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Medical Device Community Looks to LinkedIn for Lively, Varied Political Discourse

When it comes to politics—particularly during an election year—everyone seems to have an opinion. And medical device professionals are no exception. But while some industry execs have taken their gripes about the medical device tax and other pertinent issues to the media, many members of the medical device community have flocked to social media site LinkedIn to engage in political discourse with peers about pressing industry concerns.

Establishing itself as the destination of choice for many medical device professionals, the Medical Devices Group on LinkedIn, owned by medical device marketing consultant Joe Hage, boasts more than 100,000 members and serves as a lively forum for debating political and other issues affecting the industry. As expected, the most commonly discussed political issue within the group is that of the controversial 2.3% medical device excise tax, which has even prompted a movement, associated site, and petition led by Hage dubbed "No 2.3%." Touting the tag line, "kill the med device tax," the site encourages medical device professionals to sign the petition in order to prevent jobs from moving to China and medtech innovation from being crushed. The petition currently has more than 1170 signatures, though it aims to ambitiously collect 23,826 more before July 18.

Perhaps more interestingly, however, is the discussion that has taken shape in response to Hage's post inviting group members to sign the petition. More than 67 comments responding to Hage's post illuminate the polarizing nature of the tax, even within the medical device industry. Some commenters predictably are staunchly opposed to the tax and are concerned about its potential impact on U.S. jobs and innovation. But dissention is apparent as a slew of commenters accuse Hage (and the media) of "fear mongering" and espouse the need for more discussion, less bias.

This outpouring of opinions on both sides of the issue, however, raises a larger question: Do political discussions have a place in a professional group? Hage actually threw such a poll to members for their feedback; the results were a bit surprising. According to current poll results, 57% of respondents believe that there is a place for politics in the group if it is related to the medical device industry. A strong showing of 42%, however, believe that politics don't belong in a professional group.

It's an intriguing debate with both sides certainly having valid points. "I, reluctantly, voted 'yes.' Unfortunately, a lot of times, political views are stated with little more than vitriol and sound bites, the same junk stated by the talking heads. In a site like LinkedIn, we need to bring much more to the discussion, such as evidence and explanations for assumptions. If I can't understand the reasoning for anyone's point of view, I will reject it outright," commented member Paul Stein.

Taking the opposite stance was member Malcolm Taylor, who also made a fair point. "In my 60 years in engineering, in the UK and US, and in technical societies such as the Institution of Mechanical Engineers, ASME, etc., politics and religion are 'verboten.' Since the Medical Devices Group is a semitechnical group, I think it should take the same position," he commented.

While everyone is entitled to his or her opinion and both arguments are completely valid, I admit that I voted in favor of political discussion. The caveat being, of course, that the political discussion is relevant to the medical device industry, promotes healthy debate, and maintains some semblance of maturity. Such discussion can be stimulating and enlightening, as well as just plain fun. And, let's face it, there's a lot to talk about right now. As a community composed of intelligent, thoughtful individuals, medical device professionals need to just ensure that political debate does not devolve into namecalling or vitriol. Easier said than done, but we can do it.

If you're not already a member, check out the Medical Devices Group on LinkedIn for engaging discussion opportunities on politics and a wide variety of other medical device industry issues. --Shana Leonard

This Week in Devices [4/20/2012]: The ITClamp, Hackers vs. Medical Devices, Free Home Drug-Tests for 420, Creating Drugs with 3-D Printers, Proton Beams - Overpriced?

This Week in Devices [4/20/2012]

3-D Printing for At-Home Prescriptions

  • Popular Science reports on the latest development in 3-D printing. Researchers based in Glasgow are devising methods of printing their own customized labware – including chemical-filled reaction chambers than can then be used to create drugs and other chemicals on-demand.

  Are Hackers After Medical Devices?

  • Forbes examines just how vulnerable medical devices are to hackers and computer viruses, and what could be done to curb the threat.

 Special Interest Group Gives Away Free Home Drug-Testing Kits for 4/20

  • Southern California parents worried their teens may be celebrating the unofficial marijuana smoking holiday are being provided home drug-testing kits. (Source: LAWeekly)

Proton Beams. A Waste of Money? 

  • Proton accelerators to treat cancer are the most expensive medical devices in the world. But a new report in the British Medical Journal says that the purported benefits of proton beams may not be worth the price of admission.  (Source: Medical News Today)

Hair clip-inspired ITClamp Could Save Soldiers’ Lives

  • Canadian medical device manufacture Innovative Trauma Care is currently preparing for the release of its ITClamp – a device designed to stop traumatic hemorrhage bleeding. The device, whose design is inspired by a simple hair clip, would ideal for emergency situations such as in combat. (Source: CNET)
 

 
 

A Fireside Chat with the "Edison of Medicine," Thomas Fogarty, MD

Noted inventor Thomas Fogarty, MD has worked with medical technology for more than half a century. In that time, his inventions have touched the lives of millions of patients across the globe. He has emerged as something of a Rennaissance man, who is an experienced investor, vascular surgeon, winemaker, founder of 40 medtech companies, and an inventor with 150 patents on surgical instruments. 

To honor Fogarty's achievements, MD+DI has presented him with the MDEA Lifetime Achievement Award. Dean Kamen, who is a famous inventor in his own right, will be on hand in Philadelphia on May 23 at MD&M East to present Fogarty with the prize.

I recently had the opportunity to sit down with Dr. Fogarty and discuss a number of topics ranging from how he took up inventing to his thoughts on the current regulatory environment. In the first part of the discussion, below, Fogarty also explains how his namesake product, the Fogarty catheter, was developed: 

Brian Buntz is the editor-at-large at UBM Canon's medical group. Follow him on Twitter at @brian_buntz

With Healthcare Market Challenge Comes Opportunity

The New Patient-Consumer

Current trends in healthcare are accelerating the drive to adapt medical technologies to nontraditional settings and adopt consumer technologies for traditional medical applications. Aging population demographics, downward pressure on costs and an emerging receptiveness from consumers to new healthcare paradigms are all contributing to push a convergence of traditional medical and consumer technologies. A shift in focus to active prevention, along with the increasing need to address a rising burden of long-term chronic illness, is dictating the need for a revolution in point-of-care. Expensive hospitals and ER’s are out. Outpatient clinics, pharmacies, and home care are in.

Patients are increasingly being encouraged to actively participate in their own continuum of care. This encouragement is coming directly from their physicians and family, or out of necessity to avoid skyrocketing costs not covered by already pricy private insurance or Medicare. This participation is creating a market for low-cost, consumer-driven devices and services that can be offered within the clinic, in the field by healthcare professionals or self-administered by patients in the home setting.
Consumer technology is enabling entirely new medical use cases with the proliferation of smart phones, cellular data networks, wi-fi access, and Bluetooth-enabled devices. These technologies have opened up more consumer-centric interfaces, opportunities for patient-physician interactions, and new consumer-driven healthcare experiences as well as ways to do real-time monitoring, compliance tracking, efficacy surveillance, and physiological data collection.

Making Change and Embracing New Opportunities

Applying a particular technology that has been developed and matured to address a specific ailment simply falls short in the emerging paradigm. Successful new products will be systemic, requiring the collaboration of a much broader range of functional expertise and the integration of technologies not typically seen in a traditional narrow device development effort. Product platforms that include diagnostic, therapeutic, and monitoring benefits in combination are needed. Products and services may also require consumer grade ease-of-use, new sensors, full telemetry, data logging, cloud computing, security encryption, wide distribution, field training/servicing, or real-time surveillance. All of these aspects need to be considered while keeping in mind that, at the center of these solutions is the patient, and the intended health benefit that is to be addressed. These types of services can be daunting to implement to ensure user adoption, provide the expected clinical outcomes, and meet regulatory standards. However, the opportunities far outweigh the challenges if approached correctly and comprehensively.

Creating a Cohesive Team to Meet the New Challenge

The competencies, expertise, and capabilities to develop and deploy such products are typically not found within one company. New partnering, licensing, acquisitions, and organic growth strategies need to be developed in order to be successful. As market opportunities and products mature, the overall strategy and the network of partners and portfolio of innovation assets will need to be continually refined to sustain results. Companies should seek to form consortiums, acquire or license core technologies, leverage innovation partners, and find new ways to access their customers and patients directly. Completely new points of care, distribution channels and innovative system solutions will evolve driven by the healthcare consumer and their wellness needs.

Comprehensive Solutions

The biggest challenge is that the needs of the new healthcare consumer require comprehensive products, which have to be informed by a broad range of domain expertise and adapted depending on geographic deployment. Dealing with the early ambiguities and underlying complexity of potential products is the first step. Representatives from R&D, healthcare practitioners, information systems, clinical research, and distribution must work together to identify the right combination of technologies and use cases to address patients’ needs. Then, strategically choosing which aspects will be closely held (core competency), which long-term aspects will be from trusted partners or licensed (other’s competency), and which aspects will be provided on an as-needed basis from innovation providers (execution partner’s competency) will be key. New skills in collaboration, orchestration, and information coordination will be required as these contributors progress and converge on a compelling offering.

Conclusion

Future best-in-class healthcare will include much more than the traditional in-person interaction with one’s physician in a clinical setting. As this shift progresses and the convergence of traditional medical and consumer technology accelerates, new, transformational ways of delivering care will emerge. Successful companies will adopt new business models and strategically partner to innovate, create compelling products and services, and deploy these solutions to customer-driven markets. Those companies who meet the current healthcare challenge will not only grow and prosper greatly in comparison to their peers but will also improve the continuum of care for patients and caregivers of the future.

Sean MacLeod is president of Stratos Product Development LLC (Seattle). He has more than 20 years of experience as a business manager and engineer. Reach him at [email protected]

Q&A with Paul Fearis, CEO of Clinvue

Q&A with Paul Fearis, CEO of Clinvue

The client couldn’t understand why sales of its device were shrinking. Hadn’t the company just redesigned the packaging? So the device manufacturer turned to Clinvue, the start-up that Paul Fearis heads, to determine the reason for the dip.
“It transpired that the nurses preferred the packaging of their competitor’s product, because when they reached into a drawer and pulled one out they could open it in fractions of a second, whereas with our client’s new packaging, they had to pick at the corner with their fingernail to open it,” Fearis says. The nurses “went for the easy one every time.”

Fearis says the discovery exemplifies the ability of the Westminster, MD–based company to get to the heart of successful product innovation through a “scrubbed-in” approach that takes the chief executive and his colleagues into a range of healthcare settings around the world. Visits to large medical centers and small, community hospitals enable Clinvue to discern the needs of the stakeholders with the most pressing device requirements and prioritize their needs to come up with the best developmental direction. The most important product stakeholder could be the outpatient nurse, the ER surgeon, the patient, or “the guy who wheels it out onto the loading dock and throws it away at the end of the day,” Fearis says.

‘We have to make sure that the ladder is leaning against the right wall,’ says Paul Fearis.

Launched on July 4, 2010, Clinvue specializes in a broad range of products, including those used in cardiology, thoracic surgery, drug delivery, and high-volume disposable settings. The British-born Fearis holds master’s degrees in both mechanical engineering and industrial design and was technology director of PDD Ltd., a product and services innovation company based in London. Fearis left PDD for the UK–based product development firm Sagentia in the mid-90s. In 2001 he came to the United States, where he became president of Sagentia and developed its U.S. client base.

Fearis cofounded Clinvue with Jonathan Sackier, a trained surgeon originally from the UK, and Brandon Craft, an industrial designer from the U.S. who also worked at Sagentia. “I’ve been really active in the front end of medical device innovation for easily the last 15 years, and years in product development before that—good old-fashioned handle-turning, you know, Stage-Gate product development stuff since about 1988,” he says.

Although Fearis acknowledges an “a-ha!” moment could strike when a bar of soap falls on your head in the shower, he says product innovation is typically hard work that requires channeled creativity. It’s a theme he emphasizes in numerous company speaking engagements and academic lectures, including those he and Craft have delivered recently at Johns Hopkins University.

In addition to product stakeholders, Fearis talks with MX about the urgent need for cost reduction, how healthcare reform is not stifling innovation, Clinvue’s embedded approach to market research, the role of “sunshine” laws in Clinvue’s debut, and his love of aviation and Lotus race cars.

MX: How often do you have speaking engagements, either on behalf of Clinvue or at industry conferences?

Paul Fearis: It kind of comes in fits and starts. If you’d asked me that question 10 years ago, I’d have said, “I’ve already done six this year.” Probably in the last six months there are two elements to it: There’s speaking at in-company conferences and things like that. I’ve done quite a lot of that, probably three or four of those [but] nothing in the mainstream or big conferences in the last year or so. What I have [also] been doing is lecturing at John Hopkins. That was like 12 intense weeks of a complete, full semester with Johns Hopkins University…teaching the master’s biomedical engineering students there. We’ve got another [meeting] the week after next where we’re the keynote speaker for a company off-site. We’ve been doing these in-house sessions most recently.

MX: How are the lectures working out?

PF: They’re working out remarkably well. I’ve had a kind of casual relationship with Johns Hopkins, just acting as a guest lecturer for about the last three years. They have a great course there; it’s a Master’s BME course that’s part of the Whiting School of Engineering and the Center for Bioengineering Innovation and Design. It was casual lectures turned into a request to run a solid, 12-week credit course as part of the master’s [candidates] last year. We did that basically through the fall semester—myself and one of my partners, Brandon Craft. We did 12 lectures of about 2½ to 3 hours each solidly, every week.

Essentially, we taught our process, and the course is titled “Insights: Informed Innovation.” We taught opportunity discovery, which is how to find opportunities for what people need and how to determine ways that could be achieved and then determine ways that should be achieved—in other words, product embodiment. The course was actually the highest ranked one by the students in the faculty for the year, so I think we did a good job.

MX: Regarding innovation, you’ve referred to it as the lifeblood of the medical products business. How would you describe the state of innovation these days? What factors currently affect device innovation?

PF: I think it’s in a different place to that which it has been. If you read the media and what have you, one of the things that people are making quite a lot of noise about is that healthcare reform, or Obamacare, is stifling innovation et cetera. The truth is that I’m not particularly seeing that. What I am seeing is a redirection of innovation effort toward more meeting the challenges that the economy and the recession and the current healthcare environment create.

This kind of innovation is context-specific. It hasn’t gone away; it’s just sort of shifted sideways and perhaps modulated a bit in amplitude. By that I mean innovation at the moment is less about—and this is a generalization, of course—massive sea-change innovation and more about optimizing products and bringing new features and perhaps reducing cost. I think cost is a big issue that we could talk about in some depth. Innovation doesn’t necessarily mean entirely new and never-seen-before. It’s more about the commercial application of creativity. Innovation at the moment is more about delivering the same or slightly better standard of care, but at significantly less cost. So innovation has just moved its focus slightly. I think the huge fireworks that we were seeing a few years ago have gone away a little, but it’s now much more focused on helping healthcare continue as we know it.

MX: What you’re saying ties into comments I read by some of the jurors for this year’s Medical Design Excellence Awards. They mention that the 2012 finalists feature no completely new technology but are longstanding products with incremental improvements. One possible reason is that it takes three years on average to develop a product, and the development process for this year’s entrants would have coincided with the beginning of the economic downturn. Does that analysis make sense to you, given what you just said?

PF: I think it does. Senior managers in industry are constantly managing risk. They’re managing commercial risk, financial risk, shareholder risk, right down to project risk. I don’t think that it’s surprising when you enter a period of financial uncertainty, which was certainly the case three years ago, that those managers and their companies reduced their innovation risk profile, if you want to call it that.

I think that supports what your jurors say. I still call that innovation. That’s just innovation in this climate. I think the interesting thing and the telling part is if we set our minds back—and I kind of lived through this—to 2001 and the recession around then. Many companies did an emergency stop on innovation and dove into their bunkers and pulled the covers over the top. This time innovation has actually stayed quite strong in industry. It’s actually remained in the front and center of companies, because people realized they caught a cold after the last recession and didn’t have those new products and those new opportunities. So innovation remains pretty strong this time compared with last time. I think it’s there, [but] per my previous comment it’s more about one quantum leap at a time. That’s the way I like to think about it.

MX: This may be reductive and I hope you’ll correct me, but my understanding is that Clinvue favors a structured approach to innovation, as you alluded to, as opposed to a “fuzzy” methodology. Is there a fine line between adhering strictly to a framework and letting creativity sort of wash over you, say, in order to develop new products? Do you have to find a balance between those two approaches?

PF: It’s a good question, and one I run into quite a lot. It’s one of my hot topics, actually, and I take quite a robust stance here. If you define innovation—and this is a fairly well-tried and tested definition—as “the commercial application of creativity,” creativity can exist completely unhindered inside an innovation process. Coming from an art school background, I’m always going to advocate very, very hard for creativity. But in the commercial world creativity has to be pointed in the right direction and guided toward a useful goal, because innovation is about the commercial application of creativity. I don’t think the two are by any means mutually exclusive.

Innovation is a tough ladder to climb, so we have to make sure that the ladder is leaning against the right wall. So our innovation process here is by no means restrictive. It makes sure that we’re leaning the ladder against the right wall. It’s targeted toward what matters to stakeholders, or customers, and we might have that conversation in a while, it’s managed toward achieving that goal, it’s creative, and it’s fun. So I don’t think the two are mutually exclusive, but I think to just be creative without a process isn’t appropriate in a commercial environment. That’s an art school environment.

MX: During your lectures at Johns Hopkins and your other speaking engagements has anything struck you about the types of questions you receive from your audiences over the past few years?

PF: I’m not sure how well this answer will sit with your readers, but I ask [audiences] to just take a quiet moment in a darkened room and be introspective for a minute. If I think about the common thread that runs through questions I get at the end of speaking inside companies and in public, the truth is the questions tend to center on how hard the work of doing customer-centric innovation is. It takes a long time; it costs a quite lot of money. It’s grueling, gut-wrenching hard work.

Some companies tend to communicate that they see that as almost too hard, and they want some kind of magic bullet that lets them short-circuit the whole thing; you know, “please just tell us the answer.” I’m afraid to report that you can’t do that, and it seldom works. Once in a while the soap falls on your head in the shower and you have a blinding flash of inspiration. But if you’ve got to get up at eight o’clock every morning and be innovative till five o’clock every night that takes process and hard work. There’s that famous Thomas Edison quote where he said something along the lines of “opportunity is missed by most people because it’s dressed in overalls and looks like hard work.” That is a common theme running through those kinds of questions: “Is it really this grueling? Is it really this hard?” Yes, it is, and there are still no guarantees.

MX: Clinvue asserts that access to clinicians in their working environments is becoming difficult. Why is that and how has your company been able to overcome that problem?

PF: One of the points that led to the formation of Clinvue was that many states in the U.S. have instituted “sunshine” acts, and sunshine acts are aimed at controlling the financial interaction between medical companies and healthcare workers. It was born of the whole slightly distasteful exchange of money for favors and so on. The sunshine acts aim to control that. Even in places where the laws haven’t been passed, there are very, very strong guidelines laid down to control these issues of conflict of interest between a surgeon or nurse and a company trying to sell something.

It’s sad, but it’s proven necessary to do that. It does create a better space for a commercial environment. Unfortunately, it has the downside of actively discouraging caregivers and particularly doctors from engaging with industry in helpful and innovative ways, in case they fall afoul of these sunshine act laws or conflict of interest. Obviously, it’s easier for them to not engage and to do nothing, because that’s failsafe. One of the points about Clinvue is we don’t buy or sell medical devices. We never have and we never will. We represent a safe interaction that hospitals can have because we don’t represent a conflict of interest. We can’t influence or sell the product, and we don’t buy services from them.

There is no conflict. I think that’s the important point. We can act as something of a firewall, as insulation between our mainstream clients, who could suffer from conflict of interest, and the hospitals and the healthcare workers. And it’s important because we find that the doctors do still want to be innovative and be part of making things better, be that devices or healthcare as a whole. We kind of represent a safe way to do that.

That’s the first point. The second point, which is a bit softer, is that we’ve really gone out of our way to build strong and trusted relationships with a network of hospitals. We’ve proven that we can work alongside surgeons in an OR or nurses in an ED, in the care environment, and not disrupt their daily activity and their workflows. We’ve also proven that we can respect patient confidentiality, HIPA et al, and we’ve built some pretty strong personal relationships. When we’re working on a nursing floor or in an OR we’re often so embedded that other nurses and doctors often ask us for directions to the canteen or what’s good to eat today. We’ve had surgeons have us scrub-in, and they’ve pulled us right onto their elbows so we can almost feel what they’re doing. It’s pretty intense stuff, and of course that’s where the real insight around unmet, unarticulated, underserved needs comes from. So a little bit has been building those relationships and proving that we can go and get that information and not disrupt them.

Anecdotally, the reaction we get is: “We’re really pleased that you guys want to come and listen.”

MX: Clinvue says its network is growing. How big is the network?

PF: A good example would really be if we look at the last three months of January, February, March when we worked in—and I mean not just walked through the lobby but spent days in—24 hospitals across seven countries, of which the U.S. was one. So we’ve been to Japan, Turkey, Italy, the UK, Germany, France, all over. So that kind of gives you a scale. The important point to make is that those [visits] span large, academic teaching hospitals right down to small, community hospitals. There’s an important point there that I would like to make: Companies tend to focus on adding key opinion leaders to their armories, and often those key opinion leaders come from massive academic hospitals. But that guy can take out your gall bladder with a coat hanger. He’s an absolutely brilliant surgeon, for example, but he’s not necessarily representative of the bulk of the market. Everything in life is a bell curve: He’s right over there on the right-hand side. But it’s important to engage with the smaller community hospitals where the guy’s trying to do that emergency gall bladder surgery or whatever it may be at 10 o’clock at night and he’s not done one all week. We try to vary our network and mix our network up to cover the bell curve there.

MX: Right, the devices would have to suit a range of situations and medical environments.

PF: And skill levels.

MX: You work with medtech clients around the world then. What are some of the regional differences and similarities in terms of medical device development?

PF: It’s an interesting question. There’s a pretty important point to make here for the U.S. to listen to. Particularly in the last six months we’ve spent a lot of time working in Europe with European hospitals and European physicians. And interacting with some very high-level people inside the UK’s National Health Service. I think I’ve seen a portent of what is to come as a result of that. If you look at the UK specifically as a bit of a trailblazer here, and some other European countries, there’s a very, very strong sentiment now around medical device innovation, and it was captured by a very senior guy in the NHS as part of a client project a little while ago. The quote pretty much verbatim was: “Without cost impact data—and I don’t care how good the product is—if it doesn’t save us money, it won’t be used in the new NHS.”

The point is that the criteria for successful innovation are changing and becoming much more focused upon reducing the cost and at least maintaining, and ideally improving, the standard of care, but at least maintaining it. That is not to say that innovation can’t be radical or push boundaries, but it has to come with a very robust cost benefit to the healthcare system or it simply won’t fly. Many European countries are now bound by government undertaking to reduce healthcare costs by published large numbers of millions of pounds or dollars or euros or whatever. That’s really the new innovation challenge. It’s less about a better mousetrap; it’s about catching the mouse more efficiently at lower cost.

So I think some of the challenges that Europe is going through really paint a good picture of what innovation needs to deliver in the U.S. It’s very well publicized that healthcare in this country can’t continue the way it’s going. Many companies are picking up on this, and innovation is now about delivering the benefits but at reduced cost or with improved efficiency: How can we get more out of what we’ve got? How can we make peoples’ lives easier so they can do more, do better, spend more time with patients, and reduce the cost of doing that?

MX: Yes, that touches on one of the key elements of the healthcare reform debate—“bending the cost curve.”

PF: It’s a big innovation challenge. An innovation challenge doesn’t have to be putting a man on the moon or whatever, it can be putting that three-cent device in the nurse’s hand for two cents.

MX: As far as products developed—or midwifed, if you will—by Clinvue is there such a thing as an unsuccessful development process? You never get to that point, right? Because of cost concerns you obviously want to find out pretty quickly that the process isn’t working before you spend a lot of money.

PF: Exactly. It comes down to whether you characterize that as a success or a failure. (Laughs.) Certainly, sometimes our work leads to us saying to our client, “Actually, the answer’s ‘no.’ Actually, the answer is people don’t care enough to want to do this, so we suggest that you don’t develop this product.” There’s despondency and people [digging in] their heels, but ultimately the senior management in that company is saying, “Phew, we didn’t invest another million or five million, or worse, in that.” So sometimes our answer is no. More often than not it’s yes, because, of course, what we do is customer-led or customer insight–led, so we’re not inventing something and trying to see whether it’s going to be successful in the market. We’re going to the market and determining what’s going to be successful and then inventing it. That tends to put us on the right side of that curve.

MX: Speaking of clients, what are the most challenging aspects of working with clients today?

PF: The hardest clients to work with are when we run into senior management that is doing innovation because they’ve been told to rather than because they support it or love it. The easiest moments are when a client is aligned all the way to the top, and they understand there’s no magic bullet and they can’t short-circuit the process and they’re willing to roll up their sleeves and dive in with us.

We’ve got a client like that at the moment, and it’s just great. You can’t tell where their company stops and ours starts. It’s really just the way we like it. That’s certainly the easiest, and the hardest is when it’s not like that.

MX: Is there a premium for Clinvue’s services? Do you find companies balking at what you charge for your guidance?

PF: Our cost is for the largest part driven by the time it takes literally going into a sensible number [of hospitals]. I’m not talking about hundreds or even tens; we’re talking about 9 or 12 hospitals and spending a day or two days or whatever it may be, immersed in that environment. That drives a big chunk of cost. Our clients look at our proposals and they say, “That’s expensive,” and then we point out, “Well, yes, but look, there were three weeks spent across five nursing units, doing whole shifts with nurses.” They nod and say, “Actually, we can understand where that cost comes from then.” They’re pretty comfortable with the work before and after. So it’s really a case of how we scope the program and do the research segmentation: What hospitals do we really need to go see and how many? Which countries do we really think we’re going to see differences in that are valid for the research?

Often, our clients begin with massive market segmentation. They want to go six different countries and see three different types of care facilities and three of each, et cetera. And that gets obscenely expensive. But when we start to really challenge them and say, “But where’s the value; where are we going to learn different things?” we can normally pretty quickly come to an agreement.

MX: That leads to a question about the stakeholders that you alluded to earlier as distinct from customers. Can you elaborate on that distinction?

PF: Our clients are our customers. We’re talking about the customers of our clients, the people who end up using or adopting this device or service. The traditional term for that is “VOC,” or “voice of the customer.” If you think about it, in the medical world who on earth is the customer? Is it the patient? It could be the patient, but the patient may well be unconscious. So perhaps it’s not the patient. Is it the doctor? Well, yes, the doctor may be using the device, but he doesn’t write the check. Is it the nurse? A nurse may end up cleaning up after the use of the device or after the procedure, but she doesn’t sign the check either. Is it the purchasing committee? Well, it might be the purchasing committee, but they don’t use the device so they don’t understand what the device requirements are. Is it the salesman who works for our client, the company? If he’s not incentivized to get the product out of his bag, he’s going to show the other product that he’s got in his bag when he’s got 45 seconds in front of a doctor in a meeting room.

The point is that the customer is not immediately obvious. Actually, there are a whole bunch of stakeholders all around who affect the purchase and adoption and use. There are classic cases of products that have been bought by a purchasing committee and aren’t used by nurses because they hate them. So what we do is we recognize who those people are, and we recognize that “good” looks different to each of them. What each one of those people needs out of that product is slightly different, and a successful product needs to meet the needs—to a lesser or greater extent—of each of those stakeholders, and to understand how those stakeholders influence each other. One of the first things I do with our clients is say, “Let’s stop talking about ‘voice of the customer.’ You can’t point to your customer. Let’s talk about voice of the stakeholder.” Normally, everybody’s face lights up and they all start nodding. It’s all those people that we need to understand: right through to the guy who wheels it out onto the loading dock and throws it away at the end of the day.

MX: That almost seems like an impossible task. How can you satisfy that many stakeholders? Wouldn’t you have to lean toward one product value or another?

PF: It’s about understanding what their needs are and going beyond that to prioritize those needs and understand what the key success factors are. The key success factors may not apply to all the stakeholders. An example here is medical packaging. We had a case where a piece of medical packaging had been changed by our client to a new packet for his device. And his device lives in a drawer with its competitors’ devices. And the device does pretty much the same [thing] as everybody else’s. The problem in this case is that a nurse sits in an out-patient clinic with patients and shows new patients how to use this device in their home, and they’re going to use this device for many years to come. The client’s sales were diminishing, and he wanted to understand why. It transpired that the nurses preferred the packaging of their competitor’s product, because when they reached into a drawer and pulled one out they could open it in fractions of a second, whereas with our client’s new packaging, they had to pick at the corner with their fingernail to open it. Human nature [being what it is] they went for the easy one every time. After they’d used 10 of those, they would finally reach in and pull our client’s one out.

It was a case where a packaging change that they thought would make things better for some reason, [and] actually it was a different stakeholder down the line that really affected adoption. It was this nurse sitting with a patient in an outpatient clinic, just showing him how to use a device after the doctor had come and done all his cool stuff that was affecting whether this device got used on a patient. And once this patient has started using one type of device he would rarely ever change to another, so it sets the scene for the treatment of that ailment. That’s an example of how it’s not necessarily the stakeholder you think it is. A part of what we do is understand that world and then prioritize from there.

MX: Speaking of field research, what is your day-to-day role in the company? How often do you travel, lecture, and the like?


The lecturing, we gave up our evenings to do that in the fall semester. We thankfully have been off for the spring semester, and we’ll be starting again in the summer with some boot camps and what-have-you for Hopkins. That’s two or three hours a week of preparation and two or three hours a week of lecturing. That’s that part of the equation.

PF: My role is very hands-on for project work, maybe even too much people might say. I’m currently managing active projects that we have in the company, and I’m a team member on other projects under other managers. We have a pretty flat hierarchy in that way, so I can be “managing” or “managed” in any one day. In between that, I’m kind of the marketing evangelist, so I’m out there in the market being hugely enthusiastic about what we do, which comes easy, as you can probably tell. I’m the bookkeeper and the coffee maker, and last week I vacuumed the office and tidied up the coffee mugs. It’s pretty blood-and-guts stuff really. I’m not sitting in a corner office gazing out the window being particularly strategic; we’re doing the work.

MX: As chief executive don’t you need some downtime? Don’t you need moments when you can…

PF: Eat?

MX: …let your mind wander, if you will, to let your creative juices flow? You can still be working subconsciously when you’re walking to the coffee machine. It’s almost like a computer program running on background.

PF: Absolutely. The answer is “get a dog.” Getting a dog makes me go out and walk, and by far the best time for noodling on all that stuff is when I’m in the middle of a field walking a dog.

MX: I understand you also pilot planes as a hobby. Does aviation play a role in your ability to be creative?

PF: I’d like to say there is some deeper connection between Clinvue and aviation, but actually aviation is just totally absorbing in that you have to concentrate on it 100%. That kind of helps me switch off from work and have some of those maybe more meandering thoughts. I also found that horses help, and maybe there’s a connection between aviation and horses and running Clinvue in that if you take your hands off the controls of either of these things for very long and gaze at the scenery things are going to go bad very quickly.

MX: Does your interest in Lotus cars also tie into that need to focus in the moment as well? Or is the appeal their design and performance?

PF: Hmmm, actually it was primarily a schoolboy fantasy, at age 12 I saw the James Bond movie “The Spy Who Loved Me,” and Bond drove a white Lotus Esprit that drove into the sea and turned into a submarine, won an undersea battle, and then drove up onto a tourist beach. I fell in love with Lotus at age 12.

If I think about it a moment, I think I love Lotus cars because if you ask a kid to draw a sports car in 10 seconds they will basically draw a Lotus Esprit. Also Lotus’s founder Colin Chapman once famously scrawled across a design his engineers presented to him to “simplify and add lightness.” I think that’s a pretty good motto for life.

MX: It is. How did your experience with PDD in London and Sagentia in the U.S. also inform what you do now as CEO of Clinvue?

There are a couple of useful points to make here. Both of those companies taught me different things. Art—and I’m using the word art—and creativity do have real commercial value in industry. Creating art is very hard but it’s also very worth it. Innovation still contains a very good measure of art. I always say to my clients, “Don’t let anyone who’s written a book or who has a piece of software tell you there isn’t art in innovation, because there still is.”

That was one thing I learned there. I also learned that building strong relationships with clients, built upon deep trust over multiple projects, is more important than making enough money to buy a Caribbean island. If you can build mutual trust and respect, every once in a while a project will go south, but the chances are you can sit down, have a sensible conversation about it, and retain your client, rather than end up in a terminal screaming match
 

Understanding the Software Development Process When You’re Not a Software Engineer

Jason Machacek is a software engineer at Stratos Product Development and can be reached at [email protected].
While it’s easy to see progress as mechanical and electrical engineers work—you can observe as 3-D models are developed, schematics and board layouts are designed, and breadboards are assembled – software is a different story. An engineer may work for weeks and the only visible fruit of their labor is a barely-noticeable change to a trace on an oscilloscope.
 
Software development is hard to observe because it’s abstract. Complex languages of words and numbers represent machine-code instructions that are executed by a processor, which in turn represent bursts of electrons flowing through hundreds of millions of transistors at speeds barely comprehensible by the human brain. Software languages were invented to frame this incredibly complex behavior into terms understandable by people.
So, how do you turn an intangible concept like software development into something you can confidently work into a finite project schedule? By understanding the different phases of software development and applying an iterative process from start to finish. 

Planning and Architecture – The Backbone of Your Project

Accurate planning and documentation can make or break a development effort. In this initial phase of the project, software engineers – along with the entire team – are laying the groundwork for the development effort. The goal during this phase is to plan the activities that will occur during the Detailed Design and Formal Test phases.
 
During the Planning and Architecture phase, the team creates a Software Development Plan that outlines the efforts and tasks for the project. Additionally, the software team is analyzing the project’s Product Requirements Document (PRD) and interacting heavily with the customer to determine the behavior of the system. The team makes decisions during this phase about which languages, processors and tools will be used for the project. Some initial breadboards may be developed in this phase to prove out technically risky or difficult parts of the system. The software team also conducts a detailed risk analysis along with the rest of the team to identify the parts of the system that will require the most attention; this is an extremely important step in mission- and safety-critical applications. Tasks are prioritized and options are presented to the customer based on risks, marketing needs and features that add value to the product.
 
As the engineers’ understanding of the system solidifies, they develop a preliminary software architecture and the Software Requirements Document (SRD). Developing the Software Requirements Document is one of the most challenging tasks in the software development process. The SRD is critical—it’s the software engineers’ line in the sand, describing exactly what they will be delivering. Every requirement is carefully written to describe what the software will do, and must be testable: the SRD says what the software team will deliver, and the Software Quality Assurance (SQA) team holds them to this standard during the Formal Test phase by verifying that every requirement is met by the end product.

Detailed Design – Iterative Increments for Success

The team will spend 60-70% of the development effort in the Detailed Design phase, during which the software team goes through several incremental development efforts. Projects are split into three, four, or more increments. The increments are designed to deliver critical functionality at key points in the product development process, typically to support the testing of critical system functionality or electromechanical prototypes before the end product is complete. Note that the software team typically does not write any code for the project before this phase.
 
Each increment follows the cycle of design-develop-test. The team develops complex design documents, fleshing out the information in the architecture document pertaining to the current increment. They then write the code that implements the design and integrate it into the system. Finally, they perform tests on the software at both modular and system levels prior to delivering each incremental software build.
 
Also, throughout this phase, customer changes are being absorbed at the requirements level, fed into the risk analysis, prioritized based on risk and necessity, and incorporated into the design and codebase. Requirement changes during this phase become progressively more expensive and constrained as more and more design and code needs to be updated to accommodate them.
 
Note that for software engineers, focus and concentration are extremely important during the Detailed Design phase. Studies have shown that a single interruption (a phone call, email, or visitor at their desk) instantly breaks a person’s focus, and for complex tasks it can take an average of 25 minutes to regain that same level of concentration! If a software engineer is interrupted once an hour throughout a day, they lose as much as half their productivity. If that happens every day, their tasks will take twice as long as they should. Consider instituting office hours for engineers on a project; that way, interruptions can be limited to a couple of hours a day, providing the engineer with more useful, focused time to make progress on the project.

Formal Test – Delivering a Quality Product

When the project hits the Formal Test phase, the SQA team takes over and the software team takes on a support role. The software team assists with tracing each item in the Product Requirements Document and Risk Analysis to the Software Requirements Document, the Software Design Document, and finally the Formal Test Procedures
.
The software team’s role shifts at this point; in addition to updating documentation and fixing any software bugs that are found during testing, the team will begin work on features to be added after a product is on the market. These features may include internationalization, user interface improvements, wireless communications, internet connectivity, and more.

Final Notes 

Software development is difficult to monitor externally. While the nature of software itself makes it a mystery to those without a software background, with a better understanding of the development process it becomes easier to measure and observe the progress of your team’s software development effort. Your best chances for success lie in forming a team with an interdisciplinary vantage point. Building these skills internally or through partnerships will put your team in the best position to efficiently deliver the optimal product to market on time and on budget.
 
 
 

Massachusetts Congressman Calls for 510(k) Reform Provisions in User Fee Act

A U.S. Congressman who was among the group that introduced the SOUND Devices Act in the House of Representatives in February is again pushing for legislation to improve the safety of medical devices.

Edward J. Markey (D-MA) is pressing for 510(k) reforms to be included in a legislative package intended to update the FDA User Fee Act. Following a subcommittee on health hearing titled “FDA User Fees 2012: How Innovation Helps Patients and Jobs,” Markey expressed his disappointment that a discussion draft of the User Fee Act does not include measures to increase device safeguards.

“While the current version of the discussion draft contains several provisions that I have authored, I am disappointed that it is missing an opportunity to vastly improve the safety of medical devices and protect patients from serious harm,” Markey said in a statement.

He said he plans to work with other lawmakers to add a provision that would allow FDA to reject 510(k) applications that cite devices recalled due to safety concerns as predicates.

Mark-ups on bills to reauthorize the Medical Device User Fee Act are scheduled for next week.

Jamie Hartford is the associate editor of MD+DI and MED. Follow her on Twitter at @readMED.
 

Patent Reform: Is The Cure Worse Than The Disease?

This article examines two key aspects of the AIA: The first-inventor-to-file patent scheme and what constitutes prior art after patent reform is fully implemented. AIA simplifies identification of activities that constitute prior art and transforms the U.S. patent system to give priority to inventors who are the first to file patent applications rather than to those who are the first to invent. Given the rapid pace of innovation in the medical technology field, companies in the near future will be pressured to file patent applications as quickly as possible in order to maintain competitive advantage.

Given the rapid pace of innovation in the medical technology field, companies in the near future will be pressured to file patent applications as quickly as possible in order to maintain competitive advantage.

This simplification has also broadened the scope and content of prior art that can be utilized against patents and patent applications in the medical device industry. It also puts limits on the one-year grace period between the creation of prior art and the patent application filing.

The first-to-file and prior art provisions of the AIA will take effect March 16, 2013. It is not too early, therefore, to begin considering the implications of the new patent scheme for device companies.

Major Departures

The U.S. Patent and Trademark Office (USPTO) will no longer grant patents to the first person to invent a new medical device. Instead, the patent will be granted to the first inventor who files for a patent on that new device. A patent for a new human organism, however, will not be granted to anyone—  it is specifically barred from issuance under the AIA.

If that inventor inadvertently fails to describe the best mode of the device’s construction or manufacture as required in a patent application, that omission will not be held against the inventor so as to render the patent unenforceable.

Should a competitor know of prior art that might invalidate or prevent the granting of the patent, that competitor can use  administrative mechanisms in lieu of litigation to challenge the patent. During the pendency of the application and after the patent is granted, competitors can submit prior art for consideration by the examiner or the USPTO’s Patent and Trial Appeal Board. After the patent is granted, competitors can invoke two different yet similar mechanisms to invalidate the patent. Post-grant review, which is the first of the two mechanisms available chronologically, can be used to invalidate the patent on a wide array of grounds, but only if a review request is filed for within the first nine months after the patent is granted. Inter partes review, the second of the two mechanisms, can be initiated at any time after the post-grant review time period has lapsed.

Finally, should the inventor decide to enforce the patent against perceived infringers, no longer can the inventor hold an entire industry hostage by filing one lawsuit naming all the industry’s players. Rather, naming multiple defendants is permitted only where the infringement results from the same transaction or a series of transactions or occurrences—or both situations—that relate to the same product or process. Should the accused infringer have previously and commercially used the patented device at least a year prior to the filing of the application that resulted in the patent, then the accused infringer will have a broader scope of prior user rights to assert as a defense to the accused infringement.

A Broader View

With the implementation of the AIA, the exclusively American concept of awarding a patent to the invention’s first inventor will disappear. Before lamenting the demise of this American ideal, we should recognize that this concept instilled a significant level of uncertainty in U.S. patents. A patent could always be later held invalid if it was shown that others in the United States had known of or used the invention described in the patent before the first inventor created the invention.

As set out in current Section 102(g), a person is entitled to a patent unless

"Before such person’s invention thereof, the invention was made in this country by another inventor who had not abandoned, suppressed, or concealed it. In determining priority of invention under this subsection, there shall be considered not only the respective dates of conception and reduction to practice of the invention, but also the reasonable diligence of one who was first to conceive and last to reduce to practice, from a time prior to conception by the other.

This first part of Section 102(g)(2), not only established the U.S. patent system as a first-inventor entitlement scheme but also imputed uncertainty into the validity of all issued patents. With implementation of the AIA, this uncertainty about the possible existence of a prior inventor is eliminated. As stated in Section 102(a)(2) of the AIA, a person is entitled to a patent unless the claimed invention is disclosed in an issued patent or published application that names another inventor and was filed before the filing date of the claimed invention. This stipulation creates what some have deemed to be a race to the USPTO to obtain the patent.

That race also exists, to a certain extent, under the current law. In the above-quoted portion of Section 102(g)(2), reduction to practice (putting an invention to practical use), or due diligence in reducing the invention to practice, is required when considering prior inventorship. One means for constructively reducing an invention to practice is to file a patent application on the invention. Conception of an invention, coupled with prompt filing of a patent application, is therefore encouraged under the current system. The current system’s one-year period, prior to filing, for the exclusion of prior art, also encourages the faster filing of patent applications as a means to exclude the availability of additional prior art.

In addition to this uncertainty concerning prior inventors, the application and qualification of prior art under the current statute is complicated, because not all prior art is treated equally. Even after practicing patent law for many years, a seasoned patent attorney will likely refer to the text of current Section 102(a)-(g) when determining whether a reference will constitute prior art against a given patent application. The section is convoluted and always requires detailed consideration.

For example, under current Section 102, prior art is treated differently depending on whether it predates the applicant’s invention date or occurred more than a year before the date on which the applicant filed for a U.S. patent. Regarding the former, current Section 102(a) states:

A person shall be entitled to a patent unless. . . (a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for patent, or …

Regarding the latter, current Section 102(b) states:

The invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than a year prior to the date of the application for patent in the United States, or …

Thus, knowledge and use would be considered prior art if they occurred before the applicant’s invention date. Prior patenting, publication, public use, and on-sale activities are considered prior art only if they occur more than a year before the applicant’s U.S. filing date.

In addition to the timing of the prior art, under paragraphs (a) and (b) of the current Section 102, prior art is currently treated differently depending on the nature of the prior art itself and where it exists. Knowledge and use are important only if that knowledge or use occurred in the United States, whereas a printed publication or a patent is considered prior art regardless of where it is published or granted. Prior use and on-sale activities must occur in the United States to be considered as prior art.

The remaining paragraphs of current Section 102, paragraphs (c)-(g), provide additional exclusions for the obtaining of a patent. Specifically, prior art is excluded if the invention was abandoned by the inventor; if prior application for a patent in a foreign country occurred more than 12 months before filing in the United States; if an application was published by another or granting of a patent to another was filed before the U.S. applicant’s invention date; if a noninventor filed for a patent; or if prior invention was established by another who did not abandon, suppress, or conceal the invention.

Prior Art Simplified

Under the AIA, the complicated application of current Section 102 is eliminated and the definition of prior art is simplified. The new key to whether an item is considered prior art is to determine whether it existed before the effective filing date of the claimed invention. Section 102 of the AIA recites in part:

A person shall be entitled to a patent unless—
(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention; or…

Simply stated, under the AIA prior art to a claimed invention is that which, before the effective filing of the claimed invention, was patented, described in a printed publication, in public use, on sale, or otherwise available to the public anywhere in the world. This single definition replaces Sections 102(a)-(d), (f), and (g) of the current law. Eliminated from the analysis are the separate considerations of whether the prior art predates the filing date of the claimed invention or a date one year prior to the filing date of the claimed invention.

Also eliminated from the analysis is consideration of the nature of the prior art. Patents, printed publications, public use, and on-sale activities are all treated similarly whether they occurred in the United States or in a foreign country. In other words, no geographic limitation would exclude or otherwise limit consideration of any form of prior art. Going forward, the removal of this geographic limitation vastly enlarges the scope of prior art that can be considered by an examiner weighing patentability and by an adversary investigating invalidity of a medical device patent.

Various Exceptions

A discussion of the AIA’s changes to Section 102 would be incomplete if it did not mention the existence of various exceptions under the new law. These exceptions are intended to grant to the inventor or owner of the claimed subject matter some relief from the application of the new Section 102.

Generally, such disclosures by the inventor or a joint inventor (or another who obtained the disclosed subject matter from the inventor or joint inventor) are not considered to be prior art against the claimed invention if they occur within one year of the effective filing date of the claimed invention. Under the AIA this exception continues the current law’s one-year grace period. This grace period will protect the inventor from third-party disclosures only if subject matter disclosed by a third party had already been publicly disclosed by the inventor or joint inventor. The rationale behind this exception is that, once begun, the one-year grace period being afforded to the inventor should not be limited or cut off as a result of the activities of a third party. A significant downside, however, is that such a disclosure by the inventor would prevent patenting of the subject matter in foreign countries in almost all cases.

Another exception, to which the one-year limitation does not apply, relates to disclosures appearing in other patents or patent applications. These disclosures will not be considered prior art if the disclosed subject matter was obtained from the inventor, previously disclosed by the inventor, or commonly owned. A claimed invention and disclosed subject matter will be considered as commonly owned if the claimed invention was made by and the disclosed subject matter was developed by or on behalf of at least one party to a joint research agreement. To avail oneself of this definition, the joint research agreement must have been created before the effective filing date of the claimed subject matter; the claimed invention must have been the result of activities under the joint research agreement; and the patent application for the claimed invention must disclose the names of the parties to the joint research agreement.

Notably absent from the list of exceptions is an express exception for experimental use. The courts had previously held that the experimental use is an exception to otherwise public use.1 New Section 102(1) includes identical language relating to “in public use” as is found in current Section 102(b). This favors an argument that prior case law relating to the experimental use exception should continue to apply under the AIA.

Note that Section 102 has been completely rewritten, not edited. However, the absence of express language in the AIA can be construed as intent to exclude an experimental use exception under the new law. It could further be argued that experimental use was intended to fall within, and therefore be excluded by, the new language of Section 102(a)(1) relating to a claimed invention being “otherwise available to the public.” This new language is not defined in the AIA, but is widely viewed as a catchall for establishing prior art.

As discussed above, the determination of what constitutes prior art has been simplified under the AIA and the new law fundamentally alters the patent filing scheme. When reform is conducted on such an extensive scale, trade-offs are expected, but the unintended consequences are sometimes harsh. As the AIA begins to take effect, one question is inevitable: Is the cure worse than the disease?

Reference

1. Clock Spring L.P. v. Wrapmaster Inc., 560 F.3d 1317, 1328 (Fed. Cir.2009).

Eric J. Sosenko is an attorney with Brinks Hofer Gilson & Lione (Chicago), an intellectual property law firm. He can be reached at [email protected] or 734/302-6038.
 

Tips for Improving Extrusion Efficiency and Preventing Problems

  • Adjust feed throat temperature. When processing polyolefins, the feed throat should be warm to the touch. It improves processing by enhancing solids conveying, and reduces energy by not displacing heat through the feed throat water discharge.
     
  • Maintain a consistent regrind form. Maintaining a consistent shape promotes bulk density, improves flow in the feed hopper, and a gives a consistent conveyance in the screw's feed section. All of these factors influence the screw's output stability.
     
  •  Cool screws when processing polymers to minimize degradation. This is important when using polymers that have a tendency to stick to the root of the screw in the feed section. The cooling bore should stop before the end of the section. Extending the bore beyond this point could cause the screw to become unstable. Use a full-length bore to process thermally sensitive materials like rigid PVC.
     
  • Return to: Proper Machine Selection + Setup = Success for Medical Extruders
  •  When starting an extruder with an empty screw, start turning the screw slowly and then introduce the resin by opening the feed throat slide gate. This gradual action allows the polymer to slowly work down the screw and melt, providing a lubricant between the screw flights and barrel. The lubrication prevents the possibility of damaging the screw flight hard surface and the barrel lining. Opening the slide gate after the screw is turning will help reduce the possibility of a melt block forming on the screw. 
     
  •  Use only treated water in your closed-loop, water-cooled barrel system (commonly found on larger sized extruders). Water that is high in minerals will foul the water passages in the system’s heater passage, heat exchanger, and other components. Adding glycol to the system can reduce its effectiveness to cool because the glycol changes the flash point of the water.
     
  •  Align extruder barrels as part of the maintenance procedure. Be sure an experienced firm does the alignment. This should be done every six months or once a year so you have a history of the condition of the equipment. It also needs to be done each time a barrel, feed throat, or gearbox is mounted to the extruder and when an extruder is being relocated. A properly performed barrel alignment reduces the risk these components failing.
     
  •  Choose a screw supplier with an extrusion lab where you can bring in trials. That allows extruders to customize and change screws more quickly especially when working with new materials.
     
  •  Have the capability to run a variety of resins and tubing sizes. Extruders may have multiple screw designs for one machine because there’s no such thing as a “one screw fits all” scenario.

Proper Machine Selection + Setup = Success for Medical Extruders

Proper Machine Selection + Setup = Success for Medical Extruders

The challenges of changing regulations, evolving material options, and tightening tolerances mean extruders must make sure they have the appropriate machines and control software for the job.

Single screw extruders make many types of critical medical tubing such as single and multi-lumen, bump, taper, multi-layer, PVS, dialysis, catheter and drug delivery.
This article looks at the main challenges confronting medical extruders, offering solutions that can help them overcome these issues while achieving maximum efficiency and, ultimately, developing better-quality, more reliable end products.
 
Cleanroom Considerations
Medical extruders face a stringent set of sterilization and process requirements that directly affect their equipment choices in a variety of ways. Medical products have to be produced in cleanroom environments, adding a level of complexity to production.
 
FDA’s quality system regulation (QSR) also has consistency requirements. Medical extrusion companies must consistently meet predetermined specifications in production. FDA also requires companies to establish and maintain procedures for monitoring and controlling process parameters.
 
Overcoming oil, dust, and other issues that can affect a production line poses the biggest issue in creating cleanrooms. It’s important to look for the following extruder features to maintain room cleanliness:
 
  • Stainless-steel barrel covers and feed hopper versus painted carbon steel can be more easily sanitized and won’t discolor and chip.
  • The use of direct coupled motor-gearboxes or gearless motor technology versus a belt drive, which can produce dust if the belts become misaligned or when they begin to wear.
  • Extruder designs that can easily be wiped down and the use of quality gear drive trains, which reduce the risk of oil leaks.
 These considerations apply to either of the two main types of extrusion machinery: single or twin screw.
 
Single-screw extruders are the industry workhorse, processing a variety of materials in many different applications. While it’s possible to produce medical tubing on almost any of these machines that have a small-diameter screw (generally 1.5” or smaller), some are much better suited for medical applications than others.
 
Twin-screw extruders are typically used in compound production, when two or more ingredients are mixed and extruded in order to produce a pellet. Twin-screw extruders are particularly useful in the production of rigid polyvinyl chloride (PVC) and wood fiber blends. Twin-screw extruders with corotating, intermeshing, and segmented screws are ideal machines for preparing polymer compounds with high percentages of fillers, reinforcing, fibers, or with particularly heat-sensitive or shear-sensitive additives.
 
While tubing is the most prominently extruded medical part, items such as surgical trays, blood bag parts and sheet for thermoformed containers are also created as a result of the plastics extrusion process.
Navigating Material Selection
Material selection is important to the success of any manufactured product. This is especially true of medical devices that require physical attributes such as antimicrobial properties, impact resistance, and extreme temperature capabilities. Medical extrusion companies must balance not only those qualities, but also increasing industry regulatory and public pressure toward eliminating phthalates—plastic additives that can enhance a material’s durability and flexibility, for example. PVC previously incorporated phthalates, but many material suppliers now are using chemistries that don’t use phthalates, but still achieve the same benefits. For example, PolyOne is developing with vinyl products that are both phthalate-free and flexible.
 
Material suppliers have developed unique chemistries that provide a wide range of physical and mechanical properties. Extruders looking to incorporate these materials must first consider the OEM’s requirements and the product’s end-user application in the work environment. Implementing the best-performing material early on is critical for medical devices because a change in material specifications often means going back to the beginning of a time-consuming, costly FDA approval process.
 
They also must anticipate and address processing problems associated with newer materials. For example, materials such as Pebax from Arkema can make it hard to maintain the precision needed for the small diameters, thin walls, and tight tolerances common to medical tubing and other products. Products such as dialysis tubing, blood tubing, and transfusion tubing need a tighter tolerance versus commercial air tubes. Proper tool and machine design that maximizes process control can help meet precision requirements and makes part production with these important medical resins easier.
 
Medical grade extrusion machines often feature medical-white paint, stainless steel construction, advanced control for system monitoring, management and reporting, high-speed precision capability and AC motors with encoders for precise control.
Focus on Tool and Machine Design
Medical extruders need a tool design that maximizes the process control. Because the right screw can improve precision at high speeds with minimal imperfections, screw design should be recognized as being about more than pumping plastic into an accumulator. A balanced screw design provides a quality melt in a stable fashion. Extruders need a full homogenous melt coming off the screw. Not having a properly set/balanced screw design could result in a lot of scrap.
 
To enhance precision in the system, machines need high-quality gearboxes that control the motor system and speed through encoders on ac motors. One of the current trends is toward servo motor drives, which are typically found on servo-hydraulic injection machines and robots, for example. Smaller machines created with servo drives in place of ac motors give more precise extrusion capabilities on smaller tubes.
 
Another trend is the use of a torque drive motor in place of a traditional ac motor. These motors offer increased energy efficiency and the elimination of the gearbox. There are factors that must be considered when using these motors on your extruder. The motors cost more than a traditional ac motor and drive system. Secondly they require cooling, so a properly treated water supply is necessary. A plus is the elimination of the gearbox, which increases the energy efficiency of the system typically by 10%.  Although the gearbox has been eliminated, there is still a trust bearing which is integral to the system. A common use for this technology is a cleanroom application because of the elimination gearbox and therefore the potential for oil leaks.
 
Adding a melt pump is another effective approach to achieving increased process control on a new or existing installation. Although extruder screws can efficiently melt, mix, and convey polymers, they can only achieve a certain level of precision. The output accuracy of an extruder is highly dependent on a number of factors, such as the viscosity of the plastic, the size and shape of the pellets, temperature control of the barrel zones, and a properly designed screw.
 
When extruding larger tubes, reaching the desired accuracy can be achieved by effectively controlling the prior mentioned process factors. However, with small-diameter tubing, the extruder coupled with a melt pump can greatly enhance the accuracy of the extrusion process.
 
That’s where melt pumps can help maintain tight tolerances with a variety of resins. The melt pump enables processors to build a consistent level of pressure and meter the polymer output, which dramatically increases both the precision of an extruder and overall production line flexibility.
 
The Brain of the Operation: Control Software
After the extruding process, the necessity for control software increases. The control software monitors and adjusts processes and downstream equipment to fully optimize the production process.
 
Downstream equipment usually consists of a vacuum sizing tank, a cooling tank, and various types of pulling, cutting, and collection equipment. To understand the process, let’s look at the extrusion process to form a medical tube.
 
The tube created in the extruder gets pulled through the vacuum tank that creates suction to form the tube and maintain its size. From there, it enters the cooling tank, and then into any auxiliary cutting or collection equipment. Usually, extruders use laser or ultrasonic measuring devices to monitor variances in wall thickness, diameter, and other dimensions. By integrating these measurement signals with the other equipment, the control system can adjust different parts of the operation, as necessary, to ensure specifications are being met.
 
To illustrate the potential for variances, consider a system that links its downstream equipment to an ultrasonic device in the vacuum tank that monitors wall thickness variations, and a laser that measures OD variations. By integrating signals coming from the different devices, the control software can detect if any measurements deviate toward the high or low end of the tolerance and adjust the process in real time. This process will ensure consistent, precise production and reduced waste.
 
Parting Advice
Beyond machine, material, and control considerations, medical extrusion companies should consider additional elements in the extruding process to improve operational efficiency and prevent problems (see "Tips for Improving Efficiency and Preventing Problems”).
 
Medical extrusion companies can keep up with changes in medical technology by following a simple recipe: mix the right machine, the right knowledge, and the correct application of the latest processing technology. The result will be the ability to meet today’s demands even when dealing with more challenging materials.
Mike Puhalla is the general manager of global extrusion at Milacron Plastics Technologies (Batavia, OH). He has 28 years’ experience in the plastics extrusion industry and has been with Milacron for 11 years. He has presented at ANTEC, the Society of the Plastics Industry’s technical event and TAPPI, the association for pulp, paper, packaging & converting industries. He is a past Society of Plastics Engineers Extrusion Division board member and has held technical management positions at New Castle Industries and various other extrusion processors over the years. Reach him at [email protected].