Biomedical Business & Technology Executive Editor

Pamela McNamara is president of the U.S. business of Cambridge Consultants (Cambridge, UK/Cambridge, Massachusetts). She joined the company earlier this year and is leading its work in high-technology product and systems development for clients in the med-tech, wireless, defense and clean-tech sectors.

Prior to joining Cambridge Consultants, McNamara was CEO of CRF (Lansdale, Pennsylvania), a leading electronic patient-reported outcomes (e-PRO, or e-diary) technology company providing global wireless data collection solutions for the life sciences industry.

Prior to that, she was with the Arthur D. Little consulting firm for more than 20 years, holding a number of senior technology and management positions in the company's Global Health Care group, and eventually serving as CEO of the entire organization. Cambridge Consultants formerly was a subsidiary of ADL when McNamara was CEO of the company.

BB&T: The announcement of your appointment as CEO of the U.S. unit of Cambridge Consultants included a comment by you that the U.S. operation "has seen significant growth over the past 18 months in its core markets of medical diagnostics, drug delivery and surgical devices." Could you talk about those markets and what you'll do to continue your growth within them?

McNamara:What we've seen significant growth in over the past 18 months in our U.S. business has been drug delivery. That is a very significant area for us; we've had a lot of history in that area and have a lot of intellectual property, as well as work with customers to develop intellectual property for them in a variety of drug delivery technologies – injection systems, inhalers and the like. What we are seeing is opportunities for products, whether they are new products, new drugs that are coming through pipelines, or in some cases, drugs that have already been out in the market, but where companies now are looking for new, patient-friendly ways of administration.

The solutions we've been working on have typically involved understanding the drug compound and formulation itself, and we have then added from the aspect of those delivery technologies, bringing to bear how to make them the right size, scalable from a production standpoint, bring them to market rapidly, do prototyping, do clinical trials, to bring them forward into the marketplace in a top-quality, but rapid way.

The surgical device area also has been active. We have a lot of history that we're now applying in that area, in antennas and wireless technologies. Being able to implant those antennas, as an example. So that's an area where we're seeing some good growth.

We also see more growth in front of us in diagnostics. There is maybe a bit of a bridge to the patient as consumer – more consumer diagnostic products, with a similar theme of how do we bring these new innovations or new technologies rapidly? How do we take the different components required to make them work – develop them, scale them, prototype them, bring them out? That's the constant theme of the kinds of programs we've been involved in, and we see that that activity area is going to continue its growth.

BB&T: The whole area of combination products – coatings and other things – is very interesting as well. It's not yet at a point of booming, but it's getting to the point where it's going to. There was a real barrier in that area, because the FDA didn't seem to know how to treat them. The agency looks like it now has its act together about combo products.

McNamara: I think you're right. And they're doing that just at the right time, because there is an awful lot of opportunity for improving the delivered outcome both in terms of effectiveness and very much in terms of cost and patient involvement in the solution, and overall, just a better outcome.

BB&T: Cambridge Consultants also has areas of emphasis in the wireless, defense and clean-tech sectors. Are there crossover opportunities between those areas and med-tech, especially in terms of implantable technologies? You talked earlier about implantable antennas. Can you elaborate some more on that?

McNamara: We're already seeing implantable antennas as a growth area for us. Also in the wireless area, under the frame, if you will, of "connected health," we're doing quite a lot in that area. Connecting different devices, for example – monitoring devices, whether it be a P-12 meter for an asthmatic patient or glucometers for diabetics – being able to track their medications, being able to potentially connect either them to an electronic diary or to a laptop, and be able to track the readings and keep that in a form that is consistent with that patient's medical record. Being able to have communications of those patterns and trends back and forth between the patient and the medical provider, for nstance. That whole area of connected health is a very significant one and our wireless group, working with our medical technology teams, are quite active in that area.

One of the industry leadership initiatives has been through a group called Continua, so we've been involved and active in that, to be able to help set the standards of information transition and interoperability across different aspects. Getting those standards established is extremely important. That medical wireless is very dynamic, and we're pursuing that.

In defense, for example, our teams have done a lot of work in the authentication area, and we're also doing a bit of work in the pharmaceutical industry around drug authentication and anti-counterfitting. There's another example of a crossover area that we think is quite significant. And then between defense, where historically we've done a lot of work in radar and missile-tracking, for example, and a variety of other sensing technologies, those technologies are coming into play in the clean-tech domain, where we have a holographic radar solution to help address the problems of air traffic interference by wind farms, so we see significant crossover opportunities.

That's why we're focusing on those related areas where we see an opportunity to make a real difference in our clients' businesses to bring those kinds of solutions forward.

BB&T: One of the points you mentioned was about monitoring, and disease management, things like that. It's interesting that a company such as Medtronic – huge company that it is, built on implantables – unabashedly says that the core of its business moving forward is monitoring.

McNamara: Yes, absolutely. It's enormous – it has enormous potential.

BB&T: There is a significant move toward near-patient and home diagnostic products. Could you comment on the business – and social – impact of that trend?

McNamara: Clearly, the current move in healthcare reform is a major driver in terms of looking for areas to achieve, in home healthcare, with diagnostics and monitoring being a big part of that, to reduce the cost of healthcare, but also to have a more reasonable patient experience. Related to that trend is much greater involvement by patients and their families in patient care. One of the ways to achieve that is through the kind of technologies we're talking about today. We see that as a very significant and continuing trend. It dovetails with the healthcare reform drivers.

BB&T: When you were at Arthur D. Little, healthcare was a particular area of interest. What do you bring from that experience to your Cambridge Consultants position?

McNamara: The biggest experience that carries over is always keeping a very clear focus on the business impact and bring-it-to-market imperatives, or urgency, in all that we do. Cambridge Consulting was a sister company at that time, and when the two got together, the outcome had that kind of business impact/get-to-market focus.

BB&T: Another area of involvement prior to joining Cambridge was in the e-diary, or data collection, sector of life sciences. That's vitally important in the increasing importance of clinical trials in the life sciences industry, especially with the new emphasis on post-marketing studies. What should we be looking for from that sector?

McNamara: In the area of post-marketing studies for sure. How can those studies be done cost-effectively, and in the right length of time to get the full information needed, but done as rapidly as possible. I think the move to electronic information through electronic diaries, through better and smarter use of electronic data capture – in doing that, getting much better quality data from patients.

The patient data quality from an electronic diary is up in the 90% range when patients comply with clinical trial protocol. That compares to paper diaries, which are down in the 11% to 20% compliance-to-protocol range. It's a huge difference, and to be able to get that kind of real-time data and that level of data quality ultimately means much more efficient clinical trials.

At Cambridge Consultants, we also see that technology having great potential to connect to some of the monitoring devices and reporting that we talked about earlier, given the trends in healthcare to have more connected healthcare, to have better monitoring, better reporting, better management.

BB&T: You are a civil engineer by academic training. How does that translate to the product-development orientation of your position now?

McNamara: The aspect of civil engineering that I enjoyed most was the mathematics around stresses and design of structures and different materials. More relevant to my day-to-day work is the problem-solving and how do you make sure that you've got the right data, the right compelling logic and argument, the right project plan, molding all the pieces together so that ultimately an integrated solution works. The drive to develop a solution that works in the market – that's the big takeaway.

BB&T: Taking a macro view, where do you see global healthcare heading? It's so fascinating, given where we are with the economy, with the cost of healthcare, where do you see us being in say, 10 years?

McNamara: The way I see it, there remain huge unmet needs in healthcare, so that's Point 1, and therefore, opportunities.

Point 2 is that, with many aspects of global healthcare today, the Internet keeps us all more connected. We're able to share information, share solutions, build solutions across many different boundaries. From a global perspective, there is the opportunity for us to try out solutions or gather solutions in many far reaches of the globe. Doing clinical trials in dozens of countries at the same time, for example, and being able to take one set of results out of India, another out of China, another out of Peoria, Illinois, and be able to gather the most relevant and useful medical insights and medical experience out of these different markets. So, harnessing more effectively the global information-sharing, the global solutions, the global technologies would be the second trend that I see as being significant.

The third major trend is the patient as the focal point of medical solutions. I think we're going to see more and more medical solutions that have the patient's interest, not only from the outcome perspective, but the patient's involvement from the management of the condition and the patient's family, whether it's something acute or something chronic. So the role of the patient in medical management is going to continue to be a driver, and the kind of technologies we've talked about in today's call really play into enabling and achieving that.

BB&T: How does the Obama administration's obvious determination to reform healthcare system in the U.S. play into that?

McNamara: Lots of solutions are being considered. Lots of parts of the problem are being analyzed in new ways and with great input. I think two things are clear. One is, how do we keep driving for better patient outcomes, and at the same time, how do we find more cost-effective ways to achieve that? Some might say those are at cross-purposes, but it is apparent that they have to be aligned – we have to do both. And I think that's what's going to drive the policies and the solutions that come out of Washington.

No Comments