MD+DI Online is part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

How Physicians Are Improving the Bottom Line for Device Companies

How Physicians Are Improving the Bottom Line for Device Companies

Bringing surgeons into the product development process can save time and money for device makers. How big a role are clinicians playing in R&D?

Jeff Schell

The role of physicians in business is evolving. Many are exploring entrepreneurism and developing ideas, procedures, and products that directly serve the needs of their patients. But for many physicians, the time it takes to develop and produce new products creates barriers to bringing new concepts to market.

On a similar note, medical device companies are increasingly seeking physician input to drive innovation. Early stage collaboration with physicians can reduce the need for redevelopment, along with the time and money that comes with it. The rise of physician entrepreneurship along with device companies seeking surgeon input has driven a new paradigm in research and development--one that is led by physicians, enhanced by inventors, created by designers, and then marketed by businesses to create the best products in the medical field to date.

Hear Schell discuss "The Trans1 Experience: Developing Design Processes That Incorporate Clinician Input" at MD&M West in Anaheim, Feb. 7-9, 2017.

The overarching objective for both surgeons and device companies is to improve patient outcomes, so the collaboration between the two groups is a natural fit. Savvy health technology companies have developed innovative design processes that incorporate surgeon input. What does this development cycle look like, and where are surgeons contributing the most, thus far?

Innovation Assessment

R&D is time and resource-intensive. Concept analysis is a crucial step in early-stage R&D contribution from surgeons that can preserve time and money. Surgeons can draw on their hands-on experience to provide an assessment of whether a concept is viable from the onset of the development process. In a world of limited resources, this reduces wasteful spending on R&D for a concept that will not be viable in the operating room. For instance, physicians have expertise on whether a certain product is unique or if it fills a specific need in the marketplace. With the ever-growing number of medical devices available, surgeons are in the best position to assess whether a product would work and would fill a need.

Ideation and Concept Development

Surgeons also play a vital role in taking a concept and refining it into a real-world device. Physicians are now joining inventors and designers to begin an iterative, creative process to identify different potential solutions to current holes in the marketplace. Engineering and product team incorporate physician input to improve on a concept and to create new iterations of the idea. Incorporating surgeon input in this creative process is not only engaging for the physician, but it saves time and money on the back-end of the development process.

Financial and Regulatory

Further in the R&D process, the need for regulatory approval arises. This process is tedious, but also critical to getting products and procedures in front of patients. Physicians' involvement in the financial and regulatory phase helps by lending a critical third-party credibility to new products seeking FDA approval.

Though the trend of surgeon-led innovation is just beginning to blossom, it's fair to say this collaboration benefits surgeons, device companies, and patients alike. At the end of the day, positive patient outcomes are what drives physicians and medical device companies to create and improve healthcare options for patients.

We may begin to see this trend rise and evolve into an even more collaborative process. Thus far, we have seen breakthrough innovations evolve from this development strategy, driving positive results in the operating room. 

Jeff Schell is CEO of TranS1®. Reach him at [email protected].

[Image courtesy of TAOTY/FREEDIGITALPHOTOS.NET]

M&A Means Big Shifts in Medtech Job Numbers

    Arrow  backDancing Elephants M&A

In many cases the frenzy of major M&A deals caused big swings in medical device company headcounts that did not really indicate any hiring or firing, according to EP Vantage

Here are a few that stuck out: 

The new Zimmer Biomet, created after Zimmer closed on its $13.4 billion acquisition of Biomet last year, has a workforce 75% larger than what Zimmer had;

BD's workforce grew 62% after its $12.2 billion purchase of CareFusion;

St. Jude Medical added 2000 staff, a 22% increase, through its $3.4 billion buy of major LVAD maker Thoratec.

10 Hot Medical Device Industry Trends>>

[Image by Annesley Rozairo - World66, CC BY-SA 1.0]

Sunshine Heart: Cutting Jobs

    Arrow  back
Sunshine-Heart

Sunshine Heart (Eden Prairie, MN) cut its workforce by nearly a third, to 38, in 2015 as it twice had to halt the pivotal U.S. trial for its C-Pulse heart failure device, according to EP Vantage

Sunshine Heart's implantable device is meant to assist the pumping of heart failure patients' hearts without having to come in contact with blood. It uses a balloon counter-pulsation technology, an extra aortic cuff implanted above the aortic valve. Leads exit the skin and are connected to an external driver housed in a bag that can be carried around. EP Vantage, though, notes that there was investor disappointment over the need to implant the device through a sternotomy, not exactly as minimally invasive as the procedure was thought to be. 

Continue >>

[Image courtesy of Sunshine Heart]

GI Dynamics: Cutting Jobs

    Arrow  backGI Dynamics EndoBarrier

GI Dynamics in July 2015 opted for an early termination of the U.S. pivotal trial of its EndoBarrier device (illustrated above), which provides an impermeable lining in the first part of the small intestine in order to reduce blood sugar and aid in weight loss. The reason for the early termination? There were higher than expected occurrence of hepatic abscess. GI Dynamics, though, still plans to move its technology forward in obese type 2 diabetes patients after it finishes investigating the causes of the abscesses.

In the meantime, the Lexington, MA-based company has had to engage in cost-cutting and restructuring. It cut its headcount by 48%, to 36, in 2015, according to EP Vantage.

Continue >>

[Image courtesy of GI Dynamics]

Develop a Strategy to Ensure Compliant Labeling Inspection

With half of all medical device recalls in recent years caused by packaging and/or labeling errors, it's time for manufacturers to rethink their approach to labeling inspection.

Warren Stacey

Despite the continual tightening of regulations around the packaging and labeling of medical devices, global device manufacturers continue to persist with traditional approaches to and infrastructure for labeling. The result is that the annual volume of medical device recalls remains consistent and the implications for cost, reputation, and--at the worse extreme--patient safety are as significant as ever.

Data show that more than half of all FDA recalls of medical devices since the first quarter of 2014 have been caused by packaging and/or labeling error. Given this, and with FDA starting to crack down on organizations that do not comply with its Quality System Regulations, medical device manufacturers must start treating compliant labeling inspection as business critical.

Learn how to meet tough regulatory requirements and design devices hospitals will actually buy in this special conference track at MD&M Minneapols on September 21. MD+DI readers get 20% off with promo code MDDI16.

Regulatory Drivers

Worryingly, a large percentage of the medical device industry appears oblivious to FDA regulations around the quality requirements for label inspection. A 2016 PRISYM ID survey of medical device and pharmaceutical organizations revealed that almost two-thirds of respondents were either unsure or unaware of FDA's regulations on the quality system requirements for label inspections.

Label inspection is a regulatory requirement in both the U.S. and European markets, irrespective of the size of an organization, with requirements outlined across a number of regulations, including:

  • 21 CFR 820.80b, which deals with Quality System Regulation for medical devices.
  • 21 CFR 820.120, which is specific to device labeling.
  • 21 CFR 211.122, subpart G, dealing with packaging and labeling control, which also specifically highlights the importance of 100% inspection.
  • EU Directive 2001/83/EC, article 65, which outlines how detailed guidance concerning a range of medical and healthcare products will be drawn up and published.

The scope and detail of global regulations underline that the 100% inspection of labels in the production, manufacture, and distribution of medical devices is a requirement, not an option.  To underline the point, FDA has already begun to issue warning letters to organizations that have fallen foul of these regulations. In 2014, 48 warning letters were issued relating to breaches of 21 CFR 820.80, and an additional four were issued regarding 21 CFR 820.120. These notices, quite literally, serve as a warning that companies must set in place robust mechanisms and processes to manage risk and maintain compliance.

Current Methodologies

The nature of the regulations, not least 21 CFR 211.122g, which allows provision for human and automated inspection processes, has led to a divergence in approach across the medical device sector.  However, as label content becomes more complex and evolves to include variables such as local languages and country-specific requirements, there is increasing concern that current labeling processes and infrastructure do not sufficiently protect companies against error.

In particular, many companies could do more to monitor, identify, capture, and collate errors that occur at the crucial print stage. This is an important distinction. While organizations invest a large amount of time and resources in ensuring preproduction data integrity, in failing to apply the same rigor to inspection once an operator has pressed print, they open themselves up to significant risk.

Making the assumption that a job will print in the way it was intended is ill-judged, not least because a variety of unforeseen mishaps--such as print driver conflict, material quality deterioration, and print hardware issues--can inadvertently impair the print process and lead to print inconsistency or illegibility.

The potential for error during the print process is significant. What's more, it can seriously undermine earlier efforts to secure data integrity in the pre-production setting.

Current Methodologies

At present, the ways in which companies approach labeling inspection tend to fall into two distinct camps; manual and standalone inspection.

Manual inspection methods include (though are not limited to) the following:

  • Manual pre-label and post-label inspection.
  • Random inspection.
  • 100% manual inspection.
  • 100% manual inspection, post-print.
  • Manual template.

Standalone vision inspection is an alternative method, whereby the print inspection system is entirely separate from the label management system. The approach uses a standalone application--a "vision system"--to design a label template in line with individual company specifications, then uses the template to form an inspection mask that supports automated checking post-print. While a huge step forward for manual processes, allowing more accurate inspection of every single label, its application within the medical device industry is constrained.

In contrast to commercial pharmaceutical manufacturing, where standalone vision has successfully supported large production runs with limited data to inspect, print runs in the device sector are often smaller, while labeling data and designs are much more complex. As such, the expertise and time required to configure a vision inspection application to identify all errors has often proved prohibitive, resulting in many technology trials failing an operational return-on-investment assessment.

Moreover, this standalone approach treats inspection and label management as two siloed activities. The lack of integration is problematic: It is not inefficient and increases risk throughout the label life cycle, and it leaves companies with two individual audit logs--one for printing, the other for inspection.

While all of the mentioned methods can be used as a risk assessment to determine whether finished labels are accurate, they each have limitations--some more substantial than others. Moreover, the vast majority fail to meet the basic requirement of 100% inspection and leave companies exposed to risk. As FDA turns up the heat on medical device organizations, large and small, to demonstrate compliance, the industry needs a more effective way to mitigate risk.

A Fully Integrated Approach

Companies need to find a solution that gives them end-to-end label tracking and the ability to understand that what was sent to the printer not only physically printed, but can also be proved in a single audit log. For more effective, joined-up thinking, an integrated approach is the only solution.

The full integration of label software and print inspection solutions provide complete print inspection set-up, test, and management functionality, automatically creating inspection masks from label designs and reducing the effort and expertise required for configuration and testing. Moreover, since they are fully integrated with in-line print verification systems, they can successfully marry label management and print inspection, facilitating the automated inspection of every label using the design and content sent to print.

Crucially, as the labeling infrastructure of medical device organizations becomes increasingly scrutinized, these solutions are underpinned by an integrated audit log to document a single source of the truth. In doing so, fully integrated label software and print inspection solutions not only help companies ensure FDA compliance, they minimize operational costs, increase throughput and efficiency, and significantly mitigate the risk of error throughout the labeling process.

Conclusion

The medical device industry spends huge amounts of time ensuring its datasets are accurate, integrated, designed, and approved for compliant labeling outputs. However, few companies spend sufficient time ensuring that the label that emerges at the end of the process is printed correctly. The repercussions of this could potentially be severe. As the regulatory climate becomes ever more challenging, global organizations must do all that they can to ensure that they have optimal labeling systems and processes to meet the demands of the FDA and European regulators. This requires cross-functional, organization-wide collaboration to assure that data formats, integration points and production infrastructure are all aligned--and are underpinned by a system that delivers that single source of the truth.

In the highly regulated environment of medical devices, label life cycle management is without doubt a business-critical system. It should be treated as such.

Warren Stacey is senior vice president of global sales at PRISYM ID. Reach him at [email protected]

[image courtesy of SIRA ANAMWONG/FREEDIGITALPHOTOS.NET]

Smith & Nephew: Adding Jobs

    Arrow  backSmith & Nephew Syncera

Smith & Nephew grew its headcount by 1,218 workers, or 9%, to 14,686 in 2015, according to EP Vantage (London). Much of the growth was organic, and not due to M&A activity.

The company has nearly doubled its workforce over the past five years.

In fact, S&N under the leadership of CEO Olivier Bohuon has stayed away from a major M&A deal. Instead, there has been a push for organic growth and innovation internally, with $222 million spent on R&D in 2015 along. The company was even included in Forbes's latest list of the world's most innovative companies. 

Innovations at the British medtech giant include not only products but new business models, such as the Syncera system (marketing image above) for bundling a total joint replacement episode. Syncera includes not only the implant systems but also digital services, performance reviews, and metrics. 

Going forward, headcount numbers could be affected by Smith & Nephew's sale of its gynecology business to Medtronic, which closed in August. The potential effects of Britain's Brexit vote may also come into play; S&N's stock temporarily took a hit after the June 23 vote. 

Continue >>

[Image courtesy of Smith & Nephew]

Medtech Companies: Who Is Hiring and Who Is Firing?

    Giving the Axe

Study the financial reports of many medical device companies, and big swings in jobs numbers are likely the result of the M&A frenzy that has hit the industry in recent years. (Although, the deals are slowing down a bit.)

Some companies are exceptions to the rule, though. Here are five companies that received attention in EP Vantage's latest medtech jobs report.

Continue >>

Structural Heart Opportunities and Challenges

TAVR and TMVR are among the hottest technologies in medtech right now. Learn what it takes to innovate in the structural heart space at the MD&M Minneapolis conference on September 21. Qmed readers get 20% off with promo code Qmed16.

Chris Newmarker is senior editor of Qmed. Follow him on Twitter at @newmarker.

Like what you're reading? Subscribe to our daily e-newsletter.

[Image courtesy of Pixabay]

An earlier version of this slideshow mistakenly listed Coloplast as a job cutter, per the EP Vantage report. Coloplast actually plans to grow its number of employees by 3000 in coming years.

Why Do Women Leave Engineering?

New data out of MIT and the MD+DI Medtech Salary Survey sheds light on gender discrimination problems in engineering, including in the medical device industry. 

Nancy Crotti

Women EngineeringMore women leave engineering than men because they feel marginalized during internships and team-based work, according to a new study by the Massachusetts Institute of Technology. 

In those settings, men are more likely to to be chosen to work on the most challenging problems, while women are assigned routine tasks or simple managerial duties, the study found. The problem, then, isn't the curriculum or the classroom; it's men in the profession treating women as inferiors.

"It turns out gender makes a big difference," said Susan Silbey, a professor of humanities, sociology, and anthropology at MIT, and co-author of the paper, "Persistence is Cultural: Professional Socialization and the Reproduction of Sex Segregation," which appears in the journal Work and Occupations.

The result? Women who expected to make positive social change as engineers can become disillusioned with their career prospects.

In the medical device industry, women who continue working as engineers appear to face more discrimination. According to data from the MD+DI Medtech Salary Survey 2016, male and female respondents said they enjoy their work about equally, but the women are paid an average of $111,105, compared with the average male salary of $130,667. Only 20% of respondents were women; both the men and women were in their 40s on average. (Download a copy of the full report here.)

TAVR and TMVR are among the hottest technologies in medtech right now. Learn what it takes to innovate in the structural heart space at the MD&M Minneapolis conference on September 21. Qmed readers get 20% off with promo code Qmed16.

Just two years ago, a Qmed survey found blatant sexism among males in medtech.  Responses to a question about women leaders in the industry included ,"There are none," and, "Are you going to provide some training for them?"

More recently, a Minnesota medtech firm agreed to pay more than $1 million to settle a federal gender, age discrimination, and retaliation lawsuit. The Equal Employment Opportunity Commission filed suit in March 2014 accusing PMT Corp. (Chanhassen, MN) of refusing to hire women or any applicants over age 40 as sales reps between Jan. 1 2007 and Oct. 27, 2010. The company's phone number is 1-800-MANKIND.

Fixing Engineering Education

Engineering schools are facing a "cultural phenomenon" that educators could address, Silbey said of the way this group-dynamics problem crops up at a variety of key points during students' training.

Overall, about 20% of undergraduate engineering degrees are awarded to women, but only 13% of the engineering workforce is female, according to the MIT researchers.  The new study supplements previous explanations for this discrepancy, including a lack of mentorship for women in the field; a variety of factors that produce less confidence for female engineers; and the demands on women to maintain a balance between work and family life.

The researchers asked more than 40 undergraduate engineering students from MIT, the Franklin W. Olin College of Engineering, Smith College, and the University of Massachusetts at Amherst to keep twice-monthly diaries. From the more than 3000 diary entries they examined, the researchers found that old gender roles prevailed in team-based activities outside the classroom.

Here's how one female student described a design class: "Two girls in a group had been working on the robot we were building in that class for hours, and the guys in their group came in and within minutes had sentenced them to doing menial tasks while the guys went and had all the fun in the machine shop."

Many women's first encounter with collaboration "is to be treated in gender stereotypical ways," the researchers found. "Almost without exception, we find that the men interpret the experience of internships and summer jobs as a positive experience."

Such experiences lead women who entered engineering to reconsider their career choices, the study says.

Silbey recommended that institutions develop "directed internship seminars," in which student internship experiences could be dissected to help people understand and learn from the problems women face.

Nancy Crotti is a contributor to Qmed.

Like what you're reading? Subscribe to our daily e-newsletter.

[Image courtesy of MIT]