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Medical Starts with ME OPEN ACCESS

You’d Never Get the Device Without the Engineer

[+] Author Notes

Jean Thilmany is an associate editor of Mechanical Engineering.

Mechanical Engineering 135(05), 30-35 (May 01, 2013) (6 pages) Paper No: ME-13-MAY1; doi: 10.1115/1.2013-MAY-1

This article discusses the importance of mechanical engineers and their various roles in projects. Experts in the industry agree that mechanical engineers are integral to device design regardless of its complexity. The engineers work with a number of people from different backgrounds—physicians, marketers, and engineers of other disciplines—during the development process and come up with creative solutions that make many advances in medical treatment possible. Mechanical engineers are often creating the practical foundation on which a project rests to develop a medical device. Students studying to be mechanical engineers can expect the medical device business to offer plenty of opportunity in the years ahead, according to practitioners in the field. Engineers are not only involved in design, they also help drive development of the entire device these days. Experts believe that engineers will be stronger players if they can truly hear a doctor or patients’ problems and design for them; otherwise, a lot gets lost in translation.

from commercial to hospital grade: from the case you might plunk your contact lenses in at night to the heart-lung bypass machine that keeps patients’ blood pumping during heart surgery. Likewise, device design covers the same spectrum, from the simple to the complex.

Experts in the industry agree that mechanical engineers are integral to device design regardless of its complexity. The engineers work with a number of people from different back- grounds—physicians, marketers, and engineers of other disciplines—during the development process and come up with creative solutions that make many advances in medical treatment possible.

Devices are being remade or reinvented for new applications, said May Sayco, industry solution director at Sparta Systems, a Hamilton, N.J., maker of compliance tracking software used in the medical design industry.

“Ten years ago devices were of simpler design and less invasive and applications were more limited,” she said. “Now there’s the concept of having a device do more than what it was initially designed for.”

Take a surgical incision tool like a simple hand-held scalpel, for example. Device designers are now looking at how the tool could be adapted to be used for extraction during the same surgery, Sayco said.

Engineers at Siemens Healthcare developed their whole-body scanner, Biograph, (above center, left, and right) after much time spent working together and documenting each step. Most medical devices need input from many types of engineers and researchers.

Grahic Jump LocationEngineers at Siemens Healthcare developed their whole-body scanner, Biograph, (above center, left, and right) after much time spent working together and documenting each step. Most medical devices need input from many types of engineers and researchers.

According to Graham Lacy, technical director at PDD Group Ltd., a consultancy in London, “Mechanical engineers are absolutely, inescapably, necessary. They’re at the core of development. Look at it this way, a successful product needs to be wanted, different, to work well, to be safe, and made profi tably. A lot of disciplines work to make a product wanted,” Lacy said.

The marketing team works with physicians to ensure a product will be wanted and meet doctors’ and patients’ needs, for example, and quality assurance people make sure the product is made safely. Those in finance keep an eye on numbers.

“The engineer has almost primary responsibility for everything else,” Lacy said.

PDD Group helps create many types of products, for industrial, medical, and consumer use. Recently, the company simplifi ed the Saizen automatic growth hormone injector from Merck Serono and designed an electrocardiography recording system for Spacelabs Healthcare.

Mechanical engineers are often creating the practical foundation on which a project rests to develop a medical device, said David Faul, an engineer at Siemens Healthcare in Malvern, Pa.

At left, more images captured by the MR/PET developed by Siemens:

a. brain scan following successful tumor therapy

b. whole body scan

c. a scan of a cancerous lung

Grahic Jump LocationAt left, more images captured by the MR/PET developed by Siemens:a. brain scan following successful tumor therapyb. whole body scanc. a scan of a cancerous lung

Faul speaks with the authority that comes from years spent in the field. In the 1970s he worked as a nuclear engineer at the Lawrence Livermore National Laboratory in California. In the 1980s he moved to the University of California, San Francisco, to do postdoctoral research as a medical physicist.

Most recently Faul served as systems engineer for Siemens Healthcare’s new magnetic resonance/positron emission tomography imaging system, called Biograph mMR. According to Siemens Healthcare, it is the first device to combine MR and PET in a single machine.

The whole-body scanner depicts the anatomy, function, and metabolic activity of organs within one image. The manufacturer says the system could help identify malignancies, improve therapy planning, and begin cancer treatments earlier than otherwise possible. The U.S. Food and Drug Administration approved the whole-body scanner in June 2011.

During his time in industry, Faul has witnessed firsthand the role engineers play in the medical device industry and he’s pinned down the skills he finds most important for mechanical engineers to possess: the capability to collaborate and to bring imagination to the job at hand.

“Engineers need to bring a creative mind to the task today,” Faul said. “If I were to build—as I have—an imaging scanner, the first person to be involved in a serious way is almost always a mechanical engineer. This is particularly true for the PET system because the PET components were new to the system.

The most Important Skills for Mechanical Engineers to Possess:

The Capability to Collaborate and to Bring Imagination to the Job at Hand.

“Engineers need to have some creative feel for what the system is going to do and to imagine the best architecture, mechanically, for system layout,” Faul said. “They need to participate in the parsing of the components into functions. All these things are essential to the success of the product.”

The mechanical design for the Biograph mMR scanner came before anything else.

“Before we had the design layout we had to have a concept for how we’d shield the electronic detectors from 124 megahertz radio waves used by the system,” he said. “Because of the magnetic fields we had to know where we’d put the electronics that discriminate the signals for energy, digitize them, and send them for coincidence processing and data storage.”

A Growing Focus on Cost of Care

Students Studying to be Mechanical Engineers can expect the medical device business to offer plenty of opportunity in the years ahead, according to practitioners in the field.

Especially suited for the task, they say, will be those who can design for growing rules and regulations, and with an eye toward keeping costs down.

According to Graham Lacy, technical director at the design consultancy PDD Group Ltd. of London, there will be a myriad of opportunities for mechanical engineers as the field shifts to the creation of more economic, useable, and sustainable tools than have been designed in the past.

“There’s lots of opportunity for engineering and technology and ingenuity in the field, but the needs are going to be different over the next fifty years than they were in the past fifty,” he said. “For one thing, we’re seeing increasing pressures on the cost of care due to demographics.”

A demographic shift will make fewer people available to work in health services field caring for the growing aging population, Lacy said. Couple that with an emerging number of people in developing countries who seek improved health care at affordable rates and designed for those in developing nations, said Vinesh Narayan, a product manager at D-Rev, a nonprofit design firm in San Francisco with the mission to improve the health and incomes of those living on less than $4 per day.

The ReMotion Knee, a prosthetic knee joint designed by D-Rev engineers was originally created in a Stanford University medical device design class in 2008, he said. The class joined forces with the Jaipur Foot Organization, of Jaipur, India, which distributes free or low-cost prosthetics in India. The organization sought an affordable knee joint that could work with its Jaipur Foot system, said Narayan, who was part of the design class one year later.

After the class ended, several students from the 2008 and 2009 sessions joined to create D-Rev to distribute the prosthetic knee joints, which will be injection molded then distributed to prosthetic clinics in locations in Indonesia, Philippines, Guatemala, and Nicaragua.

David Faul, systems engineer at Siemens Healthcare, Malvern, Pa., said today’s mechanical engineering students need to study more than engineering to become employable in the field.

“They should learn a lot about packaging because there are a number of places in the mechanical part of medical engineering where you have to package photo-optical or ultrasound devices with electronics in the smallest possible space. With the Biograph MR/PET, we had to pack electronics in a three-centimeter space and still make it manufacturable.”

The continuing cost pressures on medical instrumentation means devices of the future will need to be manufacturable, low-cost, and robust, Faul said.

... there will be a myriad of opportunities for mechanical engineers as the field shifts to the creation of more economic, useable, and sustainable tools...

Mechanical engineers for the project needed to know about electricity and magnetism, and about how much copper would be needed to shield electronics from high frequency radio waves.

“Engineering these days is multidisciplinary for sure,” Faul said. “To say you have experience means you have experience with more than one technology and you know how to combine them.

“There’s no more room anymore for the lone-wolf genius engineer,” he added.

According to Lacy, PDD employs as many aeronautical, structural, and electrical engineers as it does mechanical engineers. They all bring the skills from their separate backgrounds to device design.

“We quite like what an aeronautical engineer can bring to a drug developer product, for example, in terms of being resistant to impact and durable,” he said. “Aeronautical engineers are almost all specialists in terms of structure and thermal and fluids. And drug delivery devices, with their thin-walled plastics, are specialized structures.

“We also value designers who’ve worked on mobile phones because of their miniaturization and human factors experience, which can be brought to diagnostic instruments,” Lacy said.

Mechanical Engineers are often Creating the Practical Foundation on which to Develop a Medical Device.

Grahic Jump LocationMechanical Engineers are often Creating the Practical Foundation on which to Develop a Medical Device.

Engineers are not only involved in design, they also help drive development of the entire device these days, said Vinesh Narayan, product manager at D-Rev, a nonprofit product development company based in San Francisco. In addition to technical skills, engineers need people skills and the ability to wear many hats and to change them frequently, he said.

The company designs low-cost devices for use in the developing world. Narayan led development of D-Rev’s ReMotion Knee, an affordable knee joint for amputees in the developing world. The prosthetic axis allows for 165-degree range of motion for kneeling and squatting and allows for a natural swinging motion. Many low-cost prosthetic leg systems typically the need for lower-cost devices becomes clear, Lacy said.

Those devices will need to be created against an ever-increasing regulatory and best-practices framework that, Lacy predicted, will soon include targets for sustainable design. He noted legislative pushes in many countries for sustainable design within all areas of manufacturing and consumer awareness of reuse and recycling issues.

He expects that when today's students become engineers, they may design devices subject to safe-disposal legislation as well as to laws that would dictate what percentage of materials used within the devices must be reclaimed, recycled, or reused.

Attendant to that will be growth in devices specifically use single-axis knee joints similar to a door hinge, Narayan said. The ReMotion Knee works with standard prosthetic leg systems.

Vinesh Narayan, product manager at D-Rev, a San Francisco nonprofit, tests a ReMotion Knee on a wearer. The company makes affordable knee joints that allow for kneeling and squatting for amputees living off less than $4 a day in the developing world.

Grahic Jump LocationVinesh Narayan, product manager at D-Rev, a San Francisco nonprofit, tests a ReMotion Knee on a wearer. The company makes affordable knee joints that allow for kneeling and squatting for amputees living off less than $4 a day in the developing world.

Engineers will be Stronger Players if they can Truly Hear a Doctor or Patients’ Problems and Design for them. Otherwise, a lot gets lost in Translation.

Grahic Jump LocationEngineers will be Stronger Players if they can Truly Hear a Doctor or Patients’ Problems and Design for them. Otherwise, a lot gets lost in Translation.

The D-Rev teams believes it’s important to first speak to the people who will be wearing their medical devices and the doctors who will be fitting them before they begin to design the devices. That way, they can find out exactly what users need and want.

Grahic Jump LocationThe D-Rev teams believes it’s important to first speak to the people who will be wearing their medical devices and the doctors who will be fitting them before they begin to design the devices. That way, they can find out exactly what users need and want.

Features of that type were introduced after feedback from potential users, he said. Historically, doctors have presented device makers with the need for devices like prosthetic limbs and joints, and have identified the problems with available products. The device makers would convey this information to their engineers. But now design engineers are often talking directly to patients and doctors to understand problems, Narayan said.

“There’ll always be engineers involved in medical devices, and they’ll still do what we think of as traditional roles like writing reports and specs. But they’ll be stronger players if they can truly hear a doctor or patients’ problems and design for them,” he said. “Otherwise, a lot gets lost in translation.”

For instance, the ReMotion knee joint curves at the top to look natural under clothes, he said.

“If I just saw that requirement on paper I might think ‘That’s a nice thing to have, but our focus is a knee joint that has to swing the right way,’ ” Narayan said.

“When we first started talking to amputees we thought the draw would be that this swings like an anatomical knee; it doesn’t buckle. But we found out what’s important to them is that it doesn’t look obvious,” he said.

And that bit of feedback hits hard on why it’s important for engineers to able to converse with users and to tease out exactly what they need and want.

“As an engineer I know that the curve at the top is not just nice to have; it’s critical. Or else no one will want to wear it when it gets out in the field,” Narayan said.

As a student at Stanford University, Narayan said he misperceived what it meant to be a mechanical engineer working on medical devices. He thought he’d work on technical problems most of the workday. But today soft skills like the capability to speak with end users and then incorporate their needs and wants are what drive device adoption.

D-REV d-rev.org

Location: San Francisco

Founded: 2007

Employees: 11, plus a board of directors and a board of advisors

D-Rev, a nonprofit, develops products that improve the life of people living on less than $4 per day. CEO Krista Donaldson gave a talk last year at TedXStanford about why context is critical for impact and innovation. It is available online at https://www.youtube.com/watch?v=wxNOXNCpQJQ&feature=youtube. The company was recently as one of Fast Company’s 50 most innovative companies for 2013.

Equally necessary today—particularly as many engineers work at small or start-up device developers—is the need for mechanical engineers to pitch in on many types ofjobs at the company, Narayan said.

D-Rev employs 12 people, of which eight are engineers or have an engineering background. Regardless of their training, however, everyone’s informal job description includes a range of responsibilities, he said.

“One minute you’re doing something you’re trained for and then the next you’re doing something you’re being trained for quickly,” he said.

One day in January, for example, Narayan reviewed manufacturing quotes and 2-D designs and 3-D prints. He’d compiled photos of the ReMotion Knee for the marketing department, worked on a budget for a grant, and helped draft a legal contract.

“That’s not the stuff I thought about when I studied mechanical engineering in college,” he said. “But it’s really not often we get a problem like: The fatigue life of this part isn’t meeting expectations so what material should we use?”

Documentation and testing are facts of professional life, and they will not diminish anytime soon. This part of the job helps meet good manufacturing practices and gain FDA approval.

The mechanical engineer is charged with maintaining the device master record, a large technical file and attendant components that include everything about the history of a device, said Sayco of Sparta Systems. This tracking record goes with the device when it’s submitted for FDA approval, she said.

The record includes everything from the initial concept to design prototype to final design plans as well as any clinical engineering studies involved. It also likely includes the application for use, which outlines the intended user, whether an average consumer or a physician, she said.

Her company has found a place in providing software that keeps track of all these disparate documents.

Siemens Healthcare siemens.com/healthcare

Location: Erlangen, Germany; United States headquarters in Malvern, Pa.

Employees: Around 50,000

Founded: 1847

Siemens Healthcare (formerly Siemens Medical Solutions) is the medical products arm of German industrial giant Siemens AG. The group makes a range of medical equipment, including imaging systems, radiation therapy equipment, hearing aids, and respiratory machines.

PDD pdd.co.uk

Location: London

Founded: 1980

Designers at this product design consultancy offer human-centered design classes that teach participants how to determine the context of users’ lives when developing products for them.

Robotic Mind Meld

 

Grahic Jump Location 

An Internet just for Robots? Kind of.

Researchers at a consortium of robotics European institutes and industries are at work on a way to get robots to learn from each other.

In order for robots to share information and to learn from each other, they need a way to exchange data. One method that naturally comes to mind is the Internet.

So the RoboEarth project, which kicked off in 2009, aims to eventually create a giant open-source network database using the Internet, which robots can access and continually update. By learning from each other, robots will be able to get better and better at 3-D sensing, at acting in 3-D space, and at learning from one another, said Mohanarajah Gajamohan. He’s a researcher at the Swiss Federal Institute of Technology in Zurich who's part of the research.

A robot that learns to sense where objects are in space could find specific medical tools on its own within a drawer or help hospitalized patients. Robots capable of learning may even be capable of performing some types of surgery.

The technology would have applications in many fields besides medicine.

The project’s researchers have recently introduced RoboEarth Cloud Engine, a computing platform that allows robots connected to the Internet to access the computational power and storage capabilities of giant server farms for robotics tasks and learning, said Gajamohan, who took technical lead on that part of the project.

The various server farms are said to exist “in the cloud.”

“With the rapid increase in wireless data rates caused by the booming demand of mobile communications devices, more and more of a robot’s computational tasks can be moved into the cloud,” Gajamohan said. “The RoboEarth Cloud Engine is particularly useful for mobile robots such as drones or autonomous cars, which require lots of computation infrastructure.”

The in-the-cloud computing infrastructure could help pave the way towards lighter, cheaper, more intelligent robots, said Heico Sandee, RoboEarth’s program manager at Eindhoven University of Technology in the Netherlands.

More information on the project can be found at https://www.roboearth.org.

Faul has seen the need to keep these kinds of up-close records increase over the course of his career. It’s the nature of the business, he said. But he added that he loved the entire job, documentation and all.

“By the time I found the MR PET, I was at a senior position in my career and I was looking for the challenge of doing something I could be proud of and tell my grandchildren about,” Faul said. “Not that I hadn’t done that before, but it was an opportunity to do something really unique, and my competitive nature likes to be first.”

Copyright © 2013 by ASME
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