|Note from the President
Greetings BioUtah Members and Subscribers!
Building on the success of our 2013 BioUtah events calendar, we are putting together another exciting spate of events for 2014. Our 2013 events helped propel BioUtah to significantly exceed our membership, fundraising and participation goals for our first full year. Based on feedback from last year’s events, we are working to serve our members and the life science community even better in 2014, to expand membership, participation and engagement.
The remainder of our Q1 event season starts with a free webinar on QEM & CAPA on the Feb. 13 and continues with a legislative action update for BioUtah members and prospective members at the Utah State Capital on Feb. 20. This promises to be informative and a great networking opportunity. We move into March with a free all-day Quality Summit co-hosted by PathWise, which will address current quality issues facing the industry.
We will hold regulatory and networking events throughout the year. BioUtah’s well-received Masters Series is scheduled to feature global life science luminaries, including Steve Burrill and Harvard-MIT’s Elazer Edelman. The 2014 Utah Life Science Summit, the state’s signature annual event for our community, will again be held in Q4.
We invite you to join us in making 2014 the most active, engaging and rewarding year ever for Utah’s life science community!
President & CEO
Managing Director, SimplicityMD
President, EZLift Rescue Systems
By Kimball Thomson
David Robinson (not to be mistaken for the retired basketball great) is a successful serial entrepreneur and investor—with an unanticipated alter ego. On weekends, he fashions malleable heated glass into fanciful designs, and passes along his art to others as an instructor at the Kimball Arts Center in Park City.
Currently in his professional life, Robinson divides his time between his role as managing director of SimplicityMD, an innovative hands-on collaborative investment firm; and president of EZ LIFT Rescue Systems, which creates patient lift and transportation systems that minimize impact to the patient’s back and prevent injuries to the caregivers assigned to lift the patient.
A Utah native, Robinson returned to the state in 2001 after two decades working on the coasts, when he launched TechniScan, a novel non-invasive ultrasound platform.
BioUtah recently took advantage of Robinson’s graciousness and proximity at the BioInnovations Gateway incubator to engage him in a dialogue about his current projects and assessments of Utah’s medical device industry, present and future.
New Insurance Coverage for Medical Technology and Life Science Companies – Errors and Omission liability coverage
Did you know?
Life Science and medical device companies are required to assume liability for a customer’s financial loss if the products or services they offer are deficient or do not meet customer’s expectations.
Over the last 6 months, several insurance carriers have unveiled a new product for manufactures, suppliers, and distributors of medical technology, medical device, and pharmaceutical companies which help cover third – party financial losses. Medical device manufactures and distributors commonly purchase product liability coverage to insure their product against bodily injury and property damage claims. Financial or economic injury losses are left uncovered. This creates a significant coverage gap, exposing Life Science companies to considerable, uninsured claims for damages based upon pure economic loss by their customers. E&O coverage specifically covers a third party financial loss based upon:
- A failure of the insured’s product or service to function as intended or expected:
- An error, omission or negligent act
In today’s marketplace, when it comes to medical and life science devices and products many hands are touching different phases of production. A particular product could be subcontracted through multiple vendors, manufactures, and distributors. The probability of error somewhere along this cycle increases the likelihood of an error being made. Here is one example of a real life claim.
Claim example : A customer alleged a medical device manufacturer delivered improper pre-production prototype instruments resulting in financial loss. In addition, the customer alleged that the instruments did not meet specifications.
-Claim paid greater than $250K
Some items to consider as your analyze E&O coverage for your company:
First, does the coverage offer Enterprise-wide protection? Many companies manufacture or distribute different products and possibly across different industries. Many carriers can exclude certain products.
Second, is there worldwide coverage? Since many products are distributed or manufactured in foreign countries it can be critical that you get the worldwide coverage where permitted by law.
Article by :
Joshua Creer, The Buckner Company
Life Science practice group
|White Paper: Keeping up with the New Pace of Business
UTAH LIFE SCIENCE NEWS
Two Utah cities among best for business
Published: Wednesday, Jan. 22 2014 2:30 p.m. MST
A recent report from the Milken Institute ranked the Provo-Orem area as No. 2 and Salt Lake City as No. 5 on its list of the Top 25 Best-Performing Large Cities for business.
SALT LAKE CITY — A recent report from the Milken Institute ranked the Provo-Orem area as No. 2 and Salt Lake City as No. 5 on its list of the Top 25 Best-Performing Large Cities for business.
Rankings for the study were based on data from both long- and short-term growth in jobs, wages, salaries and technology output. Provo-Orem moved up five spots from last year’s ranking, due in part to the growing technology sector and high job growth rate, according to the report.
Salt Lake City ranked No. 5 on the Milken list due to a diverse, consistently growing economy with a positive outlook for the future, the report stated. During 2012, Utah's capital city added 2,600 professional, scientific and technical services jobs — a gain of more than 7 percent from the previous year.
Sen. Orrin Hatch, R-Utah, greets Gary Shearer, vice president of manufacturing for BD Medical, before a tour of BD Medical in Sandy, Wednesday, Jan. 22, 2014. Ravell Call, Deseret News
Utah medical device manufacturer says Affordable Care Act tax will hurt innovation
By Jasen Lee, Deseret News
SANDY — Will a federally mandated tax on medical devices have a negative impact on future innovation? Critics of the measure say the answer is a resounding “yes.”
Speaking Wednesday at BD Medical's production facility at 9450 S. State, the company's vice president said a recently enacted provision of the Affordable Care Act will cost his firm about $55 million per year, forcing it to cut back on new research and potential technology breakthroughs that could benefit patients worldwide.
Health » Defibrillator delivers life-saving shocks without wires touching the heart.
By Kirsten Stewart | The Salt Lake Tribune
Doctors at Intermountain Medical Center on Tuesday successfully implanted Utah’s first subcutaneous defibrillator — which is placed farther away from the heart, with no wires touching it — in a 20-year-old man from South Jordan.
The device works like any other defibrillator, by shocking Brandon England’s irregularly beating heart into normal rhythm. "It’s kind of like having his own paramedic squad in his chest," said England’s surgeon, IMC cardiologist Jeff Osborn at a Thursday press conference.
German prosthetics company moving 200 jobs out of Minnesota
Article by: JAMES WALSH , Star Tribune
Updated: January 14, 2014 - 9:08 PM
About 200 jobs with Ottobock will be affected.
Ottobock, a private German prosthetics manufacturer that has had operations in Minnesota since 1958, is closing its North American regional headquarters, its fabrication operations and its distribution center in Plymouth, and moving about 200 jobs to Salt Lake City; Austin, Texas; and Louisville, Ky.
The moves will take place throughout the year and are designed to gain efficiencies as the company consolidates operations worldwide, said Brad Ruhl, president and CEO of Ottobock’s U.S. health care division. For example, putting fabrication operations with manufacturing will help the company better meet the needs of its patients, Ruhl said.
EdisonHealth Announces Its First Medical Destinations of Excellence
The EdisonHealth Network LLC has announced its first Medical Destinations of Excellence for spine, heart, valve and transplant surgery. Formed earlier this year, EdisonHealth helps large employers gain access to carefully chosen integrated health systems that specialize in providing high quality and appropriate care to individuals faced with these complex procedures.
Rather than limit its network to high-cost, high-volume academic medical centers, EdisonHealth contracts with leading health systems committed to offering multidisciplinary, team-based approaches in the evaluation and treatment of patients. “The emphasis of our clinical partners is appropriateness,” states Tom Emerick, company co-founder and former vice president of benefits for Walmart. “Let’s make sure the diagnosis is correct, and the treatment is appropriate. Then, when surgery is really needed, these are some of the best places in the world to receive it.”
Members of participating health plans now have preferred access to EdisonHealth’s first five Medical Destinations of Excellence, which include Geisinger Medical Center in Danville, PA; Intermountain Healthcare in Salt Lake City, UT; Mercy Hospital Springfield in Springfield, MO; Oklahoma Heart Hospital in Oklahoma City, OK; and Virginia Mason Medical Center in Seattle, WA. Specific procedures for cardiac surgery will be offered by Geisinger, Oklahoma Heart and Virginia Mason. Spine procedures will be performed by Geisinger, Mercy and Virginia Mason. Transplants will be provided by Intermountain. Additional health systems are still in the due diligence and contracting phases.
A manufacturer of medical devices
and software for treating cancer and other medical conditions with radiotherapy, radiosurgery, proton therapy and brachytherapy, Varian Medical Systems is expanding its X-ray products manufacturing headquarters in Salt Lake City, Utah
. The expansion includes a capital investment of $40 million to add 120,000 square feet to its existing 341,000 square-foot building.
The expansion will add additional space for Varian’s flat panel image detector and X-ray tube product lines, while permitting the company to add new products, pursue new business and increase capacity. The capital outlay will include cleanrooms, R&D laboratories, expanded manufacturing space and administrative offices. The expansion will include a facility that will enable the company to perform a panel production process in-house that is currently being outsourced. The firm estimates its expansion will lead to creation of 1,000 full-time jobs over the coming 15 years.
Life Science Manufacturing Survey - Salt Lake Community College
Our friends at Salt Lake Community College have co-developed an important life science manufacturing survey. In addition to giving our community a chance to voice our education and training needs, with the information provided by this survey we will develop resources for our members. Please take a moment to respond to this 7 question survey.
Body mass index may predict heart disease risk for type-2 diabetic patients new study finds
By PressRelease, January 1st, 2014 | Health | 0 Comments
Researchers from the Intermountain Medical Center Heart Institute, in collaboration with researchers from Johns Hopkins University and the National Institutes of Health, have discovered a simple way to further predict a diabetic patient’s risk for heart disease: by measuring their body mass index or BMI.
The Intermountain Medical Center Heart Institute study is part of a larger study called faCTor-64, which is a landmark, randomized trial designed to determine if using CT scans to screen for heart disease in diabetic patients who don’t have heart disease symptoms can help save lives.
|NATIONAL LIFE SCIENCE NEWS
That doesn’t mean that the tax, which helps pay for the Affordable Care Act, will be abolished. A deficit-neutral reserve fund is essentially a procedural tool for letting budget writers revise allocations to pay for specific legislation. The repeal of the medical device tax would still require the approval of Congress and the president.
But the fund’s inclusion in the budget bill gave device-tax opponents a glimmer of hope.
Johnson & Johnson Has Healthy Quarter, but Medical Tax Weighs
1/21/14 10:24 AM EST
Johnson & Johnson beat earnings estimates for the fourth quarter but gave guidance for the fiscal year on the low side of expectations. J&J mentioned the medical device tax included in the Affordable Care Act several times in the company's conference call. Johnson & Johnson outlined several ways to bring down healthcare costs and suggested focusing on one product's costs was overlooking the bigger picture.
Rep. Charlie Dent's jobs bill would repeal medtech tax
January 15, 2014
by Arezu Sarvestani
Rep. Charlie Dent (R-Pa.) plans to introduce new legislation that would repeal the medical device tax alongside measures to restore emergency unemployment assistance.
Rep. Charlie Dent (R-Pa.) is taking another swing at the medical device tax, including a repeal measure in a jobs bill that he plans to introduce this week.
Dent's legislation would strike the medtech levy alongside measures to restore emergency unemployment benefits, which he plans to pay for through a change the child tax credit, and measures to authorize the Keystone XL oil sands pipeline, Politico reported.
Is agile management a medical device innovation solution?
January 13, 2014 by MassDevice
Why are so few people within the medical device community aware of agile software development methods? Rod Cain of RBC Medical Innovations looks at the history of agile software development and how it can be used in designing medical devices (sponsored).
By: Rod Cain
During the 1990′s the global business community was investing enormous sums of money on the automation of resources leveraging advancements in modern technology and systems software (Boom and Bust in Information Technology Investment), as well as supporting the consolidation of organizations via mergers as a means of gaining competitive advantages. Failure was commonplace and despite the subsequent increase in investments, firing of personnel, and executive leadership support, the business community continued to fall short in their efforts to produce innovative advantages. Big stakes for the international economy were at hand, so something had to change.
In February 2001 software developers met at resort in Snowbird, Utah to discuss lightweight development methodologies as a potential alternative for traditional heavyweight waterfall methods, which several were beginning to suspect as a contributing factor for why so many project teams were failing to provide the continuous innovation objectives their business management teams were demanding. The group gathering in the Rocky Mountains of Utah understood that early lightweight development methods were born out of challenging requirement projects; from the Easel Corporation project that helped spawn the SCRUM methodology in 1993 to the Chrysler Comprehensive Compensation System (C3) project that was credited with creating the Extreme Programming methodology in 1996. As the group of software developers discussed these case studies and analyzed other similar lightweight methodologies such as the Rational United Process (RUP), Crystal Clear, Adaptive Software Development, Feature Driven Development, and Dynamic Systems Development (DSDM), a common theme was emerging.
NIH Cuts, Reimbursement Fears Cited as M&A Deals in Life Science Tools, MDx Industries Drop 15 Percent in 2013
December 30, 2013
The number of M&A deals completed in 2013 or announced during the year totaled 47, down 15 percent from 55 transactions in 2012, and down from 58 in 2011. Activity was down in both the first and second halves of 2013 year over year as 23 deals were done in H2 2013, compared to 28 in the comparable year-ago period. In the first half of 2013, 24 deals were completed, down from 27 a year ago.
The year-over-year drop-off had been expected by some industry experts who predicted a year ago that an M&A rebound may be at least a year away while companies continued digesting acquisitions made in prior years, and a contentious political environment in Washington made life science firms nervous about spending.