Teleporting into meetings, collaborating with economists, learning frugal engineering . . . welcome to the future of medtech development and manufacturing.
Editor's Note: To discuss how many of the trends discussed in this article you see happening at your workplace, and what other changes you think the medtech workplace will go through, visit the discussion on future trends in medical technology in the EMDT group on LinkedIn.
The way we develop medical devices is changing now, not later. Brace yourself. The view from your desk is going to change dramatically.
You will have a new boss as a generational change sweeps in a new breed of executives.
You will not recognise the people sitting next to you, nor understand what they are talking about, as biologists, economists, software developers and medical doctors join your work team.
Your desk and its files will be moving online into a world of virtual meetings and shared documents.
Cost, co-location, collaboration and convergence are the themes that will dominate the re-engineering of medical technology and the ways that you work.
Consider this vision of the future: Your next meeting will be with a robot. Moving beyond tele-conferencing, colleagues from distant work sites will visit by tele-porting into a robot.
“Think of it as Skype on wheels,” says Daniel Kraft, MD, who chairs the medicine track for Singularity University. “You can beam yourself into an office as a virtual visitor, interacting with people on your work team.”
Dr. Kraft is more comfortable than most at embracing such startling changes to work life—he leads graduate studies on disruptive technologies at Singularity’s campus based at the NASA Research Park in the heart of California’s Silicon Valley.
“This is more than looking someone in the eye to know what they are thinking,” he says, suggesting that with the sensing capabilities for vital signs already available in smart phones, the robot visitor could know exactly how you feel about the proposed changes to a project by monitoring your breathing and heart rate.
Blueprint for the future
Now, let’s beam down to the new GE Healthcare facility in Buc, France.
At its peak 130 engineers were working on the project. The development centre dedicated to this single programme covers 15,000 square feet in a renovated airplane hangar built by Gustave Eiffel at the turn of the century.
The investment in the workspace cost €8 million for the renovation alone, which is not included in the total €18 million cost of the project.
This is change on a large scale, a massive effort for co-locating diverse teams centred on the redesign of a medical imaging system that began rolling off the production line in May 2012.
The company promotes the new system as a way for surgeons to re-invent the way they work. Behind the scenes, the re-engineering of the Discovery IGS 730 is a landmark case study in how medical technology companies can reinvent the ways that they work.
True to the finest tradition in medical technology, the programme began with an idea from an engineer: why not slide a motorised base under the gantry of the company’s high-end Innova imaging system used to guide complex interventional surgeries?
Spurred by fierce competition from Siemens and Philips to build hybrid operating rooms, GE Healthcare put its formidable strength behind the idea.
In less than two years, the project was completed and presented to customers at the meeting of the Radiology Society of North America in November 2011. The system received 510(k) clearance from US FDA in February 2012, and is expected to receive a CE mark for commercialisation in Europe once the production line is certified this summer.
Discovery IGS 730 differentiates the GE Healthcare offer to hospitals by breaking the paradigm of fixed imaging systems for surgery that are anchored to the floor or hung from the ceiling.
Here is a massive gantry that glides into position when needed and parks itself in a corner when an interventional procedure needs to be converted to open surgery.
Twelve patents were filed in the process of development and 31 permanent full-time employees were hired, staying on to generate more products.
Lifting the roof on the erstwhile airplane hangar, which GE Healthcare has named AgiLabs, reveals a workspace of 11 development labs that feature key elements for the future of medtech.
Industrial partners moved teams into the new development facility. Experts in robotics and holonomic laser guidance systems from prestigious academic institutions were given desks in dedicated lab spaces. And customers were invited to participate in the development process with surgical teams flown in from around the world to recreate procedures on phantoms in what is called the Validation Lab, which looks and feels like an operating theatre.
Merging traditional medtech with new teams of actors is affecting not only the heavy metal of radiology but the more fluid sphere of biomedical engineering, as well.
At the recent European Connectathon in Bern, Switzerland, a five-day marathon for testing the interoperability of medical devices with health IT, another major player, Abbott Diagnostics, was putting its OneLab system through the paces.
This new laboratory IT solution combines innovative tools for high-volume laboratories to turn results from in vitro diagnostic tests into reportable results for clinicians.
The lead software engineer from Abbott says that his group does not interact directly with colleagues in biology and chemistry but that increasingly the design briefs show the impact of these sciences.
“It depends on where you are in the hierarchy of your organisation,” he says, preferring to stay anonymous within that hierarchy.
“We are not yet at the event horizon where software meets biology—we still have a layer or two protecting us,” he says. “But this is happening for more and more software teams.”
Meet the new boss
It is easy to get lost on your way to the future. It’s fun to talk about, but it can make your head spin. Usually someone ends the blue sky talk by bringing everyone back to Earth with a practical reminder that medtech is all about making money.
In fact, the business of medical technology is a great starting point for understanding the changes shaping the future medtech space.
Making money is the first item on the to-do list for the new boss, according to Ulrika Hagle with Korn/Ferry International, who searches the world for new executive talent to lead medical technology companies.
“There is a massive shift in recruiting today to find people who can instil a bottom-line focus for companies,” says Hagle in a call from Singapore. “Today, all CEO recruitment is about the bottom line.
“We are seeing a generational change,” she notes. “For years medical technology companies were used to double-digit sales growth and high margins. That has slowed to low single-digit growth and this translates into companies recognising the need to act differently. The work culture needs to change in fundamental ways, and this is happening now.”
Managers who are technical experts with a top-line focused on driving sales are giving up their desks to executives who are change agents, who can instil a bottom-line focus, and who are true marketers leading the company into new opportunities in emerging markets, especially in Asia.
The pressure is coming from the customer, hospitals that have shifted from being clinical to financial buyers. Products that used to be sold directly to surgeons or physicians are now purchased by procurement groups and hospital committees.
“The more the product is commoditised, the higher the price pressure,” says Hagle.
Market dynamics are forcing the new CEOs to reassess products in a new light, challenging research and development on planned product features.
“They have to ask if a product really needs all the bells and whistles the company can offer, not only from a user’s point of view, but under the scrutiny of health economics,” she says, suggesting that “maybe they can build a Rolls Royce, but perhaps all that is needed is a Ford.”
The move towards emerging markets will force a streamlining of product design with fewer sophisticated features, and will encourage companies to develop a globally more homogenous product line.
Working with a new cast of characters
In the new world of health technology economic assessments, cheaper is not the only answer.
New products from R&D can shoot for higher standards as long as that product can measure up against increasingly demanding requirements, according to Joerg Vienken, Vice President for BioSciences at Fresenius Medical Care.
“Higher quality is related to a higher price,” he says. But winning that price “brings new kinds of actors into the space, ones we might not be thinking about yet, such as quality managers.”
François Berger, MD, says he regrets overlooking these new actors when planning the new Clinatec centre that opened in Grenoble, France, in December 2011.
A professor of oncology at Grenoble University Hospital, Berger is also Director of Clinatec, which he describes as “a unique conjunction of technologists and engineers, biologists and practitioners.”
Dedicated to creating highly innovative nano-devices for diagnosing and treating neurological disorders, the new 50,000-sq-ft facility is fully powered with high-end imaging systems, multiple development labs and a fully accredited operating room. It brings together teams of experts from diverse sciences.
Yet if he had to do it all over again, Berger says he would bring in more bureaucrats.
“We underestimated [the need for] participation early in the process of regulatory expertise, medico-economic assessment, quality control and quality management,” he says.
Increasingly, including these capabilities is crucial to de-risk medtech projects, he adds.
“Just because a product is innovative, even if we have validated the project preclinically, it is not necessarily going to be welcomed by a large medical device company,” says Berger, unless the developer can show a regulatory pathway and make a case for reimbursement.
Another player who needs to be involved early on when developing new medical technologies is the customer, he says.
“The traditional medtech model no longer works,” he says. “We are successful at developing products from a technical point of view. We know how to get the CE mark. But without the involvement of doctors, these products [will be] missing a lot of elements needed in the clinic.”
As a result, many projects are being financed for development in Europe but “few deliverables are validated and have an industrial value,” says Berger. “The problem is that these devices are funded for a prototype but are not financed for preclinical development and are poorly adapted to medical reality.”
Now, it’s personal
The million-dollar research work in medtech has always seemed like the poor cousin to the billion-dollar efforts in the pharmaceutical industry.
Yet, as medical treatment becomes more personalised, the two industries are converging.
There are already examples of this biotech-medtech fusion. In the well-funded field of oncology, we have seen biomarkers that illuminate a tumour to facilitate a biopsy performed with medical devices. And nanoprobe devices are being developed to deliver pharmaceutical therapies to precise locations within the body.
The profound impact of companion in vitro diagnostics, combining microfluidics with chemistry and biology on lab-on-chip devices, has now altered the course of drug development.
We will see more collaborations as the man-machine interface reaches the cellular and even the molecular levels.
Both Vienken and Berger are focused on surface interactions, the moment where man-made materials created by engineers such as polymers trigger reactions of natural cells and molecular reactions, areas of expertise for biologists.
Another opportunity to adapt medical devices to the individual needs of patients circles around the development of innovative new sensors, according to Vienken.
“We will only be able to manage what we can measure, and we can only measure if we have sensors of all kinds—for blood pressure, allergies, infections or individual behaviours—to identify acute behaviours,” he says.
The market opportunity is enormous, he adds. “As we do not have the people needed to provide care for a growing population of elderly citizens, we will need to support the staff with medical devices.
“This support is only possible if you have sensing technology, which is connected to a transmission technology, like mobile phones,” says Vienken. “This transmitted data needs to be actionable, so we need IT, but it cannot be centralised, so it needs to be proximate to the devices. This requires miniaturisation of electronics. We also need safety controls, algorithms. It soon becomes a complex technology.” It also complicates the ability of a co-located, collaborative team to work together.
“There needs to be a shared working language. As an engineer, you must be able to express yourself in a way that a medically trained person can understand. Jargon and abbreviations become a barrier to understanding,” says Vienken. “Those companies who can find a common language among different disciplines will be successful.”
“This is a revolution,” says Berger, who acknowledged that putting together a team of engineers and medical biologists took two years at Clinatec before they understood each other well enough to accelerate the work processes.
The future is always a work in progress.
is a freelance writer based in Paris covering the medical technology industry.