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Articles from 2011 In December

FDA’s Jeffrey Shuren on How Regulatory Science Could Reduce Cost and Time to Market

Jeffrey ShurenIn early December 2011, CDRH director Jeffrey Shuren, MD, while giving a keynote presentation at the LifeScience Alley Conference in Minneapolis titled "Regulatory Science—Reducing the Cost and Time to Market Through Scientific Innovations." Bill Betten, senior technical advisor of UBM TechInsights shares his notes from the presentation here:

  • In addition to acknowledging Minnesota’s long history of medical device development and large number of medical companies located in the state, one of Shuren’s purposes in attending the conference was to announce that a Memo of Understanding (MOU) had been signed between CDRH and Life Science Alley. The MOU formalizes interactions that had been occurring between LifeScience Alley and CDRH for more than a year regarding the advancement of regulatory science. The MOU recognizes that CDRH and LifeScience Alley, which represents the industrial and academic medical technology community sectors, have shared interests in further developing regulatory science for medical devices and in enhancing the understanding of the safety, effectiveness, quality, and performance of medical devices. It also forms the basis for the development of scientific and intellectual collaborations, outreach, and educational initiatives among the FDA, LifeScience Alley, the University of Minnesota, the medical device community and eventually other partners across the country.
  • This MOU was focused around regulatory science. An interesting definition of it was provided and provides a stark contrast to the criticism that the FDA has been under. The definition said that regulatory science provides the tools, standards, and approaches needed to evaluate the safety, effectiveness, performance, and quality of medical products. It was also suggested that this benefits patients by speeding the rate of important technologies reaching market and reducing time and resources needed for device development, assessment, and review. The definition is hard to argue with. However, the impact of the FDA on these issues was the subject of much of the rest of the talk.
  • Much of Shuren’s presentation related to the issues related to the FDA’s pace of regulatory approvals, a topic about which much has been written recently so I won’t dwell on it at this time. However, as a former VP of Engineering for a medical device company, I can say that even relatively routine 30-day submissions were frustrating, often with questions coming back from the FDA examiner on day 29. In addition, training and knowledge of the examiners with regard to the subjects they were being asked to review were often an issue as many of the questions were not representative of someone with a knowledge of the particular space. Shuren has been on the defensive on these issues for some time.
  • Shuren did discuss relative funding issues, contrasting spending on basic R&D by the government and industry with that on basic regulatory and engineering issues. He pointed out that, from 1990–2008, federal spending for applied R&D had dropped from about 40% to 20% of the total, with industry basically filling in by growing to almost 80% of the total during that time. He also commented that the U.S. government contribution to R&D had stayed relatively flat as a percentage of economic output while a number of countries (notably Japan, South Korea, and China) are increasing theirs. However, percentages can be deceiving as the U.S. economic output is larger than those countries so total overall spend is more. Finally, from a financial investment perspective, he pointed out that in fiscal year 2011 NIH invested $30 billion in research, while the FDA investment in regulatory science was $15 million, accentuating a previous call made for additional resources to address some of the issues associated with device reviews and approvals.
  • Shuren did have recommendations for addressing some of the concerns, most of which tie back to the MOU. These included establishing a public-private partnership between industry, the FDA, and academia; working on projects where there is shared interest; implementing a governance structure; sharing human and financial resources; and validating tools, standards, approaches developed. There was substantial focus on the issues associated with the last point on validation and development of tools, with a suggestion that by standardizing and defining approaches to product development and testing, that perhaps time to market could be accelerated. There was also some brief suggestion of perhaps a set of tests that could be passed (perhaps a certification?) that could be used as a basis for decision making by the FDA.

General Reaction to the Presentation

I first met Shuren a couple of years ago at an FDA-sponsored meeting on device interoperability shortly after he was appointed to the Director’s role. He seemed to say all of the right things. However, it has now been a couple of years since then and the FDA is under even more fire from industry with regard to product approvals. Perhaps it is a case of good vision with poor operational execution, which plays to the resource issue. However, many device companies have been vocal about these issues and we are now seeing products introduced overseas well before the United States, in some cases years before introduction here. While product safety is indeed important, it is clear that the system today is not working well. When a product development team worries more about the two R’s (regulatory and reimbursement) than the technical issues, it isn’t a healthy product development environment and threatens our competitiveness. Perhaps Shuren’s call for greater engagement with industry will work. At the very least it may be an attempt to quiet the FDA’s harshest critics by engaging them as part of the solution. Only time will tell, but it can’t be allowed to get worse if U.S. medical device companies expect to continue to be world leaders. Finally, one challenge that I will watch with interest, particularly with regard to presentation from Leslie Saxon, MD earlier [during the conference] on mobile devices and health care, will be how the FDA addresses the rapid proliferation of mobile devices and the convergence between consumer and medical. This was not explicitly addressed during his talk nor during the Q&A.

—Bill Betten

Body Computing Visionary Leslie Saxon on the Convergence of Consumer Products and Medical Technology

Leslie SaxonThe annual LifeScience Alley conference held in Minneapolis featured in early December featured a keynote talk titled “Body Computing and Patient-Networked Technologies” by Leslie Saxon, MD, chief, division of cardiovascular medicine at the USC Keck School of Medicine.

Bill Betten, UBM TechInsights’ senior technical advisor, medical devices was there and he was kind enough to share his detailed notes from the conference with us, which we provide below:

  • The main themes of the talk included what is happening in the networking of technologies, the impact of smart phone technology on medicine, and the potential outcomes of that interaction.
  • One of the impediments to potential change in the current, dated model of medical delivery is the reluctance of current medical establishment to abandon the current model.
  • Smartphones are set to overtake PC shipments in 2012. Dr. Saxon indicated that they would be a primary tool in medical treatment in the future. USC asked the following questions in a 2010 survey: “How likely are you to use mobile data services for the following reasons: Keep track of important personal and wellness data? Manage a nutrition and Exercise diary?” High responses were 43% and 38% in Singapore; Low responses of 10% and 11% in Japan; U.S. responses were 29% and 26% respectively. Interesting question is whether the Internet is “sticky” enough to really change habits in terms of access. Study by Kliner Perkins shows that social networks surpassed Internet portal use in June 2011.

Dr. Saxon also showed the following chart from IBM, which shows a flattened normalized distribution curve with “consumer electronics companies” on the left and “medical device makers” on the right, with a very large central portion labeled “Battleground for Adopters.” It is that large gray zone in the middle that will define what happens in the medical arena. It is also the area of confusion that is not yet defined from the regulatory perspective either.

Battleground between consumer electronics and medical devices.

  • USC’s Body Computing Center is uniting medicine, engineering, communications, and entertainment into a new paradigm—connected healthcare. The focus is on personalized applications that play toward the social aspect, but with experience personnel to examine the collected data. She referenced “The Measured Life,” a site run by MIT oriented toward collection of information by individuals about themselves.
  • She referenced a number of companies and devices as evidence of the trend for the change in devices. Many of these are still under development and are clearly not yet “medical” devices. They included Sotera, the “Patient Advisory Module” collaboration between USC and St. Jude Medical, as well as “Altitude” from Boston Scientific.
    • tricorder
    Spock from Star Trek holds a tricorder device.
  • She mentioned the medical “X Prize” of $20 million for the equivalent of a Star Trek tricorder that could monitor patients as well as board certified physicians. The communicator seems to have arrived in the guise of the cell phone, so perhaps we’ll see the tricorder as well.
  • She then moved on to discuss social websites such as “LiveStrong” and others that are actively engaging people in changes ranging from health monitoring to quitting smoking. Key reasons that they work are that they provide daily tracking, a strong community of support, positive feedback, and simplicity.
  • She then discussed sports medicine and gaming and the use of sensors and quasi-medical devices in those areas. There were lots of examples including a couple ECG applications and Dr. David Albert’s AliveCor product.

In conclusion, she commented that she didn't know the answer to where all of this was going, particularly with regard to the regulatory issues. However, she said that she would utilize the information gathered and commented on assessing the condition of someone from India by way of Africa via a smart phone device. My impression is that this will be the proverbial avalanche coming and the FDA is standing in the way. It will be interesting to see what happens.

—Bill Betten and Brian Buntz

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Things Will Get Interesting in Medicine When Siri Meets Watson

Things Will Get Interesting in Medicine When Siri Meets Watson

David AlbertThe headline above was inspired by something iPhone ECG inventor David Albert, MD, said at a TCT conference session in San Francisco in November: "When Siri meets Watson meets medical decision-making, that is when things will get interesting." I had a chance to chat with Dr. Albert before Christmas, and I asked him for some more perspective on what the intersection of Siri, Apple's intelligent assistant, and Watson, IBM's supercomputer, could mean for medicine.

For one thing, as the Baby Boomers continue to get older, the demand for healthcare will increase, Albert says. "The number of healthcare professionals is not going to go up at nearly the pace. Therefore, we have to use technology and tools to empower nurse practitioners, nurses, paramedics, nurse techs—all kinds of people," he explains. "We have to make physicians more efficient. Electronic medical records (EMRs) are making a lot of physicians less efficient because they are not familiar with them. But the new generation, they grew up on computers, smartphones, and gaming machines—they don’t have any problem [with EMRs]."

Albert said the age of 50 could be a sort of cutoff point for physicians; doctors under that age will likely find it easier to use electronic medical records "just because of when they were trained and how technology was integrated into their lives," he says.

But we will have no choice but to use healthcare IT and artificial intelligence to advance medicine.

"When a physician can take Epocrates and Siri—be hands free—and combine that with the global power of Watson, you see those kind of tools come together and you say 'amazing!'" he says. "You will have amazing things." For instance, somebody in Africa can get a diagnosis by a physician in the United States. Or a dermatologist could look at a patient's mole remotely and determine whether it is melanoma or not. 

"Finally, telemedicine is going to find its place," Albert says. "And that is going to come out of necessity. Before, people were trying to push telemedicine to rural areas. We are going to use telemedicine in all of these new forms. It means telemedicine from the home."

Making Sense of the Mountain of Data

Artificial intelligence will also be important in cutting through the data that is piling up as medicine goes digital. As medicine becomes personalized and human genome sequencing grows, data is only going to build at an accelerating pace.

"So we need something like Watson to help us cut through the data and find clarity. And we need something like Siri so we don’t have to be sitting near with a keyboard," he says. "And we need to be able to go past it so that a 60-year old doctor and a 30-year old doctor can both interface to the system."

"When Siri meets Watson, things will get interesting because we will improve the delivery of care and the efficiency. And we have to do it. The incentives [now in place] mean we have to do it. We have no choice." 

—Brian Buntz

Related Content:

Albert also recommends checking out Daniel Kraft's TEDxMaastricht presentation on the future of medicine, which also touches on the import of Watson in medicine:

Patient-Focused Innovation

Innovation: Cultivation. The institute’s mentorship team selects between one and three applicants and gives them the resources they need to develop their product. Innovators have access to the institute’s lab, offices, engineering space, and other R&D resources. They are also given financial aid to cover equipment, supply, and staff expenses.
Clinical Research: Validation. The Taft Center for Clinical Research was established after the hospital received a $4 million donation. It helps accelerated the process of clinical research programs by supporting trials and allowing patient participation in trials involving innovative treatments.
Education. The institute conducts external educational activities via workshops, seminars, and medical fellowships.

Competitive Business Practices: Employee Poaching in the Medical Device Industry

It’s a competitive world out there. Medical device companies seek out talented engineers who have demonstrated skills

Jeffrey Boxer

in developing successful products and sales people who have strong relationships with hospitals and clinicians to launch those products into practice. So what happens when a talented employee leaves your company to work for a competitor? Sometimes nothing happens. In other cases, the issue can be serious and the company takes the former employee to court. In a Q&A with Jeffrey Boxer, commercial litigation partner at Carter Ledyard & Milburn (New York City), MD+DI’s Maria Fontanazza finds out what you need to know about employee poaching—whether you’re an executive searching for talent or an employee looking to get out of your company.

MD+DI: How common is the prevalence of poaching employees from competitors in the medical device industry?
Jeffrey Boxer: It’s moderately common, but it [hasn’t reached] epidemic levels. It’s an industry where having somebody with experience, whether it’s a sales person who knows doctors and hospitals and understands how devices work, or a scientist, doctor, or technologist who is involved in creating and producing products, [is valuable]. It’s not uncommon to see one company try to bring on somebody from another company who has that knowledge.
In terms of trends, I can’t say there’s been an increase or decrease over the last couple of years. I don’t think the economic downtown has slowed the pace of hiring from competitors or the pace of litigation resulting from those hirings.
MD+DI: Is it illegal to poach from a competitor?
Boxer: Illegal is a loaded word. If you’re saying illegal in terms of the criminal side, no. Generally this isn’t criminal conduct. You’re talking about civil relief, and that comes in two forms. One is an injunction from a court saying that the employee who is moving can’t go to work for the new company. The other [form] is a ruling by a court that the employee’s move to the competitor has resulted in money damages to the former employer and that the employee or the new company is liable for those damages. In that sense, if the noncompete is well written and enforceable and if the employee has violated it, then yes, you can get those kinds of orders from the court—an order saying you can’t go compete, and down the road, saying that your competing caused a level of damages to the former employer, and you and possibly your new employer are liable for that.
As a practical matter, most companies looking to enforce these noncompetes are far more interested in step one—getting the injunction that says, I have a valid contract with my former employee that says he or she can’t do what he or she is doing, and [asking the court to stop him or her]. That’s where the big battles are.
MD+DI: When can a company go after a former employee? Can you provide a background on noncompete agreements?
Boxer: In virtually every state in the United States, and most non-U.S. locations where you might find this kind of work, employees are free to leave and go to a competitor unless they’ve agreed not to do so. If you have an employment contract with your employee that just says, you’ll work for me and give me 30 days’ notice when you leave, and it doesn’t say anything about not going to a competitor or about protecting confidential information, then that employee can leave whenever he or she wants and go work for a competitor with no problem and no claims by the former employee.
Generally speaking, in almost every U.S. state, noncompete agreements are disfavored and only enforceable in very limited circumstances. Generally, they’re only enforceable to protect a legitimate interest of the company. Most states have defined a legitimate interest of the company as being confidential information or trade secrets, and relationships with customers. Even if you can show a legitimate interest, the noncompete is only enforceable if it is reasonable in scope. Generally speaking, you can’t preclude someone from competing for 10 years, because that’s not reasonable. In this industry, noncompetes of one or two years have been held up as reasonable.
[The noncompete agreement] has to be reasonable in geographic scope as well. [For example, if] I’m a sales rep who covers the Northeast for a particular product for a company and I go work for a competitor. [I’m] selling the same product but I’m now working in the Southwest and I don’t have any contacts down there from my prior employment. [If] the restrictive covenant says [I] can’t work anywhere in the U.S., that’s probably not reasonable, because I’m not really threatening a legitimate interest of the company down there.
The key is for companies in this or any industry, [is] to look at their employees and how they are situated and make a decision about whether they want to have noncompete [agreements] with those employees. If they do, then they need to make sure that they’re reasonable –that they can justify them if it comes to court. You don’t want to be in a position of overreaching and having a noncompete that when you go to enforce it just isn’t going to get enforced. Then you’ve really wasted the benefit that you could get from having a well-written noncompete agreement.
MD+DI: Are there any sectors of the medical device industry in which your seeing employee poaching occurring more often?
Boxer: There have been a lot of reported cases recently in connection with cardiac products. It’s odd; I don’t know if there’s a reason; I haven’t seen anything going on in that segment of the market. There’s been no consolidation; there’s been no new products offered that would lead to people from one place to another.
Sometimes companies go the other way and try to keep it quiet that they’ve lost key people. [They] don’t look to enforce the noncompete, because they don’t want to make a big deal of it or they don’t want the risk of having the noncompete found to be unenforceable, or [face] the cost (which can be significant) to go to court to enforce it. We can only talk about what’s been published in terms of court cases about these incidents.
MD+DI: When employees are moving to a competitor, what are the main concerns faced by the previous employer?
Boxer: The main concern when you’re losing an employee is outward-facing employees—sales people, the people who go into hospitals, and [those] meeting with doctors, etc. The company is concerned about the relationships that employees have with the company’s customers. Once you’ve lost the person with the relationship, how do you replace that? One way is by having a well-written valid noncompete and a realistic understanding of its likely enforceability, the cost of enforcing it, and other ramifications of going to court. Another way to handle this [issue] is to structure your team so that you don’t have just one person who has a unique relationship with each client—that you have teams or backups or that you’re structured in a way that losing one person doesn’t lose an entire relationship with a hospital, doctor, or wherever your selling.
MD+DI: Is poaching employees becoming a larger issue given the globally connected environment in which we live?
Boxer: Absolutely . Employees are more mobile, not only within the United States but around the world. The United States has a very well developed set of laws and rules on enforceability of noncompetes, and on protection of intellectual property and trade secrets. That law is different or isn’t as developed in some of the locations where these companies are doing business. It’s important for companies to understand when they’re doing business in countries outside the United States what those countries laws are, what the likelihood of getting a court to enforce those laws is, and what the process is for doing that. The globalization of this, and other industries, makes those very important issues.
MD+DI: What are your thoughts on recruiting new talent at medical device companies?
Boxer: Recruiting new talent into the industry is, from a legal standpoint, a safer way to bring someone into your fold rather than going out and recruiting someone from a competitor who is going to bring along potential legal action. But getting the right person is difficult. By recruiting laterally from a competitor, you generally know what you’re getting—you have an experienced person with relationships and skills that have been demonstrated over time. Bringing in new talent is key and it’s great, but in some ways, it’s harder to do, because it’s harder to identify, and it takes more time and money to train [new employees].
MD+DI: Where do you think poaching in the device industry is headed?
Boxer: I don’t see it happening less often. I think the competition for talent out there in a very competitive industry with a lot of significant players is always going to be high. That leads to experienced employees moving from one company to another and that leads to the type of litigation we are talking about. I don’t see it decreasing.

Healthcare Delivery Could Change Significantly in 2012

Healthcare Delivery Could Change Significantly in 2012

Today, Information Week listed its top 10 Health IT predictions for 2012. Sure, there are tons of predictions to sift through this time of year, but, at first glance, three of these ten seem particularly significant. They are:

  1. By the end of 2012, the bulk of U.S. providers will be using electronic medical records (EMR).
  2. Successful accountable care organizations (ACOs) will be established.
  3. Payment for healthcare costs will be increasingly tied to successful outcomes.

electronicsIf those three predictions turn out to be accurate, they would represent a sea change for how healthcare is delivered in this country. (The remaining seven predictions are worth checking out, too.)

The first is tied to the broader trend of information technology continually revamping our lives. And there are countless entrepreneurs, tech proponents, and people in high places in U.S. government that believe that health IT will completely transform healthcare—for the better. On the other end of the spectrum, however, are people with a variety of concerns about the technology, whether it be related to privacy or simply the belief that health IT is overhyped. There may be something to this skepticism. It may be a matter of years before electronic medical records begin living up to their potential to cut costs or improve care. And, in some cases, EMRs may lead to unintended consequences and they are now unpopular among many clinicians.

But it's hard not to believe that something big is happening, and that health IT will make good on at least some of its promises. Information technology has already reinvented countless parts of most peoples lives—from paying your bills online to streaming films in your living room. So far, however, the impact of information technology hasn't been nearly as significant in healthcare. But that may start to change as soon as consumer technology and healthcare technology converge—helping to bring cost savings to medicine in the process.

The second two predictions—regarding ACOs and outcome-based payments—attempt to address the problem of rising healthcare costs through changing how physicians get paid. In the past, the vast majority of healthcare in this country was delivered using a fee-for-service model. That is, if you get sick, you go to the doctor, and pay the physician for the time. The incentive that emerges from this is that physicians are largely rewarded for healthcare volume. This setup has an obvious corollary in the device space: selling more devices yields more revenue. But as these predictions make clear, there is pressure to alter this paradigm for payment and pressure to develop innovative, safe, and effective technology at a (relatively) low price point.

So, what could these three predictions mean for medical device companies? Well, the old healthcare delivery model could crumble, for one thing—directly affecting medtech firms. 

"The world is going to change [...] Nobody is saying we are going to spend more money on Medicare. We are going to spend less."

In a recent interview, David Albert, MD, inventor of the iPhone ECG recently shared his thoughts on this matter. "The notion of [healthcare providers] buying devices to generate more revenue is not going to be the case," he said. Instead, physicians will be incentivized to "do the appropriate thing to try to spend as little money to take as good care of the patient as possible." This is a stark contrast from the "more I do, the more I get paid" model that physicians have worked under historically. "The world is going to change; it’s changing as we speak. We can talk politics, but the reality is, I don’t care if you are a Republican or a Democrat, nobody is saying we are going to spend more money on Medicare. We are going to spend less."

Enter electronics and health IT. The power of computing for countless applications has the potential to save cash. Consider an example described in a Wall Street Daily earlier this year. Four days of heart monitoring in a hospital costs roughly $25,000. A study from the Tufts Medical Center could cut that cost by as much as 72%. Albert's AliveCor iPhone ECG is another example of a high-performance medical device that comes at an unthinkably low price point; it is expected to cost $99 and to be available to both physicians and consumers.

As ACOs gain more power, the incentives will build for care providers to try to keep patients out of the hospital. And there wil be an incentive to, for instance, keep atrial fibrillation patients from having a stroke, Albert says. "Those are the opportunities," he adds. There will also be somewhat of a a shift from disease treatment to disease management. Consider, for instance, the Health Buddy from Bosch Telehealth. Or the fact that many innovators are working on turning smartphones into increasingly powerful diagnostic medical devices.

"We are going to see a transitioning," Albert says. "And I think that transitioning will open the way [to preventive-based care]."

—Brian Buntz

Related Content:

Things Will Get Interesting in Medicine When Siri Meets Watson

Image from iStockphoto

A Sound Reimbursement Strategy Plays an Integral Role in the Da Vinci Robot's Success

The da Vinci robot from Intuitive Surgical is a fascinating device. The robot, which enables physicians to perform surgery from a remote console, transformed the standard of care and created a new market segment when it debuted a decade ago. It has since played a significant role in bolstering the adoption of minimally invasive surgical procedures. Hospitals that own a da Vinci robot or two often promote the fact that they do because it makes good sense from a PR standpoint; owning a da Vinci robot helps hospitals look high tech. The manufacturer has played a role in this, of course, and has supported robust media relations efforts.

The maker of the device has essentially a monopoly in the market segment and was thus able to have a compound annual growth rate of 59% from 2001 to 2009. And the device is anything but cheap, costing an average of $1.4 million. Hospitals with the device typically pay hundreds of thousands of dollars annually for service-related costs and to purchase new instruments for the device. 

Despite its high cost, many hospitals over the years have felt compelled to buy one—often because other local academic of community hospitals had done so.

Once a hospital owns a Da Vinci, they must ensure that the units are used frequently enough to make the purchase a worthy investment. As a recent article titled "Reimbursement and Coverage Strategies Matter, Here's Why" explains, hospitals owning a Da Vinci have a vested interest in maintaining a procedural volume that is "sufficiently high to cover the equipment's amortization, operating costs, and return investment." 

The fact that the robot sells for over $1,000,000 makes Intuitive Surgical's reimbursement strategy a crucial component of the company's success. The firm had a relatively easy time getting regulatory clearance for the device from FDA. And, as the above article surmises, "[b]y working with existing procedural codes, Intuitive Surgical was able to bypass some of the difficulties other device manufacturers have encountered in securing reimbursement codes. [...] Although empiric, comparative effectiveness research is lacking, da Vinci benefited from a procedural shift from open to laparoscopic procedures (for which reimbursement codes already existed), and its initial perceived value has stood up over time."

Here's a clip showing the da Vinci's prowess of precision, demonstrated here through the folding of tiny origami:

—Brian Buntz

Image from Wikipedia

Radio-Frequency Heat-Sealing Equipment Features Programmable Logic Controllers

A company and its subsidiary manufacture radio-frequency (RF) heat-sealing equipment for use in medical device manufacturing. The machines are designed to support the validation of production specifications and compliance with FDA regulations. Through the integration of programmable logic controllers, manufacturers have a choice of process controls for the range of RF sealing machines available. The leading areas of control include the monitoring of process parameters, control of output power, accurate temperature sensing, control of die penetration, ram force control, and data acquisition and collection for subsequent statistical analysis.

Cosmos Electronic Machine Corp. and Kabar Manufacturing Corp.
Farmingdale, NY


Tubing Connectors Available in Polycarbonate and Polysulfone

A line of quick-disconnect medical-grade tubing connectors has been expanded to accommodate a wider range of low-flow applications. The MPC coupling series includes hose barbs suitable for flexible tubing down to 1/8 in. ID, and additional adapters and terminations let users build modular systems that work with a broad range of systems and configurations. Designed to maximize process flexibility and provide secure, leak-free performance, the connectors are offered in polycarbonate and polysulfone. The 1/8-in. connector will mate with any corresponding connector in the series regardless of hose barb size. The tube couplings provide safe small-bore connections, preventing potentially dangerous misconnections with luers. Applications include wound drainage, blood salvage, IV therapies, and enteral feeding.

Colder Products Co.
St. Paul, MN


Tube Cutting and Assembly Systems Prevent Repetitive Stress Injuries

A suite of tabletop machines is available for tube cutting and the assembly of tubes and fittings. Offering precise-tolerance tubing cuts, tubing expanders for inserting fittings, and automated fitting inserters, the machines are engineered to address problem areas in tube and fitting handling and to accelerate production in and outside of the cleanroom environment. All are designed to help users avoid the repetitive stress injuries associated with tube cutting and the insertion of fittings into tubing. The latest products developed by the manufacturer include a fully pneumatic cleanroom tubing cutter, an economical manual tubing cutter, and a reel stand to complement the cutting machines.

Clean Room Devices LLC
Westminster, CO