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Telling the CQ Story – The Beginning

January 31, 2013 By Leave a Comment

I recently did a quick video to share more about the Creo Quality passion:

I have decided to tell more of the CQ story in blogs and videos. Let’s start with a short story on how I got into the medical device industry.

It was late winter of 1998. Graduation from Rose-Hulman was a few months away. While I would soon have a BS in chemical engineering, the chemical engineering job market was weak at best. It was an era of the “dot com” and computer science and electrical engineering majors were in high demand. At the suggestion of a couple friends, I decided to take a couple biomedical engineering course electives. Initially I did so because, well I needed engineering electives. But I soon became enamored and interested in the course content. Seeing what engineers in the biomedical industry did on a day to day basis to improve and save lives was fascinating.

A couple friends had interviewed with and received job offers from Cook Medical and encouraged me to submit my resume. And it’s funny that despite growing up ~30 minutes from Cook’s Bloomington headquarters and going to Rose-Hulman where the football stadium was named after Bill Cook, founder of Cook Medical, I had never heard of this company. Regardless, I needed a job and Cook was hiring new engineers. I sent my resume. A couple weeks later, I was asked to come in for an interview. I felt I nailed it. I was hungry, and my excitement from the biomedical engineering classes must have been evident. The next couple weeks seemed to drag on. And then I received word that I was being offered a job.

A few months later, I started at Cook, along with two close friends. Those first few weeks were amazing. Being a 22 year old kid starting a professional career as an engineer for a medical device company was, well kind of scary. But exciting and fun at the same time. Each morning I got up easily and before an alarm clock would wake me. I enjoyed the opportunity and tried to be a sponge soaking up as much as possible. Looking back, I very much appreciate the approach Cook took with new engineers. We spent time in all production and departments within the company. Sometimes that meant I was gowned up sitting in production learning how to make catheters. It was a terribly humbling, yet invaluable, experience. The relationships I formed and lessons I learned in those first few weeks set the foundation for the rest of my career at Cook.

After a couple months of training, I was really itching for a real project. I was given a couple to start working on. I dove right in. In those days, the projects I was given were in a manila binder and file folders. And the projects had in some cases been around for a while. Let’s just say these first few projects were “back burner” projects. But it didn’t matter. I was thrilled to take ownership and make progress. My appetite grew, though. I was anxious to have a new project where I got to work directly with the physician from start to end. Soon, that day came. And my experience on this first real project was enough for me to know that I would likely spend the rest of my professional career working in the medical device industry.

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Comments from Cook Medical’s Yonkman on 2.3% Medical Device Tax

August 1, 2012 By Leave a Comment

Pete Yonkman of Cook Medical speaks about the impending 2.3% medical device tax and its impact on Cook. He also shares some thoughts about the potential affects of increased regulation.

 

 

UPDATE: I just came across another interview with Pete Yonkman on this topic and thought I’d share:

 

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Medical Device Concentration Is Strong In Indiana

January 23, 2012 By Leave a Comment

There are a number of strong, stable medical device companies in Indiana. Warsaw is the “Orthopedics Capital of the World” and home to companies like Zimmer, Biomet, and DePuy. Bloomington is home to Cook Medical, the “largest private medical device company in the world”. Also in the Bloomington area is a Boston Scientific manufacturing facility. Along with these large medical device companies, there are numerous start-ups and service providers supporting this industry.

Recently, Gerry Dick from Inside Indiana Business talked with Bill McConnell about the medical device sector in Indiana.

Watch the interview

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Life Sciences in the Midwest

April 20, 2011 By Leave a Comment

A new contract sterilization company locating near Warsaw hopes to capitalize on the existing strength of the “Orthopedic Capital of the World,” while also expanding into other areas. Canada-based Iotron Industries says Columbia City, located in the agricultural heartland between Warsaw and Fort Wayne, offers the perfect geography for its three-prong growth strategy to increase its business in medical devices, commercial defense and agribusiness.

The $15 million facility in Columbia City is the company’s first U.S. operation and will split the distance between two major industry clusters: Warsaw’s orthopedic sector and Fort Wayne’s commercial defense industry, in which plastics and composites are used in aircraft and aerospace applications.

Indianapolis-based Medical Animatics, a 3D animation company, is making a foray into the game business. The company will develop a game for kids ages 6-12 to help them learn safe behaviors at home, in their neighborhoods, at school or at a park. Medical Animatics will develop the game for Ohio-based Nationwide Children’s Hospital. Health games designed to be both educational and enjoyable are being developed by two other companies with Indiana ties—Bloomington-based Wisdom Tools LLC and Indianapolis-based Gabriel Entertainment, as well as by growing numbers of developers around the country. Medical Animatics also develops 3D animated instructional and informational materials for the health care, higher education and sports industries.

Northern Indiana’s Manchester College plans to begin work this summer on its new $18 million pharmacy school. School spokeswoman Jeri Kornegay said Thursday that a ground-breaking for the 75,000-square-foot building in Fort Wayne is expected early this summer, possibly in June. Until the building is complete in July 2012, the college’s School of Pharmacy will continue to occupy space at Parkview Hospital in Fort Wayne, about 30 miles east of North Manchester. The project is supported by a $35 million grant from Lilly Endowment that’s the largest gift in the college’s history. While pharmacy schools have opened on a rapid pace around the nation in recent years, Indiana is one of 18 states with a shortage of pharmacists. Manchester’s will be the third in Indiana offering doctorates in pharmacy, joining schools at Butler University in Indianapolis and Purdue University in West Lafayette.

Indianapolis-based medical device maker NICO Corporation announced at the American Association of Neurological Society (AANS) annual meeting that it has received CE Mark approval for its automated minimally invasive brain tumor removal device, the NICO Myriad™. The approval allows NICO to sell the Myriad system in the 27 countries that make up the European Union. The device has been commercially available in the United States since 2009 with more than 1,000 procedures performed with adults and children, sometimes in cases that would have previously been considered inoperable.

On a sad note, Bill Cook, founder of the Bloomington-based medical equipment manufacturer Cook Group Inc., passed away this past week.  He was 80 years old.  Cook built Cook Group Inc. into a worldwide conglomerate, with 42 companies under its umbrella. The Cook Group employs about 10,000 worldwide with sales estimated at more than $1.5 billion.  Cook’s company is one of the largest employers in Central Indiana, with about 3,000 workers in the Bloomington area.

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Life Sciences in the Midwest – December 2010

December 15, 2010 By 2 Comments

In the November edition of “Life Sciences in the Midwest”, we laid a little bit of a foundation for this recurring post. This month, I thought I would share a few thoughts about some of the major life science players in Indiana. You might have read the Inside Indiana Business article about 2010 being a record year for life sciences in Indiana. I also wrote a brief editorial on this topic.

Let me share my opinions about the Hoosier life science players.

Major Indiana Life Science Companies

Cook Medical – Their claim to being the largest private medical device company in the world appears to be undisputed. I spent a significant part of my career with this company (and may have a slight bias). Cook continues to grow, focusing on niche product areas, especially in areas of Aortic Intervention and Peripheral Intervention. One thing I always appreciate and admire about Cook is their primary focus on doing what’s right for patient care.

Lilly – The layoffs are happening in volumes. Several friends and acquaintances whom I thought would be protected are no longer employed by the Indiana’s pharmaceutical giant. From my perspective, Lilly is caught in a struggle just like many other big pharma companies; it’s perceived that the days of blockbuster drugs are nearly gone. Many pharmaceutical companies are fighting to figure out their niche–many moving towards biotech and personal medicine. Lilly has long been regarded as the figurehead and leader of life sciences in Indiana. How long this will continue (maybe this has already ended) seems less about if and more about when.

Roche Diagnostics – I don’t have much to report from Roche. They started massive layoffs a couple years ago. The trend seems to be continuing; I received a call from an acquaintance today who was just let go. Roche is still a major player in in vitro diagnostics (IVD).

Boston Scientific – While headquarters are in the Boston area, the company does have a large presence in Spencer, IN. Boston Scientific is still reeling from their acquisition of Guidant from several years ago. Soon after the acquisition, FDA came down very hard on the company for poor business practices. Only recently did Boston Scientific satisfactorily address warning letter issues with FDA.

Beckman Coulter – Company headquarters are in Southern California but Beckman Coulter does have an Indianapolis presence.  Local news reports in recent months have indicated Beckman Coulter Indy is growing and will be adding jobs. However, the news for the corporation has not been good this year. The company has been dealing with some major product recalls and resignation of their CEO. Also, recent news reports indicate Beckman Coulter is for sale.

Zimmer – The largest orthopedic company (I think) in Warsaw, which is dubbed the “Orthopedic Capital of the World” (see blurbs about DePuy and Biomet below). Orthopedic regulations throughout the world have evolved affecting Zimmer and other orthopedic companies throughout the world.

DePuy – Also a large orthopedic company (division of Johnson&Johnson) headquartered in Warsaw, IN. Like Zimmer, DePuy has been adjusting to a more heavily regulated environment.

Biomet – Again, an orthopedic company headquartered in Warsaw, IN. A few years ago, the Department of Justice was involved in reforming orthopedic industry. Biomet might have been one of the hardest hit of the major orthopedic companies. The company went from being publicly held to being acquired by private equity and is privately held.

Suros Surgical – Now a division of Hologic as a result of acquisition a few years ago. Hologic, headquartered in the Boston area, has acquired many companies to build a company focused on women’s health issues. Suros is a true Indiana life science success story, going from start-up to multi-million dollar purchase in a short period of time. Many throughout the state are waiting for the “next Suros” to happen (see blurbs on SonarMed and NICO below).

Potential Indiana Life Science Juggernauts

SonarMed – The core technology of SonarMed comes from Purdue University. The company has been very successful in getting funding (primarily in the form of grants) in a very difficult time for life science start-ups. SonarMed received FDA 510(k) clearance earlier this year. They appear to be in the process of establishing market opportunities for the technology. The company has received quite a bit of positive press in recent months.

NICO Corporation – Founded by the leadership team that led Suros Surgical, leveraging platform technology from Suros for neurological applications. The founders started NICO with a very savvy business strategy; much of the ground work, development, and regulatory clearances were achieved years ago during Suros days. NICO is quietly doing their thing, following a growth model strikingly similar to their success with Suros.

Indiana Start-Ups

There are still numerous life science start-ups throughout Indiana. There is a good mix of medical device, pharmaceutical, and biotech. The biggest obstacle plaguing most of these early stage companies is lack of funding. Indiana has always been conservative when it comes to start-up investments. In these economic times, Indiana is even more conservative than ever. It will be interesting to see which of these life science start-ups survives tough economic times.

Conclusion

The life science regulatory environment across the board and the world has become significantly more challenging for all companies in the industry. Many large life science companies in Indiana and across the world are under more scrutiny from FDA and other regulatory agencies.

The days of large life science companies seem to be numbered. Many of the big companies seem to be constantly laying off hundreds, sometimes thousands, of employees. The emergence of outsourcing is a growing phenomenon that many companies, large and small, are relying on to get new products to market.

Today is a very tough time for life science start-ups. Investment dollars are very tight in Indiana and across the country. While many in Indiana claim stake to being a leader in life sciences, the current reality is that places like Silicon Valley, San Diego, Boston, Seattle, and Austin are much more actively investing in life science start-ups.

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Life Sciences in the Midwest – November 2010

November 18, 2010 By 1 Comment

This month in The Catalyst enewsletter, we have decided to start a new feature that gives a snapshot of Life Sciences industry from Indiana and the Midwest. Since this is the first edition, I’ll start by building a little bit of a foundation, starting with life sciences in Indiana.

Indiana has a fantastic mix of life science companies, service providers, and organizations. A few of those organizations are:

  • BioCrossroads
  • OrthoWorx (a BioCrossroads initiative)
  • Indiana Health Industry Forum (IHIF)
  • Indiana Medical Device Manufacturers Council (IMDMC)
  • ASQ Biomedical Midwest Discussion Group (MWDG)
  • Indiana Biomedical Entrepreneur Network (IBEN)
  • Indiana Pharmaceutical Research Alliance (IPhRA)
  • INpact

All of these organizations have a vested interest in securing and growing the life science industry throughout Indiana and the Midwest. I could go into detail about each group, but I recommend you visit each organization’s web site to learn more about them.

Indiana is also home to a diverse group of life science companies and divisions — including medical device, in vitro diagnostic, pharmaceutical, orthopedics, and biotech firms. Some of these companies include:

The state also has a decent presence from the life science entrepreneurial and start-up community — thanks in large part from funding sources such as BioCrossroads and Indiana Economic Development Corporation 21st Century Fund.

Indiana is also fortunate to have many, many providers for just about any service required to support the life sciences industry. The list is just too large (but you can get a good start by reviewing the members of INpact).

Also supporting Indiana life sciences are the colleges and universities providing education for future life sciences professionals and supporting entrepreneurship. Most notably in this space, Indiana is home to Rose-Hulman Institute of Technology, Purdue University, and Indiana University. The list below includes some of the initiatives these schools have to support the life sciences industry’s growth:

In future snapshots, we will review other regions within the Midwest and examine some of the trends and issues within the life sciences industry.

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Zilver PTX Saves Limbs

September 29, 2010 By Leave a Comment

Just read an article in the Indianapolis Business Journal an update about the Cook Zilver PTX stent used for patients with peripheral artery disease. Turns out a clinical study shows this stent is more effective at preventing reclogging of peripheral arteries than the current method of treatment. Preventing peripheral arteries from becoming reclogged with plaque will reduce amputations.

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Low Cost of Living in Indiana Not Enough

November 7, 2009 By Leave a Comment

Why Should People Move to Indiana? Most Hoosiers would say that our cost of living is low (currently $29,959.42, US City Average = $34,868.00) and it’s a great place to raise a family. In fact, Brownsburg (33) and St. John (48) were ranked in the Top 100 Best Places to Live by Money Magazine for 2009.

Is this enough if we want to be an innovative center in the US?

We have Biomet, Cook Medical, DePuy, etc in or around central Indiana, which is a good start, but I believe we need to foster better innovative centers and drive entrepreneurs to see more innovative value to moving to Indiana.

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Bill Cook Proposes Radical Approach to Healthcare Reform

November 4, 2009 By Leave a Comment

On October 19, 2009, Bill Cook of Cook Medical released his alternative approach to the current healthcare reform debate.

Highlights from the article:

  • focus should be on improved patient outcomes through preventive care via a national system of local medical clinics
  • most serious flaw in present health care is caused by difficult access to our healthcare system
  • Cook suggests development of low-cost or free primary care clinics “that are plentiful and spread throughout cities, towns and the countryside” to allow for early diagnosis of chronic conditions
  • expansion of innovative medical service delivery programs to provide free health care to those in need
  • enacting a national monetary cap on medical liability claims, reforming medical tort law, and allowing medical insurance providers to sell across state lines to create greater competition and cost reductions

To read the full article, click here.

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November 13, 2009 – Indiana Life Sciences Collaboration series

October 21, 2009 By Leave a Comment

The second offering of the Indiana Life Sciences Collaboration series for 2009/2010 is just a month away – Friday, November 13th at Cook Medical’s world headquarters in Bloomington. The topic of this conference is Comparative Effectiveness: the Dollars and Sense.

We thank our lead sponsors: Cook Medical, Taft Stettinius & Hollister LLP, AIT Laboratories and the IU Johnson Center for Entrepreneurship & Innovation  for developing this great program.  This topic touches everyone in the life sciences value chain in a time when healthcare reform promises to bring more emphasis on consumer choice and empowerment. Recognition of the importance of this topic is found in the stimulus package that was enacted earlier this year which allocated $1.1 billion for Comparative Effectiveness research.

Keynote presentations:

  • Scott Gottlieb, M.D., Resident Fellow, American Enterprise Institute for Public Policy Research
  • Paul Keckley, Executive Director, Deloitte Center for Health Solutions
  • And other experts from the following key organizations: Cook Group, IU School of Medicine, Clarian Health, NoMoreClipboard, OrthoPediatrics, Eli Lilly and Company, Indiana Health Information Exchange, SIHO Insurance Services and more!

To view the complete program, directions,  and to register please visit the Center for the Business of Life Sciences website.

This series works because of the great support and efforts of all our sponsors. See a full listing of the many companies and organizations who help us bring these conferences to you at- http://kelley.iu.edu/CBLS/sponsors/conference/page16541.html

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Marshall Goldsmith – Thank You!

September 2, 2009 By Leave a Comment

Rose-Hulman’s Office of Outreach held an event on September 1, 2009 in Indy. The event featured one of RHIT’s most famous alums: Marshall Goldsmith. Very motivating, yet simple advice! Thank you!

I jotted a couple of thoughts during the speech:

  • Help more; judge less
  • Values aren’t what we say but what we do

Another coaching tip Marshall offered: Imagine that you are 95 years old and about to take your last breath. If you had a chance to go back in time to this very moment and offer one piece of advice to yourself, what would it be?

After leaving the event, I had a couple hour road trip. Plenty of time to reflect. One thing I thought about was thanking all those people and companies who have provided opportunities to me. Here is a short list:

  • Rose-Hulman – Is there a better engineering school?
  • Cook Medical – I had so many opportunities and responsibilty as an engineer fresh out of school. My experience at Cook established my professional foundation.
  • Theron, Inc. – I learned the good and bad of running a business. I’m forever grateful.
  • SonarMed – A medical device start-up willing to give me my first gig as Creo Quality.
  • Anson Group – Always there when I need them. I hope I help build their brand and integrity just a little bit.
  • FlowCo – Another med device start-up willing to trust my experience.
  • Suros (now Hologic) – Former colleagues from Cook willing to have Creo Quality help them multiple times.
  • Priio – Allowed Creo Quality to help refine their business using strategy.
  • Medical Polymers – Had faith in Creo Quality’s ability to help them improve efficiency.
  • Tomato Fish Marketing – Willing to bend over backwards to help Creo Quality grow. Great marketing partner!
  • INpact – I’m humbled by what this group has become. The credit belongs to the members.
  • My wife – There is no bigger chearleader for me and Creo Quality!
  • My kids – Have accepted that sometimes daddy works on the weekend. I plan to limit this and give them my full attention from now on. We all need this.
  • Boundless Design – Helps ensure the Creo Quality brand is as strong as possible. Plus, she is my sister and endured a great deal from me growing up. Sorry!
  • My parents – Thank you for establishing ethics, morals, and principles. I hope I can do half as good with my kids.
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