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Articles from 2011 In October


IN3 Summit Panelists Consider 510(k)'s Future after IOM Report

In a discussion titled “FDA, IOM and 510(k): Now What?” panelist Joshua Makower, MD captured the sentiment of many in the industry by doing the following: He first asked attendees directly involved in the device industry to raise their hands. Makower then asked those involved in the medtech sector if they had encountered frustration in dealing with FDA. Nearly everyone whose hands had been raised kept them up. Finally, he asked those from the industry if they felt FDA’s efforts to improve recently had paid off. Of the dozens of people who raised their hands in the first place, maybe one or two kept them raised at that point.

At that point, Makower added that the feedback from the crowd resonated with how he felt. In a small number of ways, FDA had made progress but there was still a lot of work yet to be done.

The Tenor of the Discussion

In addition to Makower, the panel included Joni Foy, acting deputy director for science and regulatory policy at FDA and Elaine Tseng, a partner at King & Spalding.
 
The discussion, as you might expect, began with a summary of the 510(k) process and the Institute of Medicine concerning it. Tseng said that the key finding of the Institute of Medicine report was fairly dramatic but from a day to day perspective, [she doesn't] think that the report is written at the level of granularity that would have that much impact," she said.

Foy said that although the agency isn't planning on throwing the 510(k) out as the Institute of Medicine advised, it is considering the remaining seven recommendations that the institute submitted. In fact, in some sense, FDA is already acting on them, Foy said. A report concerning the agency's plans regarding the 510(k) will be released "soon," Foy added.  

Foy explained that, according to the agency's internal research, FDA inappropriately requested information from device firms about 8% of the time. "So based on that, we've put some additional steps into place. When we see anomalies that are happening, we are capturing that," Foy said.

She also pointed to the CDRH Center Science Council, which she says will help the agency "have active dialogue." "We needed a fresh perspective," she added.

In addition, the agency has a entrepreneur in residence program that is "really looking at the innovation pieces," Foy said. "We are trying to enact steps to ensure that there is transparency and predictability." Another major goal of the agency is to "streamline" the approval process for products that are innovative, Foy added.

An Industry Perspective

When asked for his thoughts on FDA's attempts at streamlining the approval process and fostering innovation, Makower said that he thinks it's great that the agency is trying things like this. "I think it's also great where we have come to a place that there is an acknowledgement that there are some problems. There is a concern on the impact FDA is having on innovation." [Ed note: these comments echoed something Dr. Thomas Fogarty had also said: namely, "The FDA has finally woken up and realized what is happening in the United States to the medical industrial complex."]

Makower acknowledged that FDA was working hard. The agency's efforts are well intentioned but "perhaps not on target yet," he added. "The guidance documents that came out in the summer and early fall have the right headlines, but, in the details, there are concerns about caveats that would bring us right back to where we were before," he said, adding that through the comment process, hopefully, these issues would be resolved. 

He, however, didn't approve of the guidance on clinical trials.It is sort of putting a gold star on double-blind tests, which are extremely expensive and almost impossible for a manufacturer to realistically carry out, he said. "It is sort of unachievable from a financial or a practical standpoint.

As for the innovation pathway, Makower thinks "the language [describing it] sounds right" but the ideas aren't fully there yet. "I don't think [the currenty pathway] is scalable and it is expensive and will consume a lot of resources," he said. "As a way of fixing our existing problem, it's an expensive way to get there." He added that the pathway would only apply to a small number of projects and then asked "who is going to decide what's innovative or not?"

FDA should redouble its efforts on focusing on what is the most efficient and can demonstrate real returns early. "Some of these things [that are proposed] look like they won't have a benefit for a while," he said

Brian Buntz

Note: Check back soon for more from insights from the discussion.

Wireless Patient Monitors Crowned Fastest-Growing Medical Device

Wireless patient monitors are the fastest-growing medical devices based on revenue earned, according to "Remote and Wireless Patient Monitoring Markets," a recent report from market research firm Kalorama Information. Beating out such high-growth areas as minimally invasive surgical devices, specialty catheters, and defibrillators, wireless patient monitors have seen revenues doubled in the past four years and are forecasted to double again in the next four years as well.

Driven by an aging population, their contribution to cost cutting, and their ability to deliver information directly to electronic medical records, wireless patient monitors experienced an impressive growth rate of 23% between 2008 and 2010, the report states. "It is unusual to see over twenty percent growth in the tight, volume-buy medical device market," says Bruce Carlson, publisher of Kalorama Information. "The new wireless patient monitoring systems aren't facing these obstacles because they appeal both to the need of payors to cut hospital stays and to the need of providers to deal with reduced staff."

The report cites Abbot Laboratories, Draeger Medical, GE Healthcare, Honeywell, Medtronic, and Philips Healthcare as leaders in the patient monitoring device field. However, new entrants may gain market share if offering a truly useful, innovative device, according to the report. "This is a very scattered market with large players but also scores of companies with a small amount of market share, and some of that forecasted growth is going to come from innovators whose names we may not have heard yet," Carlson adds.

For more information on remote patient monitoring, telemedicine, and wireless monitoring, check out some related articles and blog posts from MPMN's archives.

Bacterial Communication Could Provide Key to Developing Nanoscale Medical Devices

Over the next four years, researchers at the Georgia Institute of Technology (Georgia Tech; Atlanta) will be studying how bacteria communicate with one another on a molecular level. The scientists' goal is to determine whether the principles of bacterial communication can be applied to how nanodevices will one day communicate to form nanoscale networks.

Headed by Ian Akyildiz, Georgia Tech professor of electrical and computer engineering, the research team hopes to pave the way for intelligent, communicative nanonetworks that could have wide-ranging and potentially life-changing ramifications. "The nanoscale machines could potentially be injected into the blood, circulating in the body to detect viruses, bacteria and tumors," Akyildiz comments. "All these illnesses--cancer, diabetes, Alzheimer's, asthma, whatever you can think of--they will be history over the years. And that's just one application."

Most nanoscale devices that currently exist are primitive, Akyildiz notes, but with communication ability, such devices could collaborate and form a collective intelligence. "We realized that nature already has all these nanomachines. Human cells are perfect examples of nanomachines and the same is true of bacteria," Akyildiz adds. "And so, the best bet for us is to look at bacteria behavior and learn how bacteria are communicating and use those natural solutions to develop solutions for future communication problems."

Bacteria use chemical signals to communicate with one another through a process called quorum sensing, which allows a population of single-celled microbes to work like a multicellular organism. Microbiologists are beginning to learn the 'languages' bacteria speak and what activities are controlled by this cellular communication. Many disease-causing pathogenic bacteria use quorum sensing to turn on their toxins and other factors to use against a host. Potential therapeutics are currently being developed by some researchers that are designed to disrupt quorum sensing by infectious bacteria.

"A single pathogenic bacterium in your body is unlikely to kill you," remarks Brian Hammer, Georgia Tech assistant professor of biology and a member of the research team. "But since they communicate, the entire group orchestrates this coordinated behavior using chemical communication, and the end result is that they work as a group to kill their host. So can we use that same information in a positive way by harnessing and understanding the limits of the communication?"

"What can bacteria say and hear, and how do they communicate to one another?" asks Faramarz Fekri, Georgia Tech professor of electrical and computer engineering and another team member. "Information theory research will examine these issues to pave the way for this new networking paradigm. This is really revolutionary research. No one has looked at these issues before. We are dealing with the big challenges."

At the end of the four-year project, the team hopes to demonstrate the basic and fundamental underlying theories explaining how nanodevices communicate. They also hope to develop a simulation tool for the public to use to see how machines can mimic bacterial communication, which will hopefully attract other researchers to get involved in investigating this area further.

For more information on this research, check out the Georgia Tech newsroom.

Finding VC Funding for Medtech Projects in a Tough Environment

cashAt the IN3 Summit held recently in San Francisco, a panel of venture capitalists shared their thoughts on the VC funding market. While acknowledging that the dust is still settling from 2008, there is still funding to be had—if your firm is well positioned.

The panelists were:
  • Evan Norton, director, venture investments at Abbott Ventures;
  • Gerard van Hamel Platerink, managing director, Accuitive Medical Ventures;
  • Rob Abrams, partner of Sanderling Ventures; 
  • David Cassak, VP of content at Elsevier Business Intelligence; and
  • Steve Levin, editor-in-chief of Elsevier Business Intelligence.
The panelists agreed that few VC firms are doing Series A investments these days. By contrast, there seems to be a strong push for later-stage investments because they represent a lower risk. “We like to work with later-stage companies given how long it takes to move things along,” one panelist remarked. In addition, most VCs like to see some clinical data when considering potential medical device investments. In virtually all of the Power Point presentations that are presented to VCs, there is a regulatory or reimbursement slide, one of the panelists noted. Companies seeking funding that have already made it through the long journey with FDA and are prepared to commercialize products are typically well positioned to find VC backing.

Looking to Be Amazed

Late-stage investments aren’t the only projects getting funding, however. “We hear people saying they won’t do early-stage but, [I recently spoke to several people who] said they would," said Gerard van Hamel Platerink of Accuitive Medical Ventures. He added that his firm has funded some early-stage projects recently. For example, the firm recently decided to fund a company based only on a PowerPoint presentation. “Every doctor we talked to about that idea said ‘That will never work, but if it does work, that will be amazing,’” he said. “That is what we look for.” Wowing VCs seems to practically be a requirement to find early-stage funding in this market, however. The idea you are presenting has to be interesting enough for the VC to want to own the asset. So it's important that your idea stands out from the crowd.

Companies Stuck in the Middle

Despite the difficulty early-stage companies face to find funding, it is, perhaps, even more difficult for companies that are somewhere in between early and late stage. There are many start-up firms that received funding early on but are in need of more cash to pursue their business strategy. “For companies in the middle, it’s very difficult,” a panelist explained. To help with the process, companies should sit down and figure out how much money and time it will take to before commercialization occurs.

General Recommendations for Attracting Capital

Startups that want to pitch ideas to VCs should plan to meet with them early on. There needs to be a clear strategic vision to attract funding. Although it wasn't mentioned specifically at the event, startups should be conduct a thorough freedom-to-operate assessment to make sure the technology being developed won't infringed on any patents. They should also clearly understand the benefits of the technology to the patient. Patients, as they become more active in educating themselves about their health, are wielding growing power in shaping the direction of their treatment.  
 
While thoroughly considering the viewpoint of the patient is important, so is understanding the perspective of the venture capitalists. “For series A folks approaching corporate folks, tailor your approach to your audience,” Evan Norton, director, venture investments at Abbott Ventures recommended. Really know your audience, he advised. Understand their interests and make sure that all of your reimbursement plans are thought through. “VCs don’t want to see a slide about how they will get a 12x return on the investment,” he said. “Consider what the product might look like in a significantly large medical device company. Think about what you can contribute to the company from a revenue standpoint.” Ask: “Is this idea going to move the needle?” If you start trying to think like a VC, you can anticipate the kinds of questions they will ask. And you’ll be able to provide better answers to them.
 
Although it is helpful to understand a VCs mindset, it’s not a good idea to try to come up with a financing strategy as a medical device firm. “It's very unusual for a company to come to us with a plan. Typically, we would do all of that financing work,” one panelist said. “These things happen in a way that is kind of hard [for non-VCs] to process.”
 

Related Content

Venture Capital Firms Active in the Medical Device Field

Hexagonal Copper Crystal Films Grow Highest-Quality Graphene Sheets

Graphene, a sheet of carbon just a single atom thick, has much potential in the future of electronics, but producing high-quality sheets for high- performance applications has been a challenge. Researchers at University of Illinois (Urbana-Champaign, IL) have discovered that the quality of graphene grown depends not on the surface finish, but on the crystal structure of the copper substrate on which it is grown.

Copper has been a popular substrate for graphene growth because it is inexpensive and promotes single layer growth. Graphene sheets are produced by pumping methane gas into a furnace with a sheet of copper foil. The carbon-hydrogen bonds break when the methane hits the copper, making the carbon atoms stick while the hydrogen floats away. Carbon atoms move around until they bond with each other in a single layer, resulting in graphene. Since copper foils are composed of a variety of different crystal structures, the resulting graphene is produced with many defects and multi-layer sections.

By combining data from several imaging techniques studying the graphene growth, the U of I team discovered that previous speculations that the roughness of the copper surface was the major factor in the quality of graphene were incorrect. Areas of the copper foil with hexagonally configured copper atoms resulted in the best graphene growth, with the carbon atoms growing laterally in a similar hexagonal pattern. And the copper foil sections with crystals in a cubic shape with wide gaps between atoms had the carbon atoms sticking in the holes and stacking vertically, growing the poorest quality graphene.

However, producing copper foil with only hexagonal copper crystals is difficult and prohibitively expensive, so the next challenge is finding a way to balance the value of the defect-free graphene with the cost of the single-layer copper crystal foil. One solution may be creating a foil with a higher percentage of hexagonal crystals, resulting in graphene that would be suitable for most applications. The team is also using this methodology to study the growth of other materials, including insulators to improve performance of graphene devices. The findings were published in the Nano Letters journal.

Top Stories on MD+DI for October 2011

Here are the pieces of content on MD+DI that you found the most interesting this month:

  1. Medtech Exclusive! Sneak Peek at the Salary Survey
    The median salary for those working in the medical device industry fell within the $100,000–124,999 range. Find out more from our preview of our annual salary survey.
  2. Can Your Company Afford FDA?
    A blog post on Device Talk considers the financial implications of FDA's recent conservative track record in clearing devices.
  3. Partnership: The Ultimate Expression of Supplier Control
    A new article suggests giving the supply chain "unprecedented scrutiny."
  4. Exclusive Coverage of AdvaMed 2011
    Editor-in-chief Heather Thompson and a number of guest bloggers provide the scoop on Advamed 2011.
  5. Future Medical Device Regulation in the European Union: Prospects for Reform
    An article co-written by two partners and an associate of Latham & Watkins looks at EU regulatory reform.
  6. Canaccord Genuity Lists Medtech Firms Most Likely to Be Acquired
    Many analysts predict M&A activity to pick up within the next year or so. Here's a short list of some companies that are ripe for the picking.
  7. What Thomas Fogarty, MD, Thinks of the U.S. Medtech Industry
    Managing editor Brian Buntz attended the Life Sciences Summit in Mountain View, CA, where Thomas Fogarty, MD, mused on the state of the medtech industry in 2011.
  8. Why Commercializing Devices Offshore Is So Attractive
    A growing number of medical device firms are looking for regulatory approval in the European Union and other places before they seek approval from FDA. Tessa Yamut, vice president of regulatory and clinical affairs for BioVentrix provided her thoughts on the matter at the aforementioned Life Sciences Summit.
  9. In Defense of the 510(k)
    Many parties, including FDA itself, have rushed to defend the 510(k) process after the IOM recommended doing away with it in a recent report.
  10. IAF Hopes Global Medical Device Trade Will Improve with Accredited ISO 13485 Certification
    A piece by Grant Ramaley questions the notion that harmonization will solve trade problems.

 —Brian Buntz

Image by Flickr user sam_churchill.

Weekly Vitals: VCs and Medtech Companies Get Political, Erik Paulsen Wins Industry's Vote, and More

As we head into an election year, venture capitalists (VCs) and the medical device industry are ramping up their political efforts and, in turn, opening up their wallets for candidates that support their interests, notably Congressman Erik Paulsen of Minnesota. And to no one's surprise, item number one on medtech insiders' political agenda is streamlining FDA's medical device clearance process. "As Congress considers reauthorizing a law that sets the fees for medical device makers, venture capitalists are emerging as a rich and influential ally of device companies eager to remove what they say are regulatory roadblocks in the approval process," according to the New York Times. The paper goes on to say, "People associated with funds that underwrite companies developing new devices and other health products have made more than $3.3 million in political donations to Republicans, Democrats, and political action committees over the past five years, according to an analysis of federal contributions by The New York Times. Though such people donate for many reasons, about 20% of the money from the 182 donors identified by The Times went directly to candidates and political action committees supporting a streamlining of FDA policy or other issues of importance to medical products producers." Find out more about the medical device industry's political agenda, its relationship with Paulsen, and other top stories in this week's roundup.

This Week in Devices: Medical Imaging Advances, VCs Ally with Medtech, and More

Here's what's new this week: Venture capitalists are allying themselves with the medtech industry's push to streamline FDA's review process, explains MassDevice. An article on EMDT considers international medical software standards. A blog post on Orthotec looks at funding changes for orthopedic surgeons

Brian Buntz

FDA Establishes Academic Centers to Study and Improve Drug and Device Review Processes

In an effort to improve how it reviews and evaluates medical devices and drugs, FDA is working with two Washington, DC–area universities to create academic centers devoted to regulatory science. The agency announced in a news release this week that the University of Maryland and Georgetown University will each receive a $1 million grant to establish a Center of Excellence in Regulatory Science and Innovation (CERSI). 

University researchers will collaborate with researchers from the agency to drive "innovation in medical product development" and "advance laboratory, population, behavioral, and manufacturing sciences," according to the release.

"These partnerships represent a critical, necessary, and creative investment—one that will benefit not just FDA and academia, but also American consumers and industry," FDA chief scientist Jesse L. Goodman said in the release.

The center at Georgetown will draw faculty from the school's medical and law programs.

"The very concept of regulatory science assumes sound regulation, which is the FDA's mission," Lawrence Gostin, a professor of global health law, said in a release issued by the university. "The regulation of food and drugs is one of the most important functions of government as the public comes to to rely on the FDA to ensure the safety and quality of food, vaccines, and medical products."

The center at the University of Maryland will draw researchers and staff from both the main campus (in College Park, MD) and the campus of the University of Maryland, Baltimore, according to a release issued by the school. That center will focus on bolstering FDA's ability to evaluate products and drugs in the preclinical stage, ensuring that the agency is prepared to review the most innovative products, and ensuring that the agency is able to maximize the data and information available to it. Researchers at that center will specifically work on how best to evaluate optical imaging devices and advanced materials such as nanostructured polymeric coatings. 

"This innovative new center will improve the lives of Americans," said Patrick O'Shea, vice president for research at the University of Maryland said in the release.

Catalog Features Retaining Rings, Section Rings, and Springs

A company that manufactures and develops retaining rings, section rings, and springs has released a 130-page catalog. The Parts and Engineering Catalog features the company’s previously existing series, such as the Spirolox retaining rings and the Wave springs, with newly released series, including Hoopster retaining rings, Constant section rings, Metric Wave springs, and Small Series Wave springs. The catalog includes part tables, engineering guides, design information, and expanded part offerings. It is suited for engineers who need product information for quick prototypes, and is available in both PDF and paper formats.

Smalley Steel Ring Co.
Lake Zurich, IL, 847/719-5900