Absorbable surgical staples solve problems

Incisive Surgical takes a data-driven approach to innovation

Challenge

To simplify analysis of product test and experimentation results, simplify data for regulatory submissions, and optimize manufacturing processes.

To communicate analysis results to executives and external suppliers easily and visually.

SolutionJMP helps Incisive Surgical in all phases of product development with design of experiments, data analysis and visualization, and statistical process control.
ResultsA culture of analytics helps this small company quickly evaluate new opportunities and routinely overcome challenges.

Patients scheduled for surgery have one less thing to worry about when their doctors use the INSORB® Skin Stapler system, which promotes comfortable wound healing without a return visit to get metal staples pried out.

Minnesota-based Incisive Surgical Incorporated introduced the INSORB Subcuticular Skin Stapler in 2005, melding the absorbable properties of modern sutures with the easy-to-install technique associated with metal skin staples. The INSORB staples are placed just under the skin, holding incisions together long enough for natural healing to take place. The staples are then absorbed over time.

Founded in 2001, Incisive Surgical has won several awards for its innovative product, including the 2006 Wall Street Journal Technology Innovation of the Year Award. The company has strong support from the medical community as well. In 2013 Incisive announced the sale of its one-millionth stapler – a major milestone for this small company.

The success of the product brings a host of opportunities and challenges, says Chad Naegeli, Engineering Manager for Incisive Surgical.

“Our focus is on optimizing our product,” Naegeli explains. Incisive Surgical’s understanding of its novel and proprietary modality is in large part due to the capacity for deep statistical analysis, design of experiments, statistical process control and data visualization available through JMP® statistical discovery software from SAS.

‘Let the data speak for itself’

JMP has led Incisive’s leadership to adopt a more data-driven approach throughout the company. “Now, when we need to make design decisions, we collect data and let the data speak for itself. It’s calming to have data visualizations that everybody can understand,” Naegeli says.

Naegeli works in Research and Development but says that JMP is used throughout the company for process optimization, product testing,experimental analysis, regulatory submissions, and communication with internal decision makers and outside suppliers.

Efficient experiment design speeds progress

To promote efficiency in product design and manufacturing, Incisive has relied on the unique Definitive Screening Designs platform in JMP invented by Bradley Jones, Principal Research Fellow at JMP, and Chris Nachtsheim, Chair of Operations and Management Sciences at the University of Minnesota’s Carlson School of Management. Definitive screening designs separate the vital few factors that have a substantial effect on a response from the trivial many that have negligible effects, using very few experimental runs. This innovative class of designs has won awards from the American Statistical Association, the American Society for Quality and the Journal of Quality Technology.

The color map in Figure 1 illustrates an eight-factor, 17-run definitive screening experiment used to optimize one of Incisive Surgical’s injection molding processes. The main effects and interactions are mapped using color to define the strength of the correlation.

“Even though we tested only a tiny fraction of the design space, JMP showed us where we could optimize our key outputs – strength, dimensional capability, cost, material usage, cycle time and maintenance – with confidence.”

Naegeli says he especially appreciates the speed of analysis with JMP. For example, using the Stepwise personality in the Fit Model platform lets researchers run, sort and select from literally millions of statistical models almost simultaneously, and see the results in real time.

Visualization fosters understanding

Another platform unique to JMP is Graph Builder, which enables drag-and-drop creation of interactive graphs. Graph Builder has been especially useful in projects that require solid, data-based decisions.

“It’s just so fast. In 10 minutes, we can see things that you would never see in a ream of columnar reports. JMP’s visual depiction of analysis results fosters understanding,” Naegeli says.

Naegeli uses Graph Builder to analyze a wide range of variables and work with them in various visual formats, such as bar charts, scatter plots and heat maps. The visualization of statistics is essential when sharing detailed information with people both inside and outside the company, he says.

Naegeli and his colleagues often rely on Graph Builder to bring data sets before the company’s decision makers and, he adds, “It has also been a great tool to use with our suppliers.”

JMP allows engineers to mine data and combine multiple variables. The software’s flexibility encourages exploration of data and discovery of patterns in that data. The Profiler shown in Figure 3 complements the Graph Builder. The Profiler allows you to see the slope or inflection in one variable change as other variables are adjusted. This dynamic visualization helps engineers understand what the data is saying.

The result has been an easier working relationship with suppliers. “In the past, when we asked for a new requirement or a particular dimension on a component, often there would be pushback,” Naegeli says. “The supplier might say that they don’t know if they can do it, or that making a certain design or process change would be too difficult for them.” Once they see the data, consensus grows quickly that the project goals can be satisfied. “They get this look in their eyes when they see all the data come together,” he says. “They know that this is really cool.”

Better processes with visual analysis

JMP control charts offer a clear picture of routine process variation, making it easy to identify areas of instability so that adjustments can be made to improve quality or lower costs. Incisive uses simple visual control charts to improve communications with suppliers.

“When I tell our suppliers ‘I’ve been collecting data on your process and this is what it has done over the last three years,’ everyone understands the process better. When we all look at the data together, it’s a lot easier to get the suppliers on board with changes and it makes the processes better,” he says.

Assuring regulatory compliance

Data is important not only to ensure reliability of the company’s internal processes but also to generate data summaries for submissions and reports to regulatory agencies that oversee medical device design and commercialization.

Incisive Surgical uses JMP to stay on top of regulatory matters through all stages of the product life cycle, including:

  • Analysis of regulatory submission data required by the FDA and the European Union for market approvals.
  • Analysis of key specifications within these submissions, such as packaging testing to ensure product durability during shipping.
  • Demonstrating that the risk mitigation controls throughout the supply chain are effectively implemented.
  • Analysis of complaint data to demonstrate that the product remains safe and effective.

‘There’s just no other software that can do this’

When presenting a JMP analysis to colleagues, Naegeli often receives positive feedback about the depth and thoroughness of the information. He says his teammates tell him they appreciate seeing the bigger picture – how altering a single factor may affect the design or production process.

“It is pretty powerful to demonstrate Design and Process trade-offs dynamically in front of a group.” Naegeli says he has no doubts that JMP has saved his company time and money through data analysis that is efficient, flexible and accurate. “To my knowledge, there’s just no other software out there that can do this as eloquently.”

David Herridge, Vice President of Regulatory, Quality, and Engineering for Incisive, agrees. “Building our small team’s problem-solving methods around JMP has yielded a tremendous business return,” Herridge says. “We get our annual license cost back dozens of times every year in project speed, discovery horsepower and document robustness. We can’t imagine not having JMP.”

Patient on stretcher
We get our annual license cost back dozens of times every year in project speed, discovery horsepower and document robustness. We can't imagine not having JMP.
David Herridge

Incisive Surgical

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