Builder of people, systems and businesses

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.

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.

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!

Patrick Yi | Founder and CEO | MediPurpose

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!

Patrick Yi | Founder and CEO | MediPurpose®

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?

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?

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.

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.

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.

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.

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, 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)

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 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.

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.

There’s an old saying that “the first million is the hardest.” Presumably, that “million” refers to money and wealth, accumulated by individuals, businesses, or both.

For MediPurpose, the first million in medical product sales was achieved quickly. I started MediPurpose (then known as SurgiLance Pte Ltd) in Singapore in 1999 to sell SurgiLance® Safety Lancets (then known as One-Step Safety Lancets).

By 2001, the first full year of sales, MediPurpose had made its first million; by the end of the next year, that figure had tripled.

I can’t say which million was easier or harder to make as every million and every year in business has presented its own unique challenges.

Reflections on the 10th Anniversary

Yesterday, we published a news release that officially announced our recognition of our 10th year in business, and that has put me in a reflective mood. Ironically, the more I think about the past, the more I think about the future. It also has me thinking about that old saying.

Although money is always on the mind of most people, it is only a small part of the motivation for medical device inventors and medical product innovators and entrepreneurs—or at least myself and the successful ones that I’ve met or read about.

Both then and now, my motivation has mostly been in the quest to achieve something meaningful.

For me—and for that matter, MediPurpose—that has meant solving the riddle that we like to call “from concept to commercialization.” More specifically, it involved taking my brother-in-law’s innovative safety lancet from the “good idea” phase in 1999 to what it is now: one of the world’s most popular safety lancets.

Prior to MediPurpose, I had zero experience with medical products—developing them, marketing them or distributing them. However, I did have experience in taking things “from concept to commercialization” such as the Singapore NETS debit card service. The opportunity to test my intuition and the versatility of my problem solving skills with my brother-in-law’s innovation was too tempting to resist.

Ten years later, after selling millions of dollars and more than a half-billion SurgiLance® Safety Lancets, that urge to test myself has never faded. In fact, it’s as strong as ever, especially as I look back on the past 10 years and continue to focus on the next 10 years and beyond.

It may be true that the first million was the hardest. The same can be said for the first years. During that period, I was too busy trying to get MediPurpose into the black to think much about whether I was doing things right, and the thrill of achieving each milestone sustained my efforts.

Now that I have some security and confidence with what I do in the medical product arena—especially as I now guide MediPurpose into new directions with our Medical Device Innovation and Medical Product Distribution Services divisions—I don’t expect the next 10 years to be any less difficult, stressful or challenging. Then again, I wouldn’t be doing this if it weren’t!

The central purpose of my blog is to recount a journey that started with an idea for an innovative medical device in Singapore and blossomed into the successful company that MediPurpose not only is today, but also continues to become.

All stories need a beginning, and MediPurpose's arguably began in 1998 when my brother-in-law John Teo invented the original SurgiLance One-Step Safety Lancet.

I was soon invited to help him build a company—then known as SurgiLance—that would complete his medical device's development, setup its manufacturing, and establish its marketing and distribution.

After launching the SurgiLance One-Step Safety Lancet in the United States in 2000, SurgiLance quickly achieved sales of $1 million (2001) and then $3 million (2002) and then $6.3 million in 2003—the same year we were bestowed the prestigious Frost & Sullivan Distribution Leadership Award. By 2005, after expanding into European distribution the previous year, we had achieved profitability.

In 2006, shortly after International Technidyne Corp. (ITC) appointed us as co-exclusive distributors for their Tenderfoot® Heelstick, we changed our name to MediPurpose.

2009 saw many exciting changes at MediPurpose, such as the new Website and and the launch of Medical Device Innovation and Medical Product Distribution Services divisions—with many others that we'll be rolling out in 2010 and beyond.

However, before I cast too much of an eye on the future, I want to retrace this journey up to this point, which covers five overlapping phases:

• Bringing the SurgiLance® Safety Lancet to market
• Developing medical product distribution channels
• Moving to global medical product markets
• Partnering with medical device innovators
• Serving as master distributor

I'm hoping that you'll get as much out of the journey as I am with looking forward to revisiting it!

The majority of questions that I am often asked about our medical product company almost always start with "how," such as:

• How did I develop an independent entrepreneurship in Singapore into the international medical product sales and distribution company that MediPurpose is today?

• How does a medical device inventor get funding and support for developing a medical innovation into a winning product that is ready for the global market?

• How can a medical product innovator get a medical product distributed in the United States?

This blog—or at least my contributions to it—will attempt to answer these and many other questions...but not through "here's how you should do it" checklists, but through my personal "here's how I did it" perspectives.

As you will hopefully discover, the "how I did it" informs "how you should do it" as well as "how you should not do it."

Although my journey through the process of building the broad infrastructure to commercialize a medical product has been filled with—and continues to deliver—many rewarding successes, it also has had its share of missteps, setbacks and failures. But as I learned from them—and will continue to learn from them—I hope that you will, too.

I've been very fortunate to achieve what I have at MediPurpose and elsewhere in my career, and this blog is my way to give back to the medical device innovation community. If you haven't yet, please be sure to click the RSS button and subscribe to this blog, and if you have any suggestions or ideas for this blog, please let me know.

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