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The MX Q&A: David Parkinson, Nodality

During his years leading drug-development efforts at major biomed companies, David Parkinson says his frustration mounted as the industry couldn’t quite make the best use of its scientific advancements where it counted. What bothered Parkinson was that the methods for using the breakthroughs to benefit patients were more suitable for Louis Pasteur’s day than for medicine practiced in the first decade of the 21st Century.

“Our lack of productivity in the industry was not due to our inability to produce molecules,” says Parkinson, now the president and CEO of Nodality, a new South San Francisco–based manufacturer of predictive tests for treating cancer and autoimmune diseases. It was the inefficient therapeutic use of these molecules. “You can call it whatever you want—‘personalized medicine’—I don’t care what it’s called, but what we need to do is categorize patients better than what we currently do,” Parkinson says. “Currently, these classifications are based on anatomy; they’re based on pathologists looking through microscopes as they did in the mid-1800s. While that has had many uses and benefits, it is not useful for efficient, biologically targeted therapeutics.”

With the support of the academic community Parkinson now strongly believes that the biotech industry, and Nodality in particular, is poised to overcome that challenge. Nodality is on the verge of introducing its first commercial test for acute myeloid leukemia, and it expects to soon develop tests for myelodysplastic syndrome and chronic lymphocytic leukemia. Launched in 2006, the company aims to commercialize a proprietary technology called single-cell network profiling (SNCP) that it has licensed from Garry Nolan, a professor of genetics who developed the technique at his Stanford University lab. SNCP can be used to pinpoint disease biology for more effective patient treatment through highly predictive clinical tests, the company says. In addition, the technology’s use of functional biomarkers could reduce the time and expense of drug development.

Since receiving his M.D. degree from the University of Toronto in 1977, Parkinson has had a wide-ranging career in both the public and private sectors. He trained in internal medicine and hematology/oncology at McGill University in Montreal and at the New England Medical Center in Boston. Parkinson served as chief of the investigational drug branch and acting associate director of the cancer therapy evaluation program at the National Cancer Institute from 1990 to 1997. He is also past chairman of FDA’s biologic advisory committee and has held academic posts at the M.D. Anderson Cancer Center and the University of Texas.

Parkinson joined Nodality a little over four years ago from Biogen Idec, where he was senior vice president of oncology R&D. Before working at Biogen he served as vice president of oncology development at Amgen and vice president of global clinical oncology development at Novartis. When he was at Amgen and Novartis Parkinson was instrumental in the clinical development of Gleevec, Femara, and other cancer therapeutics. It’s perhaps understandable then why the Nodality executive describes himself as a “clinician by background[and a]drug developer by inclination for the past 12 years or so.”

MX caught up with Parkinson during the mid-January J.P. Morgan Healthcare Conference in San Francisco. In this in-depth conversation, the executive discusses deal-making developments at the conference, Nodality’s unique combination of diagnostics and therapeutics, the need for changes in reimbursement, the frustrating inefficiency of current medical practices, and why he’s sticking with the healthcare industry sector.

MX: What stood out for you at the J.P. Morgan Healthcare Conference? What was the mood there?

David Parkinson: This is my fourth year of attending the conference, and the mood is clearly more upbeat than last year, which was more upbeat than the year before. One hears of lots of deals being negotiated. It’s even more crowded with even more activity going on outside of the meeting venue. That’s always been the case, but it’s at least my sense that there’s a lot of activity around. That notwithstanding, people do discuss the difficulties of raising capital, particularly for small companies, and the challenges that Big Pharma is facing and that whole opportunity for small companies with pharma interface.
This is a deal-making meeting, and it’s quite clear that there are a lot of deals being discussed.

How about Nodality? What did your company get out of this meeting?

This is a year where we haven’t presented. It’s probably our breakout year in the sense that we’ll be producing our first predictive clinical test. We are establishing major collaborations with pharma companies in both autoimmunity and in oncology. Because we have a proprietary technology platform and this platform, which gives great insight into the biology of complex populations such as malignant cell populations or lymphocyte populations in the case of immunological assays, we are at once a technology platform company and an applications company.

Those applications fall into two categories. One is personalized medicine, [which is] our precision medicine category, where we are producing highly predictive tests to link patients with appropriate biologically targeted therapeutics. The second general category of applications relates to drug development, and our technology, which originally came out of Stanford University in the lab of Garry Nolan, is applicable all the way from discovery research through preclinical.

We’re very comfortable with our accomplishments in taking an academic technology and basically industrializing it for a regulated, clinical test environment and then in partnership with pharma and biotech companies assisting them in the risk-managed and more efficient development of new therapeutics.

We just moved to a new space, which doubles our laboratory space and gives us a room for these new collaborations. It’s a pretty exciting time for us….We’re very comfortable in what we’ve achieved in terms of our technology, in terms of our collaborations we’ve established with the academic community, and we’re just delighted with our new collaborations with business partners in pharma and biotech. We’ll be announcing those over the next little while.

This year?

Oh, absolutely.

So you had a good story to tell at this year’s conference.

Yes, we’ve done this in private meetings. We’ve met with potential pharma and biotech partners; we’ve met with interested investment groups. It is a nice story, actually.

How did the licensing process work with Prof. Nolan? That happened before you arrived.

It did. The company started five-plus years ago, Garry was one of the founders. I have been with the company a little over four years. My own background is in critical oncology and hematology but also in therapeutics development. And I’ve run drug-development programs and clinical trial programs in academic medicine and then for the National Cancer Institute. Then I was also, of course, head of global clinical oncology development at Novartis for years. I headed the oncology therapeutic area at Amgen, and then I headed up oncology R&D at Biogen before I came to Nodality.

We’ve got great investors. We’ve got Kleiner Perkins; we’ve got TPG Biotechnology and Maverick Capital, and then we have strategic investors. What we’ve built is a company that uses a diagnostics technology, a proprietary technology. We have six issued patents and over 30 patent families filed, a number of these could be allowed in the next several months.

What we’ve done is build a company with the tools of the diagnostic industry but that is very, very focused on the application of therapeutics. Most of us have come from therapeutics development backgrounds, and we use these tools because we also brought in test-development technology people and we’ve used this unique technology in ways to match patients efficiently with appropriate drugs for their conditions, whether that be malignancy or autoimmunity. We’re a little [different] with respect to the diagnostics industry because of our intense focus on therapeutics development.

Single-cell network profiling is a breakthrough technology, but is a breakthrough technology alone enough for a biotech or device company to be successful?

Having an important technology—even better, a proprietary important technology—distinguishes us from most other diagnostic companies. But having that technology is a necessary, but not sufficient condition, for success. You say to yourself, “Well, what are the other conditions that one needs for success?” Let’s divide that into two application areas, the first being the development of a commercially clinical test. Well, we have to understand the clinical context in which the test will be utilized, and in many respects our approach is parallel to what we do in the therapeutics development industry….  So we look at the clinical situation with acute myeloid leukemia and we say: “Where are the important clinical decisions made in this disease or any other disease?” Then what we do as a matter of strategy is form partnerships with academic institutions, investigators, and clinical trial groups, and we obtain our clinical samples only around those clinical decision points.

What we’re interested in doing is studying the biology around a situation in which a decision is made and action is taken—that is, giving a therapeutic—and an outcome is arrived at. You call those “clinically annotated samples,” and by studying samples that are informative in that respect we are able to determine the relationship between biology, giving a treatment, and therapeutic outcome. Then we turn that in a very formal, disciplined way—very much like a therapeutics company; we have project teams; we have deliverables, milestones. In terms of our test development we follow all current and expected FDA guidelines with respect to the development of highly predictive tests, the in vitro diagnostics area. We have a CLIA-certified lab, we have a GLP lab, [and] a GMP manufacturing lab for reagents that we use in our final diagnostic tests. In addition, we have a discovery research lab.

So, we have a very formal, disciplined process that works not just for company staff but with objective, external, third-party clinical trials groups. For example, our leukemia clinical trial has been reviewed not just internally but also by cooperative groups, and then also at the National Cancer Institute itself. We work to generate the highest level of evidence, because we believe that our highly predictive clinical tests will be driving clinical decisions about the use of therapeutics in cancer and in a few years in autoimmune disease, and therefore, we expect to be regulated. It’s appropriate to be regulated, because we’re determining the use of regulated drugs.

Behaving in this way—that is, under full regulatory guidelines—also makes us a perfect partner, given our technology, with pharma development companies because they need partners that can actually work to the kinds of standards that are expected in the development of new therapeutics.

You describe a high level of detail in developing the technology. Is that how Nodality distinguishes itself from its competitors?

I think it distinguishes us from the traditional diagnostics industry. But in fact it’s a necessary evolution of specialty diagnostic companies that are really utilizing the new biotechnologies in ways that allow for highly predictive and sometimes prognostic diagnostic tests. When your tests become increasingly important in clinical decision-making, that’s a situation where FDA has said, “Okay, we’re with you. We believe in you, and therefore we’re going to regulate you and not leave this any longer to the practice of laboratory developed tests.” It seems to me that it’s a natural evolution of the level of sophistication of the diagnostics industry in the sense that as the clinical tests become more important in clinical medicine that they should expect to be regulated.

Now the challenge that the entire new  molecular diagnostics industry is facing is that—while the regulators have understood the importance of this new technology and while increasingly you see the public [supporting] the concepts of personalized…medicine, [and]the broader medical community and certainly advocacy groups understand the importance of this new genomic technology— the state of reimbursement of clinical tests, as driven largely by Medicare policy, is actually to pay for time and materials and not to recognize the kinds of high levels of clinical evidence, or “clinical validity” in the diagnostics world. That’s not recognized currently with respect to reimbursement of tests.

Presumably, this will all evolve. But until it does, this is a huge challenge for the business model of clinical test development companies. Hence, a company like ours that has the advantage of a proprietary technological platform can utilize that in partnership with biotech and pharma companies in parallel. Our success as a company is not dependent on an early generation of revenue from clinical tests. Because if it were, we’d be in trouble.

How long will it take before this reimbursement challenge starts to evolve to where it’s more favorable for diagnostic companies?

It’s hard to call, but we’re starting to see groups [move in that direction]. For example, Palmetto, which is the Blue Cross/Blue Shield provider in California and a number of other states, has released guidelines about what they expect to see in these kinds of clinical tests before they will reimburse. And in fact they just approved for reimbursement—and this was just announced publicly, I think, yesterday—a test for thyroid cancer diagnosis introduced by one of our sister companies, Veracyte. This will happen sort of one at a time. What would certainly accelerate the development of the molecular diagnostics industry would be policy change from Medicare. I know that there are groups for policy change in Washington, but that’s not going to occur quickly and unlikely to move forward in an election year.

We can’t leave ourselves in a situation where our future as a company is at the risk of unknown timelines or policy changes to reimbursement. What we can do, though, is continue in parallel with the academic community our development of these highly predictive tests, because one of the best drivers to get change is to actually show that you can develop these tests. They can be incredibly useful in improving patient care at the same time as potentially making much more efficient and rational the use of therapeutics in patients with cancer and autoimmune diseases. Those are the kinds of perspectives I bring to this field. That’s why I’m actually doing this.

You know, I’m a clinician by background; I’m a drug developer by inclination for the last 12 years or so. I became frustrated while leading large, international and global drug-development groups for the industry that…our lack of productivity was not due to our inability to produce molecules. Industry is very, very good at producing molecules, which are able to do what they’re supposed to do biologically. The inefficiencies and the risks and the failures are the inability to position the patient populations appropriate to the use of these therapeutics. You can call it whatever you want—“personalized medicine.” I don’t care what it’s called, but what we need to do is categorize patients better than what we currently do. Currently, these classifications are based on anatomy; they’re based on pathologists looking through microscopes as they did in the mid-1800s. While that has had many uses and benefits, it is not useful for efficient, biologically targeted therapeutics.

In the area of cancer prevention and cure you’ve worked in both the public sector at the National Cancer Institute and the private sector. What are the benefits and drawbacks of each, and what can the two learn from each other in order to move forward in helping patients?

Those are really great questions, and I speak with a strong bias for the oncology community, where frankly there’s been the greatest parallel public and private development. When I was first involved in cancer drug development, there were relatively few companies actually in the field, and most of the agents came out of large-company programs that seemed like they might have applications for oncology. But the companies didn’t have a lot of expertise, and frankly they didn’t have a lot of strategic intent, because it wasn’t a paid therapeutic area in terms of revenue. In the absence of a large industry presence, the National Cancer Institute had a several-decades history of really running its own drug-development program.

As you say, I had a lot of experience with the public program, and I consider it to be a perfect complement to what goes on in the industry world. Over the last 20 years what’s happened is that in the industry…really highly talented individuals see the industry as a perfectly acceptable therapeutic and professional career. In fact, [there’s] back-and-forth between academia and industry. I’ve had many opportunities to go back and forth as I wanted to. In general, I would say that the strengths of the industry are the resources, the organizational infrastructure, the ability to focus on getting something to a point where it makes a difference in terms of…getting a drug registered and therefore out of the investigational venue and into actual clinical medicine so that the drug’s available in every pharmacy.

For example, it’s very gratifying to be able to work on Gleevec, because there we took an idea that came from academic biomedical research—basic research going back decades—and we used the powers of the pharmaceutical industry’s…technology to identify the appropriate patient population [and] come up with an agent that was specific for the target associated with this particular population of leukemic patients. Then in about 3½ years using the entire power of this global company, we were able to change the natural history of chronic myeloid leukemia. That’s the power of the industry.

Meanwhile, part of the reason we were successful was the fact that all around the world, supported by public dollars, there were academic clinical trial groups whose raison d’être was basically to do clinical trials of new therapeutics in chronic myelogenous leukemia. So we partnered with them, and that helped drive the process to the benefit of people with CML. Although the company ran the global drug development program entirely, it partnered with clinical trial groups that were partly funded by public funds around the globe. There are many examples. Even in my current position, I continue to interact with and support activities at the National Cancer Institute, just because I believe so strongly in the importance of the public clinical trials. Along the way, I have also interacted with other public entities, including FDA, where I chaired advisory committees and sat on other science boards, just because what we’re doing is so complicated that although the industry brings particular resources and technical strengths you need the academic community because they are the source of new biological information and they are also the group taking care of these patients. Then you also need to engage government, scientific, and regulatory individuals, because they’re part of the ecosystem, too. And it works best when everybody is pulling together, and then ultimately it goes to the regulators. They are the arbitrators, but I’ll tell you it’s much easier for them to arbitrate when the entire community has been engaged [together] to get it right.

Touching on some of the comments you just made, I know that Nodality is a member of the California Healthcare Institute. In a CHI survey released in January biomedical company CEOs say that access to capital, burdensome regulations, and a lack of R&D innovation are big threats to industry growth over the next five years. That sounds kind of dire. Do you have any thoughts on these issues?

First of all, I’m part of that survey—just full disclosure. We are members; they’re must be hundreds of CEOs. They’re right. I touched on the reimbursement hurdles. I also indicated that while I think it’s appropriate that FDA regulate highly predictive tests, the fact that FDA is now regulating these tests and higher levels of evidence are being required means that the amount of resources and the time to actually develop and commercialize these tests have now increased dramatically. That is a huge challenge to the models of financing these start-up molecular diagnostic companies.

How much of an increase are we talking about?

If you developed a clinical test, and you were able to develop this test in a single lab and establish its analytic validity, you could commercialize it if you published a paper or two. That was all you had to do. And now—and I’m indicating I think it’s appropriate—FDA has said, “I’m sorry. These tests are so important in the practice of medicine that we intend to regulate them, because frankly they’re driving the use of the drugs we already regulate.” What that means is that a lot of diagnostic companies now have to acquire the skill sets to develop these levels of evidence. That’s actually not trivial.

When you said, listen, Nodality sounds like it’s a lot more complicated and maybe differentiated from many of the other kinds of diagnostic companies historically, well, you’re absolutely correct. But historically the industry was not required to develop these levels of evidence. Furthermore, they were not rewarded for doing so. The role of the diagnostics industry was basically to develop the tests, and then it was the role of the academic community to develop the evidence around the meaning of the test. But, you know, those tests didn’t utilize the kinds of sophisticated technologies now being utilized.

We’re now in a transition state. The technologies are more powerful. The potential for developing much more important clinical tests is present. The regulators have said they agree, and therefore you need to increase the levels of evidence. The cost, the time, the resources, and, frankly, the risks have increased before you can even commercialize a test and start to get revenue. And yet when you get to the other end you don’t have the easy recognition of the value of the test, and therefore there isn’t a reward system.

What does that mean? That gets back to what those biotech executives said in the survey, and I would have said exactly the same thing: Listen, the hurdles are great, the business models are challenging, the investment community is skittish because they haven’t seen a lot of commercially successful molecular diagnostics companies emerge. Everybody believes in the potential, but everybody also recognizes the hurdles.

So this is where policy change that could help minimize the hurdles ultimately will lead to the utilization of these tests, which to my mind is absolutely necessary if we are to move to a more efficient practice of medicine. Right now, the practice of medicine is quite inefficient. The ability to match a patient with appropriate therapeutics, get the right dose of that therapeutic, know whether the therapeutic’s making a difference, know when it stops making a difference, know how it should be used in combinations—it’s all really quite limited and the potential of these new technologies is to change all that. You know this euphemism “right patient, right drug, right time”? It sounds like a marketing thing, but when you think about, it’s what you would want for yourself.

Pfizer Ventures and other investors provided Nodality $15.5 in March 2010. According to a December 2011 article in EETimes, the CEO of a medical design company said that VC funding has dried up over the past few years. You were saying at the top of our conversation that you see some positive signs at the J.P. Morgan conference this year and last year. This executive also says the regulatory climate is forcing companies to go Europe, and I’ve heard that from other CEOs I’ve interviewed. How is Nodality faring in regard to these issues?

First, the movement of companies to Europe, as I understand it—and I have some insight into this—is largely about device-related companies and the CE mark. I understand that’s a phenomenon, and I know from personal experience because I’ve been involved in conversations that it’s a major concern to the [Obama] Administration. So they’re talking about ways of trying to help.

When I said there was a lot of deal-making going on at J.P. Morgan, what I don’t know is who’s making those deals. The issue is where are the sources of capital? You know better than I do about relative sources of capital from the venture world versus investment by pharma and large biotech. Those are the kinds of deals that I hear about and those are the larger deals. Sometimes it’s the venture groups around the pharma companies, but increasingly we’re seeing partnerships, mergers, and acquisitions of assets by pharma companies.

Now we’re just starting to see the kinds of things that we’ve been working on, which are major strategic collaborations between pharma and diagnostic companies with technologies that can give them a competitive advantage in their drug development. That’s our focus. We believe our technology can do that, and I suspect that as pharma begins to understand that the problem in productivity of drug development is not just the lack of molecules [but] a lack of insight into how to efficiently risk-manage and develop these molecules and that there are actually solutions to managing that risk and accelerating time, we’re going to see a lot more strategic collaboration between pharma and companies like ours.

Is Nodality itself an acquisition target down the line?

All I know is what I need to do. Our first challenge was to develop the technology and industrialize it. It was a great academic technology, but we needed to make it something that [could be regulated] and we’ve done that. The next thing we needed to do was to prove that it could actually develop predictive clinical tests of unprecedented accuracy; we’ve done that. And the next thing we need to do is to show examples and convince pharma partners that we could get them a leg up in terms of their drug development, and we’re absolutely doing that.

The interesting thing about us is that we are both a technology platform and an applications play. And we work right at the interface of diagnostics and therapeutics. It confuses people, and I say, “Look at our model,” because we represent the future of therapeutics and diagnostics development. I’m very proud of the way we are organized. What does that mean in terms of our future? Ach, I don’t know. I can’t predict; all I can do is execute.

Will the change to first-to-file in the new U.S. patent law have any effect on Nodality or Stanford IP going forward?

I don’t believe so. We’re a small company, and we file pretty quickly on our inventions because we have an in-house IP attorney. Our general counsel is an IP attorney. That was part of my own strategy, because we are an invention machine, an innovation machine. So it doesn’t really change things very much from our perspective.

On a positive note a recent story in the L.A. Times Business section detailed how different market sectors performed in 2011, and the healthcare segment came in third in the S&P 500’s index for the year. In a macroeconomic sense I’d take that as good news for medtech, wouldn’t you?

What were the first two? I’m curious. Maybe I’ll switch industries.

The first sector was utilities, and the second was consumer staples. Utilities funds performed 14.8% better than they did in 2010, consumer goods were up 10.5%, and healthcare funds rose 10.2%.

Well, I don’t know anything about utilities or consumer staples, so I’d better stick with what I’m doing, I guess. (Laughs.)

Indiana Medical Device Industry Generates $10 Billion Annually, Report Finds

Employing more than 20,000 people and generating more than $10 billion of annual economic output, the medical device industry in Indiana is one of the state's most valuable economic assets, according to a new report from BioCrossroads (Indianapolis). The first report of its kind, "From Hearts to Hips: Indiana's Leadership in Medical Devices," was compiled by FaegreBD Consulting and BioCrossroads to highlight the sector and identify upcoming challenges.

With the fifth largest percentage of medical technology employees in the United States, Indiana's medical device sector accounts for more than 40% of the jobs in the state's life sciences industry. In 2010, the state's medical device companies manufactured more than $2 billion worth of exports, or approximately $100,000 per employee. The average employee earns $60,000 annually, more than 56% higher than the state's average private sector worker.

"From small towns to larger cities, the economic impact of the medical devices industry is significant and is well-distributed throughout the state," notes David Johnson, president and CEO of BioCrossroads. According to the report, the geographic diversity of the sector ranges from Warsaw and Indianapolis to Bloomington, Spencer, and West Lafayette.

In addition to its relative size, Indiana's medical device sector is highly diversified, offering a spectrum of products used throughout the world. Major companies such as Biomet, Boston Scientific, Cook Medical, DePuy, Medtronic, Roche Diagnostics, and Zimmer are either headquartered or maintain major operations in the state and develop a variety of medical products, from cardiovascular and urological to diagnostic and orthopedic devices.

"This report is proof that Indiana's medical devices sector is robust and resides on a solid foundation that positions us well for future growth," Johnson remarks. "There are still many external factors like the economic, regulatory, and healthcare reform environment that pose real challenges for this industry."

In addition to the current economic conditions, which have lowered the demand for some medical devices, the industry faces even bigger challenges in the next decade, including a rapidly changing health care market, tax policies that discourage innovation, increasing regulatory uncertainty, a shift to overseas production and expansion to overseas markets, technological changes requiring that workers receive more education, and an increasingly competitive global market.

"Indiana's medical device industry is a cornerstone to the state's life sciences sector and the state's economy overall," says Dave Zook, chair of FaegreBD Consulting. "There are several looming challenges that, if unaddressed, will significantly weaken the industry and the state's economy."

To read more about the state's crucial orthopedic device sector, check out "Indiana's Medical Device Mecca Has Good Bones."

MD&M West: The Details

In February, medical device industry professionals will gather in Anaheim, CA, for the 2012 Medical Design & Manufacturing (MD&M) West trade show event. Featuring an exposition and conference, MD&M West brings together medical device manufacturers, suppliers, and industry experts for three days of networking and education at the Anaheim Convention Center. 

The two-day expo will feature qualified suppliers showcasing all the products and services OEMs need to develop innovative medical devices. Attendees can browse exhibits featuring everything from materials to components to design services. As an added bonus, an MD&M badge also gets attendees access to eight other colocated events: Electronics West, West Pack, Pacific Design & Manufacturing, Automation Technology Expo West, Sensor Tec, PlasTec West, AeroCon, and Sustainability in Manufacturing.

This year’s conference features five tracks covering topics including regulatory affairs, quality assurance, design, and testing. Expert instructors ensure that attendees leave with practical knowledge they can apply on the job.

For More Information:
UBM Canon
Tel: 310/445-4200
E-mail: [email protected]
Web: www.mdmwest.com
 

—Jamie Hartford

All Your Product Design and Life Cycle Management Questions Answered

The medical device industry is a complex business with a lot of ins and outs. As such, sessions at many industry conferences focus on specific applications, often sending attendees home with unanswered questions and without a sense of the bigger picture. That’s precisely what W. Heath Rushing, cofounder and principal consultant at analytics-focused consulting firm Adsurgo, wants to avoid in his MD&M West session on design control principles.

Rushing

“In two days we’re going to cover all the hard questions that need to be answered from the time you design a medical device to the time it’s actually out on the market,” says Rushing, who holds a masters degree in operations research from the Air Force Institute of Technology and is a Six Sigma Black Belt in biopharmaceutical manufacturing and R&D. “You won’t need to attend five conferences to get the entire picture.”

Wednesday’s session will focus on applying product design tools. The day’s presentations cover design for manufacturing tools, medical product design methods, prototyping tools, and designing for the direct metal laser sintering process.

On Thursday, the track shifts to product life cycle management. Speakers will touch on systems engineering and requirements management, design verification and validation, process design for outsourcing and technology management, and process transfer.

“If you look at the different speakers, we have everyone from consultants to people in regulatory and quality affairs,” Rushing says. “You have everyone from product and process engineers to a vice president of a medical device company to system designers.”

Rushing says his track should be especially beneficial for product managers, systems engineers, process engineers, and those working in quality assurance and regulatory affairs.

“Each morning is going to start off with a talk that’s really going to set the tone for the rest of the day,” Rushing says. “What you’re going to get are great ideas about how to integrate this into your particular product life cycle. You’ll leave with ideas you can actually implement immediately.”

The sessions Rushing chairs, “301: Applying Product Design Tools” and “401: Product Life Cycle Management,” take place Wednesday, February 15, and Thursday, February 16. On Tuesday, February 14, he instructs “201: Integrating Design Control Principles into Process Validation.” All sessions run from 9 a.m. to 4 p.m. with a one-hour lunch break.

Jamie Hartford

Keeping the Focus on the Problem

In December, 2011, I had a conversation with medtech pioneer Mir Imran, who explained the importance of thoroughly studying a problem in the process of innovation.

Over on MedSider, Arlen Meyers, MD, who is president and CEO of Society of Physician Entrepreneurs, echoes that advice, recommending that entrepreneurs become "problem seekers" instead of "problem solvers."

In that interview, Meyers also explains that “no one knows the [medical device] market better than the doctors.”

It is certainly true that doctors have an advantage here. For instance, one area that physician inventors are noticing is the obesity epidemic is creating the need for new kinds of medical devices that can accommodate patients who are overweight. For instance, surgical tools may simply not be long enough to reach inside such a patient. Noticing this unmet need is easy for the surgeon who is on the front lines—actually operating on patients.

Imran points out that disruptive innovation, however, is rare among physician inventors because it demands a rigorous questioning of how medicine is taught and practiced. That can be tough to do when in a physician's daily practice. What is more likely is that a physician entrepreneur comes up with an incremental innovation; he or she looks at a area of his or practice and identify the pain points where surrounding a device or procedure. “And by that observation, [physicians] can come up with a list of improvements that you can make,” Imran says.

Brian Buntz
 

Incremental vs. Disruptive: A Parallel Entrepreneur on What Innovation Really Is

Incremental vs. Disruptive: A Parallel Entrepreneur on What Innovation Really Is

The Way to Look at It

Mir Imran, who helped develop the first FDA-approved automatic implantable cardioverter defibrillator, has founded more than 20 life sciences companies.

Through his experience as an entrepreneur and investor, Imran has learned about innovation from the inside out. He offers the following definition:

“Innovation is the process of defining the problem and understanding the problem—not solving it,” Imran says. “The solution comes later. Understanding the problem is at the heart of it.”

He explains: “You pick something and you say ‘this is what I know about it,’ ‘this is what I don’t know about it.’ ‘And the things I don’t know, I’m going to find more about,’” he recommends. “As you peel the layers of that problem, after a while—if you are lucky, and if you have the background to really understand and tackle it—you will have understood it in its entirety,” Imran explains. “Or you will have gotten as close to understanding it as you can come. And then the solution will emerge from that understanding.”

Instead of sitting back and attempting to solve the problem, the problem solves itself. “You are just the agent of understanding and opening up the issues. And as your understanding deepens, the solution becomes obvious,” he says. Once the problem is thoroughly understood, it is also possible to end up with a set of solutions.

A Path Seldom Followed

Most innovators and entrepreneurs don’t follow this approach, Imran notes. “Instead, they fall in love with their technology,” he says. “For instance, a mechanical engineer who works with catheters looks at the whole world through the lens of a catheter,” he adds. And consequently, such an engineer will be tempted to solve problems with that tool.

“That’s a classic example of a solution looking for a problem to solve.”

Another example of this can be found in nanotechnology, where researchers commonly announce that they have made a breakthrough that will enable the solution of a number of problems. “That’s a classic example of a solution looking for a problem to solve,” Imran explains. As a result of that approach, there is usually not a good fit between the proposed solution and the targeted problem. “Occasionally, you might get lucky, but that’s randomness. That’s not deliberate innovation.”

Nevertheless, this approach is common. “I grew up as a scientist and a technologist, and I’ve seen it in myself and in every engineer I’ve worked with,” Imran says. “To most engineers, innovation is about technology and applying whatever they have learned,” he adds.

And, as it turns out, medical device engineers often lack a multidisciplinary scientific background, which can prove crucial in addressing many clinical problems. “They often look at an issue through the lens of a single discipline,” Imran says. “As a result of that, they are only going to see a small portion of the problem.”

Understanding a problem completely, or as well as reasonably possible, is a process that can take months or years—even decades. “And many times, you may not be able to understand it even though you try to; it may not yield to you,” Imran says. When that happens, you might lack the necessary background. Or the question might not be framed correctly.

Incremental Innovation

At the MD&M West event held in February 2013 in Anaheim, Imran will participate in a panel discussion with MD+DI's 2012 Manufacturers of the Year on February 12. The following day, he will host a roundtable discussion with entrepreneurs. 

The process for incremental innovation is slightly different than for disruptive innovation. “Incremental innovation is much more bounded,” Imran says. Basically, an inventor has a widget and wants to improve it. To do that, she observes how the widget is used and the environment it is used in. “And she identifies the areas of friction where the user has difficulty with the widget or the widget requires too much time to do something with,” Imran says. “And by that observation, the engineer or scientist can come up with a list of improvements to make.”

Incremental innovation isn’t limited to tangible devices. An inventor can observe a procedure and attempt to come up with a better way of doing the same thing.

This approach is common among physician innovators. “They are dealing with certain tools, processes, and things, and they say: 'I wish [this device] was longer or shorter,' 'I want to reach that part of the organ,' or 'I need a curvature like this,’” Imran explains. Physician inventors often come up with new ideas for products they use: surgical instruments, a procedure, tools, and so forth.

Disruptive Innovation

When you start thinking about disruptive innovation, the process gets more complex, Imran says. And as a result, this form of innovation requires questioning the very fundamentals of the problem. “So you have to sort of step back and really question everything—the foundation of where the problem rests.”

This approach requires asking basic questions such as:

  • Why are we treating chronic pain the way we are?
  • Why are we treating atrial fibrillation the way we are?
  • What are the long term outcomes?
  • Does it make sense to do it this way?

Disruptive innovation is not common among most physician innovators, who are locked into a given perspective. They might consider what they have been taught in medical school or how they practice medicine and seek to optimize it. They are not trained to question whether the way they are, for instance, diagnosing or treating patients is the best possible option. Doctors rarely take on their own understanding of a problem head on—questioning the textbooks and teachers who taught them how to practice medicine.

“Each interaction gives you insights.”

But disruptive innovation requires an approach like that. It starts by identifying clinical problems that lack a good solution. Then, start defining the issues and the process of digging into them. Ask, for instance, what kind of patient does this condition affect? Why does the condition manifest this way? What is happening at the cellular level?

You can learn a great deal about a problem by watching its interaction with current therapies—even though they might be inadequate, Imran says. “Each interaction gives you insights.” Even failures can be useful because they give you information about the problem.

Control Issues: Next-Gen Pill Cameras Focus on Maneuverability

As it turns out, the concept of capsule endoscopy has been relatively easy for physicians and patients alike to digest. In fact, the innovative pill camera technology, pioneered by Given Imaging in 2001, has proven to be a less-invasive and effective means of visualizing and diagnosing conditions or problems in the small intestine. But while the underlying diagnostic technology offers indisputable advantages, the gut feeling of healthcare providers is that these patient-friendly devices should offer some semblance of control or maneuverability to optimize patient care.

digestive issuesEndeavoring to address this market need, researchers at Brigham and Women's Hospital (BWH) recently announced that they have developed an endoscopic capsule that provides clinicians with the ability to control the movement of the pill inside the body using an MRI machine. Like the pill cameras currently on the market, the researchers' version is ingested and captures a multitude of images as it travels through the digestive tract. Images are transmitted wirelessly and examined by trained gastroenterologists.

In contrast to existing capsules, however, the BWH team's pill camera can exercise control over the contents being photographed, and can steer the pill toward areas of interest or concern for better diagnoses. Current pill cameras simply move through the body at random. "Our goal is to develop this capsule so that it could be used to deliver images in real time, and allow clinicians to make a diagnosis during a single procedure with little discomfort or risk to the patient," says Noby Hata, a researcher in the hospital's department of radiology and leader of the development team for the endoscopic capsule. "Ideally, in the future, we would be able to utilize this technology to deliver drugs or other treatments, such as laser surgery, directly to tumors or injuries within the digestive tract."

Like BWH, a team of German researchers made strides in the area of capsule endoscopy last year when it demonstrated the feasibility of guiding a modified capsule endoscope through the stomach of healthy patients using magnetic materials. Conventional capsule endoscopies are suited for diagnosis of conditions or problems in the small intestine, yielding variable image results for areas such as the stomach. However, studies have indicated that gastric cancer screening could reduce mortality rates, and capsule endoscopies could offer a patient-friendly alternative to upper endoscopy procedures.

"To address the problems with a conventional capsule endoscope in visualizing the stomach, a new tool for maneuvering the capsule using an external handheld magnet was developed, allowing targeted investigation of all regions of the stomach," says study lead author Junta Keller of the department of internal medicine at the University of Hamburg. "The aim of our study was to evaluate the safety and feasibility of the magnetic maneuvering of a capsule endoscope in a human stomach. We found that the magnetic maneuvering of the capsule was safe and very well-tolerated, with excellent responsiveness of the capsule to movements of the outer magnet so that detailed visualization of the gastric mucosa could be achieved." The researchers employed a handheld external magnet for the experiment.

Such controllable spins on the conventional pill camera demonstrate promising innovation and a distinct trend in next-generation capsule endoscopy device designs. As a result, these controllable device designs will likely facilitate earlier and more-accurate diagnoses of digestive tract complications or conditions. And these promises represent a concept that is pretty easy to swallow. --Shana Leonard


 

Ford Expands Efforts to Develop Doctors Offices on Wheels

Last year, our colleagues at Medical Electronic Design and Medical Device and Diagnostic Industry reported that Ford Motor Co. would be partnering with Medtronic to integrate medical devices into its cars. The automobile manufacturer's goal was to develop smartphone-like apps that could be integrated into the display panel in modern vehicles. Such applications would incorporate Bluetooth synchronizers for blood glucose meters and provide health-related data, such as pollen count and air quality.

That was then. Now, Ford is going even further, allying with Microsoft, Healthrageous, and BlueMetal Architects to make its cars even more like virtual doctors offices. While BlueMetal Architects designs a prototype system for extending health management into the vehicle in a nonintrusive fashion, Healthrageous hopes to advise drivers--based on such health information as blood pressure, fitness activity, and glucose levels--how to live healthier lives. It is worth noting in passing, however, that driving on America's highways and streets is often not conducive to lowering blood pressure. As for Microsoft, its technology translates robotic sensory information provided by the vehicle into a voice- and touch-activated interface to control the user experience. Also part of the system, its HealthVault will be used to process much of the data and provide the driver with useful graphical reports.

Obviously, the move to turn cars into patient monitoring stations should provide food for thought to designers and manufacturers of medical devices about how they can provide the enabling technologies--such as sensors and graphical user interfaces--to develop and expand doctors offices on wheels.

To get a better idea of what Ford and its partners have in mind, see the video below. --Bob Michaels

Novel Microtweezers Expand MEMS Possibilities

Microtweezers developed by researchers at Purdue University (Lafayette, IN) may facilitate the manufacture and assembly of microelectromechanical systems (MEMS). Capable of manipulating tiny structures, the microtweezers could contribute to the development of advanced sensors and may someday be suitable for working with live stem cell spheres in research settings as well.

Purdue microtweezers for MEMS
Purdue microtweezers can be used to assemble tiny polystyrene spheres, each with a diameter of 40 micrometers, at left, into 3-D shapes. The device also might be used to weigh tiny particles by placing them onto the tip of a structure called a microcantilever, at right. Photo: Birck Nanotechnology Center

Potentially broadening the scope of MEMS devices, the microtweezers allow users to assemble components in a manner comparable to building with Legos, according to Cagri Savran, an associate professor of mechanical engineering at Purdue. "We've shown how this might be accomplished easily using new compact and user-friendly microtweezers to assemble polystyrene spheres into three-dimensional shapes," he says.

Consisting of a standard micrometer, a two-pronged silicon tweezer, and a graphite interface, the tool does not require electrical power sources nor does it feature hinges or components that operate via thermal, magnetic, or electric influences, according to the researchers. Instead, the Purdue researchers' compact, portable microtweezers feature a single, springy compliant structure. As a result, the researchers note, their design is simpler and less expensive to manufacture than other microtweezers.

The new design could allow for precise isolation of individual stem cell spheres and subsequent positioning of the particles, Savran notes. "We currently are working to weigh single microparticles, individually selected among many others, which is important because precise measurements of an object's mass reveal key traits, making it possible to identify composition and other characteristics," he says. "This will now be as easy as selecting and weighing a single melon out of many melons in a supermarket."

In addition, the microtweezers, if commercialized, could be employed in the printing of chemical or protein dots onto microcantilevers. By creating a functionalized surface on these components, the researchers believe that the enhanced microcantilevers could enable development of advanced sensing technologies. Resulting technologies could potentially detect several substances simultaneously and require smaller sample sizes than conventional diagnostic methods.

Which Republican Presidential Hopefuls are Getting the Most MedTech Money?

For better or worse, money plays a huge role in politics. The candidates atop the polls are often the ones with the deepest pockets. Before a single ballot is punched, individuals and companies begin pumping cash to their favorite candidates. I took a look at the flow of medtech campaign contributions to see which candidates the industry is supporting in the race to become this year's Republican presidential candidate.

So far, the frontrunner is far and away Mitt Romney. As of December 5, 2011, the former Massachusetts governor had received $171,750 in contributions from the pharmaceuticals and health products industry (which includes medical device companies), according to OpenSecrets.org, a Web site that tracks money in politics. That's more than a quarter of all the contributions the industry has thrown at the 2012 election so far and more than the next six Republican primary candidates combined. 

In a distant second place in the medtech money race is former Texas governor Rick Perry, who has raised $55,750 from industry donors. Michelle Bachman and Tim Pawlenty—candidates affiliated with the state of Minnesota, where medtech is big business—follow at third and fourth place respectively, though both have suspended their campaigns.

The other candidates still competing with Romney for the GOP nomination haven't seen a lot of financial love from medtech. Texas Congressman Ron Paul has received just over $18,000 in contributions from the industry, while Rick Santorum, a former U.S. senator from Pennsylvania, and former House Speaker Newt Gingerich haven't even hit the $15,000 mark.

But while Romney appears to be medtech's preferred candidate in the Republican primary, he's still trailing President Obama by almost $100,000 in contributions from the industry. Overall, though, the pharmaceuticals and health products industry has given more money to Republicans in the 2012 presidential race (57%, as opposed to 44% given to Democrats).

Jamie Hartford