Insights for FDA Regulated and HIPAA Compliant Organizations

25 Years of experience in marketing, sales and customer service provides priceless insights into what is needed for today's bio-kitting & fulfillment customers.

Brian Butler is Vice President of Sales and Marketing of TAGmedica, a leading provider of bio-kitting & fulfillment services and high impact marketing communications programs for the life science industries. For the past 25 years he has held various positions in marketing, sales and customer service. In his current role, he directs the efforts of a 35-person sales and marketing team, guiding strategic direction and spearheading business growth efforts. He is the author of Find 'Em, Get 'Em, Keep 'Em Proven Strategies for Attracting, Acquiring and Retaining the Right Customers created from his diverse experiences in sales and marketing and life. Brian holds a BS in marketing, graduating with honors from The University of Bridgeport, where he attended school on a two-sport athletic scholarship for soccer and baseball and an MBA from Century University.

Evaluation of Suppliers, Contractors, and Consultants

Medical Device and Diagnostics manufacturers by law and FDA regulation need to establish and maintain supplier management requirements, including quality requirements, that must be met by suppliers, contractors, and consultants. Supplier quality criteria are defined by FDA as "the supplier's ability to meet specified requirements including quality ...
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Manufacturing Has Interesting New Contours

​ The strategic questions medical device and diagnostic companies face goes beyond outsourcing. Whether a company runs its own manufacturing and distribution operations or outsources these functions, it still has to make improvements and align them based on changing industry needs. Factors such as tightening global regulations, increased global com...
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ISO 13485 Supplier Audit Check List

​ The international standard ISO 13485:2016 for Medical Devices quality management systems was published in March 2016. The ISO Standard has been released and manufacturers need to ensure their supplier quality-related procedures are compliant. Now, OEMs need to ensure all supplier quality-related procedures are compliant. This article will provide...
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We have perfected the art of final article assembly and kitting!

Medical Device and Diagnostic companies looking to drive growth this year are looking to outsource their final assembly and kitting.   The past few years have seen a rise in "value" customers—those who gravitate to products that are good enough and competitively priced. Unlike customers who seek premium products, value customers are willing to...
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THE NEW GROWTH IMPERATIVE – UNLOCKING VALUE FOR CLIENTS AND CUSTOMERS

Manufacturers of Class I and II Medical Devices and Diagnostics have increased their focus on core competencies and is the main driver of outsourcing in all its forms.   The trend is nurtured by corporate leaders' desire to concentrate on those elements of the value chain that they master best and delegate everything else to specialized third-...
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Flex Your Supply Chain to Enhance Additive Manufacturing

Additive manufacturing is  defined as the process of joining materials to make objects from 3D model data, usually layer upon layer, as opposed to subtractive manufacturing methodologies. Synonyms are additive fabrication, additive processes, additive techniques, additive layer manufacturing, layer manufacturing, and freeform fabrication. The ...
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How does a patient-centric supply chain operate?

​ Supply Chain Management in life sciences and HIPAA organizations includes a variety of players, including Pharma and Biotech companies, Contract Research Organizations (CRO's) that support them, and Medical Device manufacturers. Each has very different needs, but the shift in care to a more market based model is placing significant margin pressur...
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Radical Change Coming to Warehouse Management Systems and Fulfillment

The traditional supply chain is moving to a highly integrated, digitized, and collaborative extended supply chain. Manufacturers in life science and elsewhere are deploying technology to improve warehouse management and fulfillment management in their supply chain process. While manufacturing can be diverse, common business issues prevail such...
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Are You Ready?

Executives want to know everything about their supply chains — each shipment leaving a supplier's dock, each unit sitting on a contract manufacturer's assembly line, each pallet being unloaded at a distribution center or customer's storeroom. But this pervasive visibility cannot require any extra effort from supply chain partners. Simply put, it mu...
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The Breaking Point for Supply Chains

Over the last decade, many companies faced extreme supply chain challenges that stretched their capabilities to the breaking point. Supply chains, which once functioned almost on autopilot, face many dangers today in both the global and the domestic market. Due to its global nature and systemic impact on the firm's financial performance, the supply...
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Adapt to Changing Markets and Customer Demand

Volatile times demand pervasive visibility & flexibility. Cost and currency fluctuations, supply disruptions, transportation capacity constraints and production recalls. As a Supply Chain Executive, you handle all of this volatility, and more, in a transparent manner. If you don't – if there is even one misstep – your whole Supply Chain an...
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INNOVATIVE SUPPLY CHAIN PARTNERS ARE GOOD MEDICINE

​ Shifting customer needs has always been a driver for innovation. Life science manufacturers will need the services of innovative supply chain partners that can deliver one-stop shopping for all their customers shipping needs, from small packages to large freight deliveries to expedited shipping – locally and around the world. Life science compani...
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Driving Innovation with Supply Chain Agility

Innovation is a critical capability for life sciences organizations to help them identify and bring new life-saving treatments to patients. Indeed, the real-world outcomes would also suggest that life sciences organizations are improving their success at bringing new treatments to market. However, based on industry research, it is clear that even l...
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Change Requires Escape Velocity

Change Requires Escape Velocity
Think about change for a moment.  Change is a word and a concept that often immobilizes even the most goal-oriented, determined and successful people among us. Think of a happy circumstance you are experiencing right now or the flush of pride over some recent accomplishment. The reality is that something had to change for you to create and enj...
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​The Right Way to Look for a Third-Party Logistics Provider

For medical device and other life science manufacturers, global business plays a critical role in delivering life-saving and life-enhancing therapies for tens of thousands of patients.  Lately, third-party logistics providers (3PL's) are focusing on ways in which they can deliver optimal service to their customers. This involves providing...
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3 Sales Lessons Learned From March Madness

​ To say that the Men's NCAA Division 1 basketball tournament (aka March Madness) is wildly popular is an enormous understatement. While the ubiquitous office betting pool based on the four regional brackets is certainly one reason, I suspect that there are several others as well. The unique format, the incredible unpredictability, and the almost e...
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Integrating Partners for Beyond Pill Innovation

The Internet of Things (IoT) is getting personal. Wearables, ingestables, even implantables – devices that can monitor and manage disease and its treatment – are right around the corner. 

And where the IoT goes, money follows. In this case, Big Pharma smells opportunity, writes Jason Bloomberg , contributing writer in Forbes magazine.  Life science companies are looking beyond traditional mergers and acquisitions by acquiring ‘beyond-the-pill’ products and services to bolster their portfolios and pipelines of drugs.”

As an example of companies moving beyond the pill is Teva Pharmaceutical which purchased Gecko Health, a manufacturer of inhalers which empowers children and their parents to better manage their asthma by monitoring medication use, providing reminders and increasing disease awareness. 

Changing industry fundamentals has created a new challenge for FDA regulated companies.  Pressure to control healthcare spending, a decline in productivity in research and development (R&D), and the rise of emerging markets are major trends affecting the direction of the global pharmaceutical market.

The last few years have seen numerous innovation crossovers as pharma looks towards unconventional partnerships.  Biotech, medtech, specialty pharma and particularly big pharma are looking towards innovative partners to fuel growth and move beyond traditional lines of business. A patient centered model in healthcare is driving the need to streamline, innovate and the rise of precision medicine.  

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The Line for Supply Chain Solutions Starts with TAGmedica

At TAGmedica, you’ll find the solutions you need to solve tough FDA regulated supply chain challenges that exceed customer demands and help companies gain competitive edge.

At TAGmedica, our most successful partnerships are those with rapidly growing, biologic companies that have outgrown the ability to kit, warehouse and distribute on their own. 

Increased compliance and regulatory protocols require partnering with a vendor who can document, trace and manage outsourcing processes under ISO 13485:2003 certification. 

Growth rates for FDA regulated industry manufacturing have been high. The entrance of numerous small, virtual startups into the market that have no manufacturing capacity is a prime reason.

The desired end at TAGMedica is to help you execute your business plans and roll out product.  A recent study from The Council of Supply Chain Management Professionals (CSCMP), reports that virtual startups that are outpacing the industry in terms of growth, will need to build better end to end supply chains.  

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Biopharma's New Business Model

The less costy and shorter pathway to commercialism 

Inherent with the goal of commercialization, lies the problems of production methods and costs, which must be worked out before manufacturing begins.

FDA regulated companies are looking for a shorter and less costly regulatory pathway to commercialism, especially for smaller specialty pharma and biopharma organizations. 

The rise of biopharma and specialty pharma could be applied to companies developing generics, reformulating existing drugs, or targeting niche markets.

As the popularity of specialty pharma has expanded, so has its scope. Today, many use the term “specialty pharma” interchangeably with development-centric pharmaceutical or biopharmaceutical companies.

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Increasing competition. A complex regulatory environment.

The shift towards outcomes. Trends in the Life Sciences industry are driving pharmaceutical, biotechnology, medical device, and diagnostic companies to rapidly transform their business operations.

These trends in the Life Sciences industry are putting new pressure on companies’ manufacturing and supply chain organizations to simultaneously improve the quality of products, increase the speed of delivery, and lower costs.

We're at the early stages of a fundamental transformation, marking what could be one of the most significant disruptions to the life science and healthcare industry since the Industrial Revolution.

Manufacturers of medical devices and instrumentation are increasingly adding software, sensors, and wireless connectivity to their products, providing a foundation for the Internet of Things (IoT), which IDC defines as a network of uniquely identifiable endpoints (or "things") that communicate without human interaction using IP connectivity.

IDC forecasts that by 2020, there will be 30 billion connected devices / products in use by consumers and businesses. These smart and connected products in turn become critical components in the connected supply chain and smart manufacturing. 

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