MediPurpose® Blog

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®

 

Tags: Untagged Read More

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?

Tags: Untagged Read More

Casual filmgoers, professional film critics, and academic film professors often have markedly different perspectives on what makes "great" cinema, but there are a handful of films—and filmmakers—in which there is often little debate about their greatness. Francis Ford Coppola is certainly one of those filmmakers, and The Godfather is certainly one of those films.

Yet, despite producing one of film history's most fabled movies in 1973, by the end of the decade, Coppola would be facing complete financial, professional and personal devastation while making what would become yet another of the virtually indisputable cinematic masterpieces, 1979's Apocalypse Now.

To make a long story very short, the film's allegory of a man's descent into madness as he attempts to track another man (that also descended into madness) ultimately became an accurate description of the filmmaker and his film's development and production. (In fact, an award-winning film about the film—Heart of Darkness: A Filmmaker's Apocalypse—was released in 1991).

Medical device inventors and innovators can probably very easily relate to Coppola's saga. After all, how many of you have invested or risked innumerable hours and dollars—as well your reputation and sanity—while trying to create, launch or distribute a medical product that you believe in as much as Coppola believed in his film?

Like a film, a developing medical product needs support at all phases, from conception and pre-production phases through development and distribution. This is why MediPurpose has expanded its scope to provide funding and distribution services for medical device inventors and medical product innovators.

Although the process is by no means willy-nilly—in fact, there's a carefully structured methodology for selecting and developing the "right" medical product—it is led by somebody (company founder Patrick Yi) that has experienced many of the challenges (and risks) that you have faced.

Tags: Medical Device Innovation Read More

"Seems like just yesterday" to coin a phrase, but that is how fast 10 years can fly by—as it has since MediPurpose first launched the SurgiLance® Safety Lancet in 1999.

Once just an idea for an innovative healthcare safety product and today a solid market leader in safety lancets, it almost seems unlikely—considering the dominance of some large companies like Roche and B-D—that a small medical product startup like MediPurpose could not only exist, but actually be successful.

I'm not the first author in this blog to say it, but it can't be stated enough: MediPurpose's good fortune is not only a credit to not only the product, but also to the founder, Patrick Yi, for his unwillingness to allow the company to fail.

Achieving this success has meant providing a quality product at a competitive price. It has also meant his personal sacrifice of moving his family halfway around the world...and then asking people that had never heard of this product to "trust me."

As with all small and young organizations, there were the usual struggles early on (some of which will soon be revisited in this blog), but having weathered them, MediPurpose is now spreading its wings to help new and exciting medical device inventions, products and companies discover their own success.

Ten years is something very few startup companies ever experience, and being a witness and participant to some of that growth is something for which I am very proud.

Changes are happening all around us, but this organization continues to stick with its original philosophy of quality products and great customer service. I can only imagine what the next 10 years will bring, but am excited to seeing it unfold!

Tags: Medical Device Innovation, Medical Product Sales Read More

As MediPurpose celebrates its first 10 years in business—and perhaps because this is also the end of the year and the close of a decade—there's been a lot of reflecting around the office.

Like with MediPurpose founder and CEO Patrick Yi's recent blog, my contemplations have toggled between reviewing our company's success and the trajectory of my own career—including the last four years that I've spent at MediPurpose.

Similar to most senior sales and marketing professionals, I have worked for a range of companies that span a spectrum of sizes, scopes and requisite responsibilities. Although I don't have any illusions of having complete clarity with how MediPurpose achieved its success, I do believe that my experiences have given me some perspective.

More specifically, my current perspective is that there are three fundamental reasons for why MediPurpose has not only survived, but has thrived and is poised to continue doing so for another 10 years and beyond. After all, an estimated 50 percent of startups fail, and MediPurpose has had the additional challenge of being a single-line medical device company in a field of Fortune 50 healthcare titans.

Reason #1: MediPurpose has Always Been Customer-Centric

This exceeds the standard "the customer comes first" credo. Any business that doesn't put the customer first is doomed.

A company that wants to do more than "not fail" and truly achieve success must be customer-centric. To me, "customer-centric" sensibilities means:

• Embracing an honest, straightforward approach to problem solving that simultaneously puts in a fix to prevent the problem from resurfacing.

• Always assuming accountability in the eyes of our customer.

• No excuses. No fluffy explanations.

Reason #2: MediPurpose Founder CEO Patrick Yi has Never Forgotten His Experiences as a Struggling Entrepreneur

Remaining grounded to those early years-in spite of our 10-year success-has produced a unique workplace culture.

Not only is there still a sense of excitement and discovery in our ongoing business our first product, the SurgiLance® Safety Lancet, but it's fostering a sense of empathy and understanding for new medical device inventors within our Medical Device Innovation division, as well as with medical product companies looking to bring medical product innovations to the market through our Medical Product Distribution Services division.

Reason #3: People Come and Go in All Companies

The litmus test for a company that claims to provide the nurturing environment for the good to get better is when its talent comes back after spreading its wings.

I've seen it at MediPurpose quite recently with the return of VP of Sales and Marketing Mark Stoppenbach. His return reinforces the notion that although we will always learn from our mistakes, we fortunately make more wise decisions than not.

Pleasin' Reasons

Although I would agree that this is certainly not an exhaustive list of factors for success at our company, I will say that they are essential elements.

In my entire career, I have seldom seen them all come together as consistently and effectively as they have at MediPurpose, and that alchemy has me very excited for the next 10 years.

Tags: Medical Product Sales, Medical Device Innovation Read More