MediPurpose® Blog

Since the 1990s, silver has been so frequently incorporated into advanced wound care dressings, silver-containing formats are now available in virtually the entire range of advanced wound dressings. But what is it that has made silver such a popular feature for wound care dressings?

The short answer is that silver works—something that has been known for a very long time. In past centuries, silver has been used in drinking and storage vessels to prevent spoilage. More recently, silver—and silver compounds such as silver sulphadiazine and silver nitrate—have been adopted by the medical community because of its ability to:

• Prevent infections

• Sterilize medical devices

• Discourage the formation of biofilms in heart valves, endotracheal tubes and catheters.

Yet, despite its popularity and versatility, the benefits claimed for silver in wound dressings—and the mechanisms that deliver these benefits—still maintain some controversy and will probably not be totally resolved in the near future.

An Atomic Appreciation of Silver

The active antimicrobial agent associated with silver is the positive silver ion (Ag⁺). This ion has an oligodynamic effect, meaning that extremely low concentrations are required.

The ion is short-lived and can be easily removed from a solution by combining it with negative ions (Cl^-). The ion readily binds with many microbial structures, proteins and nucleic acids, enabling it to inactivate microbes by several different pathways at once. This is thought to greatly reduce the opportunity for infectious agents to develop resistance to the actions of silver, and it contributes to its broad spectrum of activity.

Getting the Silver Into Silver Wound Dressings

Silver is incorporated into wound dressings as elemental silver (e.g., Acticoat^®, Silverlon^®, MediPlus™ Foam Ag) or as a component of various silver salts (e.g., silver sulphadiazine, silver lactate).

To be effective, the silver element or compound must be moistened with water or exudate to release the silver ion. Elemental silver is not very soluble, so it must be presented over a large surface area (such as with fibers or nets) to insure the dissociation of a sufficient number of ions.

Silver salts vary in their dissociation constant and are easier to incorporate into foams, hydrocolloids and hydrogels. Silver dressings can contain a large reservoir of silver, allowing continuous replacement of ions as they are taken up by microbes and inactivated by other components of the wound fluid. The long-acting effect supports longer intervals between wound dressing changes and less disturbance of wound healing.

Silver Wound Dressing Studies and Toxicity

Silver wound dressing studies have compared the amounts of silver in a dressing and the rate of silver release in-vitro, but this kind of data often shows poor correlation with a dressing’s activity, suggesting that several variables are in play. Apparently, once effective levels of silver are reached, excess ions have little additional activity, and that speed of release is less important a factor in the time/dose effect than might be seen in the in-vitro studies.

In-vivo, however, the fluid and biological environment in which ions are released are vastly different. It would be anticipated that in-vitro ionization would be less than in an aqueous solution and that ion removal would be faster and greater. Sufficient levels of silver ion constantly replaced during use would appear to provide optimal performance.

The toxic effects of silver to human cells are well documented and understood. Many observations are based on high blood and tissue levels that may occur in burn patients where a large body area may be covered with silver sulfadiazine for extended periods. In most cases, silver is cleared from the body over time and without toxic effects. The amount presented for systemic absorption by advanced wound care dressings in considerably less.

Silver Wound Dressings and Bioburden Reduction

Although there are few randomized controlled studies that achieve statistical significance in showing a reduction in the infection rate associated with the use of silver wound dressings, ample clinical evidence indicates they are associated with reduction in pain, reduction in odor, and improved quality-of-life measures.

Silver-containing wound dressings have been shown to reduce wound complications and to reduce the occurrence of critical colonization when compared to the same materials without silver. Further, Silver wound dressings are associated with reduced inflammation, increased rate of healing and reduction in biofilm formation.

The observed benefits are thought to result from silver’s broad spectrum of antimicrobial activity helping to control bioburden. The antimicrobial action may provide benefit at the wound-dressing interface and within the dressing where fluid-containing pathogens are sequestered. Reduction in bioburden improves the wound-healing environment by reducing competition for resources and the production of toxic metabolites. With fewer pathogens present, inflammation due to critical colonization may be sufficiently reduced to allow the wound to progress unimpeded to the proliferative phase of healing.

With silver available in a large number of advanced wound care products, the selection of a wound dressing can be optimized for the type and condition of the wound, with the silver component providing the extra security derived from broad-spectrum antimicrobial activity. Reduction in bioburden may result in:

• Reduced inflammatory response (including a reduction in MMP generation and activity)

• Reduced exudation

• Reduced pain

• Removal of many of the factors that impede the healing of chronic wounds

In conclusion, silver dressings offer the health care professional a valuable tool for use in treating acute, chronic and difficult wounds. The availability of new cost-effective wound care products allows their benefits to be extended to a larger population of patients.

Tags: Medical Devices | Medical Products Read More

To anybody whose professional life is in some way connected to wound care dressings, last month’s announcement that MediPlus expanded its portfolio to include silver (Ag) dressings was likely recognized as a very important headline. But why is it so important to offer silver? One way to appreciate this is to understand the evolution of wound care dressings, since many of the products in that evolutionary timeline are still sold and used today.

There have been several critical milestones in the evolution of wound care that have lead to noticeable improvements in treatment outcomes. Each step reflects a better understanding of the needs of the wound and the needs of the patient, which, when supported, have lead to an increase in the quality, speed and reliability of wound healing. Each step forward has led to a new plateau of improvement, which in turn has served as the new baseline for standards of care. In most instances, the step involved the recognition of a barrier to healing and the adoption of means to overcome that barrier.

Let There be Gauze!

Looking back approximately 100 years ago, it was an era when gauze was the first choice for wound care dressing. This era represents the first baseline and lengthiest plateau in the wound care dressing evolution.

Wounds underwent surgical, mechanical enzymatic or chemical debridement to expose viable tissue. Dry or saline-moistened gauze that was changed several times a day and packed into the wound was often accompanied by the liberal use of antiseptics at each dressing change. Under these gauze protocols, healing was frequently disrupted since multiple daily dressing changes and moist gauze enabled a direct route for microbial colonization of the wound.

Licking a Wound with Moist Wound Dressings

It would eventually be discovered that the first “advanced” moist wound dressings—transparent films—could seal the wound from further contamination and allow the natural exudate to support the physiology of wound healing

Dressing options would soon rapidly evolve to optimize moisture levels and conform to wound surfaces in ever more efficient ways. For example, dressings were left in place longer, reducing the mechanical and thermal disruptions to the healing process, reducing time to healing, and the resources expended on dressing changes. As the wound began to heal, the dressing selection could be modified to provide optimal moisture levels for healing at each stage and to reflect the changes associated with the wounds progression.

The practice of moist wound healing after wound debridement soon became state-of-the-art, and with the introduction of hydrogels, it provided an alternative to surgical and mechanical debridement. Consequently, most wounds could now be managed by non-physician practitioners at lower cost and with dramatic increases in success.

How Compression Caused an Expansion in Wound Dressings

Moist wound healing and advanced wound care represented a new healing plateau of wound care that lasted with minor changes for decades. The next evolution came from the recognition that different wound etiologies required targeted adjuvant therapy to get to the next level of healing.

The most dramatic demonstration of this philosophy came with the adoption ofcompression to support the healing of venous stasis ulcers. Once compression was accepted as a best practice, the methods to deliver effective compression proliferated from four-layer elastic to two-layer short stretch, with phenomenal changes documented in healing outcome.

Additionally, etiology focus directly improved the outcome of other chronic wound groups by demonstrating the dramatic efficacy of total contact casting for neuropathic diabetic foot ulcers and pressure relief for pressure ulcers.

Once wound etiology was addressed (e.g. restoration of circulation) and a moist wound environment was provided, additional barriers to healing became apparent. Two key related concepts arose that focused attention back to the local conditions within the wound: matrix metalloproteinases (MMPs), which surfaced as a hot topic of discussion and research, and critical colonization came forward to account for wounds stalled in the inflammatory stages of healing.

Solving the Riddle of Critical Colonization with Advanced Wound Dressings

Although all wounds might have been seen as colonized, not all colonized wounds progressed to infection, and not all colonized wounds healed routinely. Instead, as many wounds would stall in the inflammatory stage of healing, it became apparent that one of the factors involved in this barrier to healing was the presence of microbes in sufficient quantities to stimulate a chronic inflammatory response by the host.

The concept of critical colonization was recognized as a state between contamination levels that were managed and resolved by host defenses and full-blown infection with the classic signs of heat, redness, swelling and pain. The objective soon became one of shifting bioburden within the wound (i.e., the number of organisms and their toxic products) back towards levels below those that generated a chronic inflammatory state and away from the serious risk and expense involved with wound inflection.

Silver Dressings Becomes a Gold Standard

The routine use of antiseptics as prophylaxis against infection had declined dramatically as study of the stages and physiology of wound healing revealed their toxic effect on cells and the processes required for healing. Local antibiotics were known to have limited spectra of activity, with the potential to generate resistant microbial strains. Of utmost importance was the fact that neither worked well with the advanced wound care dressings, bandaging systems or TCC that had become so important in supporting efficient wound repair.

Silver, by comparison, had a long history as an antimicrobial agent from its use in silver-coated vessels in ancient times to reduce the spoilage of wine and water. It had also demonstrated great success in helping to prevent infection in burn patients when it was formulated as silver sulphadiazine cream.

Silver could be readily incorporated into advanced wound care dressings as elemental silver (e.g., Acticoat®, Silverlon®) or in any number of silver compounds (silver lactate). Silver dressings preserved the beneficial properties of advanced wound care moisture interactive dressings while adding antimicrobial activity to stop microbial populations progressing from contamination to critical colonization to infection. Silver also provided effective antimicrobial action, a broad spectrum of coverage with low cytotoxicity and the long duration of action required for efficacy under bandaging and advanced wound care dressings.

Ultimately, the evolution of wound care dressings that would manifest with a rapid adoption of silver wound care dressings would also signify acknowledgement that the prevention of infection and critical colonization has beneficial consequences on the speed and cost of wound healing treatment.

The Real Value of Silver

Although silver dressings are more expensive to produce—and in turn cost more for a treatment center—they are treated as standard wound dressings under the HCPCS Level II reimbursement system.

Inexplicably, silver foam dressings are reimbursed at the same rate as non-silver foam dressings. However, obtaining FDA 510(k) marketing approval for silver dressings has now become a more intensive and costly process, requiring significantly more supporting clinical and laboratory data.

Wound care dressing manufacturers with the most recent 510(k) clearances meet the new standards demanded by the FDA. Manufacturers of older established products should be challenged to document similar performance parameters before being considered for use in the clinic.

MediPlus’ Silver Foam dressings were recently cleared by the FDA under these new standards. MediPurpose is now marketing these dressings at a very competitive price point to be more affordable, and thus more widely available in appropriate treatment settings to a larger patient population.

Do you use or sell silver wound dressings? What are your opinions about their efficacy and value?

Tags: Medical Device Innovation Read More

Another year is about to end, and another is about to begin…and what a year it’s been at MediPurpose!

As at most small companies—and especially a medical product company such as ours—every day is exhilarating, and 2011 was especially filled with many achievements, milestones and notable events. Here are some of the top headlines at MediPurpose in 2011:

MediPurpose goes virtual: We started the year by formally announcing that we had become a virtual company. Although we still maintain physical offices in Singapore, London and Atlanta, we made ambitious and active strides with embracing online technology to both reduce our operational expenses and to expand our sales and marketing teams.

MediPurpose honors long-service employees: Later in January, we honored three MediPurpose employees that have faithfully served our company for at least five years.

MediPurpose launches MediPlus Advanced Wound Care Products and gets 510(k): In March, we announced our latest medical product offering, MediPlus. In September, we received U.S. FDA 510(k) clearance for our soon-to-be launched Silver (Ag) Foam dressings. In October, MediPlus became available for distribution, and earlier this month, we expanded our independent sales force.

New team members and promotions: In June, we welcomed Shelly Philips to our sales team. Later than month, Michael Riddle was promoted to Vice President–Advanced Wound Care, and Derek Rudnak became the Director of Marketing.

SurgiLance gets a new look: Our flagship product, the SurgiLance safety lancet, got new packaging in November. Along with adoption of new GTIN bar code standards, packaging language was expanded into 11 translations.

Giving back: MediPurpose recognizes its responsibility to be a socially responsible company, and it demonstrated this by donating medical products to (among others) the American Diabetes Association and the Summer Medical Institute, as well as a cash donation to the Rally Foundation.

And as sensational as 2011 was, just wait for 2012. We’ve got some very exciting announcements that we’ll be making early in the year.

All of us at MediPurpose wish you happy holidays and a safe and prosperous new year!

Tags: Medical Devices | Medical Products Read More

Let’s be honest: Very few of us had childhood dreams of becoming part of medical product industry. If you had asked me as a kid if I thought I’d be working in this business, I’d probably roll my eyes and laugh. Medical products? Nah, I had more romantic notions of becoming a professional baseball player or writing for Rolling Stone magazine.

Before I became a medical product marketer (which I am now), I was a medical product copywriter. Before that, I was a hospital and healthcare marcom copywriter. Before that, I was a general copywriter that made the successful jump from old school “traditional”/print media to “new” media and online. And before that, I was a journalist. And even before all of that, I was an aspiring academic with fantasies of being a scholar of media and culture. Of course, all of it was prefaced with the dreams I had as a kid.

Some people never stop pursuing those childhood dreams…even if that means a nightmarish adult reality. Comedian Louis CK is a shining example. After graduating high school in the early 1980s, he went after one specific goal: to become a successful comedian. And, as a result, like so many others that share that dream, he toiled in obscurity for decades in that ironically lonely and depressing world of standup comedy.

Skip ahead to last week when he announced that his self-produced and distributed online video netted him more than $200,000 in profit in less than four days. As impressive as the profits might be, what’s perhaps more intriguing is how he made it.

By his own admission, Louis CK could have made even more money had he produced and distributed the video through the traditional path of working with a major entertainment company. But that would have resulted in even more overhead—which gets passed on to the customer—and the sticky tangle of digital rights management (DRM) and DVD region complications (which provides even more hassles for customers).

Instead, he kept it painfully simple: Go to his remarkably low-tech Website, pay $5 (through PayPal), and either stream the video or download it and do whatever you want with it (e.g., burn your own DVD, watch it on your computer). Compare that to what a commercial DVD costs and the process of having to acquire it.

But back to the headline: What can we in the medical product business learn from Louis CK?

Being Good is Not Good Enough

Louis CK is widely regarded as one of the best comedians today. However, it took him years to rise above a very crowded and competitive market.

Whether it’s comedy, baseball players or medical devices, being “good” is never enough. For every good—great, even—comedian, athlete or medical device out there, there are countless others that are just as good, if not better.

For medical products, the basic algebra of having low prices and high quality is not enough to succeed. Rather, it requires tremendous belief in your product just to get it brought to market, and then even more dedication to improve it and market it so that it even has a chance of being competitive. And then there’s the intangibles, the x factors, the je nais se quoi, luck, etc.

You’ve Got to be Innovative in Your Marketing And Distribution

Nothing stays the same. Whomever—or whatever—is “good” today is mediocre tomorrow. Best practices for marketing and distribution can quickly become obsolete.

The music industry—which, due to increasingly vertical integration in the past couple decades—controls the distribution of most other complementary entertainment products, such as DVDs. Because it failed to recognize and embrace radical shifts in how entertainment is distributed channels (e.g., peer-to-peer file sharing, Napster, torrents, the ease of duplicating DVDs), it watched its profits erode—and perhaps worse, its power. This is precisely what Louis CK exploited with his relatively marginal investment in a $34,000 Website that is the portal to his video.

Twenty years ago, MediPurpose didn’t even exist. As illustrated in its success stories, ten years ago, it was a struggling startup in Singapore that would soon find a niche in the U.S. medical product market for its new SurgiLance safety lancet (a niche opened, in part, because of the 2000 U.S. Needlestick Safety and Prevention Act). The company leveraged emerging online communications with an aggressive independent sales force and got itself on the map.

Ten years later, it’s a profitable company that has since introduced two successful product lines—babyLance infant heelsticks and MediPlus Advanced Wound Care—with zero guarantees that it will be here in 10 years unless it remains dedicated to finding innovative solutions for its manufacturing, distribution, marketing and new business development.

You’ve Got to Put the Customer First

Good economy or not, people value their money, and they don’t want to feel ripped off. They also don’t want to be inconvenienced. Louis CK’s innovative use of the Internet to deliver product drastically simplified the process of acquiring (and using) a product and significantly reduced the cost—and his customers responded in kind.

MediPurpose is constantly striving to find ways to keep the customer first—which creates unique challenges because we not only offer several distinct products and services, but also because our customers are diverse. Along with the obvious “end users” (e.g., patients, nurses, doctors), we also serve our distribution partners, inventors and innovators, manufacturers and others.

You’ve Got to Embrace Online Communications

Social media, online/inbound marketing, etc. are not trends, fads or options. On the other hand, traditional marketing techniques—print advertising and direct mail, for instance—are both expensive and very low ROI.

Louis CK more than demonstrated that it no longer requires cutting-edge Websites or bloated marketing campaigns to move product.

For medical product companies, the same holds true. Although the diminished importance and value of print advertising might seem the obvious example, trade shows are perhaps an even better example.

Even to just attend a show as a non-exhibitor to “walk the halls” is expensive. Factor in airfare, hotels, per diems, entry fees and the lost productivity from not being in the office, and the cost to attend can quickly becoming a pricy investment. With a tight economy and the impact of inexpensive global communications (e.g., Websites, Skype, GoToMeeting, LinkedIn), and it’s not hard to understand why trade show attendance seems lower (in general) or scaled down (by exhibitors).

There is perhaps more than can be extrapolated from Louis CK’s recent success, but the point should be clear: Being and staying competitive in business is not for the uninspired and unimaginative. The keys for success are always out there; the challenge is with finding and knowing how to use them. 

Tags: Medical Product Distribution, Medical Product Marketing & Communications, Medical Product Sales Read More

Having spent more than 30 years intimately involved in the development and marketing of medical products (such as wound dressings), I find the history of innovation in the wound care field to be of great interest.

Although wound care dressings have existed for decades, the 1980s were a pivotal time for wound care products. The few wound dressing categories that existed were dominated by a few large companies that heavily promoted their technology for the hole in the patient. For instance, ConvaTec pushed their hydrocolloid technology (developed for ostomy applications) against all other substrates and claimed higher healing power versus competitors. Smith & Nephew pushed foams, and Carrington championed hydrogels as the best product for wounds.

As medical product companies were devoting more attention to wound care, it soon became apparent that there was more to treating the wound than the wound itself. As a result, their attentions broadened to include skin care and incontinence management, and the major wound care competitors began snapping up the major skin care manufacturers. For example, Calgon Vestal and Sween skin care lines were added to the dressing lines of ConvaTec and Coloplast.

The Rise of Wound Care Product Categories and Perceived Advantages

As wound care dressing categories evolved, so did the role of dressing healing studies. Although these studies had always compared different wound care products from start of treatment to healing, they also began to indicate different product classes’ advantages for different stages of wound healing.

For instance, studies started to indicate that hydrogels might be excellent selections for autolytic debridement of eschar, while alginates or foams might be excellent selections to fill cavities and manage high levels of exudate during the inflammatory phase of deeper wounds. As healing progressed and wound depth decreased with production of granulation tissue, more appropriate product selection might shift to hydrocolloid and eventually transparent films as a secondary and then primary dressing.

Value Prop Priorities: Price and Ease of Acquisition vs. Quality

This evolution soon began to impact the medical supply industry’s landscape. The dominant players began to add several—or all—wound care product categories to their lines as they evolved from specialty product promoters to one-stop-shop providers of all products required for wound care. Consequently, clinics and hospitals could now purchase all categories of dressing from several large providers and bundle their purchases to control cost of acquisition.

As dominant corporations added categories to their lines, the marginal differences between products within a dressing class were rarely considered. Practitioners were exposed to various competing hydrocolloids as the institutional supply contract shifted between major players, and they came to realize that none possessed superior healing benefits over others of similar quality.

Further, the source of the hydrocolloid, foam or other dressings became less important that the cost and ease of acquisition and the selection of products needed by the clinic. Anyone with solid wound care knowledge and good connections with medical product converters could have a product line produced that included the most frequently used dressing classes and the number of “full line” suppliers expanded dramatically.

There’s More Room Than You Think

In such a market, the need for yet another supplier of advanced wound care dressings would appear limited. So, a couple years ago when MediPurpose first asked me if I thought it would be a good idea to introduce a new line, my immediate reaction was to advise that since the market was already saturated with so many established players, MediPurpose’s chances for significant market penetration was minimal.

I suggested that unless they offered a full line of wound care products with high quality that matched the market leaders at a significant cost advantage, they would probably be better served investing time and dollars elsewhere. However, I did agree to take a closer look at what would eventually become their MediPlus™ Advanced Wound Care product line and the process MediPurpose uses to select new medical products for potential investment and development.

A review of each product class and each line item within the class quickly showed that the company had managed to acquire well-made wound care products with the handling characteristics most appreciated in clinical use. Others may be able to supply as broad a product line, but few can match MediPlus’ depth of product line offerings by size and application.

Given they had the required quality and breadth of line, the key remaining issue was whether they could bring the MediPlus brand to market at price points that could encourage customers to evaluate the wound care products and switch when performance met expectations. However, MediPurpose has been successful in partnering with truly low-cost and high-quality producers, and it does not incur the expense of a large sales and marketing staff to promote the MediPlus line.

Today in the 2010s when clinic costs are rising and reimbursement has stagnated or declined, the MediPlus Advanced Wound Care line can indeed fulfill dressing requirements while significantly reducing costs and returning profits to its customers.

Sounds like a recipe for success for all.

Tags: Medical Devices | Medical Products Read More

Over the past few months, the LinkedIn group discussion that I moderated on the Medical Device Inventors forum yielded some valuable information on best practices in safeguarding medical device IP. Now that ideas have been presented on what to do, let me address for a moment why it is so important to implement these measures. Besides protecting medical device ideas and product designs from theft or misuse, what other undesirable—and costly—circumstances might be avoided?

For those who have never been through a patent dispute, a centimeter of personal experience may equal a kilometer of knowledge for new medical device innovators who are not only unsure about the protections available, but also the immediate and long-term costs if one must ultimately go to court to protect their medical device IP interests.

Here are just a few of the issues that medical device innovators could face if a patent dispute makes it into a public forum:

• Legal Expenses: These are what everyone thinks of first when they hear the word “lawsuit.” Court costs, attorneys’ fees, travel costs to-and-from court proceedings, and expert witness compensation are just a few of the financial burdens associated with being involved in a medical device IP dispute.

• Public Relations: Simply being a party to a lawsuit can be damaging to your standing as a medical device innovator or IP owner, regardless of whether you are a designer or an unintentional infringer. If you have just started building your reputation in the medical device market or establishing a medical product brand, quick work may have to be done to repair any collateral damage and to even save your fledgling startup.

• Relationship Building: There could be temporary or irreparable harm done to your relationships with investors, distributors, manufacturers, strategic partners and customers when they evaluate the uncertainties that a patent dispute could impact their businesses.

• Development/Production/Sales: Even though you are the plaintiff, be prepared for counter suits by the defendant (read Apple vs. Samsung). Cases could result in a court-ordered cessation in development, production or sales that could sideline medical product product advancement for months or even years.

• Management Distraction: Cases may drag on for months and years, taking away valuable management time which could be better used on developing, manufacturing and selling your new medical product.

Although it is important to note that not all patent infringements are malicious, it can be quite costly to both your bottom line and your reputation. For this reason, it is best to shield your medical device IP during each stage of its journey to market. Based upon the results of the LinkedIn discussion, the following represents the offensive and defensive strategies to employ at the most critical stages of your medical product’s lifecycle.

Protect Your Medical Device IP From Inception

To ensure that your new medical product IP is protected from its first stage of development:

• File for both medical device patent and medical product trademark protection.

• Reverse-engineer your medical product: It is best to file for protection for each alternate design or improvement.

• Establish where the medical product will be manufactured, sold and distributed: It is recommended that you file for protection in countries where the cost/benefit ratio is balanced.

• Require non-disclosure agreements (NDA): Obtain these from all investment partners, developers, manufacturers and distributors, as well as any other individuals who will have access to proprietary information.

• Consider IP insurance, balancing the cost versus the protection you’ll get.

• Utilize Google Alerts: Keep track of your own trademark, company name and generic product identification.

• Enforce your rights without an infringement lawsuit: This can be accomplished by a) sending a warning letter to the offender, b) requesting an opinion on patent infringement from independent counsel, or c) filing a complaint with the U.S. International Trade Commission.

• Enforce your rights with an infringement lawsuit: When selecting your legal team, remember that the size of the law firm chosen is not as important as the experience and expertise of the attorneys. If you cannot afford representation, locate counsel who will take a patent case on a contingency basis.

• Negotiate a license and royalty agreement with a patent infringer: Higher royalties charged to an offender can offset their past infringement and keep them out of direct market competition.

Protect Your Medical Device IP From Your Suppliers and Partners

Now that you have a solid idea on paper and you have built some protections around your medical device IP, you are ready to contend with potential issues that could arise as you bring suppliers and partners into your development circle.

To ensure that your medical device IP is protected from misuse by suppliers and partners:

• Select the right partners: Get recommendations or referrals from trusted colleagues or networks.

• Select the right countries in which to do business: Consult with representation that specializes in IP management.

• Research each country’s legal infrastructure: Investigate the protections that are afforded to IP owners.

• Use experienced counsel to draft all agreements.

• Execute non-disclosure agreements (NDA): Require all suppliers and partners with whom you intend to discuss proprietary information to assert their commitment to confidentiality in writing.

• Prevent medical device IP dilution: Ensure that your agreements specifically address all additions made to the original design.

• Control access to information: Divide all proprietary components among several suppliers and limit the number of individuals who have internal or external access to sensitive information.

• Monitor partners’ and competitors’ activities: Subscribe to patent-listing Websites, or pay a firm to monitor for the appearance of similar medical device IP filings.

• Address any infringements swiftly and thoroughly: This will benefit both parties involved.

Protect Your Medical Product in the Marketplace

Once your new medical product is ready for market, you will need a new arsenal of tools to help you stay ahead of infringers and copycats. To ensure that your new product is protected from intentional or unintentional IP infringement or reverse engineering:

• Be the first one to market: Strive to expand the gap between your medical product and similar ones that may follow.

• Expedite regulatory clearancesfor your medical device.

• Develop the market: Make a concerted effort to establish benchmarks in medical product quality and customer service.

• Establish a broad network of medical product distributors: Ensure that your product is inserted into all corners of the market.

• Continue to improve your medical product: Stay abreast of advancing technologies in order to provide your customers with the best, most up-to-date product available.

• Build your brand: Establish your reputation by being consistent with medical product quality. Develop recognition by being persistent with marketing messages.

Knowing about the potential threats that exist in a competitive marketplace is only half of the battle for new medical device inventors. Understanding how to shield your medical device intellectual property is key to facilitating a secure environment for bringing your ideas to fruition. The three stages above highlight critical steps in protecting your medical device IP as your product moves from concept to market.

At MediPurpose, our commitment to medical device innovation stems from our proven success at every level of the medical product development process. We are pleased to provide supplemental information about topics like medical IP protection, in addition to offering more comprehensive support to medical device inventors and innovators. For more information or to submit an idea, please contact us.

Thank you to everyone from the LinkedIn Medical Device Inventors forum that contributed his or her comments and suggestions to this discussion. Your input has helped us to provide support to medical device inventors and innovators.

 

 

 

Tags: Medical Device Innovation, Medical Devices | Medical Products, Medical Device Intellectual Property (IP) Read More

Special thanks to Ryan Schneider, a registered patent attorney and partner at Troutman Sanders LLC, for contributing this guest blog.

On September 16, 2011, President Barack Obama signed the Leahy-Smith America Invents Act (AIA) into law. This legislation introduces some of the most sweeping statutory changes to U.S. patent law in decades.

Here are some of the key changes that will take effect over the next 18 months:

First-to-File

The AIA implements a first-to-file system in the United States, where priority is given to an applicant that is the first to file a patent application rather than the first to invent.

The change to first-to-file is the most significant change to the law and was originally intended to harmonize U.S. patent law with the majority of the world. However, the numerous additional caveats in this new statute may essentially create what has been described as a “first-to-publicize” system, which is substantially different from the traditional first-to-file systems of other countries.

This change will apply to applications with priority claims that begin 18 months after the date of enactment.

Changed Reexamination Standard

The burden for granting aninter partes patent reexamination will change from a “substantial new question of patentability” to a “reasonable likelihood that the requester would prevail.”

This change will take place upon enactment.

Post-Grant Review

Chapter 32, a new chapter in the statute, will create a nine-month window for Post-Grant Review (PGR) challenging a patent on any ground, including challenges based on written description (which was previously not possible in re-exam).

PGR will take effect in one year for some patents, but otherwise will apply only to applications with priority claims that fall 18 months after the date of enactment.

PGR will be granted upon a showing by the challenger that it is more likely than not that at least one of the challenged claims is un-patentable.

Post-Grant Review of Business-Method Patents

The bill requires the PTO to issue regulations establishing a post-grant review process allowing those accused of infringement to challenge the validity of certain business method patents, presumably including challenges to the eligibility of the claimed subject matter. This new process will take effect one year after enactment.

Third-Party Submissions

The AIA gives third parties the right to submit prior art to the patent office for consideration and inclusion in the record for a limited time during the pendency of an application.

The prior art must be submitted before a notice of allowance and the later of (1) six months after publication or (2) the date of the first rejection by the examiner.

This provision takes effect one year after enactment and applies to all patent applications filed before, on, or after that effective date.

Supplemental Examination

Beginning on the one-year anniversary of the AIA’s enactment, new Section 257 permits a patent owner to request supplemental examination of its patent to consider, reconsider or correct information believed to be relevant to the patent.

If the PTO determines that the patent owner’s request raises a substantial new question of patentability, a reexamination will be ordered. This provision provides, in effect, an opportunity for the patent owner to preemptively avoid allegations of inequitable conduct based on withheld or mischaracterized information.

But in order to take advantage of this potential avoidance of inequitable conduct, the supplemental examination (a) must be requested before an allegation of inequitable conduct is pled with particularity in a civil action or (b) must be completed before the institution of a Section 337 action in the International Trade Commission

The submission of a supplemental examination request is not without its risks to the patent owner, however. In addition to exposing the patent to potential invalidity, the provision permits the PTO to refer matters involving fraud discovered during the course of the supplemental examination to the Attorney General for possible prosecution.

Micro-Entity

Micro-entities will be entitled to pay 75 percent of the total fee amount (50 percent of the small entity fee).

A micro-entity is defined as an entity that meets a number of requirements, including qualifying as a small entity, not being named as inventor on more than four previously filed patents, and not having gross income exceeding three times the median household income for the preceding calendar year.

This change is effective upon enactment.

Increased Fees

All surcharge fees will be increased by 15 percent, and many other statutory fees will be increased, including a $400 fee for documents, which are not filed electronically.

These take place either upon enactment, 10 days after enactment, or 60 days after enactment.

Marking

The AIA effectively ends current and future qui tam actions of false patent marking brought by anyone other than the United States or a person who has actually suffered a competitive injury. Only the United States may recover statutory damages for false marking. A competitor may recover only those damages adequate to compensate them for their injury.

The revisions also make clear that marking a product with an expired patent that once covered the product is not actionable.

The AIA also permits Virtual Marking. In lieu of physically marking products with patent numbers, the patent owner can “virtually” mark their product with the word “patent” or abbreviation “pat,” along with a publicly accessible website address that associates the product with the patents covering the product.

The change will take place on enactment. With regards to qui tam actions, the change will apply to any False Marking case that is pending on, or commenced on or after, the date of enactment.

Prior Commercial Use Defense

The AIA creates a defense to patent infringement if the alleged infringer can prove a good faith commercial use of the infringing device/method more than one year prior to the earlier of (a) the effective date (filing date of earliest application to which priority is claimed) of the patent or (b) the date the subject matter of the patent was publicly disclosed by the inventor.

This provision applies to all patents issued on or after the date of enactment.

Best-Mode Defense Eliminated

The best-mode defense has been eliminated and is no longer included in the list of invalidity defenses.

While no longer a defense, the best mode requirement remains in 35. U.S.C. 112, and thus theoretically could be used by a patent examiner to reject an application.

This change is effective upon enactment.

Tax Strategy Patents or Patents With Claims Encompassing Human Organisms Eliminated

Patents with claims regarding “reducing, avoiding, or deferring tax liability” will no longer be granted. These exclusions will not apply to certain inventions relating to particular types of tax preparation software and financial management software.

Additionally, patents may no longer issue “on a claim directed to or encompassing a human organism.”

These changes are effective upon enactment.

In addition to those changes briefly outlined above, the 37 sections of the AIA include numerous additional provisions that will have far-reaching changes in the U.S. Patent law system. Please feel free to contact Troutman Sanders LLC for a detailed discussion of how the changes will affect you.

Do you expect this new legislation to better help you protect your medical product intellectual property? Why or why not?

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Ryan Schneider | Registered Patent Attorney and Partner | Troutman Sanders LLC

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So far, all of our blogs have been authored by MediPurpose staff.

As a “master medical product distributor,” there is much more to us than our staff. We have a network of partners and consultants that are an essential part of the MediPurpose family, including Troutman Sanders LLP, an international law firm that has been our trusted ally in our ongoing battle to protect our medical device intellectual property.

Our relationship with them now advances to a new dimension: the blogosphere. Tomorrow, we will be publishing our first guest blog, written by Ryan Schneider, a registered patent attorney and partner at Troutman Sanders. His blog will provide some fascinating and qualified perspectives on the Leahy-Smith America Invents Act (AIA), which President Barack Obama signed into law on September 16, 2011.

We want this blog to be an interactive forum for both newcomers and experts in the medical product industry. Along with encouraging you to comment on any of our blogs, we also welcome submissions from guest bloggers.

In the meantime, check back tomorrow for Ryan’s blog…I’m sure that you’ll find it to be very informative.

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Patrick Yi | Founder and CEO | MediPurpose®

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How did MediPurpose, which in 2000 was a medical device startup in Singapore—with limited resources and knowledge of the unique U.S. medical product market—penetrate the U.S. healthcare market and become a profitable business? Many friends, business partners and fellow entrepreneurs have asked me this question.

Each year that MediPurpose continues to thrive, I remain as grateful and proud as ever about what this tiny company has accomplished and continues to achieve. I also occasionally reflect on those early years when I could only dream of MediPurpose being where it is today. Although they were exciting times, they were also extremely challenging—in most part because I didn’t have a map or a recipe to point the way. Rather, I relied upon my intuition, learning from my mistakes, and some good old-fashioned luck!

This is why I am very pleased to announce that we have published another of our company’s medical product success stories! SurgiLance®: Penetrating the U.S. Healthcare Market, picks up where SurgiLance®: From Concept to Commercialization left off.

While the first story examined how I helped a first-time medical device inventor’s safety lancet find the funding and support to help bring it to market, the second story illustrates my decision to focus on a specific market—the U.S. healthcare market—and how I did it while still primarily based in Singapore.

Writing and publishing my journey is my way to count my blessings, and if it can help educate an aspiring medical device inventor, innovator or entrepreneur, then I feel that the effort has been more than worth it!

In sum, these success stories are intended to be what I wish had been available to me in those years: an illustration of how success in the medical product industry was achieved in both practice and theory.

Enjoy reading our success stories!

What did you think of our latest chapter? Do you have a story of your own to share…or perhaps you are in the early stages of your own? Please share your opinions and experiences with us!

 

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Patrick Yi | Founder and CEO | MediPurpose

 

 

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We are giving away three free Amazon Kindle e-book readers in daily drawings at the NANN 27th Annual Conference in Orlando, September 14–16!

A drawing will be held at the end of the opening reception on Wednesday (5:30–7:30 p.m.) and after each exhibit hall session on Thursday and Friday (10 a.m.–2 p.m.). Winners will be able to claim their prizes immediately.

To earn entry into the drawings, registered NANN attendees must complete a brief written or video evaluation of the babyLance® infant heel incision device at MediPurpose’s exhibitor booth 436.

See you there, and good luck!

Bonus: Mention this blog and get an extra entry!

 

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I have recently been invited to share my experience and insights on how to penetrate the U.S. healthcare market with local med-tech companies, start-ups and research institutions in Singapore in November 2011.

The invitation inspired me to finish the second chapter of our company’s medical product success story, SurgiLance®: Penetrating the U.S. Healthcare Market, which picks up where SurgiLance®: From Concept to Commercialization left off.

While the first story examined how I helped a first-time medical device inventor find the funding and support to bring his innovative safety lancet to market, the second story illustrated my decision to focus on a specific medical product market—the U.S. healthcare market—and how I did it while still primarily based in Singapore.

In retrospect, I realize that although the journey I took worked for the SurgiLance® safety lancet, other medical product entrepreneurs might find it better to take another path. But what are some of those other paths? And how might a medical product innovator make a decision to choose one path versus another? In order to make my sharing more useful for the medical device professionals in Singapore, I would like to generalize my experience and offer insights into alternative paths.

If you also share my interest in educating aspiring medical device inventors, innovators and entrepreneurs, I would love to hear your experiences and insights on how you navigated the U.S. healthcare market for your medical product.

Or, if you’re an aspiring medical device inventor, innovator or entrepreneur, do you have questions on how you might approach this challenge for your own medical product?

It is my aspiration for these success stories, tips and shared ideas to provide a useful roadmap for other medical device entrepreneurs—something that I wish had been available to me in those startup years!

Let’s start the discussion! Please share your stories, experiences, insights, tips and comments, either here on the blog or privately with me. I look forward to hearing from many of you!

 

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Patrick Yi | Founder and CEO | MediPurpose®

 

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Recently, Google announced an upgrade to their free online Google Translation napplication, which is now an interactive service that allows users to improve the quality of their translation by rating the resulting translation.

MediPurpose® is an international master medical product distributor that currently offers medical products in more than 30 countries. We are always striving to improve our ability to communicate both accurately and succinctly with our partners around the world.

As I reviewed the new feature, I was not surprised by the some of the feedback offered by others regarding the service.  Some indicated it “would be helpful,” while others voiced an opinion that you can “get the gist, but not the translations.”  It was also no surprise that still others felt that a "computerized translation" will never be adequate for all purposes.

Thinking back on how MediPurpose has approached translations for our babyLance® heel incision device, it reminded me of the importance that translations have when you are a medical device manufacturer and distributor. Aside from the physical labeling of the product (e.g., brand name, package contents), writing and translating the IFU (instructions for use) is perhaps the most critical component of the labeling process, as it is often the most singular document that details the proper use of your device.

Evet…çeviri! Oui....tout est dans la traduction! Ja....es ist alles in der Übersetzung! Sí....todo está en la traducción! 是的...它是所有的翻譯！ Ya...itu semua dalam terjemahan! Yes...it is all in the translation!

Whether it’s for medical device IFUs or not, the seemingly simple task of translating any text is compounded by the notions that:

• Languages are inherently ambiguous. Medical device IFUs most certainly should not contain ambiguities, as that could result in an end-user potentially misusing the device, which might impact either their own or their patients' safety.

• There is no such thing as one proper translation—even within the same language. Our babyLance® display box is labeled with French, German and Spanish versions of the IFU. But despite our best efforts (and due to the complexities of linguistics), it was impossible to draft a multilingual IFU that would be considered a perfect translation. When drafting and translating the IFU copy, we reached out to our international partners for guidance on the respective translations. As expected, each of our three French sources provided translations that although similar, still had striking dissimilarities. The same held true for our Spanish and German translations. Because of the critical nature of getting the translations as accurate as possible, we consulted with a firm that specializes in medical translations. And as expected, after again asking for feedback from our international partners, each said that the translations conveyed the desired actions without ambiguity—due in no small part to avoiding the specific peculiarities of each partner’s preferred use of the language.

• Translations magnify the semantic differences between the literal (closely following the grammatical and lexical form of the language) and the idiomatic (communicating the meaning of the source text). This essentially illustrates the conflicts between the partners’ translations and the consultant’s. As where the former used literal phrasing, the consultant used idiomatic, which results in much less ambiguity.

• One letter can have major impact. In German, “Baby beginnt ein Gerät Ferse Einschnitt” translates to "Baby starts a device heel incision.” Although not the most elegant literal translation, it clearly and effectively conveys the idiomatic intend. However, one simple spelling error—such as omitting the "t" on the end of the "Einschnitt"—and the translation becomes "Baby starts a unit heel gashes"! In the neonatal world of heel incision devices, the difference between an "incision" and "gash" in clearly the difference between a positive and negative representation of your device! Remembering the difference in translations noted above, it is no surprise that at MediPurpose, we always make sure we "dot those i's and include those "t's."

In the coming weeks, MediPurpose will be launching an upgraded version of its Website, which will include a nifty Google Translation toolbar above every page, enabling instant translations for more than 50 languages. Although it predictably won’t deliver the most elegant or accurate translations, we are confident that it will have enough balance of the literal and the idiomatic so that we can relate the fundamental message and better serve our worldwide partners and their customers and patients.

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Randy Prather | President and COO | MediPurpose®

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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?

 

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

 

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Last month, I wrote a blog that emerged from a question that I first posed in a LinkedIn discussion forum for members of the Medical Device Inventors group. In that blog, I digested suggestions for what you can do if somebody copies your medical device invention.

Since that time, the conversation has evolved to address other related issues, such as Ian. S.’ question about how to protect medical device IP from medical product suppliers and other partners in the manufacturing and distribution chain.

Coincidentally, I also discovered a SPRING Singapore white paper, Best Practices in Intellectual Property Protection: Are Your Asian Suppliers Protecting Your Interests?

So, as I did last month, I’m summarizing some key points from the LinkedIn discussion and the SPRING white paper.

The Best Defenses

Following the old saying “an ounce of prevention is your best defense” and using some common sense can go a long way in protecting your medical device IP:

• Have IP to protect: Firstly, if you haven’t taken the steps to establish your medical products’ IP, you don’t have anything to protect. Much of what was covered in the “IP Protection” section of my previous blog provides some crucial considerations related to establishing IP.

• Mitigate risks: Although legal systems are in place to assist in resolving medical product IP disputes, the best defense, according to SPRING, is to create systems that minimize the likelihood of IP being stolen. As mentioned in my previous blog, once IP is infringed, it can be very expensive to resolve matters.

Select the Right Partners in the Right Countries

It’s very difficult and often economically impossible to not outsource any part of your medical product’s manufacturing or distribution. But while having partners in some countries may yield economic advantages, this might expose you to greater IP infringement risk. So how do you select the right partners in the right countries?

• Consider a country’s legal infrastructure and protections: Select countries that are “reinforced by a highly ethical culture,” are signatories to key international IP protection conventions and practice an effective legal system.

• Seek expert advice: Another great point from SPRING is to find corporate counsel or a firm specializing in IP management in the selected region.

• Get recommendations and referrals: Trust is easy to lose and hard to get, so it’s worth the effort to seek trusted partners—whether through your own networks or by reaching out to LinkedIn members such as Ian S. who can vouch for “having a supplier for many years that would never consider ‘screwing me over.’”

Execute Effective Agreements

Once you’ve established your medical product IP and have found the right partners, ensure that the agreements that bind you go as far as they can to protect you.

• Execute non-disclosure agreements (NDA): According to SPRING, this should be done with ALL medical product suppliers before discussing ANY proprietary information. And don’t worry about offending them—if they have passed the recommendations and referral litmus tests, they know that NDAs are an SOP (standard operating procedure).

• Use experienced attorneys to draft agreements: Don’t just copy an NDA or manufacturing agreement that somebody else once had you sign or something that you downloaded from the Internet, especially if you are dealing with international partners. Use an attorney with experience in manufacturing practices in the countries you’ve selected.

• Clarify agreements to prevent IP dilution: As Nick W. pointed out, it can become very difficult to maintain “IP identity and value,” especially if a prototype gets additional development from manufacturers and partners. What started off as “your” unique and novel IP can ultimately end up as “their” IP if too much creative license is allowed.

Control Access to Key Information

• Diversify the information: As Jory T. suggested, medical device IP owners should “split the product patent, know-how, core software/firmware (if any), market control, key-component supplier agreement, and module product design with multiple suppliers.”

• Diversify access to the information: As with the different departments in your company, not every partner needs to know what every other partner knows in order to maintain an efficient, productive workflow. SPRING encourages medical product IP owners to both control internal access to sensitive documents and ensure that all external persons and suppliers handling sensitive information understand their responsibility to protect that information by restricting access only to those who need to know.

Monitor Partners and Competitors

• Keep an eye on patent filings: Just because you have a medical device patent, it doesn’t mean that everybody is aware of it, especially if others are filing medical device patents that unintentionally infringe upon yours, said Nick W.  The sooner you discover such filings, the better.

Andy. R. mentioned two ways to monitor medical product patent filings. One is to subscribe to Websites such as Free Patents Online.com, or to even hire a search firm to monitor patent filings for you.

De-escalate Problems

Whether they occur intentionally or not, medical device IP infringements are unavoidable in the medical product industry. When preventative measures aren’t enough, Nick W. advised, “A key part of effective IP enforcement is diligence and speed. Help your infringers to cave in gracefully and cheaply. Save them money and bask in their gratitude.”

As before, these tips and suggestions are anything but an exhaustive list. Can you suggest others? How do you protect your medical product IP? Has your IP ever been infringed? How did you handle it? What did you learn?

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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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Last month, I asked­ this question in a LinkedIn discussion forum for members of the Medical Device Inventors group. Several knowledgeable participants responded to my question sharing their advice and experiences.

One member, Jory T., suggested that a summarized "operation cookbook” for IP owners to minimize infringement damage be created. So, using that as a cue, I am in the process of putting together such a resource. In the meantime, I thought I’d summarize the key points that were made in the group conversation. Here they are, divided into two groups: IP Protection and Market Protection.

IP Protection

• Consider the “what”, “where” and “when’ of IP: Before you can protect your IP, you first need to articulate exactly what that IP should be. Matthew A. made a valuable point not thinking about intellectual property as a singular concept, but instead, to evaluate features (or combinations of features) as multiple intellectual properties. Michael Z. offered the additional advice of filing and enforcing trademarks in addition to patents.

  The next step is to figure out where to protect that IP—which, as I and Matthew A. suggested, should not only evaluate where the medical product will eventually be manufactured, sold and distributed, but also balancing the cost of filing for patent protection versus the business potential in those countries

  Finally, there’s the timing of getting IP protection. Ralph A. astutely mentioned the need to at least require non-disclosure agreements (NDA) before introducing your invention to manufacturers, distributors or the market. Otherwise, premature disclosure could prohibit your ability to file your patent later.
• Find infringers: “If a tree falls in the woods and nobody hears it, does it make a sound?” If somebody infringes your IP you would want to know immediately. One of the easiest—and virtually cost-free—ways to immediately discover infringement, as Matthew A. explained, is to setup free Google Alerts for your trademark, company name and generic product name.
• Enforce your rights without an infringement lawsuit: Before attempting to resolve matters in court, which can be a lengthy and expensive process, there are some easier, faster and more affordable options.

  When I suspect a possible infringement on one of MediPurpose’s IPs, my first action is to have an IP attorney send a warning letter to the offending company.

  If a warning letter doesn’t succeed, a next possible step, as Matthew A. said, is to request an opinion on patent infringement. A positive infringement opinion might dissuade some infringers, rather than continuing and allowing the matter to reach the courts. Yet another reasonable method is to file a complaint at the U.S. International Trade Commission (ITC), as indicated by Darrin A. and Ralph A., who said that the ITC, a specialized court could provide a speedy resolution, broad jurisdiction and general/limited exclusion orders with customs enforcement.
• Enforce your rights with an infringement lawsuit: “Laws are made to be broken,” the saying goes, and when you believe that laws that protect your IP have been violated, an unfortunate reality of the medical device business is that matters may need to be resolved in the courtroom. As I can attest, this is a very unpleasant, time consuming and outrageously expensive process. One way to mitigate the cost of an IP lawsuit is to invest in IP insurance, which Matthew A. and I discussed. As with any type of insurance, it’s a gamble that doesn’t reveal its value until it’s needed—which includes being able to collect a settlement if the lawsuit is won. Another way to reduce and even offset IP legal fees is to find creative and cooperative solutions with attorneys. Ralph A. suggested using a mixed contingency or hybrid contingency fee arrangement if you can't afford counsel. Maria G. mentioned that there are now many law firms that take a patent case on contingency.
• Negotiate a license and royalty agreement: As an alternate to expensive lawsuits, and rather than competing with an infringer that also may try to undercut your pricing, Dawn E. opted to create a hybrid license/OEM agreement where her client charged the infringer a higher royalty payment than usual in lieu of any cash up front for past infringement.

Market Protection

Lawsuits and other legal actions are only some of the weapons in a medical device IP owner’s arsenal for defending against or fighting back against IP infringers. As John S. said, IP protection is just one leg of a defensive strategy.

The other leg moves the strategy out of the attorneys’ offices and courtrooms and into a venue where most of us are better equipped for battle: the market.

• Be the first mover: John S. made a solid point about leveraging first-mover status by accelerating the distance between yourself and a follower.
• Expedite regulatory clearance: John S.’ suggestion of accelerating your medical device’s regulatory clearance can be another way to improve your product’s competitive advantage over an infringing competitor’s. 
• Develop the market: Simon S. put it simply, “Don't focus energy and money on protecting the intellectual property when starting out. The device does not sell itself. It's rather how the company develops the marketplace that is key to success and victory.”
• Establish distribution channels: When starting out, the small medical device manufacturer needs to go through established distributors to reach the market. MediPurpose took a year to sign up most of the key distributors in our market and even longer to build relationships with GPOs (Group Purchasing Organizations).
• Add more features over time: Jory T. urged us to monitor newer replacement technologies to provide cheaper, better, and friendlier products.
• Ensure quality products: Customers will pay a slight premium for better quality products. When cheaper competitors attacked our customer base, MediPurpose was able to keep most of our customers because of our focus on product quality.
• Reduce cost: As I mentioned above, quality products only command a small premium. So we have to continually improve our processes to lower costs. As David M. said, “Exceeding your customer's expectation and being the low cost producer wins.”
• Build your brand: When all is said and done—especially if it’s been done well—building a respected and widely recognized brand in your niche can not only reinforce critical marketing protection, but as Michael Z. said, it can help protect IP since such a brand’s trademark (if properly filed and enforced) can be much easier to defend than a patent.

  For MediPurpose, a consistent priority of delivering quality medical products and increasing their value to customers has been essential for our survival, growth and competitiveness, as well as dashing the maligned ambitions of IP infringers.

  In simplest terms, we have done this by being savvy and diligent marketers, establishing medical product distribution channels and GPO relationships, providing excellent customer service and reducing costs.

These are but a handful of options. Can you suggest others? Have you had your medical device invention’s IP infringed? How did you handle it?

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Last month, we unveiled the logo for our new advanced wound care product line, MediPlus™.

In the news release that I wrote, I mentioned a link to an “official list of print and Web equivalents” for the new logo. If you visit the page, you’ll see the official colors for all of our logos, including the corporate logo for MediPurpose® and the brand logos for SurgiLance® safety lancets and babyLance® infant heel incision devices.

Somebody that saw that page recently asked me about the differences between RGB, CMYK, Hex and Pantone. You might have never heard of some or all of these terms, but they are worth understanding, especially if you are responsible for your medical device company’s marketing and branding.

Along with your own print and online documents, encouraging color consistency from everybody at your medical device company is a key technique to ensuring consistency with your brand awareness.

When talking about "color" in regards to printers or online displays, there are several ways to ensure consistency, especially since the "red" you see on your screen might not exactly what's on mine—or what you might expect to come out of a printer. These are called “color systems” or “color models.” Among the most common are RGB, CMYK, Hex and Pantone.

What is Pantone CMS?

The Pantone® CMS (color matching system) is a standardized list of virtually every color imaginable. It's what professional printers often use to keep things consistent.

For instance, if I had a printer print our logo on a business card, I would tell them to make the red part of the logo "Pantone 206c." That helps differentiate from other shades or red, such as the red that is used by The University of Georgia.

What are RGB and CMYK?

Most devices that create color images—televisions, inkjet printers, etc.—typically use red, green and blue to create the image; this color model is known as RGB (for Red, Green and Blue). Colors are identified by specific combinations of RGB (on a scale of 0–255) are used.

There’s another similar color model called CMYK (for Cyan, Magenta, Yellow and blacK), which is a more sophisticated "four-color process" that is often used by professional printers. Similar to RGB, colors are identified by specific combinations of CMYK (with percentages of 0–100 percent).

What is “Hex” Color?

Websites that use HTML (HyperText Markup Language, which is the predominant coding language for Web pages) have their own system of color standardization, which is known as "hexadecimal," or just "hex," because it uses a combination of six letters and numbers to identify specific colors and shades. Colors are identified by specific combinations of letters A–G and numbers 0–9.

So, What Color is “MediPurpose® Red”?

Depending on the color system or model, there are several ways to identify the red in our logo:

• Pantone: Pantone 206
• RGB: R (211) | G (5) | B (71) •
• CMYK: C (1%) | M (94%) | Y (45%) | K (1%) •
• Hex: #D30547

See It For Yourself!

One of the easiest ways to experiment with color models is to open a Microsoft Word document. Write some sample text and select it; then use the "color" sliders to choose a palette (e.g., RGB, CMYK). The above image is what the RGB sliders look like in Word for Mac; the selected color is "babyLance® green."

Once you have a color selected in a particular color model, you can see its equivalent in another model by selecting another palette.

There are many converters available online, e.g., RGB to HEX, or CMYK to RGB; one is the Pantone Color Cross Reference. Design software such as Adobe Photoshop also includes palettes that can be used with the eyedropper tool to pinpoint your medical device company’s colors.

After you’ve identified your company’s colors, it’s best to draft a “style guide” that should in your company’s internal communication governance, as well as a public resource for distributors and other clients.

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Last week, I wrote a blog about three traits of a “great employee.” In it, I referenced three MediPurpose® employees that were recently honored for service of five years or more. At that same event, we also honored several businesses that have been our partners for five years or more.

Our small business is not unique in its reliance on a host of business partners to provide essential services. From the day I launched MediPurpose (then known as SurgiLance) as a startup in Singapore in 1999, our business has been built around partners, consultants and other outsourced talent. This allows us to leverage expert resources, keep costs down and ensure a lean, efficient operation.

Like employees, there are all types of partners, ranging from bad to good. And whether through my choice or their own, only the good can pass the test of time, which in this case, means five years or more. Below are seven such companies or individuals, each of which provide a very important service to MediPurpose. But, other than their lengths of service, what is it that binds them to us?

In my opinion, these partners exhibit three traits of a good small business partner:

• Providing value by providing superior goods and services at fair prices and rates.

• Investing in relationships by mutual demonstration of trust, reliability and faith in its partners.

• Communicating openly and honestly about issues as well as opportunities.

Troutman Sanders LLP (with MediPurpose since 2000)

When the Troutman Sanders law firm helped incorporate SurgiLance, Inc. in October 2000, they didn’t know what kind of customer we would be. It must have been somewhat disconcerting for them to find out the following year that a competitor was suing us for patent infringement!

It took four long years and more than a million dollars before we won the case. As I was bootstrapping the startup company, I certainly did not have the financial means to pay Troutman Sanders’ legal fees. They understood our situation and most importantly believed in what we were trying to do—and demonstrated that by being flexible with payment terms, allowing me to pay them as I grew the business.

Without their generosity and understanding, I would not have been able to contest the suit and would have had to close the company prematurely.

Additionally, they have always helped me to choose the most cost effective solutions to our medical device intellectual property needs, patiently educating me on the complexities of the IP landscape.

Patrick Yi, Jay Orzech (Accounting Partners) and Valerie Yi

Accounting Partners, Inc. (with MediPurpose since 2001)

Whether for your own personal finances or for a corporation, there’s a tremendous amount of trust that must be cultivated in order for a relationship to blossom with one’s accountant—which is precisely what has occurred with MediPurpose and Accounting Partners.

Accounting Partners were first hired as our QuickBooks consultant, and then later hired to provide full accounting and tax services. More recently, their role has been expanded as an outsourced partner for our key customer service function.

All of it is because they have consistently served us well and have gained my trust. They have done so by developing relationships with us, helping with suggestions and contacts wherever they can. Furthermore, although we pay them on an hourly rate, they have never taken advantage of this arrangement and my bills are reasonable for the services they render.

Beth Craig (with MediPurpose since 2001)

The continuous and unimpeded movement of our medical products from our factories in Asia to our warehouse in Atlanta is absolutely essential for our survival in the competitive U.S. healthcare market. Yet there is always the possibility of our shipments being held up—especially with the heightened security after 9/11.

As our first and only customs broker, Beth (who is now with AIRSCHOTT) has cleared our medical products through U.S. customs and the U.S. Food and Drug Administration for the last 10 years.

We have had more than our fair share of problems, but Beth has always been responsive to our needs helping us solve problems with the shipper, carrier, customs or FDA. She has also provided valuable advice on customs and FDA procedures for the importation of medical products into the U.S.

Patrick Yi, Valerie Yi and Connie Capell (Kuehne + Nagel)

Kuehne + Nagel, Inc. (with MediPurpose since 2004)

As a master distributor of medical products, MediPurpose needs a good logistics partner to receive, warehouse and ship our inventory and Kuehne + Nagel has been doing that for our SurgiLance® safety lancet in North America since 2004.

Of course, there’s a reason why they do it and not somebody else. One is value. Before we switched to K+N, the cost of our warehousing services represented 1.7 percent of our sales. They reduced our cost to 1.4 percent in the following year, and to 1.25 percent in 2010!

Furthermore, along with lower costs, their handling error rate is consistently below 0.5%, which is very good performance.

Doug A. Stegall (with MediPurpose since 2005)

As our first and only financial auditor, Doug has always been very professional and has understood the limitations of small businesses like MediPurpose.

Prior to Kirschner & Associates, I worked with Doug at another firm. When he left it to join Kirschner, he did not contact me, being the professional that he is. However, when he was referred to us, he not only provided the same level of service to us as before, but for a lower and fixed cost.

Faye Pender (Pender & Associates), Patrick Yi and Valerie Yi

Pender & Associates (with MediPurpose since 2005)

Along with the myriad of other challenges, providing a quality employee healthcare benefits plan is something that frustrates and sometimes cripples many small businesses.

As our first and only health insurance broker, Pender & Associates had delivered competitive quotes to us every year so that we can manage our healthcare insurance cost. Further, they have assisted us with filing claims and have helped us navigate the bureaucratic insurance maze that would sap the energy of any administrator!

AVision Business Solutions Pte Ltd (with MediPurpose since 2006)

In 2005, MediPurpose was paying a hefty six-figure fee in premiums for our commercial insurance. I was not sure that our insurance broker at that time was getting competitive rates for us. I therefore decided to invite two other U.S. brokers to provide more competitive quotes.

Although AVision Business Solutions had no experience with product liability insurance at that time, I asked whether they might be interested to give us a quote as I had known Angeline, the owner, as a trusted business person for many years. Their quote came in as the most professional, cost-effective and innovative proposal.

Over the years, they have continued to provide value to us and we now pay 65 percent less in commercial insurance premium than before our relationship with them.

Seven Good Partners for Three Great Reasons

When a business-to-business relationship works, it’s truly win-win. Of course, the provider business enjoys the revenues and can commit marketing and sales efforts to expanding their client list.

As the receiving business on the other side of that equation, we benefit because we also don’t need to commit resources to finding, researching, comparing and selecting new partners. As a small business, we simply can’t afford to frequently engage in activities that only move us horizontally instead of vertically. And as a successful small business, we truly appreciate those that help us make that claim!

What other attributes have you found in your partners that have delivered value, trust, reliability and more? Let us know in the comments.

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When I was growing MediPurpose in the early days, many blogs and articles that I read about the difficulties facing startup medical product companies only motivated me to beat the odds. Now it’s the beginning of 2011 and our second decade in operation, and it is no small measure of success for me that MediPurpose has not only survived, but also flourished.

Among other factors, the MediPurpose success story has been made possible by the dedication of certain key employees who have worked with the company for more than five years. At our company’s annual dinner on 8 January 2011, we acknowledged three such employees whose contributions have not only been instrumental for our growth, but have demonstrated some of the traits that I feel define a good employee. Three of these traits include:

• Taking personal ownership of the job by working as you would for yourself, family or close friend.

• Demonstrating a commitment to the company by being selfless and able see the big picture.

• Communicating openly and honestly about personal and company matters—especially contentious issues.

Stephen Yi

Stephen Yi, Group CFO (with MediPurpose since 2003)

Three years after launching our SurgiLance® safety lancet in the American medical device market, we needed a trusted person to establish a beachhead in Europe for MediPurpose. In November 2003, I reached out to my brother, Stephen Yi, who agreed to move from his familiar accounting job to do sales and business development for a new medical device in a drastically unfamiliar industry and geography.

However, his personal commitment and his faith in MediPurpose’s potential soon paid off. Within six months, Stephen secured our first NHS contract that put us on the map for medical products in Europe.

As MediPurpose expanded its medical device distribution capabilities in Europe, additional resources were brought in. Today, as the group’s CFO, Stephen focuses on operations and accounting.

Cheryl Channell, Customer Services Manager (with MediPurpose since 2005)

Patrick Yi, Valerie Yi and Cheryl Channell

Cheryl has been the heart of our superior customer service since 2005, looking after our medical device customers with the warmth and care that she naturally shows to her friends and family. Not only is Cheryl committed to doing her best, she also takes personal ownership of her responsibilities and treats the company as her own.

Cheryl’s dedicated service was interrupted briefly in 2007 when she left MediPurpose for two weeks. A new manager I had hired was creating a lot of stress for her, and she resigned just as I was about to ask the manager to leave.

Serendipitously, Cheryl’s new job did not turn out as she expected, and she enquired about returning to MediPurpose when she found out that her former manager had left. I welcomed Cheryl back, and since then, our entire company has been committed to maintaining open channels of communication so that we never again risk losing top employees at the peril of keeping those that create stress and tension.

Randy Prather, President & COO (with MediPurpose since 2006)

Randy Prather, Patrick Yi and Valerie Yi

Randy joined MediPurpose as VP of Sales & Marketing in February 2006 and swiftly established productive relationships with a growing network of medical product distributors.  In June 2008, Randy was promoted to president and chief operating officer (COO).

Over the years, Randy assumed additional responsibilities in New Business Development, Operations, Quality and International Business—always without complaint, even when he didn’t have the experience in some of those areas. For a small entrepreneurial company, Randy was prepared to do whatever was required to further the cause of the company.

With such a diverse role in the company, Randy and I have often worked through many difficult issues at MediPurpose. The key to our successful working relationship has been our open and honest communication—occasionally heated, but always respectful and professional. More specifically, Randy has the ability to argue with me without us getting personal, offensive or angry. This speaks a lot about Randy’s communication skill, which I guess is the hallmark of a world-class salesperson!

Three Great Employees for Three Great Reasons

Stephen, Cheryl and Randy are unique individuals with unique roles and responsibilities at MediPurpose. Yet, each has thrived at MediPurpose for as long as they have because they care…about themselves, about each other, and about the company. As a result, they make it very easy for me to reward them. But as much as I can reward them with mementos, titles and money, I have a sneaking suspicion that their pride in who they are and what they do is beyond any material or financial award.

What other attributes have you found in your loyal and dedicated employees? Let us know in the comments.

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In response to growing concerns about transmitting hepatitis B virus (HBV) and other bloodborne pathogens during fingerstick procedures for blood sampling, the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have identified shared and reusable fingerstick devices as a possible cause. This is due to an increase in diabetic care HBV infections, especially in settings such as long-term care facilities (LTC) where frequent assisted blood glucose monitoring is performed.

The Differences Between Reusable and Single-Use/Disposable Fingersticks

In an alert issued on August 26, 2010, the FDA and CDC emphasized that “fingerstick devices should NEVER be used for more than one person.”

The FDA and CDC further recommended: “Auto-disabling, single-use fingerstick devices should be used for assisted monitoring of blood glucose. These devices are designed to be used only once, after which the blade is retracted, capped or otherwise made unusable. These may also be called ‘safety’ lancets.”

All MediPurpose® fingerstick devices are single-use and disposable. Of course, this includes our SurgiLance® safety lancet, but it also applies to functionally similar medical devices such as our babyLance™ infant heel incision device. We have seen reports of HBV infections due to the use of regular pen-activated lancets dating as far back as 2002. That is why MediPurpose has sold almost a billion lancets since 2000, most of them in the alternate care market.

A simple decision to switch to a safer and more convenient fingerstick device instantly eliminates one of the root causes of HBV infections in long-term care facilities. And as recently commented at the Nursing Home Reality blog, if you look at the cost of managing needlestick accidents and infections through sharing, the decision is a highly economical one, too.

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