Medical Device Start-Ups in a Global Economy: Michael Whitman at TEDxLaf
## Speaker Context - Speaker established an initial self-assessment of being very nervous, describing it as "postgraduate residual stress syndrome." - Speaker established the core theme that today's reality allows one to "organize a global medical device company in less than a year." ## People - Jessie + speaker's daughter + 12 years old. - Linda + speaker's wife + Class of '83, electrical engineer. - Chris + speaker's son + Senior student. - Catherine + speaker's daughter + Graduated last year. - Brian Hendrickson + person mentioned + Was encouraging the speaker to build up the Trenton building. - Steve Jobs + figure referenced + Gave a famous graduation commencement speech at Stanford University. - Peter Drucker + management consultant + Contemporary of Deming, wrote a lot of quality work in Japan in the 70s and 80s. - Albert Einstein + figure referenced + Associated with the quote, "the journey of a Thousand Miles begins with the first step." ## Organizations - Johnson and Johnson + small company where speaker started + Speaker worked there 30 years ago. - NASDAQ + place/institution referenced + Associated with the Bell reading. - Lafayette + educational institution + Speaker attended, mentioned representation at the event. - micro Interventional + new company + Focuses on micro Interventional devices. ## Places - Langhorne, Pennsylvania + location of company office + About an hour and 20 minutes south of the current location. - Trenton + location mentioned + The world will make it, and it is 10 minutes away from Langhorne. ## Tools, Tech & Products - Coronary stent + medical device + Goes in for cardiac disease. - Internet + communication tool + Mentioned as a tool enabling rapid global organization. - Skype + communication tool + Mentioned in comparison to today's connectivity. - Facebook + communication tool + Mentioned in comparison to today's connectivity. - micro Interventional device + focus of new company + Enables conversion of surgery to minimally invasive surgery. - PermaSeal device + proprietary medical device + Used for creating a secure attachment to the epicardial surface of the heart. - V-stays + component of the PermaSeal device + Connect six polymer anchors, creating the access point and closing the access culture. - Guide wire + medical instrument + Introduced through a needle at the access site. - Sheath + medical instrument + Allows access to the left ventricle of the heart. ## Concepts & Definitions - Postgraduate residual stress syndrome + condition speaker developed + Syndrome related to being a speaker in the room. - Global economy + economic context + Condition where one can organize a global medical device company in less than a year. - Biocompatibility + required aspect of medical devices + Must be proven and tested. - Liberal democracies + political/social concept + Concept discussed by France Truciana and seen as increasingly predominant. - Available Market + economic term + Market potential size. - Minimally invasive surgery (MIS) + surgical approach + Alternative to opening up the chest or performing cardiopulmonary bypass. ## Numbers & Data - 30 years + duration + Time speaker started in the industry. - 12 years + time taken to get a previous company (drug eluding) organized and going. - $200 million + approximate initial capital limit for a previous company. - 1988 + year + When they were testing stents in hearts. - 1982 + year + Year referenced concerning communication limitations. - 2080 + number + Number of employees in the last company (Power Medical). - Seven + number + Number of languages the last company operated in. - Three + number + Number of continents the last company operated on. - Two months + timeframe + Time it took to build the micro Interventional website from scratch. - Hundreds of thousands of dollars + comparative cost of advertising. - Three thousand [dollars] + actual cost used for the website advertising. - 500 million dollars + market size estimate for 2010. - Two billion dollars + projected market size for 2015. - Two hours + duration of operation on the heart for the comparison procedure. - Six + number + Number of polymer anchors forming the V-stays. - Four or five + number + Articles in the reading recommended by Drucker. ## Claims & Theses - The speaker's initial nervousness upon arrival was unexpected, leading to naming a condition. - The modern global economy allows one to organize a global medical device company in less than a year. - Disruptive technology is happening everywhere, not just in IoT, information systems, or the Internet. - The global communication network allows instantaneous communication impossible in 1982. - The ability to operate in a global medical device company relies on understanding local customs, monetary policy, and regulations. - The speaker's current company (Micro Interventional) was built from scratch in less than two months. - A global company means more than speaking to a group or talking in English. - The world is a dynamic changing place. - The people who think they can change the world are the people that change the world. - Becoming oriented towards the global world mindset is a fact. - The global economy and the availability of communication vehicles set up an exciting career path. - The business the speaker is in right now (related to the market) is real. - The current approach (MIS) is better than traditional surgery (sternotomy/CPB). - The proprietary anchors of the PermaSeal device were developed to create a secure attachment to the epicardial surface of the heart. - The ability to change requires having the right mindset, as demonstrated by the group creating the PermaSeal device. - The facility in Langhorne, PA, can support $100 million in revenue. - The company has a newscomber to Tokyo in less than a year and a half, and clinical trials in Germany are in approximately three weeks. ## Mechanisms & Processes - Organizing a global medical device company requires analyzing opportunity, vision, and communicating. - The process for creating the PermaSeal access enclosure involves the deployment of proprietary anchors which penetrate the pericardium and myocardium, allowing passage of subsequent instruments. - The speaker's current work involves transitioning care from invasive, open surgery to minimally invasive surgery. - The passage of the sheaths expands the purpose heel and allows access to the ventricle via the transapical access site. - The speaker's team developed the PermaSeal device by asking "how are you going to solve this" rather than following prescribed steps. ## Timeline & Events - 30 years ago + Speaker started in the industry after graduating from Lafayette. - In 1988 + Company was testing little stents in hearts. - In 1982 + Communication limitations were such that global instantaneous communication was impossible. - Last year + Catherine graduated. - Today + Speaker is presenting on the current opportunities. - 2010 + Market size was less than $500 million. - 2015 + Market size was projected to be $2 billion. ## Examples & Cases - Speaker's attendance at the event + Example of feeling intense nervousness, leading to naming a syndrome. - The speaker's first company, Power Medical Interventions + Example of a company they took public after working on the coronary stent. - The initial work on the coronary stent + Example involving cracking open chests and using tissue from the leg or foot to treat coronary artery disease. - The development of the PermaSeal device + Example based on the speaker's own intellectual property developed in a basement. - Steve Jobs' commencement speech at Stanford University + Example of a famous quote/moment. ## Trade-offs & Alternatives - Open heart surgery (Option A) vs. Minimally invasive surgery (Option B) for cardiac procedure. - Option A: Chest opened, cannulas in heart, pumped back, operated on for hours. - Option B: Small incision through ribs, operating on beating heart, going home the same day. - Doing it based on intellectual property developed in a basement vs. relying on established industry pathways. ## Counterarguments & Caveats - The speaker acknowledged that the field of medical devices is highly regulated, which slows the pace of business compared to other sectors. - The speaker noted that while standardization is occurring, different geographic regions still have variations in medical practice. - The speaker conceded that the pace of change in technology is so fast that comparing it to past historical periods is difficult (e.g., judging history from a dictatorship to a democracy). - The speaker stated that the "drug eluding" entity took about 12 years to organize and get going. ## Methodology - Analyzing the opportunity organized around the compelling vision and communication strategy. - The speaker used a side-by-side comparison of historical surgery vs. current minimally invasive options to demonstrate improvement. - The team developing the PermaSeal device approached the problem by asking "how are you going to solve this?" ## References Cited - The book *History in the Last Man* + Mentioned as a work by France Truciana (Professors aren't allowed to answer, from Hopkins). - *The World is Flat* + Book mentioned concerning the lack of required chain of command. - *What to Expect* (implied) + The speaker was comparing current capabilities to standards of the 1980s/1990s. ## Conclusions & Recommendations - The speaker strongly recommends that attendees get accustomed to the global, dynamic nature of the world. - The speaker advises belief in oneself: "if you don't think you can you're already sunk." - The speaker advises finding one's passion: "find what your passion is, it doesn't matter what it is." - The speaker advises that the best way to participate is "by doing." - Final closing encouragement: "so you may as well get to it." ## Implications & Consequences - Slowing down the pace of business due to regulation is the primary hurdle in the medical device sector. - Mastering local customs and regulations is necessary for success in global medical device fields. - The lack of a strict chain of command (due to modern communication) means organizational structure must change. ## Open Questions - What exactly was the precise historical context that led to the inability to judge history in the way the speaker used to? ## Verbatim Moments - "postgraduate residual stress syndrome" - "the people that think they can change the world are the people that change the world" - "if you don't think you can you're already sunk" - "the journey of a Thousand Miles begins with the first step" - "no sternogamy no cracking the chest no cardiopulmonary bypass will not pumping your blood out of your body you have to keep your own blood benefit shorter hospital and less pain" - "you can dream it and believe it you can do it"