Category: wireless-connected-medical-devices

3Degrees Company Founder Mike Vasquez asked Bold Type President Jose Bohorquez on the role of 3D printing in medical device product development.

Of course, Jose said he considers 3D printing a valuable part of the product development process.

Jose, paraphrased: We’re big believers in getting user feedback as early in the process as possible. There is no better way to understand how the customer is going to interact with the product and to predict what usability challenges or mechanical risks may arise. A 3D printed model allows us to visualize how the customer will use the device and limits the potential for unexpected issues to come up later in the development process, both of which can prevent the launch of a product that customers don’t like using.

3D printing also helps inform your manufacturing process.

Make sure everything fits together first.
Anyone who’s ever taken a product to volume production knows tooling can be a very time-consuming and expensive process, and you really don’t want to identify design mistakes at that point. With 3D printing, you can be sure all components fit together as intended before moving to the production phase, eliminating the need for costly redesign and retooling – and delays in your product launch plans.

Create inexpensive molded parts.
The other scenario where 3D printing can have a powerful impact is in creating inexpensive molded parts. By using 3D printing instead of injection molding and expensive molds, you can cast urethanes or silicones more quickly and efficiently. This produces less expensive parts identical to final production parts. You can complete user testing and clinical trials and fit testing and everything else much more accurately than in the past.

Mitigate risk.
There are also some regulatory benefits to using a 3D printed prototype. FDA expects to see documentation of good design controls and complete risk assessments as part of your 510k submission. 3D printing makes it possible to take early user feedback, usability studies, fit testing and more that will help you create a risk mitigation strategy fully in compliance with FDA requirements.

3D at Bold Type
Yes, in developing wireless connected medical devices from proof-of-concept prototypes to hardware, software, mechanical housings, and embedded firmware, we can create a 3D printed model of your design concept. There are so many reasons why it makes sense for us – and for you.

If you don’t think 3D printing is a valuable part of the product development cycle, you risk costly errors and launch delays – and we should talk. Bold Type™

VCOs. Voltage-Controlled Oscillators. You may not know them, but most communications devices have one.

They’ve impacted your life. Probably not as much as mine, but, still.

The Power of Networking

At 15, my high school friend Alex told me he got a job as a tech, getting paid EIGHT DOLLARS(!!) an hour (big money in 1995)! Alex was dual enrolled in electronics vocational school and he got me a job alongside him. I learned how to solder.

The Power of Exposure

The “company,” Integrated Components Systems (ICS), was a guy in a two-bedroom apartment, Alex, and me. It was my first brush with entrepreneurship and electronics.

Eliot Fenton, my boss, was brilliant, energetic, life-loving, kind, fearless. He’d talk to us about technology, business, life, cars, and college.

Had I not met Eliot, it’s unlikely I’d study electrical engineering or considered entrepreneurship. His dual path of engineering and entrepreneurship taught me to attract people from whom you wish to learn and emulate.

The Power of Doing Your Job Well

ICS was exclusively focused on designing and selling voltage-controlled oscillators.

These days, the vast majority of VCOs are fully integrated into a System-on-Chip (SOC). Back then they were composed of a tiny printed circuit board with a transistor, a few resistors, capacitors, and a varactor (variable capacitor).

My job was to assemble and hand solder them. I was a quick study, so Eliot taught me how to test VCOs. A chance to use my hands – and my mind!

A few months later, I learned how to modify a design to alter its specs.

If we had a 400 MHz VCO – but a client wanted a 450 MHz VCO – I needed to reduce this capacitance. However, I still needed to ensure it met phase noise requirements, and tuning range, and current draw.

So, I might have to tweak this resistor or that varactor.

I began to learn how to perform rudimentary multivariate analyses and how to apply heuristics because I lacked the underlying fundamentals about what I was doing.

I got a raise… NINE DOLLARS an hour(!!) and learned good things happen to those who do perform well.

I’m not a firm believer you must choose something you love as a career. That’s a first world luxury and even then, it’s reserved to few. I’m more of a believer if you’re going to do something, do it well. That’s easier when you enjoy what you do, so there is merit in choosing to do things you enjoy when that’s an option.

When doing what you love is not an option, there is even greater merit in learning to love what you must do, and choose to do it well in the process.

The Power of Mentorship

Eliot was more than a boss. He became a friend and, more importantly, a mentor.

He’d tell me stories about the University of Florida, where I’d eventually matriculate. He’d talk about race cars, his escapades, about entrepreneurship.

I saw him outgrow his apartment and get an office, where I was now one of 8-10 employees. I saw him broker a strategic partnership with a larger company. All invaluable, the most important being his mentorship.

From then on, I sought mentors and 25 years later, I still do. It’s why I choose to mentor others. As one of these mentors once told me,

It’s good to learn from your injuries. It’s even better to borrow scar tissue from others when possible.

The Power of Leverage

I was one of only two freshmen getting a coveted paid internship at Lockheed Martin, my rare VCO work experience a contributing factor. Three years later I learned Professor O was a leading VCO expert and got on his research team as the only undergraduate.

I leveraged those experiences to land a GE Healthcare internship.

I returned to the U of F as Professor O’s fully funded graduate research assistant. I finished my master’s degree under his tutelage, becoming a VCO expert along the way.

One begat the next: High school job to internship, to research team, to a debt-free Master’s Degree graduation, to VCO and wireless system expert – which presented a Big Fork in My Road.

Would I accept a job with IBM Global R&D or join little startup that just closed Series A funding?

The Power of Calculated Risks

IBM said, “We love you and plan to make you an offer.”

Startup Bitwave Semiconductor said, “We love you and here is an offer.”

A week later, IBM’s bureaucracy made Bitwave more attractive in comparison. When IBM finally called, they were dismayed to learn I’d accepted Bitwave.

I led VCO Development at Bitwave. Bitwave was developing one of the first software-defined radios and I worked on a variety of subsystems that expanded my understanding of wireless systems.

My time there solidified my passion for product development and entrepreneurship. At Bitwave, I met two MIT professors who would later become my PhD co-advisors.

Doctorate and Bold Type

I earned my doctorate with an “ultra-low power circuits and systems for medical devices” thesis. It covered many electronics, including VCOs, and software all optimized for medical devices that could operate for years from small batteries.

I haven’t worked on VCOs directly a decade now, but I reflect how VCOs were a constant presence in my journey.

In my life, VCOs are emblematic of those seemingly innocuous opportunities that alter our lives when we recognize and pounce on them.

Today, Bold Type, the product development firm specializing in connected, wireless medical devices, makes many things – all of which have at least one VCO inside.

That thought gives me great satisfaction. 😄

Coda: Here is a paper we published on super-regenerative receivers during my PhD studies. These were invented in the 1920s by Edwin Armstrong, the brilliant engineer responsible for many wireless architectures we use to this day.

Today I want to talk about the process for developing connected wireless medical devices.

Let’s take it one term at a time, starting with the end – medical devices. Any time you’re developing a medical device, you’re gonna wanna follow a process that, essentially, is dictated by FDA and is aligned with what’s given by ISO 13485.

That means it’s five or six steps around that: Generating user needs, understanding who the user is, What is the intended use? What are the indications? What are the user requirements? What does this product need to do for the user?

From there you can then generate design inputs, which are all the requirements – the system level requirements, the sub-system requirements. And usually you do that alongside development of an architecture for the product. Those go hand-in-hand because, depending on the architecture, you’ll have different sub-systems and different requirements for those sub-systems.

After that, you go through the actual engineering process – developing the device, writing code, doing schematics, doing layout, doing CAD drawings and prototyping, all of that.

And at the end of that phase what you have are design outputs, which are all of your drawings, your schematics, your source code, your packaging, anything that’s required for launching your product.

From that, you go through a design verification phase – ensuring that your design outputs meet your design inputs. In other words, for this thing that you’ve designed, each of the levels of sub-systems and then the product as a whole meets the requirements that you set up in your design inputs.

After that you’ve got your design validation phase – ensuring that the final product, the final design, meets the user needs.

The last phase of this would be transport and manufacturing. That’s where you take all your design outputs, you create what’s called the device master record, and you transfer that over to a contract manufacturer. Or, if you have manufacturing capabilities, you do that in-house. But you go through that whole process of taking all of these design outputs and transitioning them to manufacturing.

That’s generic product development. There’s some best practices within that that allow you to, ultimately, launch a better product.

You know, at Bold Type we like to use Agile, for example, in some of our software development, to split up the overall development into phases, and do some user testing over that period of time, be iterative about it, so that you eventually launch a better product.

But, from a general point of view, that’s what’s required for practically any medical device.

When it’s a wireless medical device, there are a couple of additional steps that you have to take. The first one is selecting the right architecture.

So let’s say you’re developing a blood pressure monitor that wirelessly connects to a cellular phone, and then that data goes to the cloud.

The first thing you have to do is select what type of wireless connectivity are you gonna have.

Is it gonna be Bluetooth, Bluetooth low energy? Is it going to be WiFi? Are you gonna go directly with a cellular technology, like a 4G, or an LT mobile, like LTM, which is a very low-power version of cellular, such that the data goes directly from the device all the way to a cell tower, and from the cell tower to the cloud.

That might be another approach, so you have to select the technology that you’re gonna use.

Then you have to develop the product. Importantly, during the verification test, there’s a couple of other tests that you’re gonna have to do, such as electromagnetic compatibility.

IEC 60601 is used for safety standards of electrical medical devices. And that’s a general one, but there are also some specific ones for things like electromagnetic compatibility – an extra test that you would have to do if it’s a wireless product.

And then, of course, FCC. You have to make sure that you’re not going to be violating FCC rules that get you in trouble. You wanna make sure that you’re not radiating outside of the bands that you’re supposed to be in, that your upper power isn’t too high, that your bandwidth isn’t too wide, or too narrow, those sorts of things. That’s the wireless piece of it, and then, last, there is a connected piece of it.

You’re connecting to the cloud, and you have to ensure that you’ve got proper cybersecurity. It’s really important, so make sure that you do proper risk analysis and mitigate for any potential risks.

It’s different if you’ve got something like I mentioned earlier, like a wireless blood pressure monitor, than if you’ve got a pacemaker. If somebody hacks the blood pressure monitor, the risks associated with that are not as high as if somebody hacks a pacemaker.

You have to do a proper risk analysis around that, and then put in place proper risk controls. You have to have the right architecture, and then you can incorporate features, like over-the-air software updates.

That’s a really valuable feature. It means that, after you launch a product, if there’s an update that you wanna make, if you wanna improve the functionality, if you want to fix a bug that you found, you don’t have to recall the product and bring it back.

You can do an over-the-air firmware update, or an over-the-air software update that improves the product while it’s in the field. And there’s some regulatory things that you have to keep in mind, but you don’t have to necessarily go through a new 510k to do that.

It’s one of those strong benefits, but you have to make sure you do it right, because if you do it wrong, you can effectively damage the product. You can brick it – make it such that the device no longer functions and you can’t update it. So it’s really important to get that right.

Those are some of the processes that you follow to develop connected wireless medical devices.

We strongly believe that if your device is not connected to the cloud, you risk obsolescence, and we should talk. I’m Jose Bohorquez at Bold Type.

Connected wireless medical devices bring benefits to three key stakeholders in the healthcare industry: Patients, clinicians, and medical device manufacturers.

For patients, connected devices have really opened the capabilities of telehealth. Rather than a patient having to go to a clinic for care, they can use these devices at home to gather the data that a clinician is going to need to either be able to perform a proper diagnosis, monitor their progres,s or to support them in therapy.

But it’s not just the video conference. Now, the clinician can actually see the data for the patient and make better diagnoses or provide better advice – that’s one key benefit.

The second one is that the devices that a patient brings home can improve over time. Wireless and cloud connectivity allows a medical device manufacturer to improve the product over time through over-the-air software updates, without having to bring the device back in.

Those are just two key benefits, but there are various others.

For clinicians, they’re getting the benefit, also telehealth, and the benefit would be efficiency – rather than having the patient come in as often, they can have those conversations with the patient, they can look at their data, they can see the progress that they’re making and provide better care.

They’re also able to see trends. Not just a snapshot in time of what’s happening to the patient, but how that patient is improving or declining over time. Is the patient being adherent to a therapy? Clinicians get much better visibility into that patient’s lifestyle and how they’re doing with their therapies to be able to provide better service to them.

And the third beneficiary, of course, is the medical device manufacturer. Connectivity to the cloud gives the medical device manufacturer access to critical data that helps them understand how their product is being used, helps them understand how to improve the existing product through over-the-air software updates, but also how to develop better products down the line.

It helps them understand how other things are impacting the efficacy of a product, whether it’s demographic information or lifestyle decisions. Are those things impacting how efficacious a therapy is, or the kind of diagnostic data that’s being recorded?

Medical device manufacturers can now launch a product earlier, rather than waiting until all of the features of the product are developed. A medical device manufacturer can choose a core set of features that are really critical, launch the product with those features, and then continuously improve the product over time through software releases.

And all of that can be done remotely. It can be done periodically and you don’t have to go through a new 510k with any of these changes. Sometimes you can go through the process of letter to file, sometimes you can do a catch-up 510k. You may have to do a 510k , but the product won’t have to come back to be able to launch those new features.

There are lots of benefits to incorporating cloud connectivity and wireless functionality into your medical device products. If your medical device is not cloud connected, you risk obsolescence, and we should talk. I’m José Bohorquez from Bold Type.