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Articles in category: Supply Chain Management

Understanding the Critical Differences Between Supplier Audit and Evaluations

by Martin Browning | Dec 2017

Martin Browning from EduQuest provides insight on evaluations and audits: "All of us who conduct audits recognize that most of them are nothing more than snapshots in time. In contrast, an evaluation gathers and analyzes data from all kinds of sources, without physical constraints associated with audits."...

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5 Steps to a Collaborative Supplier Agreement

by Kate Vitasek | Nov 2017

The first step is to candidly discuss three foundational elements for a successful collaborative relationship: trust, transparency and compatibility. This helps both parties to understand to what extent they can build the foundation for their relationship. ... Read more »

NuVasive Restructures Commercialization Leadership Team

by BONEZONE | Sep 2017

NuVasive restructures commercialization team to align strategy, product development and marketing and to integrate global commercial channels while they expand.... Read more »

Leading Supply Chains Adopt These Principles

by BONEZONE | May 2017

As a purchasing or sourcing professional, you face pressures to understand and work with every facet of your own business while simultaneously working with supplier customers who face their own set of demands. At the end of the day, work needs to get done. These principles provide a reminder of rela... Read more »

How to Reduce Cost and Lead Times While Maintaining Margins

by David Finch | Apr 2017

OEMs and suppliers can reduce cost and lead times while preserving or improving margins with numerous initiatives that don't require material or design changes. Simply commit to a cost-focused collaboration that is incorporated into the terms of a master supply or service agreement.... Read more »

Top Tools to Qualify Suppliers

by Robert Packard | Jan 2017

When an OEM specifies weak second-tier suppliers, its first-tier suppliers have fewer resources to devote to its own internal processes. One weak link can prevent the best outcome from occurring. This six-step program helps OEMs ensure that they’re recommending top suppliers throughout the chain.... Read more »

How Often Should You Audit Your Suppliers?

by Martin Browning | Jan 2017

EduQuest, a global team of FDA compliance experts, answers industry’s pressing questions. In this round, the experts offer Supplier Auditing insight.... Read more »

What Should Your Supply Chain Look Like in Five Years?

by BONEZONE | Nov 2016

The supply chain has undergone greater scrutiny as stakeholders question how to find efficiency in process and spend. What changes will this spur to ensure success today—and five years from now? Supply chain experts weighed in at OMTEC 2016.... Read more »

Applying Supply Chain Best Practices From Other Industries

by Chris Mosby | May 2016

OEMs are now more willing to leverage best practices and solutions from other industries. Those sources of inspiration are as diverse as high-tech, e-commerce and retail. While the highly-regulated nature of the industry presents obstacles to adopting new supply chain practices, increasing pric... Read more »

OEMs Achieve Sustainable Manufacturing Costs Through Supplier Relationships

by David Finch | Apr 2016

For cost reductions and supplier relationships to be sustainable, you must address more than just the quoted price. You must attack real supply chain improvement and cost drivers at both the supplier and the OEM with the intent to reduce cost while maintaining or improving margins. This article... Read more »

Supply Chain Experts Recommend Adoption of GPS, RFID, New Technologies

by Chris Mosby | Apr 2016

Supply chain experts from OEMs and 3PLs share thoughts on technologies and trends that will cause the most evolution in orthopaedic logistics for the next decade.... Read more »

Supply, Cost and Quality Lead Concerns among Raw Materials Providers

by BONEZONE | Mar 2016

Supply and demand factors, price pressures and enhanced regulatory scrutiny are expected to influence the raw materials portion of the orthopaedic supply chain in 2016. Eight of the 27 raw material suppliers exhibiting at OMTEC weighed in on these themes.... Read more »

Identifiable and Sterile: Trends Driving Device Packaging

by Chris Mosby | Feb 2016

Unique Device Identification (UDI) and sterilization could be driving influences for the orthopaedic device packaging industry in 2016 and beyond. With increased regulatory guidelines in the form of FDA’s guidance UDI: Convenience Kits, along with tightening price pressures, more companies are loo... Read more »

Outsource Innovation by Tapping into Supplier Expertise

by David Finch | Nov 2015

When it comes to outsourcing, the traditional role of suppliers is based upon their core competencies in manufacturing or specialty services.... Read more »

4 Questions to Answer Before Outsourcing

by David Finch | Oct 2015

Companies jump into supplier selection and contract negotiation without proper preparation and due diligence. This often results in uncovering issues well into the process.... Read more »

Three Spine Companies Implement New Manufacturing Strategies

by Carolyn LaWell | Sep 2015

Alphatec Spine, Globus Medical and NuVasive, the three largest pure-play spine companies, announced revised manufacturing strategies during 2Q15 earnings calls.... Read more »

OEMs Weigh in on Managing Supplier Quality

by BONEZONE | Aug 2015

OEMs tackled the topic of supplier quality during a panel discussion at OMTEC 2015. Here are a few highlights from the conversation on supplier approval, development and priorities.... Read more »

Purchasing Controls: Draft the Best Supplier Quality Agreement

by John Gagliardi | Jul 2015

Quality agreements are an essential management tool to prevent supply chain problems. The best contracts clearly define the extent of control exercised over products, services, suppliers and sub-tier suppliers.... Read more »

New Supply Chain Models Shift Resources from Device Makers to 3PLs

by Hannah Corcoran | May 2015

Orthopaedic device manufacturers can benefit from outsourcing services such as inventory management, warehousing, order processing and shipping, thus freeing up internal resources to focus on R&D, manufacturing and sales.... Read more »

Successful Purchasing Strategies Consider More than Price

by Jeoff Burris | Apr 2015

Proactive purchasing leaders understand the vision for the business, and manage supply chains to drive it to completion. Follow these steps to strategically manage your commodities.... Read more »

Suppliers Consolidate in Response to OEM M&A Activity

by Hannah Corcoran | Mar 2015

Suppliers in the orthopaedic industry are feeling the effects of consolidation at the OEM level. To grow in size and capabilities, suppliers are engaging in their own strategic activity to stay competitive.... Read more »

Standard, Sterile and Small: Packaging Trends Focus on Savings and Speed to Market

by Carolyn LaWell | Mar 2015

Complexities in orthopaedic device packaging have manufacturers seeking expertise from consultants and suppliers to discover process efficiencies and allow internal resources to focus on new product development and manufacturing support.... Read more »

Conflict Minerals Due Diligence: Strategies for a Successful Second Filing

by Hannah Corcoran | Jan 2015

May 31, 2015 is the second filing deadline for the conflict minerals due diligence disclosure rules. Here are some key takeaways from last year’s filing and new strategies to improve your compliance process.... Read more »

EU Proposes Significant Changes for Importers and Distributors

The EU’s proposed Medical Device Regulation will subject companies within the supply chain to the same rules, which differs from the current fragmented national regulation.... Read more »

Uncover Opportunities in Your Supply Chain Challenges

by Hannah Corcoran | Nov 2014

Overcome challenges in the orthopaedic device supply chain with these tips on how to leverage new technologies, enter new markets, form strategic partnerships and plan accordingly.... Read more »

Customer Profitability: The Why and How of SG&A Costs

by Doug Hicks | Sep 2014

Many costs that separate desirable customers from less-desirable customers lie hidden in that great “blob” of costs christened by most organizations as “selling, general and administration” or simply SG&A.... Read more »

The “Cost to Serve” Customer Fulfillment

by Doug Hicks | Aug 2014

Manufacturers can gain critical insight on customer and product profitability when “cost to serve” activities are measured and assigned.... Read more »

Suppliers Speak to Economic and Regulatory Challenges in Global Expansion

by BONEZONE | Jul 2014

New market entry presents logistical hurdles for every company. Suppliers provide insight based on their own experience of opening overseas operations.... Read more »

Six Ways to Prevent Supplier Quality Problems

by Robert Packard | Jun 2014

The root cause of defective product from suppliers is often inadequacies of your own supplier controls. The methods described in this article will help you prevent supplier quality issues that could result in a 483.... Read more »

FDA Expectations: Overcoming Supply Chain Weaknesses

by Martin Browning | Apr 2014

FDA expectations of supplier management will continue to evolve as pressures are applied to the agency, device recalls are issued and outsourcing continues to expand. To ensure that quality is maintained, it’s important to understand where weaknesses are often found. ... Read more »

Increase Lean Manufacturing Improvements through Business Plan Deployment

by Joseph Mazzeo | Apr 2014

Most companies may be satisfied with continuing to utilize the lean principles that they have implemented and, through continuous improvement, work to refine and improve their performance. But there is a key next step that businesses can take to further drive lean manufacturing improvements and resu... Read more »

Auditing Process Validation & Developing Protocols

by Robert Packard | Jan 2014

Have you ever had to perform a process validation protocol for a new piece of equipment or acquired a process that was not properly validated? If not, consider yourself lucky. For when the task does arise, here is how to perform a process validation audit and develop a protocol.... Read more »

Labor Hours or Machine Hours: Which is Preferable?

by Doug Hicks | Dec 2013

A manufacturer that fails to segregate indirect and support costs driven by the operation of equipment from those driven by the work of individuals will seldom arrive at product or process costs that reflect economic reality.... Read more »

How to Build a Better Supplier Scorecard

by Robert Packard | Nov 2013

Supplier scorecards are intended to be a simple tool to help you evaluate suppliers. These steps provide for an easier and more efficient process.... Read more »

Collaborating with Suppliers in a Changing Landscape

by Stephanie J. Gruenert | Nov 2013

OEMs operate with different expectations and visions, causing suppliers to react and accommodate each relationship. Here a supplier lends its perspective on how OEMs can develop deeper collaboration with their supply chain.... Read more »

Measuring and Assessing the Cost of Manufacturing Cells and Lines

by Doug Hicks | Oct 2013

If a company is to understand the benefits that accrue as a result of cellularization, it cannot follow an obsolete, direct labor-based costing model that fails to accurately reflect the fundamental economics that underlie a 21st Century manufacturing firm. Doug Hicks provides a step-by-step underst... Read more »

Ten Elements of a Successful Supplier Agreement

by Kate Vitasek | Sep 2013

Developing an agreement using these steps enables progressive companies to establish dynamic, collaborative and modern business relationships.... Read more »

Industry’s Achilles Heel: The Supply Chain

by Karen Conway | Aug 2013

The implantable device supply chain is ripe with more than $5 billion in inefficiencies in the U.S. alone. This knowledge provides a unique opportunity for medical device manufacturers and their customers to collaborate in reducing these costs.... Read more »

Unique Challenges in Instrument Manufacturing

by BONEZONE | Jul 2013

What challenges are unique to the manufacture of orthopaedic instruments? We ask a supplier for perspective.... Read more »

Material Cost vs. Price Plays Important Role in Sensitive Market

by Doug Hicks | Jun 2013

Manufacturers often use a 200-year-old, outdated process to arrive at the cost of producing product. Failure to incorporate these 21st century cost components leads to inappropriate and unprofitable pricing and investments.... Read more »

Accutek Weighs In on the State of Testing

by BONEZONE | May 2013

John McCloy built a nimble testing laboratory in order to handle economic and regulatory changes. BONEZONE spoke to McCloy about the current orthopaedic device market, testing and future regulations.... Read more »

ASTM Names New Standard for Raw Materials

by BONEZONE | Mar 2013

ASTM added a PEKK raw material standard for medical device implants that if met, will reduce the testing needed to obtain regulatory approval.... Read more »

Develop Orthopaedic Implants Faster Through Auditing

by Robert Packard | Feb 2013

Do your auditing techniques actually improve product development? These three techniques—one simple, one advanced and one new—will shorten the cycle.... Read more »

Six Steps to Qualifying Suppliers

by Robert Packard | Jan 2013

If an OEM specifies weak second-tier suppliers, its first-tier suppliers will have fewer resources to devote to its own internal processes. One weak link can prevent the best outcome from occurring. This six-step program helps OEMs ensure that they’re not recommending inferior suppliers anywhe... Read more »

Is Depreciation Expense a Misleading Illusion?

by Doug Hicks | Oct 2012

  “Sunk costs are irrelevant" is a principle stated in Shlomo Maital’s book Executive Economics and in almost every book on decision making ever written. Despite this well-accepted principle of decision science, most companies continue to include their biggest sunk cost as a majo... Read more »

Unique Device Identification: From Compliance to Value

by Karen Conway | Oct 2012

It took five years, but the U.S. FDA has finally issued the proposed Unique Device Identification rule that will require manufacturers of medical devices to uniquely identify their products and populate FDA’s global UDI database. Orthopaedic manufacturers will be among the first impacted... Read more »

The Dangers of Direct Labor-Based Costing at Orthopaedic Device Manufacturers

by Doug Hicks | Jun 2012

As we begin the second decade of the 21st Century – over a quarter-century into the “cost measurement and management revolution” – most U. S. manufacturers, including those who precision manufacture orthopaedic devices, continue to base not only their day-to-day cost accounting systems, but ... Read more »

Sales & Operations Planning: Beyond the Basics

by Tom Wallace | Oct 2011

When Sales & Operations Planning (S&OP) was first being used, we saw it as better way to accomplish two highly important things: balance demand and supply, and keep them balanced over time as demand and other factors shift integrate operational plans with financial plans, enabling the b... Read more »

Vested Outsourcing: A New Business Model

by Kate Vitasek | Aug 2011

My first book, Vested Outsourcing: Five Rules that Will Transform Outsourcing, [1] centered on a better, more collaborative way to outsource by outlining the need for business relationships based on trust, collaboration and working together to achieve mutually beneficial goals. Extensive research b... Read more »

Forecasting: It’s Getting Better

by Tom Wallace | Jun 2011

My business career started back in the industrial “Dark Ages”—the 1960s. One of my first promotions was to head up the company’s sales forecasting group. But don’t be misled: this was definitely not a big deal. The department was small and possessed not a lot of talent, being viewed by man... Read more »

Change Management and S&OP: Part II

by Tom Wallace | Dec 2010

In the last issue of BONEZONE, we covered the priorities involved in an implementation of Executive S&OP1 (Sales & Operations Planning) and pointed out that people were, by far, the most important element. This led to the conclusion that change management was critically important – more so... Read more »

Change Management and S&OP

by Tom Wallace | Sep 2010

Some years ago, I spoke with a gentleman from Ford Motor Company’s Lean Supplier Institute whose job it was to help Ford suppliers implement Lean Manufacturing. We were talking about making meaningful changes, and he said something I’ve remembered all these years, “The hard stuff is the soft s... Read more »

A Supply Chain Manager's Guide to Strategic Purchasing, OR How to be on top of things instead of having things on top of you!

by Rebecca A. Morgan | Sep 2010

OMTEC 2010 attendees gave Becky Morgan high ratings for her presentation on this topic in June. Therefore, we’ve asked her to summarize her session for the benefit of all BONEZONE readers. (Most speakers’ presentations, including this one, are available online at www.orthoworld.com.) Do your Su... Read more »

Vested Outsourcing: Game Changing Rules for Outsourcing

by Kate Vitasek | Mar 2010

In Search of a Better Way to Outsource For the past two years, we have participated in a University of Tennessee research program funded by the Air Force to formally study companies that were employing performance-based approaches for outsourcing. This article is based on our research and hands on ... Read more »

Nine Naive Notions About S&OP

by Tom Wallace | Mar 2010

The following is a list of “deal breakers” – things that can get in the way of successful implementation of Sales & Operations Planning (S&OP). To ensure success, you’ll need to eliminate these myths in order to get all of the key people on the same page. Myth #1: “We don’t need... Read more »

Why Offshoring Manufacturing “To Save Cost” Won’t, but Trying May Compromise Product Development, Delivery and Quality

by David Anderson, Ph.D. | Mar 2010

Many companies are offshoring – designing products here for sale here, but manufacturing them overseas – because they think it will save cost. Their primitive cost systems make such a moveappear to be justified. However, if all that is quantified is parts and labor, then moving to a “low labor... Read more »

Reducing Costs in the Supply Base

by Russell Morey, Ph.D. | Mar 2010

Organizations all too often attempt to drive costs out of maintaining the supply base by looking for a simple technique or tool which will serve as the panacea for success. The solution is not quite that simple. This article identifies a few issues that need to be addressed prior to developing and i... Read more »