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CEO successions picking up pace; effective transition is key
Premium content from Business First by Andrea Tortora
Friday, October 21, 2011
The recession prompted a rash of CEO departures. While the pace of exits has eased, how the transition from one top exec to the next is handled is critical to the confidence of investors, business partners, customers and employees.
Listen. Engage the team. Set priorities.
The actions a CEO takes as he or she comes on board at a new company are shaped by the state of the business’s health. “You have to frame things,” said Don Hunter, managing principal at Cassidy Turley, who started in the top post at the commercial real estate firm in August.
CEO transitions can by tricky business, and a one-size-fits-all strategy won’t work, Hunter said. If a CEO is joining a company with a history of success, the bar is set high to maintain that top performance. Typically, there is a reluctance to make quick changes for fear of disrupting the flow of work within a well-oiled machine.
But if the business is in crisis mode, it’s a completely different situation.
As the economy continues to lag, CEO turnover hit a 12-month high in June, with 113 CEOs in the U.S. announcing their departures, according to outplacement firm Challenger Gray & Christmas Inc. To date, 922 CEOs have left their posts, which looks to be an improvement from 2008 through 2010 activity. The reasons for an exit can range from resignation, the most-often cited reason for departure, to retirement or being forced out by corporate boards that are quickly disillusioned with CEOs who are slow to deliver expected results, according to Challenger.
The transition from one CEO to another is a critical moment for any company, writes Clarke Murphy, who leads the CEO and board services practice at New York-based Russell Reynolds Associates, an executive search business.
“A smooth transition is essential to maintain the confidence of investors, business partners, customers and employees, and provides the incoming CEO with a solid platform from which to move the company forward,” Murphy wrote in A Practical Guide to CEO Succession Planning.
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Name change to Linebacker highlights company’s IV product
Business First by Carrie Ghose, Reporter
Friday, August 26, 2011
The inventor of a strap that keeps intravenous lines from falling out has decided to hand the reins to an industry expert so the company can grow.
Dr. David Sybert also renamed his company to highlight the product instead of himself.
The former SyberMed Enterprises LLC last week changed its name to Linebacker Inc. and hired Jack Kromar as CEO.
Sybert, still a full-time anesthesiologist and department chairman at OhioHealth Corp.’s Riverside Methodist Hospital, remains medical director and will work on expanding the product line. He said Kromar is best suited to meet with investors and woo large hospital systems as clients.
There’s a point at which a part-time CEO isn’t going to actually take the company forward, Sybert said in a call from the hospital. “We need to get the business guys involved.”
Kromar has 25 years in sales and management positions in the industry, most of it at Roche Diagnostics, a division of the Swiss drugmaker. More recently he's worked with startups, including a stint as CEO of Columbus-based Diramed LLC.
Sybert invented the patented strap with hook-and-loop closures in 2006 to solve a time-consuming problem for hospitals and ambulance crews: intravenous needles that fall out because tape doesn't secure the lines well. About 40 percent of IV lines need restarting, costing $25 each time.
He told me for a feature story about safety device makers in January that 2010 sales were about $12,000. He says they’re trending up but he’s not disclosing the year-to-date figure.
The company has gotten guidance from OhioHealth's innovation foundation and won a grant through TechColumbus, where it’s an incubator tenant.
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Linebacker, Inc. Announces New CEO
SyberMed Enterprises now Linebacker, Inc.
By Amy Vick
Columbus, OH (August 18, 2011)—SyberMed Enterprises, LLC has become Linebacker, Inc. and the company is pleased to announce the recent addition of Jack Kromar as Chief Executive Officer
The Linebacker® was developed by Dr. David Sybert, Chairman of the Department of Anesthesia at Riverside Methodist Hospital in Columbus, Ohio. The patented system uses a secure hook and loop strap that replaces tape to secure IVs. In 2011, the company introduced Linebacker PEDS® and Linebacker NEONATAL®, product extensions that offer superior comfort—no more sticky tape or painful skin irritations that can damage young skin. The company recently incorporated to expand its business offerings and begin research and development on new products.
Jack Kromar, the new CEO, brings over 25 years of general management and commercial operations experience to Linebacker, Inc., including nearly 20 years at Roche Diagnostics. While at Roche, Jack held various sales, marketing, and management positions including VP of Corporate Accounts for the U.S., as well as heading up the Hospital, Laboratory and Research businesses in Montreal, Canada. Most recently, Jack has been involved in several early stage medical device companies, serving as CEO of DIRAmed LLC and VP of Sales and Marketing at Cylex.
“Jack has an outstanding, proven track record of helping new businesses succeed,” said Dr. Sybert, Founder and Medical Director of Linebacker, Inc. “We welcome his extensive experience and knowledge of the medical device field, and look forward to growing the Linebacker brand.”
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The Importance of Catheter Securement
By Gregory J. Schears, MD
Intravascular catheters whether centrally or peripherally placed, have become an essential part of modern medical care. For a catheter to perform successfully over the intended duration, they must be: made of biocompatible materials, inserted sterilely, maintained pristinely, removed when no longer needed, accessed aseptically and secured optimally. Deviation from these best practices will shorten the dwell time of the catheter and lead to a catheter associated complication. The quality of securement directly impacts the functionality, duration of dwell and likelihood of a complication for a given catheter. The purpose of this article is to focus on issues related to catheter securement. It will discuss what securement is, how it has evolved, what a securement device is, distinguish primary from secondary securement, identify securement related complications and briefly review some of the clinical trials and that make up our current evidence base.
Catheter securement is a means to anchor a catheter to the skin to reduce or prevent movement. The Infusion Nurse Society (INS) textbook says "Dressing any catheter should be considered a two-step process-one to control the catheter movement and one to cover and protect the skin and insertion site."1 INS Standards of Practice uses the word secure for IV set junctions and stabilize for catheters. According to the INS Standards # 36.1, "Vascular access device stabilization shall be used to preserve the integrity of the access device, minimize catheter movement at the hub, and prevent catheter dislodgement and loss of access".2 Further, the Food and Drug Administration defines a catheter securement device as "A device with an adhesive backing that is placed over a needle or catheter and is used to keep the hub of the needle or the catheter flat and securely anchored to the skin".3
Catheter movement falls into two categories small, so called micromovements which are less than 2-3 millimeters and large which include over 3 millimeters to multiple centimeters. Because the skin and the underlying vasculature can move independently to some degree, micromovements are difficult to prevent even with the best forms of securement. It is theorized that these micromovements may contribute to vessel injury and complications. The idea is that the catheter tip which can lie on the endothelial surface of the vessel, can piston back and forth with normal patient activity. This pistoning can injure the endothelium causing pain and is believed to be a mechanical cause of phlebitis. Continued pistoning could initiate fibrin and platelet deposition which could cause a catheter tip thrombosis. Further pistoning with or without additional catheter flushes or medications could result in a perforation of the vessel leading to an infiltration or extravasation of a medication. Thus, these micromovements may result in catheter related complications given enough time to cause injury.
The larger catheter movements can also result in the same complications as well as a few others. For the same type of securement a larger catheter movement would suggest more force has been applied. This may increase the likelihood of a vessel puncture. A larger catheter movement may also suggest that the securement is weaker or disrupted. Larger catheter movements can result in a catheter migration. A migration means that the catheter is still functional though it tip has moved 1 centimeter or more from its original position. For a peripheral IV catheter a 1-2 cm movement could completely dislodge the catheter from the vein. For a central line, it may not have a significant effect. If a central venous line moves out of the central system and is deemed no longer safe to perform necessary treatments or functions, it is no longer considered a catheter migration and is now called catheter dislodgement. If treatment is still required, a catheter restart may be necessary. This means additional pain for the patient, increased cost of care, potential reduction in acceptable access sites, delay in therapy and need for a sedation or anesthetic to perform the reinsertion. This is the catheter related complication domino effect of inadequate securement.
Catheter securement can be divided into primary and secondary. Primary catheter securement directly holds the catheter in place on the skin. Secondary securement acts as an additional anchor for the infusion set tubing or extension set to reduce the force the primary securement might receive when energy is applied to the tubing by accident or rapid patient movement. For central venous catheters the standard primary securement has been suture or sterile tape. Over the past decade engineered securement devices have demonstrated at least equivalency to superiority compared to these old standards and have become the preferred approach. The securement devices also offer an added healthcare worker safety feature of no needlestick exposure, thus helping to reduce needlestick injury of blood borne pathogens. For peripheral intravenous catheters (PIV) primary securement might also include a securement device. Modification of the catheters (increased wing size) has allowed transparent dressings to demonstrate non-inferiority to securement devices in a randomized clinical trial.7 In many centers, a transparent dressing is the only primary securement used with standard wingless catheters. This is likely to predispose the patient to catheter movement and dislodgement.
Secondary securement is often achieved with non-sterile tape proximal to the catheter insertion site directly on the skin. Sometimes this is done by directly taping the tubing to the skin or creating an umbilicus and suspending the tubing. In the recent past safety pins clipped to hospital gowns were also often used. These sharps have now been eliminated and this approach is no longer an option. A new device, called the Linebacker provides a circumferential secondary anchor using a soft spongy cloth that is held in place with hook and loop material. This band uses an adhesive flap to control the IV tubing or infusion set. Its simple, wrap around design has many advantages such as: it avoids issues of the breakdown of adhesive forces common to extended use of tape, it provides much higher pull strength than tape on skin, it avoids additional sensitization to adhesives and it does not hurt when pulled or removed as tape would on the skin. The importance of a solid secondary securement can not be over emphasized as it protects the primary securement and hence the catheter from an accidental dislodgement.
With the increasing recognition of the importance of quality catheter securement and the Federal mandate to reduce needlestick injuries, several companies have developed engineered solutions for primary securement. Until recently, only one company has performed prospective, randomized trials that have proven significant reductions in catheter associated complications compared to the standard method of primary securement. This device demonstrated this improvement for both central lines and PIVs.4-6 The improvements included a 71.4 % reduction in unplanned catheter removals, significant reduction in dislodgements, increase in original securement, ~70% reduction in unnecessary catheter restarts and faster securement time. Also, because there was a significant decrease in complications in the primary securement device group, there was a cost savings as well.
Recently, two companies collaborated to perform a prospective, randomized trial using an innovative catheter with large wings and a closed system to reduce blood exposure with a specialized transparent dressing to create an effective primary securement system.7 They compared this pairing with the prior dominant securement device and standard transparent dressing. They were able to demonstrate a reduced rate of dislodgement at 96 hours, with a cost reduction of 25%, and an overall non-inferiority of the investigational device. This study mark a new era of inter-company collaboration to help make products that perform better for our patients.
For the Linebacker (LB) secondary securement system there are no published prospective clinical efficacy trials to date. Tensile strength bench tests comparing LB to tape have demonstrated that LB is 260% stronger than 1" and 80% stronger than 2" wide tape. Healthcare providers have favored the use of LB in their facilities. Eight hundred EMS applications produced a 92% positive response.8 Also at a four hundred bed acute care facility use of the LB was positive 78% of the time. A product trial at a small Pennsylvania hospital also showed over a 75% reduction in IV restarts when the LB was used. It is likely that a prospective randomized evaluation of LB looking at the rate of catheter complications, particularly migrations and dislodgements will occur. LB is a common sense solution that may help reduce costly catheter complications.
In summary, catheter securement is now recognized as a critical component of maintaining a functional vascular catheter. Both primary and secondary securement are needed for effective catheter stabilization. Engineered solutions for securement have demonstrated their superiority over the prior standards. These devices may have an increased up front cost but they provide an overall cost savings because of reduced patient complications. More inter-industry collaboration is needed to bring vascular access and securement to the next level. No doubt innovation will play a major role in this evolution.
Dr. Schears is a pediatric intensivist and anesthesiologist from Rochester, MN. He has a long standing interest in using technology to help reduce patient complications. He has particularly focused on vascular access related issues. He is the physician liaison to the nurse PICC team and the medical director of the ECMO program.
References:
- Infusion Nurses Society, Infusion Nursing-An Evidence-Based Approach, Saunders, 3rd edition, Chapter 20, p 430, 2010
- Infusion Nursing Standards of Practice, JIN 34(1S): S46, 2011
- Food and Drug Administration, Subchapter H, Part 880, Sec. 880.5210 Intravascular catheter securement device, 2011
- Yamamoto, A.J. et.al. Sutureless securement device reduces complications of peripherally inserted central venous catheters. JVIR 13(1):77-81, 2002
- Schears, G.J. Prospective, observational study of 10,164 patients comparing an IV securement device to tape. JIN 29(4):225-231, 2006
- Schears, G.J. et.al. Statlock catheter securement device significantly reduces central catheter complications, JCAHO Patient Safety Initiative 2000-Spotlights on Solutions-Compendium of Successful Practices, Vol. 1, 28-37
- Bausone-Gazda, D. et.al. A Randomized Controlled Trial to Compare the Complications of Peripheral Intravenous Catheter-Stabilization Systems, JIN 33(6): 371-84, 2010
- Personal communication from David Sybert of SyberMed Enterprises
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SyberMed launches pediatric IV devices
MedCity News (January 12, 2011)
SyberMed Enterprises LLC has launched two new versions of its intravenous-tube-securing device, with the new products aimed at children and infants.
The company’s Linebacker disposable devices are designed to lock in a catheter and IV line with a hook and loop closure. The company says the device is stronger, more comfortable and more secure than medical tape. The device comes with a strap that allows for customization for patients.
The new products are called “Linebacker Peds” and “Linebacker Neonatal,” and they feature shorter straps than the adult version, according to a statement from the company.
“Moving into the pediatric and neonatal markets was an obvious direction for Linebacker,” said CEO Dr. David Sybert. “Young patients tend to have issues with tape, including irritation and painful removal, because their skin is more fragile.”
Sybert is also chairman of the department of anesthesia at Riverside Methodist Hospital in Columbus, Ohio. The company got its start with assistance from OhioHealth’s technology commercialization program. Riverside is one of 17 hospitals in the OhioHealth system.
SyberMed joins a fairly small group of companies that make medical devices for children, a much smaller and less lucrative market than adult devices.
Lacking devices made just for children, doctors often modify adult devices, sometimes causing their tiny patients discomfort, pain or injury. Other times, the modified devices—most often used “off label” or for uses unapproved by regulators—fail to work properly.
Cleveland entrepreneur Tim Moran last year launched PediaWorks, a not-for-profit organization that works with medical professionals to develop pediatric medical devices and then spin off for-profit companies to commercialize those devices. PediaWorks’ first venture is a pediatric catheter company, a partnership with a Japanese devicemaker.
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SyberMed Enterprises launches IV devices for kids, infants
MedCityNews.com, Brandon Glenn (January 11, 2011)—SyberMed Enterprises LLC has launched two new versions of its intravenous-tube-securing device, with the new products aimed at children and infants.
The company’s Linebacker disposable devices are designed to lock in a catheter and IV line with a hook and loop closure. The company says the device is stronger, more comfortable and more secure than medical tape. The device comes with a strap that allows for customization for patients.
The new products are called “Linebacker Peds” and “Linebacker Neonatal,” and they feature shorter straps than the adult version, according to a statement from the company.
“Moving into the pediatric and neonatal markets was an obvious direction for Linebacker,” said CEO Dr. David Sybert. “Young patients tend to have issues with tape, including irritation and painful removal, because their skin is more fragile.”
Sybert is also chairman of the department of anesthesia at Riverside Methodist Hospital in Columbus, Ohio. The company got its start with assistance from OhioHealth’s technology commercialization program. Riverside is one of 17 hospitals in the OhioHealth system.
SyberMed joins a fairly small group of companies that make medical devices for children, a much smaller and less lucrative market than adult devices.
Lacking devices made just for children, doctors often modify adult devices, sometimes causing their tiny patients discomfort, pain or injury. Other times, the modified devices—most often used “off label” or for uses unapproved by regulators—fail to work properly.
Cleveland entrepreneur Tim Moran last year launched PediaWorks, a not-for-profit organization that works with medical professionals to develop pediatric medical devices and then spin off for-profit companies to commercialize those devices. PediaWorks’ first venture is a pediatric catheter company, a partnership with a Japanese devicemaker.
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SyberMed’s Linebacker PEDS and Linebacker NEONATAL
www.onlinetmd.com (January 11, 2011)—SyberMed Enterprises, LLC executives announce the development of two new products aimed at improving comfort and reducing the opportunity for tape-related skin issues and IV catheter dislodgements in infants and young patients.
Linebacker PEDS and Linebacker NEONATAL offer superior comfort—no more sticky tape or painful skin irritations that can damage young skin. The devices lock in the catheter and IV line with a secure hook and loop closure. Both are disposable and designed for single-patient use. They protect even the smallest of patients by potentially lowering the number of restarts due to accidental dislodgement and reducing the opportunity for tape-related infections, skin irritation, and skin tears.
Additionally, using Linebacker PEDS and Linebacker NEONATAL diminishes the chance for tears in health care providers' gloves. At seven inches, the neonatal version is suitable for infants and newborns. The pediatric version, at nine inches, is perfect for older toddlers and school-age children. Linebacker PEDS and Linebacker NEONATAL were both recently named “Top Products” in the 2010 annual review by EMS PRO Magazine.
“Moving into the pediatric and neonatal markets was an obvious direction for Linebacker,” says David Sybert, M.D., president and CEO of SyberMed Enterprises, LLC. “Young patients tend to have issues with tape, including irritation and painful removal, because their skin is more fragile.
Offering products that can alleviate some of these instances, and reduce the number of IV re-starts due to catheters become dislodged, is really a win for patients, families, and healthcare professionals alike.”
Linebacker was developed by Dr. Sybert, chairman of the Department of Anesthesia at Riverside Methodist Hospital in Columbus, Ohio. The patented system uses a secure hook and loop strap to secure IV tubing and catheters. Linebacker was named a “Top Product” in 2009 and 2010 by EMS PRO Magazine.
About SyberMed
SyberMed Enterprises, LLC specializes in developing and bringing to market medical device innovations that improve the lives of patients and the healthcare practitioners who serve them. The company received early funding from the Ohio Third Frontier in the form of a TechColumbus TechGenesis grant and operates out of the TechColumbus incubator in Columbus, Ohio
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SyberMed Introduces Linebacker PEDS® and Linebacker NEONATAL®
Columbus, Ohio (January 4, 2011)—SyberMed Enterprises, LLC is excited to announce the development of two new products aimed at improving comfort and reducing the opportunity for tape-related skin issues and IV catheter dislodgements in infants and young patients.
Linebacker PEDS® and Linebacker NEONATAL® offer superior comfort—no more sticky tape or painful skin irritations that can damage young skin. The devices lock in the catheter and IV line with a secure hook and loop closure. Both are disposable and designed for single-patient use. They protect even the smallest of patients by potentially lowering the number of restarts due to accidental dislodgement and reducing the opportunity for tape-related infections, skin irritation, and skin tears.
Additionally, using Linebacker PEDS and Linebacker NEONATAL diminishes the chance for tears in health care providers’ gloves. At seven inches, the neonatal version is suitable for infants and newborns. The pediatric version, at nine inches, is perfect for older toddlers and school-age children. Linebacker PEDS and Linebacker NEONATAL were both recently named “Top Products” in the 2010 annual review by EMS PRO Magazine.
“Moving into the pediatric and neonatal markets was an obvious direction for Linebacker,” said David Sybert, M.D., president and CEO of SyberMed Enterprises, LLC. “Young patients tend to have issues with tape, including irritation and painful removal, because their skin is more fragile. Offering products that can alleviate some of these instances, and reduce the number of IV restarts due to catheters becoming dislodged, is really a win for patients, families, and health care professionals alike.”
Linebacker® was developed by Dr. Sybert, chairman of the Department of Anesthesia at Riverside Methodist Hospital in Columbus, Ohio. The patented system uses a secure hook and loop strap to secure IV tubing and catheters. Linebacker was named a “Top Product” in 2009 and 2010 by EMS PRO Magazine.
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SyberMed Enterprises and Mediquest Life Sciences Team Up to
Market and Promote Linebacker®
Columbus, OH (August 5, 2010)—SyberMed Enterprises, LLC (SME) is excited to announce a strategic partnership with MediQuest Life Sciences (MQLS), a company that has specialized in the advancement of cutting edge products to healthcare professionals for more than 20 years.
MediQuest Life Sciences will work closely with SME to develop marketing and distribution strategies as well as lead commercialization efforts for Linebacker®, a patented IV tubing securing device. MQLS areas of specialization include acute care, operating room, anesthesia, critical care, and neo-natal ICU environments.
“MediQuest Life Sciences brings a wealth of knowledge and expertise in terms of successfully marketing new products,” said David Sybert, M.D., president and CEO of SyberMed Enterprises, LLC. “We see this new partnership as a great catalyst that will help us introduce Linebacker to healthcare practitioners across the country and around the world.”
Linebacker was developed by Dr. Sybert, chairman of the department of anesthesia at Riverside Methodist Hospital in Columbus, Ohio. The patented system uses a secure hook and loop strap that replaces tape to secure IVs. The product was named a “Top Product” in the 2009 annual review by EMS PRO magazine for its superior performance in securing IV tubing and significantly reducing the incidences of IV re-starts.
About SyberMed
SyberMed Enterprises, LLC specializes in developing and bringing to market medical device innovations that improve the lives of patients and the healthcare practitioners who serve them. The company received early funding from the Ohio Third Frontier in the form of a TechColumbus TechGenesis grant and operates out of the TechColumbus incubator in Columbus, Ohio. Linebacker has received extensive interest from the medical field and was named a “Top Product” by EMS PRO magazine.
About MediQuest Life Sciences
MediQuest Life Sciences (MQLS) (www.mediquestlifesciences.com) is a consulting and distribution firm focused on brining new and innovative product ideas to medical professionals. MQLS has been enhancing the lives of patients through improved quality and safety while helping facilities reduce the cost of healthcare since 1987.
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Liberty Trustee Helps Invent New Product, Business
by Bryan Bullock, Staff Writer - The Delaware Gazette
Growing up, Curt Sybert shared a number of hobbies with his younger brother, David. Years later, they have embarked on a new endeavor: pioneering medical care products.
Curt - a lawyer, Liberty Township resident and trustee - and David - an anesthesiologist and Bexley resident - founded SyberMed Enterprises in 2006. The company recently signed an agreement with Cardinal Health to provide nationwide distribution of its initial product.
Getting to that point was a long journey for the first-time entrepreneurs.
Their business started with a simple observation. David, 45, has long worked in the operating room with intravenous tubing. He noticed the tubing would sometimes be inadvertently pulled out of a patient's arm, resulting in a time-consuming and often painful reapplication process.
"Tape was the standard tool for securing an IV tube to a patient's arm, but blood and seat made it all too easy for the tape to fall off and the IV to come out," said David, chairman of the Department of Anesthesiology at Riverside Methodist Hospital.
About 10 years he thought up a simple invention to solve the problem: a single-use mesh strap that holds an IV firmly in place - no tape needed. Not sure what to do with his simple idea, or if it was really worth anything,k David decided to sit on the creation.
"Pretty much every physician I know is running around with (product) ideas in their heads," David said. "Like them, I really didn't have any idea how to bring a product to market."
Then one day he casually mentioned the idea to Curt, 48.
"We may have just been watching the Browns game, but he started saying he couldn't keep IVs in people's arms and he knew how to fix it," Curt Sybert recalled. "I said then we ought to patent that idea."
Working together in their limited free time, they would go on to develop prototypes for the device, patent it and form a Web site to market it. Along the way they discovered TechColumbus, a non-profit group that offers assistance to central Ohio tech startups. Since TechColumbus began in 2005, it has helped more than 150 entrepreneurs get their businesses off the ground and awarded $1.7 million in grants to 34 companies.
The Syberts began working with Burton Page, TechColumbus senior director of technology commercialization, in the summer of 2007; Page heads a small team that scouts for promising tech startups in a 15-county region surrounding Columbus.
Like David, Page said he was initially skeptical of the IV securement device.
"I thought this was so low tech it wouldn't see the light of day," Page said. "But once we started scratching the surface, we realized more and more it had huge market potential."
Curt and David worked with TechColumbus and its institutional partners to bring the product, know as Linebacker, to market.
SyberMed Enterprises was awarded a $50,000 grant from TechColumbus in fall 2007. That enabled the company to hire consultants to do market validation studies. "The research showed an immediate need for the product and a market potential for $90 million in annual sales," Curt Sybert said.
The studies also showed Linebacker's target market was hospitals, not EMS responders as they had originally thought; all it required was the proper distribution network. There are more than 300 million IV starts per year in U.S. hospitals and more started in pre-hospital, extended care and worldwide domains.
Linebacker is already beginning to be used internationally, including 2,500 products donated by SyberMed for relief efforts in Haiti.
SyberMed expects to announce a CEO in the near future and continue to develop new products.
"The whole project has become bigger than we ever thought," Curt Sybert said.
He said operating the company may phase him out of his Powell practice, Scherner & Sybert.
"I spend most of my day in the operating room so the face and voice of the company has really been Curt," David said. "It's nice to work on something together."
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SyberMed Donates LineBacker Systems for Haitian Medical Relief Efforts
by TechWeek Editor
Columbus startup SyberMed Enterprises, LLC, recently donated 2,500 of their LineBacker tapeless IV securing systems for use on the ground in Haiti. The systems were donated to Project HOPE, one of the primary humanitarian relief organization providing medical care and supplies to the thousands of victims of the January 12th earthquake that devastated the island nation of Haiti.
SyberMed, a developer of durable medical supplies, reached out to Project HOPE the day following the earthquake with an offer to donate the company’s patented LineBacker Systems which secure IV catheters to a patient without the use of tape.
“In watching the coverage of the Haitian relief efforts, we felt very strongly that the LineBacker system could have a significant impact on emergency medical care on the ground,” says Curtis Sybert, vice president of operations for SyberMed. “Tape could never hold IVs securely in place in the harsh conditions health care providers are facing in Haiti.”
The LineBacker System was developed by David Sybert, chief of anesthesiology at OhioHealth. The patented system uses a strap that replaces tape to secure IVs. The product was recently named a “Top Product” in the 2009 annual review by EMS Professionals magazine for its superior performance in securing IV tubing and significantly reducing the incidences of IV re-starts.
“Even in the best environmental conditions, IV tubing can become dislodged during transport or by patient movements,” says Dr. David Sybert, founder and CEO of SyberMed. “Imagine how much more challenging securing IVs would be under disaster conditions such as those healthcare providers are facing in Haiti.”
Under normal conditions, re-starts pose many threats to patient and caregiver safety as well as increased risks of infection. These risks are amplified under disaster conditions. In addition, qualified medical personnel are in short supply in Haiti, thus efficiency of care delivery is paramount. Unnecessary re-starts take valued nursing time away from other patients in need of care. The LineBacker Systems will hopefully cut down on at least a portion of these re-starts.
Upon reviewing the specifications of the LineBacker System, Patricia Bacuros, director of Gifts-in-Kind Donations with Project HOPE, reported that medical staff was excited to get the device. Bacuros reported the units would be sent first to the Dominican Republic and then sent by ship for use on the ground in Haiti.
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Unique partnership aims to get docs off drawing board, into marketplace
By Gene Monteith, hivelocitymedia.com contributing writer
If you were to walk into Jeffrey Van Buren's physical therapy practice, you might see him working with clients using a self-designed platform that helps muscles react more quickly when presented with unexpected challenges.
Van Buren, who says he never envisioned himself as an inventor, now has dreams of getting his unique apparatus into the marketplace. And while that goal is still a dream, an innovative collaboration between his employer and TechColumbus is making it closer to reality every day.
Van Buren says his ah-ha moment came "six or seven years ago. I was reading an article in a textbook that talked about a large, movable platform that was built to study what muscles would fire when it was used. I thought that would be a great way to do therapy."
Since nothing like he needed existed in the marketplace, Van Buren, who works at OhioHealth's outpatient clinic in Westerville, drew up plans and built it. Since then, he's improved on the design several times and is using it in his practice.
Van Buren says he probably wouldn't be this far along if he hadn't learned about a two-year-old program between OhioHealth and TechColumbus to give OhioHealth medical professionals a forum for their ideas and help in commercializing innovations that have the best chance of success.
Today, he's negotiating a licensing agreement for his invention and is using the resources available through the partnership to gauge market potential, refine his invention and tap expert advice.
The collaboration represents the melding of two programs designed to help would-be entrepreneurs find the money and advice needed to put their inventions and innovative ideas into the marketplace.
One is the OhioHealth Research & Innovation Institute, established in 2006 to facilitate clinical research and innovation activities throughout the OhioHealth system. A year later, OHRI took on an additional role: to help medical personnel within the system commercialize great ideas that might not otherwise get a fair hearing.
The other organization is TechColumbus, a business incubator serving a 15-county region in central Ohio.
Burton Page, Sr. Director of Technology Commercialization for TechColumbus, says he knows of no other arrangement like it. In a nutshell, here's how it works: OhioHealth professionals who think they have a great idea fill out a questionnaire about their product or idea. That's followed by an introductory meeting before an internal panel, which asks further questions and decides whether the idea has the potential for commercial uses. If it does, the idea is sent on for review by a joint TechColumbus/OHRI panel that meets every two weeks. If that panel views the idea favorably, a decision is made as to what kind of help is the most appropriate, which may include resources needed for market analysis, coaching, funding, or other help.
"The process we've established is a commercialization model for negotiating, brainstorming and finalizing ideas coming through the OhioHealth Research & Innovation Institute," he says. "There are plenty of other commercialization programs for biomedical startups around the state, he says "but they are much more fragmented than ours."
Patricia E. Eisenhardt, OHRI's manager or commercialization, agrees.
"We're very different from a university system, where there might be a lot of great inventions, but when they come out of the lab, everybody asks 'what do we do with it?'"
Eisenhardt says the same holds true with most other hospital systems, where innovation may arise but no formal process exists for assessing market potential, hooking up with funders or helping the inventor build a team.
"The problem is this," says Wayne Poll a urological surgeon and Director of Innovation for OhioHealth. "When doctors or nurses have ideas, they don't know where to go. It's not necessarily the fact that this collaboration is one-stop shopping. . . but that the idea of farming out critical components is foreign to them – putting together a team, an attorney, a regulatory guy."
Poll should know. He says he spent 10 years cold-calling companies he thought should be interested in his innovative design for a self-cleaning laparoscopic lens, only to slam into brick wall after brick wall.
While the collaboration between Poll's employer and TechColumbus came a tad too late to help Poll – his company, Minimally Invasive Devices, finally cracked the marketplace outside that process – he says other medical professionals will surely benefit.
David Sybert, chief of Riverside Methodist Hospital's anesthesiology department, recently signed a distribution agreement with medical giant Cardinal Health for 800,000 units of Linebacker, a strap that replaces tape used to secure IVs.
After conducting a market validation study, "I found out from Wayne Poll that TechColumbus and OhioHealth had started this program." While his company, Sybermed, had refined its flagship product prior to the formal OhioHealth/TechColumbus collaboration, "we were very fortunate to have TechColumbus assistance via coaching and mentoring, which is ongoing."
Sybermed benefited early on from a $47,500-TechGenesis Fund through TechColumbus, he says. Sybermed also recently moved its offices to the TechColumbus incubator.
Poll sums up the value of the program this way:
"Every doctor and nurse has good ideas. But 95 percent of those good ideas never get heard. Eighty or 90 ideas have seen the light of day during the last two years," he says. "That represents 80 or 90 people who previously had no idea where to go."
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EMS Professional 2009 Top Products Issue - Linebacker
Linebacker is a patented medical device that allows IV tubing to be secured to a patient's limb in a revolutionary and tapeless way. The single use device is disposable, non-sterile and is a practical solution for the health care industry and professionals as a whole, from the ambulance to the operating room.
Application is simple. Once the IV is initiated, the user peels back the protective film located at the end of the durable mesh strap and places the tubing on the adhesive and folds. The strap is then wrapped around the limb and secured using a hook and loop fastener. No adhesive ever touches the patient's skin.
The benefits of utilizing a quality tapeless IV securement device are plentiful. Linebacker is quick, simple to apply and with the secure hook and loop fastener, "locks" the IV line in place. The Linebacker offers superior comfort for the patient while reducing the number of accidental dislodgment. In addition, the device protects both patient and health care providers by lowering the number of IV restarts.
To date, the most common way to secure an IV to a patient is by applying tape to the tubing and the patient. This solution has the advantages of being low cost, low tech and requiring very little training. The disadvantages, however, are more numerous. Studies have shown that 74% of tape rolls are contaminated with bacteria. These rolls are used on multiple patients, thus becoming a vector for infection.
In addition, tape is painful to remove and can remove the upper epidermis. This can cause both open sores and skin infections. The use of tape also causes leaks in caregivers' gloves 40% of the time. Finally, tape is grossly ineffective in holding the IV in place as compared to Linebacker. Because the Linebacker adheres to itself, you do not have to worry about skin that is moist, sandy or covered in blood. While other catheter stabilization devices exist, they are not tapeless and have unfavorable pricing compared to Linebacker.
There are over 300 million IV starts per year in U.S. hospitals. This does not take into account IV starts in the pre-hospital, extended care or worldwide domains.
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Free $$$ for entrepreneurs: Seed money for a medical breakthrough
By Eilene Zimmerman, CNNMoney.com contributing writer
October 29, 2009
SyberMed Enterprises -
Columbus
As an anesthesiologist working in operating rooms, David Sybert often found himself dealing with intravenous tubing that tangle on equipment or on the patient. Sometime that tubing would get pulled out of the patient's arm and have to be reinserted — a time-consuming and often painful process.
"The gold standard for securing an IV tube to a patient's arm has always been plain old tape, but blood and sweat makes the tape fall off," Sybert says. "You get EMS personnel rescuing someone from a car accident, and the patient is thrashing around and they lose the IV."
Sybert, 44, came up with a simple way to secure the IV without tape: a Velcro-type strap that includes an area with adhesive, where the IV tubing is secured so it won't move. The strap holds the needle and tubing in place around the arm. His invention, the Linebacker, was so low-tech Sybert thought that if he applied for grant money to develop it, he would be "laughed out of the room."
Then he and his brother Curtis J. Sybert -- the other partner in his business, SyberMed Enterprises -- learned about TechColumbus, an independent nonprofit that offers grants and loans to the region's tech startups. Since TechColumbus began in 2005, it has made grants totaling $1.35 million to 60 tech startups in a 15-county region in central Ohio.
SyberMed Enterprises received a $50,000 grant from TechColumbus in October 2007. That enabled the company to hire consultants to do market validation studies. "Their research showed an immediate need for the product, and we used the grant money to retain one of the consultants, who helped us develop a strategy to enter the market," Sybert says. The company is now in talks with Cardinal Health about nationwide distribution.
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