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Weekly Vitals: Boston Scientific Has a Worldly View, Who's Making Money in Medtech, and More

Boston Scientific's interim CEO offered up some insight this week on the medtech giant's corporate strategy as it looks to build on momentum gained from recent acquisitions, FDA approvals, and positive Q1 earnings. Hank Kucheman chatted with the Boston Herald in an exclusive interview this week about Boston Sci's "rejuvenated, revitalized product pipeline and a three-pronged strategy for global expansion." In other news, statistics were released on medical device engineering salaries. Find out who's raking in the big bucks and more in this week's roundup below.

Reader Response: EMR Will Help the Healthcare System Learn from Errors

Jane Orient, MDIn February, MD+DI interviewed Jane M. Orient, MD, an author and a practicing physician who had, at the time, just written a piece titled "Shall We Take the Liberty of “the 1%”?" In the interview, Dr. Orient shared her thoughts on everything from the physician shortage to electronic medical records (EMR).

A reader wrote in expressing his thoughts on the article: 

I find the opinion article by Brian Buntz/Dr. Jane Orient interesting more for the attitude it displays than for the content itself. Before dealing with medical devices, I spent a long time in the semiconductor industry. The transition to computer systems had similar impacts on the people involved. The systems had a number of benefits if properly implemented and embraced. I implemented these systems in several facilities, both as an employee and as a consultant. They had a profound impact on how people at all levels did their jobs. This was particularly evident with respect to the engineers, who were used to doing things the way the specific engineer wanted to do them. The systems required them to do things in a specific systematic way. Those who didn't want to conform to that methodology hated the system and were less effective than before. Those who embraced the system found that it provided them with a lot of new leverage to get things done that they had previously not had. The systems were not perfect, but there was enough flexibility to do the job better. The worst situations were in facilities where management inflicted a system on a facility without getting the users to accept it. An implementation done with the cooperation of the users produced fewer errors and good, useful data. 

The one non-cooperative situation I was involved in produced no improvement in the operation and the data was useless. I suspect that Dr. Orient is in the non-cooperative camp. My personal physician works in a facility with electronic records and has no trouble dealing with it and has time to deal with me on a personal level. I would hope that these systems can do what they have done for the semiconductor industry- provide the data needed to reduce errors in real time, provide the data for learning that improves the product and lowers costs. 

In health care, we need to reduce the easy errors and collect the data that will help us find what works on which subsets of patients. This will help us build the foundation for a system that not only provides better care at lower cost, but gets us away from the idea that when something goes wrong, someone made a mistake. Running to a lawyer is not helping, but failing to acknowledge errors (and learning from them) guarantees that both preventable errors and lawyers will be a part of the health care system.

---Mike Beaver 

Dr. Orient responded to this statement with the following: 

Uncooperative, am I? The question is: to cooperate with whom, to do what? Cooperate with a government-chosen vendor in a crony capitalist venture to burden or even wreck medical care while enriching the chosen winners?

If you want good engineers to do good work, you have to let them be in charge of how to do it, not make them subject to computer geeks who know nothing about engineering. Ditto for doctors.

If he thinks one can get useful data out of the usual primary care practice, he knows nothing about data collection and analysis, or about what medical practice is really like.

My mom's from Missouri. Show me.

Another physician chimes in with: 

Since when does IT drive MEDICINE? Medicine is a person to person thing. In hospital I spend so much time entering data I seldom look up to acknowledge the patient. Get it out of medicine!!!!!

GPO Urges IRS to Make Sure that Device Makers Don't Pass on Cost of Device Tax to Customers

Medical device companies have already made clear in industry surveys that price hikes will be one strategy they plan to use to deal with the impending medical device tax (if it's not repealed before its implementation in 2013). In one survey, more than half of the executives interviewed acknowledged that they were planning to do so. In fact, some hospital associations have argued that the industry could even benefit from the tax by passing the cost along to customers and write off the tax.

This week, group purchasing organisation Premier submitted a letter to IRS urging that it makes sure that device makers don't pass along the cost by raising prices of their products. However, Premier's Public Affairs VP Blair Childs acknowledged that it will be difficult for IRS to enforce such as requirement, according to MassDevice.

"We believe that Congress did not intend to have hospitals and other providers absorb the device tax," said the letter. "To this end, we urge the IRS to prevent device manufacturers from passing the tax on to providers by requiring, at the very least, that manufacturers certify that they have not included the tax in the price of their products on their requisite filing documents."

While providers are understandibly worried the tax could result in increased costs, medtech companies are increasingly concerned over what the tax will cost them. Many industry executives maintain that the device tax will do the industry more harm than good. This week, AdvaMed and a group of healthcare organisations submitted letters asking IRS to implement the device tax "responsibly."

—Camilla Andersson

This Week in Devices [5/11/2012] - Sony Gets Into Medical Devices, Bionic Women Finishes Marathon, Surgery with Boomerangs, FDA Cuts a Deal to Fast-Track Devices

Sony Gets Into Medical Devices

  • Electronics giant Sony wants to take their products out of the living room and into the hospital. The company is investing in creating patient friendly medical devices and diagnostic kits that will be used in point-of-care settings. NO word yet if any of their planned devices will be compatible with a PS3.
    Source: Dark Daily

A Bionic Women Finishes Marathon

  • A paralyzed UK woman completed the London Marathon this week with the aid of a robotic exoskeleton.
    Source: Orthotec 

Surgery with Boomerangs?

  • French scientists have developed “boomerang” light beams capable of bending around corners. With further development it is hoped that these beams could allow surgeons to make incisions behind structures inside the body.
    Source: New Scientist

FDA Cuts a Deal to Fast-Track Medical Devices

  • FDA is moving to implement legislation that will provide a fast-moving track to approval for follow-on medical devices Source: The Fiscal Times
  
 

Thomas Fogarty, MD on Overcoming Barriers to Innovation in Medtech

Thomas Fogarty, MD on Overcoming Barriers to Innovation in Medtech

“In general, what we are dealing with now is a very difficult time, at least in the medical device industry, to innovate,” says legendary device inventor Thomas Fogarty, MD. Among those hurdles are funding difficulties and regulatory challenges that stretch from the FDA down to the hospital level. This is a topic Fogarty feels strongly about and, to offer medical device innovators a helping hand, he set up the Fogarty Institute for Innovation (Mountain View, CA), to help expedite the process of medtech innovation “quickly but safely.”

In this interview with MD+DI, MDEA Lifetime Achievement Award–winner Fogarty also shares his thoughts on the lack of basic clinical research, which limits physicians’ understanding. He also tackles the idea that medical devices aren’t tested, which he explains is not true. “That rarely happens. I would venture to say that happens maybe 0.5% of the time.”

Brian Buntz is the editor-at-large at UBM Canon's medical group. Follow him on Twitter at @brian_buntz.
 

Mobile Apps, Smartphones, and Social Media. Why Aren’t Device Manufacturers More Engaged?

Smartphones, tablets, and mobile apps are changing the physician-patient dynamic. They are empowering patients to take better control of managing their health, and physicians are taking advantage of the conveniences provided by these technologies. At the same time, social media is revolutionizing communication across nearly every professional and community level.

MD+DI: What current challenges does social media present to how doctors are interacting with patients, hospitals, and device manufacturers?
 
Bunny Ellerin: Social media is being adopted more and more frequently by physicians, and they’re using it in some ways with patients. But I think the biggest issue right now is, what does social media represent? What are the benefits? What are the drawbacks? The benefit for physicians is that it gives them a voice. Historically there haven’t been a lot of open outlets where they could talk about issues that are important to them in a public way. Social media gives them a way to correct a lot of the misinformation that proliferates, whether it’s on apps, in newspapers, or on the Web. There’s a tremendous amount of health information available, but not all of it is accurate. Being able to be part of the conversation gives them a way to provide their patients with good content that’s vetted and validated.
 
[There are] some disadvantages –you’re on all the time, and none of us, whether [you’re] a doctor, lawyer, etc., want to be on all the time. That’s a challenge. How much do you really put yourself out there? Then there are regulatory and legal [concerns]. Honestly, from what’ I’ve seen, that’s a very small part of the reason why people may normally or may not engage. I think it’s really about time, and also some people don’t want to be exposed.
 
How does this relate to industry? If doctors, patients, and consumers are all there, you have to be where your customers are. For device manufactures, it’s really important to figure out how they’re going to be part of that conversation. It’s not a one-way communication where you just send out messages or you send out a rep who delivers the message. That paradigm is really shifting. Today it’s more about give and take interaction and two-way conversation. Having been in the device industry before, I’m a little surprised that they haven’t gotten there yet. The device industry is like the technology industry—there’s  constant innovation and change. It’s a little surprising they haven’t been more willing to figure out or get themselves to be part of that conversation. That’s said, there are a lot of opportunities. I’m going to look to [the device industry] to be leaders. They’re all about innovation and getting to the next iteration. So I feel confident they’re going to figure it out.
Developing technologies that enable a strong connection between medical device manufacturers, physicians, and the patient requires a change of mindset. Device companies need to engage more with their customer, the physician, to find out their needs in this rapidly changing environment , what they truly want to get out of medical apps, and where more integration needs to happen between medical apps and devices. Physicians are already very plugged in—various surveys pinpoint the smartphone adoption rate among physicians at about 75% to 80% and growing, according to Felasfa Wodajo, MD,  mHealth Editor of iMedicalApps.com. The tablet (mostly iPad) adoption rate could be as high as 45%. In addition, the market for medical apps has exploded since 2008. “There are apps in just about every niche and subspecialty addressing needs of physicians and, to a lesser extent, patients and consumers, says Wodajo, who is also a bone and soft tissue tumor surgeon. “But we’re still not there in terms of achieving the kind of mobile enablement that we hope to find one day.”
 
Wodajo suggests a few reasons why there is room for improvement for mobile medical apps:
  • High-quality specialty apps are lacking. “Right now small shops are producing decent apps, with one or two authors putting together a small app set that gives useful reference and information but doesn’t try to take the place of the larger resources that are available.”
  • The integration between mobile devices and data, mainly electronic health records (EHRs), isn’t satisfactory. The big obstacle here, Wodajo says, is that there isn’t a conversation between the mobile apps for EHRs and the larger world of medical apps.
  • The physician –patient culture needs to further evolve. More patients are connected, and they want increased access to their data and doctors.
Mobile apps have dramatically changed how many patients obtain information about conditions such as diabetes and pregnancy, along with keeping up with general wellness. Likewise, apps are helping physicians further educate patients about their conditions. Wodajo cites the Orca Health series of apps for physicians.  
 
Although such apps aren’t a platform on which physicians and patients can communicate, the market will need to reach that point for two obvious reasons, says Wodajo. The first is time and the extent to which flexible platforms should be used to share information. Surgeons can spend a lot of time counseling
“Social media isn’t about content distribution; it’s about conversation. It’s a very different thing; everybody’s equal. That’s a bit of a paradigm shift.” --Felasfa Wodajo, MD
patients, from diagnosis and discussion of treatment to the logistics of surgery. Having an app that streamlines this process would save surgeons time, and would empower patients about their condition, while also providing peace of mind.
 
The second reason is market demand. If patients keep asking for apps that enable communication with physicians, the market will need to follow.
 
“One of the real things to look forward to is the platforms that allow the physicians and patients real time together to benefit from the technology,” says Bunny Ellerin, president of NYC Health Business Leaders. Ellerin cites the drawMD app, which allows doctors to draw on an app and show the patient exactly what he or she will be going through in surgery—in a way that is palatable to the patient. “The connection enabled by technology actually could lead to a much better outcome on a lot of different levels. That’s hopefully where some of the future is.”
 
NYC Health Business Leaders is collaborating with the Mayo Clinic and Continuum Hospitals of New York on the Connecting Healthcare and Social Media conference next week, May 17-18. The event will focus on the role that social media plays in hospitals, including to build a community, media efforts, and the connection between physicians and patients. Wodajo will be speaking at the event during “The Rapidly Evolving World of Mobile Health, Apps & Devices for Physicians” session.
 
Ellerin on Healthcare Innovation in the Big Apple
"New York City Health Business Leaders is all about making sure New York is recognized as a leader in healthcare innovation. There is so much that goes on in the city, and the Tri-state area, in every sector—hospital innovation, pharma, and medical devices. We’re the undisputed healthcare media capital of the world. Now we’re seeing that health IT is becoming a really big part of the healthcare economy in the city. We’ve got incubators, accelerators, and tons of start ups. What is health IT? It can cover a wide range of disciplines from social to mobile health electronic medical records, to clinical decision support. It’s a nexus here."
 
 Maria Fontanazza is managing editor of MD+DI. Follow her on Twitter @MariaFontanazza.

The Highest Paid Engineering Positions in Medtech

Ever wonder which medtech engineering positions bring in the most pay? Recent statistics released from the U.S. Bureau of Labor Statistics (BLS) provide a clue. 

Materials engineers came out on top, earning about $21,200 more than the average for all engineering positions, according to the BLS. Chemical engineers weren't too far behind, making an average of nearly $90,000 per year. At the bottom of the list were mechanical engineers, followed by mechanical drafters.

Here's a list of the top 10:

Position
Mean Annual Wage
1.) Materials Engineers...................... $95,180
2.) Chemical Engineers...................... $89,670
3.) Health and Safety Engineeers...... $86,350
4.) Biomedical Engineers................... $86,280
5.) Electronics Engineers................... $85,710
6.) Electrical Engineers...................... $85,620
7.) Engineers (all other)...................... $85,390
8.) Industrial Engineers...................... $78,940
9.) Mechanical Engineers................... $77,020
10.) Mechanical Drafters.................... $52,430

Jamie Hartford is the associate editor of MD+DI and the managing editor of MED. Follow her on Twitter @readMED.

Six Strategies for Cash-Strapped Device Startups

Six Strategies for Cash-Strapped Device Startups

money
Image from Flickr user 401K

The U.S. medical device industry is a true American success story. More than half of the healthcare products purchased around the world come from medical technology companies based in this country. Yet this crown jewel of industry is now in serious jeopardy. According to a December 2011 survey conducted by the National Venture Capital Association (NVCA), 58% of venture capitalists expect an investment decrease in the biopharmaceutical and medical device sectors in 2012. This downward trend has been continuing since 2007, according to PricewaterhouseCoopers / NVCA, with fewer first-time companies receiving funding.

Decreased investment in early-stage medical device companies could be attributed to several factors. First, according to NVCA, it is getting more difficult for venture capitalists to raise funds for investment. This is likely a result of current economic challenges. Second, regulatory and reimbursement uncertainties in the United States are causing venture capital firms to rethink investing in U.S. medical technologies. Instead, many are shifting their investment to later stage medical device companies, to overseas ventures, or to Web-based or digital media companies. Third, the cost and time to exit have increased while the size of the exit remains roughly the same, making investment returns significantly less attractive than in the past. In addition, current tax policy and potential cuts in reimbursement by payors also threaten to stifle the industry’s next wave of innovation.

As a result of these factors, the United States could lose its leading position in the global medical technology market. Worse yet, patients, healthcare providers and the overall healthcare system may suffer a range of unintended consequences, including lower quality of care and higher costs. Furthermore, securing early-stage financing would likely become even more challenging for emerging U.S. medical device companies.

Fortunately, venture capital firms and angel investors are still funding early-stage companies that solve a real market need, have a solid leadership team in place, and have a capital efficient business model. In this new model, emerging medical device companies need to use cash efficiently to generate growth and become self-sustaining or profitable in the shortest amount of time possible. What follows is a description of a capital-efficient business model and why it is in the best interest of early stage companies and their stakeholders to accomplish as much as they can with as little cash as possible:

1. The Right Team

With a capital-efficient business model, companies have limited resources and typically only have one shot to get it right before running out of cash. Getting the right team in place is one of the main pillars of a capital-efficient business model because doing so can save both time and money. Thus, start-ups should consider partnering with professionals who have the right knowledge and experience, such as successful medical device business co-founders or entrepreneurs, champions or mentors. In addition, finding someone who has commercial experience in a similar industry or has commercialized a comparable technology or device in the past can be extremely helpful. First of all, such individuals can greatly help in determining the minimum amount of capital needed to commercialize the product, determine the regulatory and business strategy, including a capital-efficient business model, and develop an execution and/or exit plan. Secondly, these individuals can also help recruit and hire other key team members, such as management, finance, regulatory, or technical personnel, when necessary. Finally, such persons can also make introductions to investors, such as angels or venture capitalists, when appropriate.

2. Time is of the Essence

Emerging medical device companies should focus on getting their product into the hands of customers earlier rather than later. It will be important to keep in mind that it is not necessary to build the perfect product or develop the perfect process at the very beginning. It is more critical to find a balance between speed to market and developing the right product for the first commercial launch. Once the product is commercialized, emerging companies have ample opportunities to refine the product or process from customer feedback.

Emerging medical device companies should focus on getting their product into the hands of customers earlier rather than later.

The goal of any emerging medical device company should be to out-innovate larger competitors, as well as get one’s product to market before other start-up companies can do so. To succeed, emerging companies should identify the key product requirements and essential features that would result in a shorter development time and, in some cases, faster regulatory clearance. Too many times, start-up companies become bogged down by focusing too much on process and too little on product development. Manufacturing and process efficiencies, such as cost reduction, can be outsourced or refined after the product is commercialized.

In many cases, being the first to market allows medical device start-ups to sell their products at higher prices, set product requirements, establish regulatory and quality standards ahead of the competition, and obtain valuable customer feedback to further improve and refine their products. Achieving this does not mean one needs to skimp on quality or patient safety, as some might suspect. Emerging device companies must follow proper regulatory and quality protocols, obtain the necessary permits or licenses, and perform the necessary testing to ensure that the product is made with the highest quality and reliability possible. In essence, the product must meet and comply with appropriate standards to ensure patient safety.

3. Choosing a Sound Regulatory Strategy

When following a capital-efficient business model, companies may choose to seek regulatory approval and launch their products overseas before doing so in the United States. From a timeline perspective, there is generally a one- to three-year delay in launching new medical devices into general clinical practice in the United States compared to in the European Union, for example. This is partly because the regulatory process in Europe is less bureaucratic, more efficient, and more predictable than in the United States. Another reason is that FDA requires evidence of both safety and efficacy of a device, whereas a European CE Mark only requires proof of safety and that the device performs in a manner consistent with the manufacturer’s intended use. Also, it is becoming ever more difficult and arduous to conduct clinical trials in the United States as a result of FDA’s clinical data requirements (reference device regulation guidance documents available at www.fda.gov). Thus, the timeline for obtaining a CE Mark is typically much shorter than the timeline for gaining FDA approval.

In some scenarios, emerging medical device companies can start the approval process in the United States and overseas in tandem. This is the ideal strategy in terms of reducing regulatory risk due to costly delays in the launch of a device, but requires more financial resources. It is important to note here that most venture capitalists today require medical device companies to develop parallel regulatory strategies before funding. Thus, start-up companies need to determine the various regulatory options and develop capital and time efficient business strategies that include both the United States and other countries. To determine the right regulatory strategy, companies should seek advice from regulatory experts as early as possible.

4. Growing Carefully Through Strategic Marketing

Another important consideration for emerging medical device companies is to grow very carefully. This does not mean slowly, but wisely in a smaller market first. In other words, start-ups following this model should not ramp up sales and marketing teams or launch their products nationally too far in advance of revenues and market validation. In contrast, it will be more important for them to focus on local or regional markets initially to validate their products. The local or regional markets can be thought of as the launching pads for national and international sales. Selling locally or regionally first can help companies hone their sales pitches to healthcare providers, validate their products clinically, and prove to customers, distribution partners or potential acquirers that their products can be game changers in terms of efficiency, cost savings or better clinical outcomes. Launching products nationally too quickly without proper market and product validation can be disastrous for emerging companies if not done properly.

There are several marketing tactics to sell and promote new medical devices locally and regionally with limited funding. Examples include positive media coverage (also known as “free media”) obtained through public relations outreach, word-of-mouth “advertising,” and customer testimonials campaigns. We will discuss how each of these approaches can be used to promote and sell your products with limited cash and resources.

Media coverage can greatly help spread the word about new products or companies. When a new medical device is used successfully on a patient in a local or regional hospital, local or regional media are often very interested in doing a human-interest story. In some cases, local or regional media coverage is picked up by national news outlets, especially if the patient or technology makes for an exciting or important story. Media coverage can boost brand awareness and sales tremendously. Unlike advertisements, articles and stories in the press are viewed by the public as third-party endorsements.

Selling locally or regionally can also generate word-of-mouth “advertising” without a large marketing budget. Inspiring patients, healthcare professionals and customers to talk about a new product creates a “buzz” in the community. No form of marketing is more powerful than patients telling their friends, families and co-workers about their great new medical device and their much-improved health. As a side note, allowing certain influential customers (physicians or hospitals) exclusivity in a local or regional market for a period of time can create competition, which will drive demand in the long term.

Finally, getting the right customers talking can help validate and promote a new medical product or technology in a local or regional market. In every community, there are the early adopters, who usually are highly influential, and the followers, who wait to hear what others have to say, then follow. If emerging companies can market and sell their products to these early adopters and get them talking, they can usually influence the followers. One of the best and most cost-effective ways to maximize customer testimonials is to ask influential customers to give their testimonials in various local or regional markets in the form of media interviews, presentations to physicians and/or patients, live surgeries or product demonstrations, or physician referrals. Testimonials on the start-up’s Web site, in Blog posts or on social media platforms can also be effective.

5. Outsourcing Non-Critical Business Functions

With a capital-efficient business model, it is necessary to leverage external resources where appropriate. Emerging medical device companies should focus on their core technology, such as research, design and innovation, and outsource non-critical business functions, such as payroll, accounting, HR, and IT. Trying to own all of the business functions in-house and build one’s own team and infrastructure from scratch could be time-consuming and costly. There are plenty of consulting and service companies that specialize in non-core business functions that can do the job more efficiently and less costly than start-up companies.

Generally speaking, companies can also leverage offshore or on the ground consultants and design service companies to outsource their product development. Start-ups that choose this path must be careful to ensure that the product development is done under certain budget constraints and on a strict timeframe. In some instances, hiring or retaining an offshore project manager can avoid costly delays or mistakes, especially in countries where language, culture and communication could be potential obstacles. Emerging companies seeking this path should consult with outsourcing professionals that can help them avoid costly time delays.

6. Compensation for Sales Team

For start-ups operating with limited cash and resources, hiring and supporting a permanent sales team is extremely expensive; paying commissions is much more cost-effective. The ideal situation for a start-up is to have all of its sales team paid purely on commission with no base salary and benefits, such as paid vacations and health insurance. In some industries where pure commissions are not the norm, offering a minimum base salary may be necessary to attract stronger sales representatives. In addition, equity in terms of stock options might offer additional incentives for sales representatives to join a start-up’s sales team. For emerging medical device companies that need to build a productive sales team in a short timeframe, independent sales consultants paid purely on commission is the ideal way to go.

Conclusion

Considering today’s uncertain regulatory climate and challenging economic environment, emerging medical device companies have to accomplish more with less. In this article, I have discussed why a capital-efficient business model makes sense for early-stage companies seeking venture capital funding. It may also apply to some later stage companies that would like to operate more cost efficiently. Following the traditional business model for raising several rounds of financing before a start-up company becomes profitable or is acquired is no longer attractive to venture investors. This is due to lower valuation compared to other industries (such as Web-based or social networking companies). On the brighter side, the opportunities for medical device technologies have never been greater for the United States and abroad. As mergers and acquisitions continue to pcik up, venture capitalists are shifting their focus and looking for new opportunities to invest in early-stage companies with innovative medical technologies. Emerging medical device companies that can think outside the box by accomplishing more with less cash will ultimately succeed.

Charlie Chi, PhD is an electrical and computer science engineer with more than 15 years of management, operations, product development, manufacturing, and consulting experience in the medical device and high technology industries. Currently, Dr. Chi is a consultant to medical device companies throughout California and in other states. Dr. Chi is former president, CEO, and co-founder of OtisMed (now part of Stryker Orthopaedics), a medical device company co-founded by Dr. Chi to address unmet clinical problems in orthopedics. Dr. Chi can be contacted at (415) 234-7968 or [email protected].

Women in Medtech: Bray Patrick-Lake - From the Patient Perspective

In 2008 Bray Patrick-Lake had a device implanted into her heart when she participated in an aborted clinical trial involving research into patent foramen ovale (PFO), a heart condition in which there is a hole between the upper chambers. She founded the PFO Research Foundation in 2010, following her experiences with the trial, and in response to the lack of definitive scientific information regarding PFO, with the goal of improving patient care in the field. 

In addition to serving as the president and CEO of the PFO Research Foundation, Patrick-Lake is also a patient representative at FDA on a variety of advisory committees and panels. She is also an international speaker, who advocates on the patient perspective.
 
MD+DI: How did you get your start in the industry?
 
Patrick-Lake: I became a very accidental advocate after participating in an aborted clinical trial for an implantable cardiac device. After my experience in the trial, I launched a foundation for patients with my heart condition and began giving talks on the patient perspective at scientific events. I also joined the FDA Patient Representative program where I serve as needed on a variety of advisory panels and initiatives. I have since dedicated myself to improving the U.S. clinical trial enterprise, translating medical science to patients, and facilitating communication between stakeholders in order to improve patient outcomes and boost enrollment in clinical trials. Working closely with the [medtech] industry to understand its perspectives and challenges has been key to these efforts.
 
MD+DI:Where do you see the medtech industry going in the next five years as far as developing technologies and/or issues and policies?
 
Patrick-Lake: The industry is in a state of flux in response to a risk-averse climate and demand for more meaningful evidence of effectiveness for approval and reimbursement. It has become increasingly costly and time consuming to operate clinical trials to provide necessary evidence to reach the market with a reimbursable product. The next five years will force the industry to embrace disruptive change and increase efficiency and transparency when developing new products. In addition, in this era of the patient-centered care movement, the medtech industry will have to better engage in dialogue with patients and consumers and really go the extra mile to regain public trust if we are ever to move away from risk-aversion. I think the companies that are most creative, efficient, and open to partnerships and the ideas of a variety of stakeholders will navigate this period most successfully.
 
MD+DI:How can we get more women involved in the MedTech industry?
 
Patrick-Lake:I think many women aren’t aware of opportunities within industry outside of sales. We need to spread the word that opportunities for smart and creative people of all types exist in industry. Outreach efforts to university science, engineering, and general studies programs could be very beneficial in raising awareness among women about the rewarding and stimulating opportunities that exist for them within medtech. Creating more internships and co-op programs could also allow women to get a firsthand look at potential career paths within the industry.
 
MD+DI: Are there barriers to women entering the medtech field? How can they be overcome?
 
Patrick-Lake:Engagement of women in science and technology could be improved in general. I think the medtech industry can offer unique opportunities for women to use their creativity and passion, in addition to their scientific and engineering skills. The industry could do a better job of displaying its softer side so that diverse elements, which appeal to women, about these opportunities get better communicated to the female population.

MD+DI: What advice would you give to women who want to get into the medtech industry?
 
Patrick-Lake: You are the only one who can limit yourself. And only you can make yourself feel like less than you are. Work hard to be the best at what you do and proceed with confidence and competence. Being a woman in a male dominated environment can add complexity to the workplace. Be friendly, but maintain your strength, character and integrity. Know when to appropriately use your best female qualities and keep your personal life out of the office. If you have the trailblazing mentality of creating opportunities for yourself with persistence then you won’t be limited by glass ceilings.

Chris Wiltz is the assistant editor at MD+DI. Follow him on Twitter @MDDI_Chris

Processing Technology Protects Coating Integrity of Drug-Eluting Balloons

Drug-eluting balloons (DEBs) have been the focal point of intense R&D during the past several years as medical device manufacturers explore alternative and complementary treatments to stents. The emergence of these novel devices, however, has presented unique processing challenges, including the potential for damage and cross contamination during pleating and folding operations. Catering to this next-generation medial device processing need, Machine Solutions Inc. (Flagstaff, AZ) has introduced the FFS975S DEB catheter pleating and folding system, which it claims is the first and only machine designed specifically for processing DEBs.

Machine Solutions DEB
Machine Solutions has developed a pleating and folding system designed to protect coating integrity of drug-eluting balloons during processing.

As with drug-eluting stents (DES), the processing of DEBs is complicated by the incorporation of a therapeutic agent on the surface of a balloon. "[You have] to pleat and fold [the balloon] to get it down to a small profile so that you can insert it into the body. But that process of pleating and folding could damage the drug coating or, worse, take some of the drug off of one balloon and deposit it onto another balloon being processed later," explains Brian Strini, product manager at Machine Solutions. "Doing damage to the drug is bad enough, but increasing the drug dosage on another balloon is even worse. Cross contamination is a huge concern."

Previous attempts at preventing such a dangerous error have proven unsuccessful, according to Strini. Sheathing the DEB with a piece of tubing, for example, is effective during pleating operations but is problematic when folding the device. Because the tubing sheath is pulled into the balloon during the process, it can be difficult to extricate when the operation is completed. This approach also requires an operator to manually introduce the sheath prior to processing the balloon and then remove it at the end, Strini adds.

To address this need, Machine Solutions drew inspiration from its crimping equipment, which protects the drug-coating integrity of DES during processing. Extensive testing with a balloon customer then revealed that the use of a PTFE film during processing effectively created a barrier between the DEB and the stainless-steel elements of the equipment. "As the balloon is placed in the head, it's in an inflated condition. The film wraps around it as the head is closing onto it," Strini says. "The film then takes on the shape of the balloon being pleated and protects it from contacting any of the metal parts of the machinery."

The PTFE film is laced through the head of the system, serving to protect the drug coating during the process. It then cycles out of the head upon completion of the production run. "Every time you put a balloon into the machine, there's a clean sheet of film that's interacting with the product," Strini adds. In addition, the automated nature of the technology bypasses the need for operator interaction while increasing throughput and decreasing cycle times. Able to accommodate all PTCA and most PTA balloons, the FFS975S system yields minimal folded profiles while maintaining coating integrity during balloon pleating, folding, wrapping, and fluting processes.