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Best Practices: How to Source OEM Medical Products

by Michael Riddle
Michael Riddle
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Thursday, 25 August 2011 Category Medical Product Distribution 0 Comments

 

What is necessary to find OEM medical products from the right source, and at the right cost—and that can be delivered at the right time and in the right quantities?

In my previous blog, I discussed definitions and criteria for seeking quality medical products at an affordable price. I defined a “quality medical product” as one that meets the needs and expectations of customers So, with an understanding of how to identify quality medical products, how do we proceed to source and procure those products?

Procurement: Getting It Right, from Start to Finish

Let me first clarify how I define “procurement”—which to me is the process of identifying and obtaining goods and services. It includes sourcing and purchasing, and it covers all activities from identifying potential suppliers on the front end, to delivery from the supplier to the end user on the back end.

Effective, strategic medical product sourcing is a complex balancing act. But with limited time and data for analysis, successful medical product buyers frequently rely on their experience to swiftly estimate the impacts of the sourcing decision.

The first stage is to find the right medical product source by pre-qualifying OEM medical product suppliers and retaining only those that are capable and willing to work diligently to meet requirements.

The pre-qualification process will require weighing the relative merits of multiple factors that may not always be fully quantifiable up-front. For instance, many the so-called “master medical product distributors” that promise “quality” are often merely go-betweens with no long-term relationship or vested interest in the medical product manufacturing source.

As a proven master medical product distributor, MediPurpose has built its business and reputation by becoming intimately involved with its partner medical product manufacturers.

As discussed in my last blog about defining “quality medical products,” I briefly explained how our medical products fulfill that definition via strict quality control procedures. That quality control can only be achieved with a high standard for well-documented medical product manufacturing procedures, as well as equally strict sterilization procedures.

 

Determining a source’s ability to meet our standards is frequently accomplished via series of questions that are asked in our procurement/sourcing cycle. Among them:

  • Does the potential medical product source have the appropriate qualifications?
  • Does the source control the process—from manufacturing to assembly to packaging and sterilization (GMP)?
  • Does the source have ISO 9001 and ISO 13485 certification?
  • If in the United States, is the source registered with the U.S. Food and Drug Administration?
  • If in Europe, does the source’s medical products have CE Markings and the supporting technical files?
  • Do the specifications support the source’s medical product labeling and claims?

Saving Time=Saving Costs?

“Time is money,” the saying goes, and it often holds true in business. With so many important questions to be researched, answered and documented—along with the cost and difficulty of managing lesser-known (and frequently off-shore) suppliers—it is no surprise that many medical product buyers exclusively place orders with existing known vendors.

However, as the global medical product market both becomes more competitive and offers increasing economic advantages, the rewards can be significant for those willing to invest the time to discover them.

Constant and clear communication is key to finding success in this context. To be sure, resources and time have to be allocated to nurturing the relationship. And, it is understatement to say that the supplier must also be committed to making investments in the short term in order to grow the business over time.

MediPurpose has developed and streamlined its processes to ensure that the investment required to build mutually beneficial relationships with its suppliers does not diminish the savings it can obtain for its customer. At the same time, it is important that the needs of the supplier be balanced with the overall goals of achieving cost savings.

MediPurpose has made the commitments necessary to bring its customers innovative, high-quality medical products that meet their needs and expectations. Not only is this knowledge used to service its customers’ needs, but MediPurpose offers to share this expertise with innovators seeking to bring new novel technologies to market. This is just part of the value-added offered by Medipurpose as a true master distributor.

Next, I will discuss the scope and importance of vendor certification, on-site vigilance and regulatory compliance. In the meantime, what are your experiences with OEM suppliers? Do you typically go with the “known vendor” or do you try to get the best value (and quality) with a lesser-known vendor? How and why have you made the decisions you’ve made?

 


Michael Riddle | Vice President–Advanced Wound Care | MediPurpose®

 

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How Do You Define a “Quality” Advanced Wound Care Product?

by Michael Riddle
Michael Riddle
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Friday, 03 June 2011 Category Medical Product Sales 0 Comments

Hi, welcome to my blog. This is the first of what should be many more blogs that discuss a range of topics relating to advanced wound care products, which I have marketed and sold for many years.

As Director of Wound Care at MediPurpose®, I’m tasked with providing healthcare providers and medical product distributors access to quality advanced wound care products at highly competitive prices—which is precisely what we aim to do with our recently launched MediPlus™ advanced wound care product line. Critical to the process is establishing the appropriate balance between price, performance, and last but not least, quality.

Developing the process to achieve that balance requires first defining the customer requirements and quality goal. Procedures and specifications required to evaluate the processes necessary to achieve those goals must then be established. Strict adherence to those processes—from initial contact through market research, vendor certification, regulatory compliance, clinical support and ultimately product release—is essential.

As a “master distributor” of medical products, MediPurpose’s goal is to share our knowledge of these processes with others seeking to either develop or source quality medical technologies. So, with all of this rhetoric about “quality,” a brief discussion about what that means is in order.

What Does “Quality” Mean?

Medical product or not, how is “quality” defined by experts?

  • Defined by Juran, “quality is fitness for use.”
  • Defined by Crosby, “quality means conformance to requirements.”
  • According to Deming, “quality is predictability.”
  • The American Society for Quality (ASQ) states that “quality denotes an excellence in goods and services, especially to the degree they conform to requirements and satisfy customers."
  • Per the ISO 8402 (International Organization for Standardization, 1986),  “quality is the totality of features and characteristics of a product or service that have a bearing on its ability to satisfy stated or implied needs.”

Definitions of “quality” are many and varied, but when sourcing OEM medical products, it all comes down to one definitive goal: A quality product or service is one that meets the needs and expectations of customers.

MediPurpose has used this definition as a straw man in establishing the process used to source and supply the MediPlus advanced wound care product portfolio. The end result is a comprehensive line of quality advanced wound care products that meet the demanding requirements of a sophisticated customer base at a competitive yet socially responsible price point.

Other key factors to be included in a successful sourcing process are associated with validating the design process used to establish labeling claims. Use of subject matter experts to analyze data, evaluate desired performance characteristics and compliance to manufacturing standards are critical steps in the process.

How do you define “quality”—in general, and as it specifically applies to your medical products? Do you agree or disagree with the experts’ definitions that I cited or MediPurpose’s definition for its medical products?

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