Medical Device Start-Ups in a Global Economy: Michael Whitman at TEDxLaf
The speaker asserts that the modern global economy, combined with advanced communication tools, allows for the rapid establishment of global medical device companies. The core evidence supporting this is the ability to organize the new company, Micro Interventional, from scratch in under two months, and the development of the PermaSeal device through intense curiosity. Ultimately, the speaker encourages attendees to adopt a global mindset and act on their passions.
## Speakers & Context
- Speaker presents an initial self-assessment of intense nervousness, naming it "postgraduate residual stress syndrome."
- The talk is framed as an examination of what is possible in a global economy, supported by tools like the Internet, Skype, and Facebook.
- The speaker's current company, Micro Interventional, was built from scratch in less than two months.
- Family present includes daughter Jessie (12 years old), wife Linda (Class of '83, electrical engineer), son Chris (senior student), and daughter Catherine (graduated last year).
- The speaker references Brian Hendrickson's encouragement to build up the Trenton building.
## Theses & Positions
- The modern global economy allows one to organize a global medical device company in less than a year.
- Disruptive technology is advancing across all sectors, not solely in IoT or information systems.
- The ability to succeed globally requires mastering local customs, monetary policy, and regulations in addition to technological skill.
- The best path forward is through active participation: "The best way to participate is by doing."
- Success is linked to mindset: *"If you don't think you can you're already sunk."*
- The principle that *"the people that think they can change the world are the people that change the world"* guides action.
## Concepts & Definitions
- **Postgraduate residual stress syndrome:** Condition the speaker developed after his initial nervousness upon arrival.
- **Global economy:** Economic context permitting the rapid organization of a worldwide medical device enterprise.
- **Minimally invasive surgery (MIS):** Surgical approach that involves small incisions and operating on a beating heart, avoiding the need for a full sternotomy or cardiopulmonary bypass.
- **Biocompatibility:** A required aspect of medical devices that must be proven and tested.
- **Available Market:** An economic term referring to the potential size of the target market.
- **Liberty Democracties:** A political concept gaining predominance, requiring adaptability in global operations.
## Mechanisms & Processes
- **Organizing a global medical device company:** Requires analyzing opportunity, developing a compelling vision, and constant communication.
- **PermaSeal Access Enclosure:** Process for creating a secure attachment to the heart's epicardial surface using proprietary anchors that penetrate the pericardium and myocardium.
- The anchors connect via **V-stays** (six polymer anchors) to create an operative window.
- A **guide wire** is first introduced through a needle at the access site.
- A **sheath** allows access to the left ventricle via the transapical access site.
- **Technology Leap:** The shift from historical methods (cracking open chests, cannulas, cardiopulmonary bypass) to modern MIS allows patients to go home the same day.
- **Process of Innovation:** The team developing PermaSeal solved the technical problem by asking *"how are you going to solve this"* rather than following established steps.
## Timeline & Sequence
- **30 years ago:** Speaker began in the industry after graduating from Lafayette and working at Johnson and Johnson.
- **1982:** Communication limitations prevented instantaneous global communication.
- **1988:** Time when the company was testing coronary stents in hearts.
- **2010:** Market size estimate was less than $500 million.
- **2015:** Market size was projected to reach $2 billion.
- **Today:** The speaker is presenting current opportunities regarding Micro Interventional devices.
- **Near Future Milestones:** The company has a newscomber to Tokyo in less than a year and a half, and clinical trials in Germany are expected in approximately three weeks.
## Named Entities
- **Johnson and Johnson:** Small company where the speaker began his career.
- **Micro Interventional:** The speaker's current company focusing on micro Interventional devices.
- **Lafayette:** Educational institution where the speaker studied.
- **Trenton:** Location mentioned, 10 minutes from Langhorne.
- **Langhorne, Pennsylvania:** Location of the company office, about an hour and 20 minutes south of the current location.
## Tools, Tech & Products
- **Coronary stent:** Medical device used for cardiac disease, implanted into the heart.
- **PermaSeal device:** Proprietary medical device used to create a secure attachment to the epicardial surface of the heart.
- **V-stays:** Components of the PermaSeal device, consisting of six polymer anchors.
- **Guide wire:** Medical instrument introduced through a needle at the access site.
- **Sheath:** Medical instrument allowing access to the left ventricle of the heart.
- **Internet, Skype, Facebook:** Communication tools highlighted for enabling rapid global organization.
- **Micro Interventional device:** Focus of the new company, enabling the transition to minimally invasive surgery.
## Numbers & Data
- **30 years:** Duration the speaker worked at Johnson and Johnson.
- **12 years:** Time taken for the speaker's previous company (drug eluding) to organize and get going.
- **$200 million:** Approximate initial capital limit for the previous company.
- **1988:** Year when stents were tested in hearts.
- **1982:** Year referencing pre-modern communication limitations.
- **2080:** Number of employees the last company (Power Medical) had.
- **Seven:** Number of languages the last company operated in.
- **Three:** Number of continents the last company operated on.
- **2 months:** Timeframe to build the Micro Interventional website from scratch.
- **$3,000:** Actual cost used for the website advertising, compared to hundreds of thousands.
- **$500 million:** Market size estimate for 2010.
- **$2 billion:** Projected market size for 2015.
- **Two hours:** Duration of operation in the traditional, open-chest surgery comparison.
- **Six:** Number of polymer anchors forming the V-stays.
- **100 million dollars:** Revenue capacity the Langhorne facility can support.
## Examples & Cases
- **Early Surgery Example:** Treating coronary artery disease historically required cracking open chests and using tissue from the leg or foot.
- **PermaSeal Development:** The device was developed by the team based on the speaker's own intellectual property created in a basement, solving a complex surgical access problem.
- **Career Growth Example:** The previous company, Power Medical, grew to 2080 employees across seven languages and three continents.
- **Historical Comparison:** Comparing the development pace to the shift from dictatorships to democracies showed that historical change rates are not predictable.
## Trade-offs & Alternatives
- **Open Heart Surgery (Option A):** Involves cracking the chest, cannulas, re-oxygenated pump, and several hours of operation.
- **Minimally Invasive Surgery (Option B):** Involves a small incision through the ribs, operating on a beating heart, and allows the patient to go home the same day.
- **Historical Context:** Moving from eras with strict chain-of-command hierarchies to the flat nature enabled by modern communication.
## Methodology
- **Analyzing Opportunity:** The process involves analyzing the opportunity around a compelling vision and communicating that vision clearly.
- **Surgical Comparison:** Using a side-by-side comparison between open surgery and MIS to demonstrate technological improvement.
## Conclusions & Recommendations
- Attendees should adopt the global, dynamic mindset, believing that the world is changing rapidly.
- The speaker recommends building one's career by mastering global customs and local regulations.
- Final advice: *"Find what your passion is, it doesn't matter what it is."* and *"so you may as well get to it."*
## Implications & Consequences
- The medical device sector's growth is primarily slowed by necessary regulations, not technical feasibility.
- Modern communication has fundamentally eliminated the need for a strict, historical chain of command in business organization.
## 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"*
- *"what could you do in a global economy"*
- *"you can dream it and believe it you can do it"*
- *"how are you going to solve this"*