PROVIDENCE – When it comes to marrying technology to health care, and connecting medical devices to patients’ experience and outcomes, Ximedica is one of the nation’s – and the world’s – leading design and engineering laboratories. It is here where the intricate details of new products get worked out with the precision to meet FDA standards.

What has always set the iconic Rhode Island firm apart, founded by two RISD graduates in 1985, has been its focus on innovation as a process and not just product creation. For 30 years, Ximedica has emphasized research on what it has labeled human design – the understanding of how medical devices are used by clinicians and patients.

Today, with headquarters in Providence and offices in Hong Kong and Minneapolis, Ximedica is a full-service ISO 13485 certified and FDA-registered product development firm, with clients around the globe.

“As a design company, we try to facilitate the future,” said Aidan Petrie, co-founder and chief innovation officer at Ximedica, told ConvergenceRI.

In November of 2014, SV Life Sciences, a Boston-based private equity firm, purchased a majority stake in Ximedica, rebooting the company and positioning it to double or triple its size. [See link below to ConvergenceRI story.]

Toward that end, Ximedica recently announced the launch of a new division, focused on interaction design, hiring Jeff McCloud to lead that enterprise.

McCloud’s background is in human systems engineering at the Georgia Tech Research Institute and in designing clinical applications for electronic health records, or EHRs, in Boston. In a recent blog, he defined interaction design as a way to marry applications to experiences.

“These experiences can be designed to motivate and reinforce healthy behavior, such as taking medications on time or maintaining an active lifestyle and much more,” McCloud wrote. “Social networks can also be leveraged to provide encouragement and empathy to help those suffering from chronic diseases and other ailments. Tracking progress can help individuals take an active role in their care and promote self-efficacy.”

ConvergenceRI recently sat down to talk with McCloud, Petrie and Hope Hopkins, director of communications, to talk about the firm’s new plans as Ximedica expands its market reach into interaction design.

Petrie predicted that in three years, McCloud would be leading a team of 16 collaborators at Ximedica.

“I’ve been speaking at the Consumer Electronic Show for the last five years,” Petrie said, explaining the genesis of Ximedica’s new division. “There are all [these] tech guys who don’t understand the medical industry, and there are these docs, who are saying, we need help, but you don’t understand what we need.”

Petrie called the new division a convergence. “The techies have very little understanding of what is going on or required in the medical field,” he said. The people in the booths next to us at the Consumer Electronics Show, Petrie continued, “have no idea what’s coming down the pike if you go left of center with the FDA.”

Ximedica’s goal, he said, is to bring these market forces together through interaction design.

McCloud held up his smart phone and said: “This is no longer a device of technology; it’s part of my life. It’s my social network. I take it with me everywhere. [I do my banking on it.] Why shouldn’t it be the way I interact with my health? It’s a disruptive technology. The critical thing is: I have it on my person.”

Here, then, is the interview with ConvergenceRI, with Ximedica poised to become the go-to translator of apps into a broader context of health care, to meet FDA guidelines, connecting the patient world to the clinical world. It’s big news.

ConvergenceRI: Jeff, as a new face, a new wave at Ximedica, how do you fit in? How are you making things different?
McCLOUD: Interaction design is a new thing coming along in the medtech industry. There is the growing [market for] FitBits and other health-focused applications and devices. There are now more than 100,000 such applications on the Google and Apple app stores. It’s really the fastest growing trend in mobile development.

But, as of yet, there has not been a strong tie-in, with medical devices, and medtech.

ConvergenceRI: Much of the work to date has been focused on self-reporting and how that gets integrated into a medical record. How is this different?
McCLOUD: I came from a health reform organization that was focused on bettering the health care system, getting that patient data, and getting the information that patients are collecting, and getting that into the medical records.

On the other side of [the equation is the behavior of patients], where compliance with medication is a huge problem.

[Our work on interaction design] could help with that; it could help reinforce good behaviors and have a tracking aspect to it. [It would have] the active engagement that could really kind of nudge [the patients] into having better behavior based on self-evidence.

ConvergenceRI: Is the market consumer-driven, or business-driven? How do you segment the market?
PETRIE: I believe it’s a genuine virtuous circle, where what is good for the doctors and the drug companies is going to be better adherence. The patients then are going to be healthier, and that’s better for the economy, because you’re not paying for chronic sickness. [Interaction design] of health IT is there to facilitate it.

So, you get this really nice circle, where everyone is benefiting.

ConvergenceRI: Are you designing the apps, or are you designing the interface?
McCLOUD: It’s a little bit of both. Overall, it’s looking at the experience, what patients are doing contextually, understanding where you are contextually from the research, and then filtering those into the design requirements.

That [interactive process] can actually inform the users about what behaviors we really want to reinforce, what are good behaviors, and where [and when] they are experiencing them.

And, what is the best way to present [the information] to the [users].

Are we presenting [it to] them as just visual display, as part of the interface, using gestures, or is it in using navigation?

Is it having a reminder, such as to take my medication with me in a paper bag when I go to the park, because I always forget it when I go to the park….

ConvergenceRI: …Or, perhaps having a voice reminder from a child or grandchild, giving you the message on a recording: “Grandpa, did you remember to bring your medicine?”
PETRIE: Yes, you have to have the prompting side, but then, there is also the predictive [side].

If you’re taking an asthma medication, and you can see that the pollen indications are high around where you are, then, can you make it a double dose day, or take the Claritin?

You’re getting this [predictive feedback] through the mobile device, creating a more powerful interaction.

ConvergenceRI: Is this change to interaction design scary to doctors and hospitals and insurers? Is the change happening quicker than they can control?
PETRIE: The technology market is moving quicker than the FDA can regulate it and quicker than older platform companies can change. It’s true disruption right now.

McCLOUD: It’s only a matter of time before the big systems are eclipsed by these new innovations, by consumer-driven applications.

[For instance,] I won’t deal with a bank that I can’t access on my phone.

[For future interactive health IT apps and devices], I have to have security, I have to translate HIPAA regulations, I have to overcome my fear of being able to share information, not from being paranoid, but from having the control of that information and being able to share it with my colleagues and patients [securely].

It’s everything that I currently have [in a mobile device], and I want to have all those regulations, safety nets and understandings, in my health applications.

ConvergenceRI: Three years ago, a friend attempted to market an interactive app through mobile devices called Nightingale, geared at helping nurses manage the flow of patient data, but couldn’t get anyone in the market to take the risk, there were no buyers.
McCLOUD: Part of that, with nurses, is if they’re on their phone, it looks like their texting. There’s a lot of stigma attached to nurses walking around on their phones, accessing medical records. I think there is, at Children’s Hospital in Boston, an ad campaign, saying: the nurses aren’t texting, they’re just helping with your health care.

There’s a lot of push-and-pull that has to happen in a clinical environment.

But, outside of the clinical environment, there are home health care needs, being able to access a doctor, particularly if you’re disabled, [being able to access] a health care provider further away from a hospital.

[Through interaction design of health IT using mobile devices], you can access your health information, and capture those behaviors, to actually get health care, and that’s what we’re trying to achieve here.

ConvergenceRI: Did you convince Aidan, or did Aidan convince you, about this new market opportunity?
McCLOUD: Aidan kind of recruited me.

PETRIE: I’ve been speaking at the Consumer Electronics Show for the last five years. There are all [these] tech guys there who don’t understand the medical industry; and there are these docs saying, we need help, but you don’t understand what we need.

There has been a convergence; we’ve been sitting here, saying, we have to bring this together, and over the last two years, it began to get [traction].

The techies, typically, have very little understanding of what is going on – and what is required – to work in the medical field. The people in the booths next to us [at CES] have no idea what’s coming down the pike if you go left of center with the FDA.

ConvergenceRI: How does your approach reflect that there are competing needs for what the same device can do? What the patients want may be different from what the doctors want.
PETRIE: The consumer doesn’t want what the doc wants; the drug company doesn’t want what the consumer wants; they are looking for different [information].

McCLOUD: The apps have to be good enough to meet the consumers’ needs. And, there has to be an understanding what the docs need from a clinical perspective. And, there has to be a structure of security, which has been largely ignored by a lot of the apps [currently on the market].

ConvergenceRI: Is there pushback from the existing players in the market? Do hospitals and insurers want this? Is anyone really listening to what the patient wants or needs in this conversation?
PETRIE: The insurance companies are becoming very savvy. They know that they have to drive their costs down; they are not satisfied with the solutions that are being given them.

As a design company, we try and facilitate the future. We go out into the field and we spend a lot of time with consumers, with insurance companies, with the drug companies, and we put together packages that are based around technologies and devices that make those benefits work. That is the design.

ConvergenceRI: In trying to solve the problem around cost of the system, is there recognition of the difference between the health care delivery system and health, prevention and wellness? How does the effort to make the flow of information more nimble facilitate the way in which the health care delivery system, likened by some to be like a large nuclear-powered aircraft carrier, change direction more quickly?
PETRIE: Our clients don’t think of it as an aircraft carrier, rather, they think of it as a squadron of jets, where you can peel one off and then another. We work on a client-by-client basis.

The whole [health care delivery system] has to change, because [otherwise] it’s going to hit a wall; it’s unsustainable.

We look at other health systems; we spend a lot of time in Europe; we spend a lot of time in China, we’ve been in Israel this year.

ConvergenceRI: I understand that Israel has an interesting way to use primary care and how they pay for it.
PETRIE: It’s an amazing system, but they have the benefit of having a small population and a short history, so you can build something quite quickly.

Their use of data is very impressive; their use of personalized medicine is incredible.

McCLOUD: [Imagine] that a patient is prescribed an asthma device, and the doctor asks: have you had any outbreaks recently? The patient responds: no, I don’t think so.

Is there qualifying data that you can get, to show that, actually, last week, [the patient] was over here by this construction zone, [the dust was blowing], and [the patient] had taken doses there?

People forget, often on purpose.

But, with more personalized medicine, you can understand it better, and report it back to the doctor, and have better questions to ask the doctors, and have better compliance for the medication and the medical device itself.

It’s cheaper to boot. It’s kind of a win-win situation for everyone involved. It’s cheaper for the health care delivery system; we don’t have to move this giant barge.

ConvergenceRI: How will the data be analyzed? And, who will control the data systems?
McCLOUD: A lot of the problem with EHRs is that everyone likes to write notes, so there are lots of notes. With text, it’s very, very hard to get to any analytics behind it.

In data analysis, I can have nicely structured data, I go from one to zero, I can populate those ones and zeroes, and I can create a wonderful visualization, I can create maps, and I can format the use, to show the patient and the doctor about what’s happening and why it’s happening, and what to do about it.

ConvergenceRI: Is there a battle over who will control and own the data?
PETRIE: A war of competitive interests is how the U.S. does business. Apple is interested, Google is interested, UnitedHealthcare is interested, hospitals are interested, as well as the patients.

Who has the data is a huge part of the conversation. And, what rights does the patient have in being part of the conversation? Where does the data set lie?

There are significant bodies looking to own the data. I think for Ximedica, what we know is that there is a huge shift going on, and we as a company want to be at the forefront of a great deal of that shift. Bringing Jeff on board is part of that strategy.

I expect that Jeff will have a team of 16 within three years.

We’re a very unique company; we’re at the forefront of change. As you alluded to, there are significant financial forces at play. What we are doing [is to position ourselves] to be at the forefront, to be keeping our eyes on where the future is, and what the benefits are, ultimately, for our population, which is patients.

ConvergenceRI: Can you talk about the importance of predictive research analytics? For instance, if a hurricane hits Rhode Island, is there a way to know what are the kinds of illnesses that can be expected to occur, based on what happened, say, after Hurricane Sandy?
McCLOUD: You have to build in your social media about that, what is actually happening. When the earthquake hit Japan, people were actually reporting via Twitter, before they could collect the data.

You can definitely [capture] all that health information people are reporting. There’s been some research that you can determine gender and obesity rates just by how someone posts on social media.

And, research on how you can leverage this [information] to get a better understanding of the patients.

ConvergenceRI: How does the market roll out? How do the new products enter the market, and how do they get accepted? Is there, as Geoffrey Moore once described it, a chasm that you have to leap across?
PETRIE: I’m doing a tour of Denmark in about three week’s time, and I’m talking to a series of companies about the value of technology and connected health in their particular realms.

We’re developing a product, a device that has three different portals: it has a patient portal, it has doctor portal, and it has a portal back to the drug company.

So, everyone is getting the data that they need in a form that is relevant to them, in a form that is actionable to them. And, this will roll out one program at a time, but it will roll out, over the next five years.

We’re not a top-down system in the U. S. of A.; we will do it in our own way, and we will do it. It may be untidy, but we will do it in our own way.

ConvergenceRI: Will personalized medicine and connected health extend to genetics and translational genomic health?
PETRIE: That’s a touchy subject for us.

McCLOUD: Will I [be comfortable] having my genetic information on my phone? I’m OK with communicating my most intimate details of my life with my friends on social media. But most people think that [genetic information] is a little bit scary for them, because it’s a bridge too far.

There are questions about how we do that, how people understand and can communicate the information, getting everyone on board about what’s collected, how it’s collected, what it means, and at a basic level, not a scientific level, getting it down to visualizations to reinforce that. At a certain point, if you’re going to do genetic testing on a mobile app, that’s the doctor’s call.

ConvergenceRI: Can’t you now do HIV testing on a mobile app, from what I understand?
HOPKINS: It’s an accessory on a mobile device.

PETRIE: And we designed the accessory.

One of the things [to understand] is that the new phones are so locked, because Apple and Android are chasing the biggest economies in the world. One is banking, money transactions; the other is health transactions.

The idea that we can lock the bulk of your health transactions and information into your mobile device, the way that you can lock the bulk of your financial transactions, it puts Apple and Android into a very, very different position.

They want to own the channel, the pipeline.

From our point of view, as a simple maker of devices and connected health applications, we understand that is likely where things are going.

But, we’re in a simpler position: which is, really, to make sure that the work we do resonates with the patient population, that we understand who they are, how they live, and what they will be motivated by to take their medication, or won’t.

And, then, what one has to do push and pull those particular buttons.

ConvergenceRI: What is the strength of your business model?
McCLOUD: The thought is, with all these unregulated apps going on nationally, with health as the fastest-growing category of all apps, there will [emerge] a need to have more scrutiny from the FDA.

Where we shine is going through the FDA and that process, and being able to get their buy in and say: there is a safe and effective way to do this.

PETRIE: Ten years ago, everyone was excited about technology; today, technology will do whatever you want it to do.

Governments, local health care systems, hospitals, are device clients.

What we lead with is: what do you want to do? What should it do? And let the technology follow. It’s a huge shift in the market from technology-driven system, where they shove as many buttons on your cell phone as they could, to a system where you can actually do it intuitively.

You have to deconstruct it, and then you rebuild it in a way that’s relevant to the users.

It’s a process that we utilize to analyze how medical systems work; we can apply it to more or less anything.

McCLOUD: It all depends on starting from a contextual understanding.

ConvergenceRI: You’re working on a global scale, and not just Rhode Island. How does this potentially change the marketplace for Rhode Island? Will it excite and stimulate a whole lot of new opportunities here in Rhode Island?
PETRIE: I hope it’s good for Rhode Island. Frankly, we’ve been doing business here for 25 years. We are working much more with the universities, Brown, RISD and URI, than we ever have, we’re employing individuals out of all these schools. Providence has become a better town to retain bright, young people than it was when I graduated RISD. It was a pretty gloomy place then and you couldn’t leave fast enough.

ConvergenceRI: Are you finding it easier to recruit talent?
PETRIE: It’s not easy, because we’re competing with the Boston market. But, at the same time, for individuals who are interested in coming to work at Ximedica, you’ve got to care about health care. We are the biggest outsource development company [for medical devices] in the U.S. and one of the [biggest] in the world.

We believe that there is an opportunity to build a bigger health care ecosystem here. And we like to think that MedMates [a new cluster group] will help us evolve to become a hub for that.

ConvergenceRI: Is there anything I haven’t asked that you would like to talk about? I give you the last word.
McCLOUD: [holding up his smart phone] This is no longer a device of technology; it’s part of my life; it’s replaced everything. It’s my social network. I take it everywhere with me. [I do my banking on it.] Why shouldn’t it be the way I interact with my health? That’s one of the natural progressions. It’s a disruptive technology.

The critical thing is: I have it on my person. It’s about having a system that can modernize technology in people’s lives as far as they want it to go.