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Scarless Option in Brain Surgery Makes the Cut

“By performing surgery through the eye socket, we eliminate the need for a full craniotomy, gain equivalent or better access to the front of the brain, and eliminate the large ear-to-ear scar associated with major brain surgery,” says Chris Bergeron, MD, assistant professor of surgery in the head and neck division at UC San Diego Health System. Bergeron says that the technique also protects neurovascular structures such as the optic and olfactory nerves.

Patients underwent the TONES procedure to repair cerebral spinal fluid leaks, optic nerve decompression, repair of cranial base fractures, and removal of tumors. Given further research, the surgeons believe that TONES may serve as a means to treat pituitary tumors, meningiomas, and vascular malformations. TONES is currently performed at only two institutions: UC San Diego Medical Center and the University of Washington Medical Center.

In a traditional craniotomy, a large portion of skull bone is removed. With TONES, the area of bone removed is only two to three centimeters. The operating time is much shorter since the skull does not need to be repaired and there is no need to close a large incision.

To achieve access, the surgeons make a small incision behind or through the eyelid. A tiny hole is then made through the thin bone of the eye socket to reach the brain. This pathway allows repairs to be made without lifting the brain. The TONES approaches protect the optic and olfactory nerves, as well as the carotid and ophthalmic arteries. The study participants have observed reduced pain and a quicker recovery time.

Transnasal surgery, a technique performed through the nose, offers similar access to some areas of the brain but means a more crowded operating environment for the surgeon than TONES. Kris Moe, MD, chief of the division of facial plastic and reconstructive surgery and professor of otolaryngology at the University of Washington Medical Center, pioneered the TONES method in 2005. He says the technique builds on the nasal approach, which usually requires four sets of hands, but offers increased maneuverability and visibility for the surgical teams.

Researchers included Kris Moe, MD, Chris Bergeron, MD, and Richard Ellenbogen, MD. The findings were published in the September issue of Neurosurgery.

Biosensors Bring Possibility to Personalized Medicine

Associate professor Muhannad Bakir (left) holds a prototype electronic microplate, while professor John McDonald holds an example of the conventional microplate.

Essentially, the technology would replace multiwelled microplates that have been used in biomedical research and diagnostic laboratories. These traditional devices test multiple samples for response to chemicals, organisms, and antibodies.

McDonald says that the devices using the microelectronics “could quickly detect in individuals the gene mutations that are indicative of cancer and then determine what would be the optimal treatment.” He says potential applications cannot be explored with current analytical and diagnostic technologies.

Fundamental to the new biosensing system is the ability to electronically detect markers that differentiate between healthy and diseased cells. These markers could be differences in proteins, mutations in DNA, or specific levels of ions that exist at different amounts in cancer cells. Researchers are finding that such minute differences could be exploited to create fast and inexpensive electronic detection techniques that don’t rely on conventional labels.

The Georgia Tech team’s goal is to create a sensing platform technology that uses nanoelectronics and 3-D electronic systems to aid microplates in detection and diagnosis. The 3-D sensor arrays are fabricated using conventional low-cost, top-down microelectronics technology. Although existing sample preparation and loading systems may have to be modified, the biosensor arrays should be compatible with existing work flows in research and diagnostic labs.
Separating the sensing and processing portions allows fabrication to be optimized for each type of device, notes Hyung Suk Yang, a graduate research assistant also working in the Nanotechnology Research Center. Without the separation, the types of materials and processes that can be used to fabricate the sensors are severely limited.

Shown above is an electronic microplate in front of the technology it aims to replace, the conventional microplate.

So far, the researchers have demonstrated a biosensing system with silicon nanowire sensors in a 16-well device built on a 1 × 1-cm chip. The nanowires, measuring 50 × 70 nm, differentiated between ovarian cancer cells and healthy ovarian epithelial cells at a variety of cell densities.

Silicon nanowire sensor technology can be used to simultaneously detect large numbers of different cells and biomaterials without labels. The platform could accommodate a broad range of other sensors that may not have been invented yet. Ultimately, hundreds of thousands of different sensors could be included on each chip, enough to rapidly detect markers for a broad range of diseases.

Key features of the platform are that sensing is done using low-cost, disposable components, and information processing is done by reusable conventional integrated circuits connected temporarily to the array. Ultra-high-density springlike mechanically compliant connectors and through-silicon vias make the electrical connections while allowing technicians to replace the biosensor arrays without damaging the underlying circuitry.

The sensitivity of the tiny electronic sensors is potentially more efficient than current systems, thereby enabling earlier disease detection. Sample wells would be substantially smaller than those of current microplates—allowing a smaller form factor and more testing with a given sample volume.

Although many technical challenges remain, the ability to screen for thousands of disease markers in real time holds significant appeal. “With enough sensors in there, you could theoretically put all possible combinations on the array,” McDonald says. “This has not been considered possible until now because making an array large enough to detect them all with current technology is probably not feasible. But with microelectronics technology, you can easily include all the possible combinations, and that changes things.”

Papers describing the biosensing device were presented at the Electronic Components and Technology Conference and the International Interconnect Technology conference in June 2010. The research has been supported in part by the National Nanotechnology Infrastructure Network (NNIN), Georgia Tech’s Integrative BioSystems Institute (IBSI), and the Semiconductor Research Corp.

Do GPOs Help Or Hurt? Depends on Who You Ask

First, in late September, the Government Accountability Office (GAO) released a study that was heartily supported by HIGPA. Through interviews with six GPOs and several hospitals and device vendors, GAO concluded that group purchasing increased transparency and encouraged low administrative fees and discount pricing as a result of aggressive codes of conduct and other voluntary accountability initiatives. The report findings “confirm what the 8th Circuit Court of Appeals, U.S. Department of Justice, Government Accountability Office, the Federal Trade Commission, and American hospitals have already found—GPOs reduce costs for hospitals,” said Curtis Rooney in a statement. Rooney serves as president and CEO of HIGPA.

About a week later, MDMA released its own report, conducted by Robert E. Litan, a senior fellow in economic studies at the Brookings Institution, and Hal J. Singer, managing director and principal at Navigant Economics. This report states that GPOs often operate according to a compensation system that provides incentives to keep prices artificially high.

The study examined a database of 8100 hospital transactions from 2001 through 2010. Its findings indicate that when the hospital purchasing process was exposed to greater competition, hospitals were able to achieve savings up to 18% off the GPO price achieved on average for 2010.

The study authors noted that eliminating antikickback exemption for GPOs (which allows them to accept fees from device makers) would save hospitals as much as $37.5 billion per year and cut taxpayer costs by $11.5 billion. Critics contend that the antikickback exemption has created relationships with large firms and don’t help smaller companies out of the process. The result, conclude researchers, is an unfair limit to patients’ access to treatments.

“This study bolsters our argument that Congress must pass legislation that will restore the illegality of kickbacks between suppliers and GPOs,” Mark Leahey, president of MDMA, said in a statement. He added that the current GPO model adds billions of dollars in unnecessary costs to the to healthcare system.

Rooney, however, has implied that this research is colored by industry backing. “An MDMA-funded ‘study’ suggesting that device manufacturers would voluntarily reduce their prices and their profit margins under a new GPO model is a slap in the face of the more than 90% of America’s 5000-plus hospitals that use GPOs,” Rooney said. “The device industry attacks GPOs because we are working for hospitals.”

Industry Speaks Out at Town Hall Meeting

Predictably, many speakers bemoaned the current review process and the lack of clarity surrounding it. Venture capitalists argued that the regulatory uncertainty has cost the device industry in the way of investments and VC funding. Victoria Pearson of Medtronic said that industry needed more clarity on the substantially equivalent component of the 510(k).

AdvaMed’s Janet Trunzo reiterated the group’s position on the 510(k) program and proposed changes to it—namely that the system is well designed and that many of the changes aren’t necessary. “[Some recommendations] could chill device innovation and the flow of improved products to patients,” she said.

Other attendees also questioned the need for many of the changes. Several speakers, including Kevin McNerney of the Orange County Medical Device Network and Jack Dhuwalia of JD Consulting, wondered why the current 510(k) process was being vilified.

Shuren maintained that the changes should help the system become more predictable, consistent, and transparent. And as he went through the volley of audience questions, he did so with a sense of humor that has become typical. “That [question] is for the center for drugs, which by the way is the evil empire,” Shuren joked after a drug-related query from the audience.

“Our intent is to strengthen the program,” Shuren said. “The intent is not to dramatically raise the bar for device approvals.”

But even when devices are approved, there may be a long wait. “A 30-day 510(k) doesn’t seem to exist anymore,” said Joe Panetta, president of BIOCOM, a Southern California life science association. Further, he said, it was doubtful that all of the proposed changes would help, and that some of them would lead to overreporting to the agency or legal breaches.

According to Mark Deem, a partner at venture capital firm The Foundry, “the single biggest contributor to the fear and uncertainty within the financial ecosystem that supports us is uncertainty in dealing with FDA. Across our portfolio of companies, we’ve seen the full gamut of their experiences in dealing with the agency: the good, the bad, the ugly.”
CDRH reviewers were sacrificial lambs at the meeting and were blamed for a host of problems. Deem cited uncommunicative reviewers and their unreasonable data requests as part of what’s plaguing the center. “It seems to me that many of the regulatory problems that are being discussed today are human problems.”

Jack Dhuwalia of JD Consulting spoke of “a widening gap between the industry and FDA.” Part of the problem, Dhuwalia said, was “arbitrary and capricious questions” from reviewers.

Richard Eaton of the Medical Imaging & Technology Alliance noted that reviewers needed more training on elements such as split predicates. Trunzo echoed support for increased “reviewer training and management training.”
Shuren admitted that when he started working at the center, there was no reviewer training program in place. But he also said that “this isn’t about a few reviewers deciding to make decisions on their own, and it’s just about managers getting on top of them, and everything will be better tomorrow.” Rather, this is “a much more complicated problem.”

CDRH hopes to have a plan in place by the end of the year to deal with the 510(k) going forward.

The MX Q&A: Ted Driscoll, Claremont Creek Ventures

The cofounders of Tibion Bionic Technologies may want to send a thank-you note to Will Smith for helping their start-up get off on the right foot in 2004. Ted Driscoll, a technology partner at Claremont Creek Ventures (CCV) in Oakland, CA, says that Smith’s “I, Robot” was in movie theaters when he first saw a lab demonstration of Tibion’s Bionic Leg. Driscoll recalls being impressed by the device’s capacity to provide enough force “to lift a person out of a chair,” its unique lack of resistance when turned off, its computer-guided technology, and the 25 or so patents.

But the technology zeitgeist also played a role in CCV’s decision to invest venture capital funds in the start-up that was cofounded by Tibion’s chief technology officer, Robert Horst. “I, Robot” was packing theaters, and “there was a lot of talk about bionics,” Driscoll says. Sold on the applied technology, the VC executive realized that a robotic body part was no longer confined to the fictional realm of big-screen blockbusters “They could actually do this,” Driscoll thought.

Six years later, Sunnyvale, CA–based Tibion is set to finalize a $15-million B-round investment, and the Good Shepherd Rehabilitation Network in Allentown, PA, has become the first healthcare system in the United States to use the FDA-approved device. Stroke patients at the Whittier Rehabilitation Hospital in Haverhill, MA, are also using the leg, while Stanford University and UC San Francisco are conducting research with it. The leg is not a prosthetic but a rehabilitation device that patients wear during therapy until they relearn how to walk on their own.

In addition to his position as a CCV technology partner, Driscoll is an active angel investor in the Life Science Angels and a founding director of the Sand Hill Angels. Before becoming a VC investor, Driscoll helped found five imaging-related companies, including Be Here Technologies, where he was CEO. He also was responsible for MRI, ultrasound, digital x-ray, and related technologies as division president and CTO of Diasonics. At Diasonics Driscoll directed the team that developed the first commercial MRI scanners.

Holder of more than 40 U.S. and foreign patents, Driscoll received a PhD in digital imaging from Stanford, a masters degree in computer graphics and remote sensing from Harvard, and a bachelor’s degree from the University of Pennsylvania. CCV continues to be Tibion’s “anchor investor,” says the VC executive. Besides discussing why Tibion knocked his socks off, Driscoll talks to MX about what he looks for in a potential device company, the importance of securing IP rights, CCV’s view of the investment climate, and what’s in a name.

MX: As an investor in medical device start-ups, what elements do you look for that convince you to either pony up or not?
Ted Driscoll: The first thing I’m trying to look for is a market that has some venture scale to it—something that I can scale to a venture return. We don’t want to come up with a device that serves only left-handed Lithuanians; we can’t necessarily make a sufficient return to justify the time and money. We are looking for deals that will, first of all, justify the years we will put into them and the millions of dollars we will put into them. So we need to make multiple millions of dollars back to justify that. That’s a key one.

I’m also particularly interested in technologies that are unique and [IP] protectable, as opposed to just “me-too” technologies.

Generally speaking, what draws you to invest in the medical device industry?
I also find it very important that the entrepreneurs be able to succinctly and directly describe what they’ve got. This is related to [questions] one and two together. In other words, if the entrepreneur can’t …get me interested and explain what he’s got and isn’t able to describe why it’s unique and why it’s important, then he won’t be able to convince other people to invest in it.

With that in mind then, what attracted you to Tibion?
First thing, they showed us a technology capability that I had never seen before: a knee brace that could provide hundreds of pounds of force to lift a person out of a chair, even a heavy person out of a chair….

Second, it would swing back and forth like a pendulum. It didn’t have resistance. Most braces I’d seen in the past that had a hydraulic system that gets that much power meant that you do get resistance when it was turned off. When it wasn’t giving power, you got resistance. You’re effectively pumping a fluid in and out of a piston. What this machine could do—and I was seeing it on a bench in their laboratory—it was capable of lifting a 250-lb weight, but when it was turned off or sensed that it wasn’t needed, it could move back and forth like a pendulum.

That was unique. I had never seen that before. They had very good patent protection for it; something like 25 patents for that. That was interesting. At the time the movie “I, Robot” was in the theaters. There was a lot of talk about bionics and things like that. And I suddenly thought…they could actually do this. This isn’t a movie thing any more…. All the pieces to make a bionic leg were now available. These guys had bionic arrangements that could do something unique and protectable. We were impressed by that technology, and we were the first institutional investors in the deal and continue to be their anchor investor.

How important is airtight IP protection in making a decision to invest?
I tend to be old school in that I need to look at that.

Others don’t?
I think in this day and age of Web applications becoming companies, it’s harder to make an IP case about your product. It’s hardest to apply to software patents. I have a way I express it: Not having good IP protection is submitting yourself to something called a “success tax.” What I mean by that is if your company fails, nobody cares. But if your company is successful, you have to pay a “tax” [if you haven’t secured your IP, because you may have to sue to protect your rights, for instance.]

Out of 10 medical device concepts or technologies how many would you say are actually viable or worthy enough to attract VC investment?
Let me answer that question in two parts. How many do I think will get invested in by somebody? I would say two out of 10. We, however, have a certain focus. We are looking for things that are more capital-efficient, more IP-oriented, that have a computer in them. I would guess we’re investing in fewer than one in 10. Our investment focus [is different from] the overall industry’s investment focus.

Do you sometimes find that the device technology is sound but the inventor or principals lack business savvy or good business plan?
Yes. Or the start-up team may be missing some important component as they commercialize. They might not have good marketing and sales, for example. Most early start-up teams tend to be strong in technology because [that’s what their focus has been.] As early-stage investors, we first look for good, protected technologies in big markets, and we do care if the entrepreneurs are experienced and knowledgeable. But we expect to do some company construction. We expect to help build the team.

How would you describe the VC investment climate at present? Have VC firms been more discerning or even skittish?
I think you could say they look like they’re more discerning or skittish. I think what’s really happening is the investments they made a few years ago are taking longer to reach profitability. They’re taking more cash, and therefore VC firms have to preserve more cash for their existing companies and are making fewer new investments.

Do you see any changes then for VC companies going forward?
You need to see some return on previous investments…. I think the overall VC community will open up and invest more aggressively. Now, Claremont Creek Ventures is a little different. We’re a younger fund, and we raised money in 2008, so as a consequence, we are as active as we were in 2005 and 2006, whereas the overall VC community maybe is doing less early-stage investing because they’re preserving capital for existing companies.

How do you go about finding medical device companies, or do they find you?
There are a variety of pathways. We go to a lot of conventions and appear in pitch sessions with the local entrepreneurs where people pitch us. I’m also a member of four different angel [investment] groups and look at their deal flows frankly. A lot of the good deals come from people we already know from the past or have invested in the past successfully.

Let me put it this way: It’s very rare that a deal gets thrown over the transom unsolicited by e-mail in the early morning. I don’t think that we end up investing in those. I don’t think that has ever happened.

How do awards such as the recent MDEA that Tibion received help a device company, if at all?
I think it gives you visibility. Those [awards] are trailing indicators, not leading indicators, that are the result of having gotten investment, not a precursor to getting it. I can’t say that alone would make the difference in our pulling the string on an investment. But it’s certainly a positive, and it helps.

What effect has the passage of healthcare legislation had on the device industry and on the investor community?
I think it’s real early. This healthcare act is not fully in effect, so I think it’s a little early to say what the result will be. But I know that in our research on start-ups they’re now paying a little more attention to the issue of outcomes and reimbursements and the economic analysis associated with it. That’s because of the things the healthcare legislation is trying to emphasize, like outcome. We are paying more attention because in the future companies are going to have to make that case.

How was the FDA approval process for the bionic knee?
The bionic knee is similar to other external knee braces. It’s what’s known as FDA Class II exempt. That means we just had to certify in a letter to FDA that this device had little or no prospect of hurting someone; it could only help them. As long as we have good manufacturing principles and make no extraordinary claims that it cured psoriasis or something, we could go to market. It’s known as a “letter to file.”

How much does it cost, and how has the reimbursement process been?
There are two ways in which you can acquire a Tibion knee. One is to buy it outright as a piece of capital equipment. It’s approximately $36,000 retail; you’re probably looking at $40,000 or so if you buy it with disposables. The alternative is pay-as-you-go. It’s like a lease arrangement. You pay on a monthly basis. In fact you in effect rent it from us.

There are reimbursements for the use of the knee brace for a one-hour stroke rehab session. There’s a standard [reimbursement] code. The idea is that they can do more patients because with the knee on the patient doesn’t require two rehab specialists, only one. Today with stroke patients they need another specialist because the patient could fall over. They have to be able to catch him. In effect, they get an increased number of patients coming through [the rehab center.] The idea behind paying on a monthly basis is that [the knee] is paid for by the increased reimbursements they receive at the rehab clinic or hospital.

We are just launching that process now, which is renting to purchase. This is a fairly expensive piece of capital equipment. It’s a long sales cycle because you have to convince not only the clinic but also the CFO and then convince the financial people, and the reimbursement manager, and they have to go look at a big spreadsheet to make sure they have the money to pay for this piece of capital equipment. It’s a much easier [acquisition] process, and it also generates a recurring revenue source for Tibion.

What experiences did you derive from your previous executive positions that have helped you with medical device investing?
First of all, my medical device experience was in developing MRI scanners. I’m certainly familiar with the capital equipment issue, the long sales cycle. I was very happy to see that these guys at Tibion know that the knee brace could be used in a recurring revenue model—to in effect rent it. The other thing I learned from working in medical devices…is an understanding of the politics of the medical care system. You can’t, for example, sell a product that allows a radiologist to do a procedure that used to be done by a cardiologist. If you give a radiologist a product that allowed him to do procedures done by a cardiologist then the radiologist will get more revenues and the cardiologist will get less. That means it will get very difficult to sell the product because cardiologists are very important in a hospital. There are a lot of politics [and a need to understand] how the specialties interact in a hospital and who holds power. An obvious example is a product that allows a nurse to do cardiac surgery.

I would say that’s one of the things I bring. [I have long experience] in medical device investment and in understanding the politics and money flow in hospitals.

What do you see as the biggest challenges for the device industry, say, over the next three to five years?
I think we’re going to have to make sure that the devices being introduced to the marketplace do actually improve outcomes. In other words, they aren’t just sort of whiz-bang, cool shiny new devices that seem like they should work but maybe don’t. Actually, we’re going to have to be prepared to do that and respond to, frankly, the 30 million new patients. We can’t afford to use throwaway catheters at $1000 per catheter for every single one of them. Web site has a few reviews of Claremont Creek Ventures by prospects who were less than flattering about their experiences during pitches. How do you view these types of sites? Do you find them helpful? Annoying? Sour grapes?
As you probably know, most of these are referred to as “the” Most of the time, like everything you see on the Web you’ve got to read it with a grain of salt. I don’t pay much attention to it.

I’ve made the observation a number of times that VCs typically invest in fewer than 1% of the companies that they see. That means they’re saying “no” 99% more than they’re saying “yes.” By definition. I actually wrote a post on the Claremont Creek blog about what “no” means. It doesn’t mean you’re stupid. I try to help people…. If you’re good as a VC, you try to give people of indication of why you turned them down.

How important is finding the right name for a new device company?
I’ve started five or six companies, and I’ve had to pick at least three names. I’m aware of the issue. First thing I say to people is you do need a handle. You do need a name so when we talk we’re not talking about “that-deal-the-guy-came-in-on-Tuesday-and-talked-to-us-about.” I think it helps to have picked a name that’s somewhat descriptive of what you’re doing. Avoid doing a name with a lower-case “I” that ends up “tronics.” There are just so many of those that they just blur together. I think if it’s nice-sounding name with a nice connotation it definitely helps getting funded.

Do you have to do extensive name searches?
Nowadays there are Web sites that spit out names. I will peek at a thesaurus. There are groups that like to find biblical names and there are groups that like to find Latin names. Frankly, with a lot of entrepreneurs from Southeast Asia you see a lot of Indian names and companies named after some Sanskrit word for “efficiency” or something like that.

I think a name is important, and I think it’s worth paying attention to. Once we picked a name and two weeks before we launched we found it had already been taken by another company. So, when you pick a name, check it out immediately, and make sure you get it filed.

More on Concurrent Engineering

Design for Manufacturability & Concurrent Engineering; How to Design for Low Cost, Design in High Quality, Design for Lean Manufacture, and Design Quickly for Fast Production
David M. Anderson, PE, CMC. CIM Press, Cambria CA 2004

Revolutionizing Product Development—Quantum Leaps in Speed, Efficiency, and Quality
Steven C. Wheelwright and Kim B. Clark
The Free Press, A Division of Simon & Schuster, Inc. New York, NY 1992

Concurrent Engineering Effectiveness: Intergrating Product Development Across Organizations
Mitchell Fleischer and Jeffrey K. Liker
Hanser Gardner Publications, 1997

Return to "Accelerating the Product Developement Cycle."

Wrist and Reward for Stents

This Week In Brief: October 26, 2010

BeamOne LLC (San Diego) has officially opened the doors to its new Pittsburgh-area medical device E-beam sterilization service center. The facility will provide sterilization services for single-use medical devices.
The Web Marketing Association has honored Donatelle (New Brighton, MN) with the Manufacturing Standard of Excellence Web Award in recognition of the company's Web site, which was launched in April. The company specializes in the development and manufacture of components, finished assemblies, and implants.
Erie, Pennsylvania-based custom injection molder Plastikos and its sister company Micro Mold, which specializes in medical mold building, have completed a cooperative facilities expansion with the intent of improving efficiency and increasing production capabilities. Along with the addition of two presses, the Micro Mold facility will now house the majority of all R&D work for Plastikos and Micro Mold, including tool sampling, engineering sampling ,and materials sampling.
Perfecseal (Oshkosh, WI), a division of Bemis, is the recipient of the Society of Plastics Engineers' 2010 gold medal for roll-fed, thin-gauge medical thermoformed parts. The company was honored for its 100% recyclable Ascent Gyrus thermoformed tray, which features an engineered snap-fit design that uses strategically located aggressive undercuts and gussets to hold a surgical device in place without requiring a separate retainer.
DuPont Packaging (Wilmington, DE) has announced a call for entries for its 23rd DuPont Awards for Packaging Innovation. Entries will be evaluated for excellence in packaging innovation, sustainability, and cost/waste reduction. There is no fee to enter and DuPont materials do not need to be in the packaging structure. The deadline for entries is February 28, 2011.

Accelerating the Product Development Cycle

The supervisor has called a meeting. After everyone trickles into the conference room, trades small talk about last night’s ballgame and the kids’ school projects, fills their coffee mugs, and settles into their seats, the supervisor looks up from his PowerPoint presentation and finally speaks to his subordinates. “We’re going to meet all day—every day—until we figure out why no work gets done around here,” he tells them.

Like many workplace jokes, this groaner has the sting of truth in it, and it’s a truth that applies to medical device manufacturing as much as any other industry. Meetings, of course, are necessary vehicles for sharing information and for planning. Just as often, however, they stall innovation and become ends in themselves.

What if there were a way to accelerate the development of new products by minimizing the need for formal gatherings, improving meeting efficiency, and streamlining the entire process from design through engineering to the finished device or component?

Concurrent engineering is that vehicle. The concept offers a fluid approach to product development by fully integrating all department functions from the very beginning of a project. In a world of tight budgets and fast time to market, accelerating the design process in order to get the work to the production floor is the difference between introducing a new device in 12–18 months.

Although concurrent engineering is important in the development of any new product, it is essential in the design of medical devices. In medical device development the main goal is the release of products that are safe and effective for patient use. Therefore, the understanding of intended use is critical at the early stages of development. In looking at different vantage points from engineering design, regulatory compliance, project timelines, or manufacturability, concurrent engineering gives the development team early insight into the verification and validation stages. By being able to understand product function and reliability, or sterilization and biocompatibility requirements, or manufacturing materials and processing issues, the team has a more-structured and more-predictable approach to the design verification outcome. This approach results in efficient scientific tests that lead to final validation results. Ultimately, it helps meet product management timelines and release of the product, without subsequent testing.

Much has been written about concurrent engineering, mostly about the technical science and conceptual model (see the sidebar “More on Concurrent Engineering”). We’ve seen flow charts and diagrams about how it works. But at its very core, concurrent engineering is about connecting people from multiple disciplines at multiple stages of a project. This connection should be facilitated by the physical layout of the building, the cultural underpinnings of the organization, and the model for conducting business.

The right physical layout is one that frees all associates to pursue calm, deliberative discussions outside the confines of the formal meeting room. This level of seamless interaction is best achieved by laying out the work environment to facilitate ease of communication. Ideally, the footprint of the building from cubicle to cubicle and function to function should allow a production manager, for example, to stand up in her cubicle and ask her colleagues in planning and material management a question regarding the delivery of materials. Meanwhile, the QA manager a few cubicles over may overhear her and remind planning that he would like to schedule a meeting with their supplier. A well-thought-out layout also encourages impromptu meetings to resolve real-time issues in simple, collaborative, and time-efficient ways. Ten minutes with the right three people can solve many problems.

Completely In Sync

Concurrent engineering practices entail examining the way the entire business is conducted, including first customer contact, project feasibility, proof of concept, design and development, verification, and validation.
Being able to walk down an aisle to the far end of the building to discuss work-related matters is a good example of this open-architecture approach in action. Although it’s not unique to have a whole department sitting in one area, it’s important to have complementary departments sitting near each other. Figuring out the right functional placement for each department, such as business development to engineering and engineering to quality assurance and regulatory afairs (QA/RA), is critical and is specific to each company.

Such a culture of open communication in the everyday working environment is also beneficial to formal meetings. The conference room discussion becomes more concise and technically focused. The workplace layout leads to better logistics, which increases the level of communication, creating a more fluid and efficient corporate culture both inside and outside the meeting room.

Regulatory Focus

Whatever the setting for effective communications, the concurrent engineering concept also applies across departments, with QA/RA playing a central role. It entails an understanding of the part each employee plays in design and manufacturing in order to reduce the development cycle while ensuring that all products are safe, effective, and reliable once they reach the OR, doctor’s office, or home.

A key element is to design new products with regulatory guidelines in mind. This includes factors such as material biocompatibility, sterilization validation, design verification testing, and process validation. It also includes complete documentation for the design history file.

Given the importance of QA/RA to this best-practice approach, it is crucial to first understand the regulatory requirements of each new product and then evaluate the administrative and financial impact the requirements have on the development process. This evaluation may include special testing, registrations, licensing, design dossiers, and approval from regulatory agencies.

In concurrent engineering, business tasks should work as a function of time. This chart demonstrates at what point in the process departments should be involved in product development and what their expected duties entail.

The importance of QA/RA’s early involvement during the initial evaluation of a customer’s product can be seen in a real-life example involving the design and manufacture of a handheld, battery-powered surgical spinal device. The power requirements demanded a large grouping of lithium cells to meet the device’s speed and torque requirements. In this case, one battery would have been classified as hazardous material. This classification meant that special certification, training, and transportation would be required to handle each battery, all the way down to normal handling by the sales force. This limitation was discussed with the customer, who quickly changed the design requirement to an alkaline battery type to eliminate the restriction.

In the concurrent engineering concept, all department functions are involved in the first, or feasibility, stage of the project. This coordination becomes critical in the second, or proof of concept, stage. In the second phase, communications and documentation give manufacturing the opportunity to evaluate the product design to determine whether any new technologies or production methods will be needed to fabricate the device or component. In addition, the materials group is brought in to determine the effect on the supply chain, to evaluate new technologies, and to see whether new suppliers will be needed. Regarding timelines on a new product, it’s necessary to first perform a product feasibility study and estimate how long the entire development cycle will take, and then calculate a release date.

Design Control Emphasized

The primary trend affecting medical device development cycles involves regulations. Over the past five years, both U.S. and international regulatory guidelines have changed to emphasize design control requirements and documentation, supplier controls, and programs for corrective and preventive actions. The regulatory environment has shifted to a point at which business development, engineering, and operations must each fully understand and comply with regulatory guidelines in the development of a new product, further increasing the importance of concurrent engineering.

This change ultimately affects all departments from the initial phases of design to production and distribution. It is necessary to continually update all employees with these regulatory changes, revise procedures accordingly, and retrain workers in the aspects of the revisions that affect their job functions.

Concurrent engineering thrives on open communication between all employees, including the key connection between the engineering and manufacturing teams. One major opportunity to benefit from this connection occurs during the design verification phase when the production team is building devices for the first time. It’s the perfect chance for the engineers to capture the nuances of each assembly step and build them into the final release of the assembly and test procedure.

Companies that do not take advantage of concurrent engineering practices during design verification may see unfavorable results. When this connection is missed, production adapts its assembly process to blindly follow the methods and instructions from the stated procedure, causing engineering to lose visibility of potential improvements or corrections it could make in the design or assembly procedure. This practice can result in inefficiencies that remain in the manufacturing process for years to come.

Concurrent engineering doesn’t stop when the product is designed but continues with the manufacturing force through cross training. From a production standpoint, it is important to lay out the manufacturing floor in a way that optimizes workflow and efficiency. Manufacturing cells should facilitate cross training. Multiple jobs should be run through certain setups so that the production manager can look across the machine floor and observe the entire scope of manufacturing operations. This approach allows managers and employees alike to see immediate gains in efficiency.

A hanging dispatch board is another useful efficiency tool. The board’s colored boxes track the status of each job, making two weeks of staged operations visible from one vantage point. The board allows manufacturing employees to see all the jobs and their sequencing from machine to machine, with the prioritization built in.

Out of the Gate

The essential benefit of concurrent engineering is accessibility. Every employee in the office and on the floor knows the priorities and understands the proper sequence of events and the focus required on a certain project to shepherd the device from the design stage to the manufacturing plant in an appropriate way.

Every element from the capture forms at the beginning of the process to the product spec sheets to the product timelines works hand-in-glove with the business model. Even the financial collection points along the way are built into the operating template. Out of the gate, both the customer and the manufacturer know which event comes first and which is going to be the 147th. With an integrated business model and product development process, concurrent engineering enables every department to contribute fully to the timely launch of a successful product.

Joe Rotino is vice president of QA/RA and acting vice president of engineering for Pro-Dex Inc. (Irvine, CA).

Innovation by Design: Taking Cues from Apple and the iPhone

Could diabetes-management devices someday resemble or even interact with iPhones?

Back in 2007, Amy Tenderich, founder of the popular blog DiabetesMine, attracted national attention when she wrote an open letter to Apple CEO Steve Jobs requesting that his innovative team try its hand at medical product design. The creative forces at Apple had managed to fuse functionality with feature-rich and attractive designs for its consumer products, Tenderich noted. Why then, she asked, can't that sensibility be translated to the design of life-critical devices? Although this concept of taking design cues from consumer electronics is not a new one, Tenderich's plea helped to initiate an industry-wide dialogue that is still going strong today.

In the wake of Tenderich's 2007 open letter, everyone weighed in, including my predecessor at MPMN. I put in my two cents a year later when Tenderich took matters into her own hands and launched a device design contest. And just this week, a Chicago Tribune health blog referenced Tenderich's frustrated sentiments and described some 'dream' diabetes device designs suggested by patients and inventors.

According to the blog post, Apple is still regarded as the paragon of design. However, its design influence has apparently gone beyond serving as the model for what medical device design should be; rather, a demand for iPhone apps or medical devices that interface with iPhones directly are cropping up.

This desire should come as no surprise, though. "If a medical device uses some of the same interaction metaphors as a consumer electronics product, then the medical device may be easier for the patient to learn and safer to use," Matthew Jordan of Insight Product Development (Chicago) told me in 2008 for my editorial. "Similarly, consumer electronic aesthetics, when applied to medical devices, may make the device seem more familiar and approachable for the patient." And what's more familiar and approachable these days than the iPhone?

The impact that iPads, iPhones, and smartphones in general have had on medical device design was actually a topic of conversation that arose when I recently visited the offices of design firm Logic PD while in the area for MD&M Minneapolis earlier this month. Brad Löhrding, vice president of product design, commented on how clients now frequently point to consumer products  such as cell phones and iPads when describing what they want in their products: a sleek, modern user interface, intuitive features, and a slim form factor. Basically, they want a critical device with all of the bells and whistles of a consumer one. While we were treated to eye-catching examples from the company's product portfolio, the evolution of product design and influence of consumer electronics became increasingly obvious. These were sexy devices, sure to be fawned over by end-users. But, as Löhrding pointed out at our meeting, applying consumer product design elements to medical devices is great for marketability and compliance. But if you don't have the functionality, someone's life is at stake.

What do you think about the impact of consumer product design on the device industry? Let me know in the comments section. --Shana Leonard