacturers face increasing pressures related to the safety of raw materials used in implants and instruments. Consider these factors when determining material utilization for a new product.... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Aug 2014

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space. An asterisk denotes those companies receiving first clearance for an orthopaedic product. ... Read more »

Effective Tools for Patent Searches

by BONEZONE | Jul 2014

Management has given the go-ahead to design a new device. As an engineer, you’ll now conduct a patent search to ensure that your technology won’t infringe upon other patents. What tools—free or otherwise—should you use to ensure that your search is comprehensive?... Read more »

Protecting Inventions and Brands: IP Due Diligence in the Product Development Process

by John W. Boger, Esq. | Jun 2014

The importance of IP due diligence is often overlooked when bringing an orthopaedic device through each of the eight stages of product development.... Read more »

UDI Implementation: What are Your Next Steps?

by Jonathan Bretz | Jun 2014

Creating a playbook or strategic plan is an absolutely necessary step of UDI implementation. The major components of your plan should include these steps.... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | May 2014

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space: Arthrosurface, Ellipse Technologies, Extremity Medical, Flower Orthopedics, MTP Solutions, Nexus Spine, Prosidyan and Tyber Medical. ... Read more »

How Far is “Possible” for Risk Management?

A controversial interpretation of the medical device CE Marking requires risk reduction without room for economic consideration. This approach conflicts directly with the Essential Requirements of the European Medical Device Directives. In order to comply, manufacturers need to carefully review proc... Read more »

Five Steps to Regulatory Strategy Development

by Mark D. Kramer, RAC | Mar 2014

Regulatory requirements continue to evolve and become increasingly complex. A solid strategy and execution can maximize opportunity to achieve regulatory goals and provide competitive advantage.... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Mar 2014

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space: Benvenue Medical, Edge Orthopaedics, Integrity Spine, Lanterna Medical Technologies, Mikron Makina, MTP Solutions, Toby Orthopedics, Virak Orthopedic Research. ... Read more »

Five Ways to Prevent Complaint Handling Pitfalls

by Robert Packard | Mar 2014

Learn how to avoid receiving 483s from other's previous mistakes. This article analyzes the five most common 483s related to 21 CFR 820.198, reviews what FDA inspectors typically find that results in a 483 and what FDA inspectors hope to find.... Read more »

3D Printing and IP: Can They Coexist?

by John W. Boger, Esq. | Mar 2014

Analysts have predicted that by 2018, 3D printing will result in a loss of $100 billion per year in IP globally. Here is a look at why enforcing one’s IP against 3D printer infringers will be challenging.... Read more »

CDRH 2014-2015 Priorities Focus on Clinical Trials and PMAs

by BONEZONE | Feb 2014

CDRH's 2014-2015 Strategic Priorities address the difficulty that manufacturers face in seeking and obtaining regulatory approvals.... Read more »

FDA Publishes List of Priorities for 2014

by BONEZONE | Jan 2014

FDA’s Center for Device and Radiological Health issued a list of guidance documents that it intends to publish in FY2014. The topics that might be of interest to orthopaedic device companies include the following.... Read more »

FDA Posts 510(k) Communication Timeline

by BONEZONE | Jan 2014

FDA has developed a timeline that provides 510(k) applicants with an understanding of communication during the review process.... Read more »

FDA Promotes Voluntarily Correcting Violations with New Program

by BONEZONE | Jan 2014

FDA recently announced details of a new pilot program that will allow medical device companies to voluntarily identify and correct regulatory violations rather than undergo FDA inspection.... Read more »

The Hague Agreement: It May Save You Money

The Hague Agreement more closely aligns U.S. design patent laws with the international community. It also provides flexibility when filing and can save money. There are a few notes of caution to consider, though.... Read more »

U.S. OIG Issues POD Report; Reliance Medical Files a Suit

by BONEZONE | Dec 2013

The U.S. Office of Inspector General of the Dept. of Health and Human Services' overview of prevalence and use of physician owned distributors (PODs) of spinal devices does not make specific recommendations for action, but notes that in FY11, PODs supplied devices used in ~1 in 5 spinal fusions bill... Read more »

National Joint Registry for England, Wales and Northern Ireland: Findings from 10th Annual Report

by BONEZONE | Dec 2013

The NJR Steering Committee launched its tenth report in late September. Data from more than 1.4 million procedures are now registered with considerable growth expected now that elbow and shoulder replacement data collection is underwayand Northern Ireland has joined the NJR . The report also contain... Read more »

CMS Issues Proposed Decision Memo for Percutaneous Image-guided Lumbar Decompression for Lumbar Spinal Stenosis

by BONEZONE | Dec 2013

The U.S. Centers for Medicare & Medicaid Services proposes that Percutaneous Image-guided Lumbar Decompression for lumbar spinal stenosis is not reasonable and necessary. Therefore, CMS proposes that PILD for LSS is non-covered by Medicare.... Read more »

Start Early: Converting Your Spinal Technical File into a Class III Design Dossier

by Robert Packard | Dec 2013

As part of EU Commission regulatory changes, spinal implants will be reclassified from Class IIb devices to Class III devices. OEMs with spinal implants on the market should be proactive and start planning for reclassification now.... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Dec 2013

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space: Altus Spine, Anchor Innovation, Beijing Libeier Bio-Engineering Institute, Binder Biomedical, Corentec, Elite Surgical, Innovative Surgical Designs, Intelligent Implant, Jeil Medical, NovoSource, Tybe... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Nov 2013

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space: Binder Biomedical, Corentec, Jeil Medical, NovoSource, ORTHOSoft, Renovis Surgical, Tyber Medical, Vertebral Technologies.... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Oct 2013

The following companies recently received strategic FDA 510(k) clearances: Advanced Interventional Technology, CoreNexus, Crosstrees Medical, Emerge Medical, Ingen Orthopedics, JG Spine, Next Orthosurgical, Osseus Fusion Systems, Shanghai Sanyou Medical and Vivorte.... Read more »

Mitigate Patent Infringement Risk with an FTO

by John W. Boger, Esq. | Oct 2013

Performing an FTO search is a critical tool when developing or getting ready to launch a new product. Here's how to execute the three-stage process.... Read more »

Presenting Data to Show Product Cost Effectiveness

by Isabella Sledge, M.D. | Oct 2013

Shifts in the marketplace are driving a need to collect and position clinical data in order to show product effectiveness. OEMs can successfully commercialize new technologies by adopting these measurements.... Read more »

FDA Finalizes UDI Requirements

by BONEZONE | Sep 2013

Final rule does not mandate direct part marking for implantable devices, provides manufacturers of Class III implants one year to comply.... Read more »

How to Choose a Notified Body

by BONEZONE | Sep 2013

The right Notified Body will support device manufacturers in accomplishing current and long-term goals. Here are questions to ask and trends to consider when searching for the right partner.... Read more »

Postmarket Studies in Lieu of Clinical Trials

A strategic combination of premarket and postmarket clinical studies proactively establishes a process to identify design problems and generate revenue sooner.... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Aug 2013

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space: Pantheon Spinal, Pinnacle Spine, Spine Wave, Synergy Biomedical, X-Spine Systems. ... Read more »

How to Avoid Major FDA Inspection Mistakes

by Robert Packard | Jul 2013

Don’t let these details get lost in the preparation and follow up for FDA inspections.... Read more »

UDI Update: Prepping for the Final Ruling

by Karen Conway | Jul 2013

OEMs should be asking, and answering, these 11 questions in anticipation of FDA’s final ruling on UDI guidelines.... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Jun 2013

The following companies recently received strategic FDA 510(k) clearances: Apogee OrthoSolutions, Biomedical Enterprises, Cleveland Clinic/Custom Orthopaedic Solutions, Institute of Musculoskeletal Science & Education, Metasurg, NovoSource, NUTEK Orthopaedics, Pantheon Spinal, Providence Medical... Read more »

The Race to the Patent Office Is On

New regulations have converted U.S. patent law from a “first-to-invent” to a “first-inventor-to-file” system. These best practices will ensure you or your company don’t miss out on intellectual property.... Read more »

Seven Ways to Investigate Complaints When Devices Aren’t Returned

by Robert Packard | Jun 2013

One of the challenges in product complaint handling is making sure you’ve done enough when you’re unable to verify the complaint. These steps lead to a successful investigation process.... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | May 2013

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space: Alphatec Spine, Biomecanica Industria e Comerico, Dallen Medical, Facet-Link, Flower Orthopedics, Global Manufacturing Technology, Kalitec Direct, Maxim Surgical, Myelotec, Orthopaedic Implant Company... Read more »

Navigating the Clinical Research Paradigm for Cost Savings and Efficiencies

by Marcy Rogers | May 2013

By working effectively through the timelines and deliverables from reimbursement, the regulatory pathway, data requirements and clearance, companies can bring their orthopaedic devices to market on schedule, on budget and in regulatory compliance.... Read more »

Design Control Hot Buttons to Expect During an FDA Inspection

by John Gagliardi | May 2013

FDA evaluates the methods and procedures that a manufacturer has established to implement design control requirements. During an inspection, attention is turned to these design linkages.... Read more »

Six Steps to ISO 13485 Certification

by Robert Packard | May 2013

ISO 13485 Certification is the quickest pathway to achieving CE Marking approval. Manufacturers should follow these sequential steps as a roadmap to certification.... Read more »

What if Your ISO Auditor is Wrong?

by Robert Packard | Apr 2013

Auditors are human. The question is: What should you do when they're wrong?... Read more »

Just Because You’re Trained, Doesn’t Mean You’re Competent

by John Gagliardi | Apr 2013

Orthopaedic device manufacturers must define the requirements for each job, evaluate the people in those jobs, develop a gap examination for each person and then create a plan to close those gaps.... Read more »

Strategic Orthopaedic 510(k) Update

by BONEZONE | Apr 2013

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space: Alphatec Spine, Biomecanica Industria e Comerico, Dallen Medical, Flower Orthopedics, Global Manufacturing Technology, Kalitec Direct, Maxim Surgical, Myelotec, Orthopaedic Implant Company, Orthopro, ... Read more »

Get Ready for UDI: It’s All About the Data

by Karen Conway | Mar 2013

Orthopaedic OEMs will be among the first to comply with FDA's unique device identification requirements once finalized. However, the complex nature of UDI means OEMs can’t wait for the final announcement to put processes in place.... Read more »

FDA Releases New Requirements for Combination Products

by BONEZONE | Mar 2013

FDA's final rule on cGMP for combination products provides a definition of these products and the new requirements.... Read more »

Trademarks vs. Domain Names, Part II: There is a BIG Difference

by John W. Boger, Esq. | Feb 2013

What happens if your trademark or company brand becomes a victim of cybersquatting? Part II on trademarks vs. domain names provides legal steps that can be taken to protect you or your company's name.... Read more »

Rethinking the Role of Clinical Affairs

by Joel Batts | Feb 2013

“Clinical” has become virtually synonymous with Investigational Device Exemption and Premarket Approval. Really, clinical affairs should be viewed as a multi-related, multi-obligated team that collectively defines an OEM.... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Feb 2013

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space: Camber Spine, Eleven Blade Solutions, K7, LSK BioPartners, Metric Medical Devices, Stanmore Implants... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Jan 2013

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space: B2B Spine, Brainlab, Christopher D. Endara, Emerge Medical, Everest Spine, Fairway Medical, Foundry (Newco XI), Frontier Medical, InSurgical, NCS Lab, Ouroboros Medical, Stabiliz Orthopaedics, Z-Medic... Read more »

Making Smarter Product Recall Decisions: 4 Critical Steps to Meeting FDA’s Expectations

by Martin Browning | Dec 2012

FDA’s multi-layered rules for product recalls can resemble a double-edged sword. Have you under-reported your recall? Over-reported? How can you find middle ground and ensure compliance? Martin Browning proposes a 4-step decision process.... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Dec 2012

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space: Alliance Spine, Aston Medical, Iconacy Orthopedic, Implanet, Intelligent Implant Systems, Osseon Therapeutics, Providence Medical, Safe Orthopaedics, Shanghai Kinetic, Shoulder Options, Weigao Orthopa... Read more »

Trademarks vs. Domain Names, Part I: There is a BIG Difference

by John W. Boger, Esq. | Dec 2012

What happens if there is a dispute over the use of your domain name, or if someone is using your trademark as a domain name? It’s tempting to lump both under the heading “cybersquatting,” but they are not. Cybersquatting is the act of registering, selling or using a domain name with the intent... Read more »

The IPXI® - An Alternative to the License Agreement? Maybe!

by John W. Boger, Esq. | Oct 2012

  Monetizing intellectual property is the process of deriving tangible value from the IP or the technology that is protected by the IP. Currently, however, there are only a limited number of ways of deriving such value. For example, monetizing a patent usually follows one of two paths: 1) deri... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Oct 2012

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space. For certain companies, this represents a first clearance of an orthopaedic-related product. These are denoted with an asterisk. Accel SpineMatisse Anterior Cervical Interbody Fusion Cage, K121569*•... Read more »

The IP License Agreement: A View from 5,000 Feet

by John W. Boger, Esq. | Aug 2012

It is commonplace for medical device manufacturers to “license” technology to allow them to either manufacture, sell or develop a product. Licensing of patents, trademarks, copyrights or trade secrets (collectively, intellectual property or IP) from third parties is governed by a special kind of... Read more »

Medicare: Trends in Beneficiaries Served and Hospital Resources Used in Implantable Medical Device Procedures

by BONEZONE | Aug 2012

Results from a U.S. government agency report summarize data on average length of stay, patient characteristics, discharges, etc. Highlights include: In the U.S. in 2009, knee, hip and shoulder replacement and lumbar fusion procedures accounted for 98% of Medicare's orthopaedic implantable device ... Read more »

The Post-Market Imperative: Understanding the requirements for effective post-market clinical follow-up

by Hamish Forster | Aug 2012

In my previous BONEZONE article, “Basic Anatomy of a Design Dossier” (BONEZONE March 2011), I presented an overview of the key elements required within technical documentation in order to demonstrate conformity to the Medical Device Directive (MDD) 93/42/EEC. A key requirement is post-market su... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Aug 2012

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space. For certain companies, this represents a first clearance of an orthopaedic-related product. These are denoted with an asterisk. CitieffeExternal Fixator, K113384 For knee or elbow applications Fo... Read more »

Building a Basic Good Clinical Practice Foundation to Weather the Storm

OMTEC 2012 opening panel presenters, consisting of David Floyd, Bill Plovanic, Bill Kolter and Brian Moore, painted a compelling picture of the current status and upcoming challenges facing the orthopaedic industry.  According to the panel, orthopaedic sales, which saw a decline in 2010, now ap... Read more »

The Anatomy of a Warning Letter, Part Two: Excerpts and Response Strategies

by John Gagliardi | Jun 2012

This is the second of two articles dealing with the FDA Warning Letter, in which we’ll look at actual letter excerpts with recommended strategies to respond to FDA in a compliant and effective manner. As discussed in the prior article (See BONEZONE, March 2012), when FDA finds that a manufacturer ... Read more »

Trademark Searches and Availability Opinions

by John W. Boger, Esq. | Jun 2012

Branding of products and services is the key to success for almost any medical device company. For example, the NexGen® Knee by Zimmer, Rapid Recovery® Services offered by Biomet and the X-Stop® IPD® System owned by Kyphon are all well-recognized brand names in the orthopaedic marketplace. If th... Read more »

The Orthopaedic Regulatory and Clinical Affairs Program at Grace College: A Joint Partnership

by BONEZONE | Jun 2012

Grace College shares an address with a $38 billion global industry in Warsaw, Indiana, the orthopaedic capital of the world. Today, device innovators like Biomet, DePuy and Zimmer are also getting into the business of education—out of necessity. The Lilly Endowment, an Indiana-based foundation th... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Jun 2012

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space. For certain companies, this represents a first clearance of an orthopaedic-related product. These are denoted with an asterisk. Ascendx Spine Acu-Cut Vertebral Augmentation System, K113452 For use... Read more »

Daily Documentation Essentials: A Tour of the Regulatory Binder

The road to market approval for orthopaedic devices can be long and arduous, but it is impossible without valid data. Regulations governing practices in clinical research demand the highest level of ethical and clinical standards, with patient protection as the highest priority. Historical precedent... Read more »

The Anatomy of a Warning Letter, Part One: A Primer

by John Gagliardi | Mar 2012

This is the first of two articles dealing with the dreaded Food & Drug Administration (FDA) Warning Letter. This first article is an introduction, if you will, to Warning Letters. The second article will contain actual warning letter excerpts with a recommended strategy to respond to FDA in a co... Read more »

An Introduction to Patent Opinions

by John W. Boger, Esq. | Mar 2012

Whenever a medical device company develops a new product, process or technology, the topic of getting an “opinion” inevitably arises. Many different types of patent or Intellectual Property (IP) opinions exist, each one with a specific purpose. If one were to follow the typical product developm... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Mar 2012

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space. For certain companies, this represents a first clearance of an orthopaedic-related product. These are denoted with an asterisk. Arrowhead Medical Device TechnologiesArrow-Lok Digital Fusion System, K... Read more »

510(k) Clinical Data Requirements: Current Status and Considerations for Clinical Studies

In an effort to promote innovation while protecting the population at large, the US Food and Drug Administration (FDA) has for several years been on a course to revise the existing regulatory pathway surrounding the 510(k) process for medical devices. One topic of concern focuses upon clinical data.... Read more »

IP Portfolio Management Strategies for Medical Device Manufacturers

by John W. Boger, Esq. | Dec 2011

Management of a company’s intellectual property (IP) is all about two things: controlling the innovation produced by the Research and Development (R&D) staff and transforming these ideas in valuable assets, and coordinating the R&D innovation output with the sales and marketing strategy of... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Dec 2011

The following companies recently received strategic FDA 510(k) clearances for devices in the orthopaedic space. For certain companies, this represents a first clearance of an orthopaedic-related product. These are denoted with an asterisk. Algea TherapiesAffirm Vertebral Compression Fracture System... Read more »

Final Office Action Rejections for Patent Applications: It Ain’t Over until the Fat Lady Sings…Usually

by John W. Boger, Esq. | Oct 2011

The patent process can be a long and, at times, tedious process. Many inventors assume that once you file your application with the United States Patent and Trademark Office (USPTO), the hard work is done. Unfortunately, for most cases, the hard work has just begun. It is highly unusual for a patent... Read more »

The CMS/FDA Proposed Parallel Review Process: Can One Clinical Trial Really Satisfy Two Agencies?

by Kelli Hallas | Oct 2011

Readers: After this story was published, FDA and CMS launched a Pilot Program for Parallel Review of Medical Products. Current information can be found on FDA's web site. −Editor   Medically necessary vs. safe and effective. Can clinical trials, by design, realistically satisfy the needs ... Read more »

BSI Enhances its Medical Device Training Curriculum with RABQSA

by BONEZONE | Oct 2011

RABQSA International (RABQSA) and BSI Group America have co-developed an innovative Medical Devices training curriculum, created for individuals wishing either to become trained to audit to the Medical Devices Standard (ISO 13485) or simply to understand the requirements of a medical devices quality... Read more »

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

by Martin Browning | Aug 2011

Agency Announces Five Key Priorities over Next Five Years Continuously hammered by Congress, news media and the international health community, the U.S. FDA has responded with a five-year plan that could have far-reaching consequences for the medical device industry. In late April 2011, FDA Commis... Read more »

The Reimbursement Top Ten Checklist: Understanding How Coverage, Codes and Payment Impact the Success of a New Medical Technology

by Kelli Hallas | Jun 2011

The product design is flawless. The clinical trial endpoints were met. FDA has given the green light to begin marketing. Manufacturing has ramped up and can accommodate distribution deadlines. The plan is perfect; what could possibly go wrong? Bottom line is this…no matter how unique or innovativ... Read more »

Regulatory, Reimbursement & Clinical Challenges in the Orthopaedic Marketplace

by Mary Fautsch | Jun 2011

The medical device industry faces a number of significant challenges. Federal health care reform, unpredictable U.S. regulatory pathways and an uncertain economic climate are exerting a tremendous amount of pressure on the entire industry. Various segments of the orthopaedic market have been hit esp... Read more »

Patent Reform is On the Way…Maybe

by John W. Boger, Esq. | Jun 2011

For the past several years, Congress has debated several bills that would change the way that patent laws are currently written. The amendments that have been discussed would have significantly changed the way companies, both big and small, do business. The major stumbling block for all past failed ... Read more »

Basic Anatomy of a Design Dossier

by Hamish Forster | Mar 2011

This article summarizes key elements required for technical documentation of medical devices provided by manufacturers in order to demonstrate conformity to the Medical Device Directive 93/42/EEC (MDD). It is intended to provide an overview for regulatory professionals who seek to compile technical ... Read more »

Beware of the Falsely Patent Marking Boogey Man

by John W. Boger, Esq. | Mar 2011

Within the past 18 months, a cottage industry has started to emerge.  This disruptive industry exists to sue companies for allegedly mismarking products or packaging with expired or incorrect patent numbers. Importantly to the readers of BONEZONE, the reach of these “entrepreneurs” has touc... Read more »

Notified Body Requirements for Clinical Literature Evaluation

by Amie Smirthwaite | Dec 2010

The most recent revisions to the European medical devices directive have underlined the importance of clinical data in demonstrating compliance to the Essential Requirements. The first step in this process is the clinical literature evaluation, for which there are three key sources of guidance: ISO ... Read more »

Clinical Strategy Review for CE Marking

by Gert W. Bos, Ph.D. | Dec 2010

The Notified Body British Standards Institution (BSI) has launched the Clinical Strategy Review for manufacturers applying for CE marking. (See Exhibit 1.) This new service helps manufacturers ensure ahead of time that their clinical evaluation plan will be acceptable to meet the regulatory requirem... Read more »

Review of Study Results: FDA Impact on U.S. Medical Technology Innovation

by Julie Vetalice | Dec 2010

FDA Impact on U.S. Medical Technology Innovation, a study released in November 2010, was undertaken to provide a view of medical technology (medtech) industry’s experiences with the current FDA environment. The study addressed the need for quantitative and qualitative data to help evaluate the imp... Read more »

You May Own a Copyright and Not Know It!

by John W. Boger, Esq. | Dec 2010

Copyrights are rampant in the world of orthopaedics and are, most of the time, ignored or forgotten. Copyrights can be quite valuable intellectual property to both an individual and a company and, if used strategically, can provide an immensely competitive edge. Works that are protectable under copy... Read more »

MDD Regulations: What I Wish I Had Known

by Laurel Macomber, M.S. | Sep 2010

Having worked in medical device research and development for over 20 years, I have contributed to many regulatory submissions for both the U.S. and European Union (EU) markets. However, now, as an EU Notified Body technical reviewer, I’ve found that there are many things I wish I had known previou... Read more »

Truth or Myth: Does an International Patent Exist?

by John W. Boger, Esq. | Sep 2010

Almost every inventor has asked, “Can I get an international patent?” The simple answer is, no. Let’s be clear, there is no such thing as an international patent. However, an inventor can file an “international patent application” that essentially takes the place of the many individual fo... Read more »

Pssst…It’s a Secret…Don’t tell anyone!!!

by John W. Boger, Esq. | Jun 2010

Remember back to your youth when keeping secrets was an everyday occurrence? Sometimes it was between classmates or siblings, and the results of not keeping it were temporary. As one grew older, keeping secrets took on a more serious tone as the consequences of disclosure usually had a more signific... Read more »

Filing a Provisional Patent Application – Applicant Beware

by John W. Boger, Esq. | Mar 2010

The world changed as we knew it on June 8, 1995, when the United States Patent and Trademark Office (“USPTO”) was required to implement certain provisions from the GATT Uruguay Round Agreements. One of the modifications that occurred as a result of the GATT Agreements was that the lifetime of a ... Read more »