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Kaleidoscope Innovation Hires New VP, Medical Affairs, and Strengthens Commitment to User-Centered Device Development

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Kaleidoscope Innovation Hires New VP, Medical Affairs, and Strengthens Commitment to User-Centered Device Development

Former Chief of Surgery with over 20 years of medical affairs experience brings clinical and industry perspectives to product development service offering

CINCINNATI, OH. Kaleidoscope Innovation, a full-service insights, design and development firm, has hired Dr. Elliott Fegelman as the new VP of Medical Affairs. Fegelman brings over 20 years of experience as a medical and clinical leader for surgical product development to help ensure end-user perspectives remain central to the development of leading device solutions.

Fegelman is an expert clinician with success translating unmet needs at the bedside and in the OR to commercially viable products and services.

“The addition of Dr. Fegelman to the Kaleidoscope team means we can incorporate clinical user feedback throughout the development process in an even more efficient way,” said Dr. Michael Clem, VP of Research & Development for Kaleidoscope Innovation. “His extensive experience in medical affairs has the potential to decrease clinical risk and increase commercial readiness for our clients.”

Fegelman most recently served as Vice President and Therapeutic Area Expert at Johnson & Johnson Medical Devices focusing on the Ethicon business, a leading manufacturer of surgical technologies and solutions based in Cincinnati, OH. In this position, Fegelman was integral in shaping the company’s medical affairs, clinical research, business development, thought-leader engagement and training programs.

Prior to joining Ethicon, Fegelman served as the Chief of Surgery at The Cincinnati Jewish Hospital. There, Fegelman led the entire clinical and academic surgical service line at a tertiary teaching hospital. He was responsible for faculty recruitment and retention, curriculum development, credentialing of medical staff and clinical quality assurance.

Fegelman is excited about joining Kaleidoscope, where the user is central to product development. “At Kaleidoscope, I can partner with medical device manufacturers to help them understand what really matters in clinical practice and what is required for regulatory acceptance,” explained Fegelman. “This real-world experience is critical throughout the product development process, in risk assessment, during commercialization and when evaluating the acquisition of new technologies.”

Fegelman earned his medical degree from Wright State University, School of Medicine in Dayton, OH, following his graduation from Denison University. He completed his residency and chief residency in surgery at the University of Cincinnati.

About Kaleidoscope Innovation

Kaleidoscope Innovation is a full-service product development firm innovating across medical, consumer and industrial markets. For over 30 years our clients have partnered with Kaleidoscope to improve the human experience. Offering both consultancy-style and onsite services, they provide a full breadth of disciplines to meet their partners where needed, including: Insights & Human Factors, Industrial Design & User Experience, Engineering, Visualization and Software Development.

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See the press release on PRWeb.

Kaleidoscope Innovation Hires New Director of Insights and Human Factors to Promote the Value and Knowledge of User‐Centered Design

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Kaleidoscope Innovation Hires New Director of Insights and Human Factors to Promote the Value and Knowledge of User‐Centered Design

Valerie Fenster
With over 30 years of developing powerful and user‐ centered design, new director brings human‐focused insight and passion to this critical leadership role. Cincinnati, Ohio (October 2, 2018) – Kaleidoscope Innovation, a product development firm that provides services ranging from insights, design and development, has hired Valerie Fenster as the new Director of Insights and Human Factors. Valerie brings 30 years of experience in leading Human Factors Engineering and cross‐functional teams to ensure human user requirements remain foremost in developing leading device and design solutions. She is adept at developing intuitively optimized interfaces for critical business applications. Valerie is an experienced and effective advocate and teacher on the topic of implementing Human Factors Engineering and Human‐Computer Interaction best practices. “Valerie brings distinct insights, commitment to human‐focused design and perceptive leadership that to Kaleidoscope Innovation’s continuum of design solutions,” said Bo Gill, Vice President of Product Development for Kaleidoscope Innovation. “Her extensive experience in medical product development and numerous other industries will continue to strengthen our commitment to delivering human‐ centered solutions for our business partners and the individuals and communities they serve.” Valerie most recently served as Senior Manager for the Human Factors Engineering (HFE) group at Amgen, a leading biomedical developer in Thousand Oaks, CA. In this position, Valerie founded the HF Engineering group, growing the organization from just herself to nine full‐time personnel. She successfully guided the Human Factors process and regulatory filings for combination products such as Enbrel®, Repatha® and Aimovig® SureClick® autoinjectors and prefilled syringe devices. Valerie’s insight also promoted the success of the Enbrel® Mini™ with AutoTouch™ reusable autoinjector, as well as wearable devices, such as the Repatha® Pushtronix®, and the Neulasta® Onpro® devices.
Another highlight of Valerie’s career was working at Abbot, formerly St. Jude Medical. Here, Valerie was instrumental in developing the Merlin.net™ Patient Care Network – a complete remote care connectivity system that enables patients to conduct at‐home data transmissions for implantable cardiac rhythm management devices. She has also served as Vice President of Bank‐Customer Interaction for Citibank in New York and as Vice President of Marketing Planning for Ketchum Communications in San Francisco. Valerie is excited about joining Kaleidoscope Innovation, where Human Factors is an integral part of operations. “Kaleidoscope doesn’t limit the role of Human Factors to just research or as a requirement for product submissions to the FDA or other health authorities,” Valerie said. “Kaleidoscope is unique in their philosophy to incorporate Human Factors throughout the entire design continuum from feasibility to validation.” For someone like Valerie, who has a natural curiosity and insight into human behavior, Human Factors is a perfect fit. “I have always had a strong interest in what makes people tick and what makes them fear and what makes them embrace technology,” she said. “I love creating pleasing designs where the intricacy and the technology behind the physical design are transparent to the user.” She adds that her work in Human Factors Engineering provides the perfect choice for uncovering problems, unraveling pain points and finding elegant solutions to create satisfying designs. In addition to Valerie’s extensive experience in medical device and combination device development, notable non‐medical clients include American Express, AT&T, Bank of America, Citibank, General Electric, Merrill Lynch Direct, PNC Bank and Prudential Insurance. Valerie received her MS from DePaul University in Chicago; and BAs from both Argosy University in Phoenix and California State University. Valerie is based in the Los Angeles market area and will frequent Cincinnati as well as other Kaleidoscope Innovation locations throughout the U.S.

About Kaleidoscope Innovation

Founded in 1989, Kaleidoscope Innovation is a full‐service, ISO 13485:2016‐certified insights, design and development firm with extensive expertise in medical device development. Offering both consultancy‐ style and on‐site direct product development services, Kaleidoscope Innovation flexes to best help their business partners solve their development challenges. They provide a full breadth of disciplines to meet their partners where they are in their development process including: Insights & Human Factors, Industrial Design & User Experience, Engineering, Visualization and Software Development.

Media Contact

Bill Taylor 900.930.5793 btaylor@kascope.com ### See the press release on PRWeb here.

Innovation Leadership & How to Build the Ideal Innovation Team – Part 2

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Innovation Leadership & How to Build the Ideal Innovation Team – Part 2

Building a team for innovation? Wish you could get tips from an experienced innovation leader about how to structure teams for performance and results? In part 2 of this series on building the ideal innovation team, Kaleidoscope VP of R&D, Medical, Michael Clem DVM, MS, shares his insights and best practices. In this article, we’ll look at a “category structure” for lean-type startups. This is a different perspective from the “functional structure” for building the ideal innovation teams covered in part 1. (5-minute read.) Here’s Dr. Clem:

Clinical, Technical, Commercial and Organizational Considerations

Over the course of my 25 years working on and leading teams engaged in medical device development, I have experienced a variety of approaches to staffing the ideal innovation team.

In Part 1 of this series, I described a “functional approach” based on key technical skills team members should possess. Alternatively, in this section I describe a leaner approach based on critical categories of thinking required for medical device development.

In a lean startup environment, you can’t always access or afford all of the specific skills you might desire. At the same time, you do need to ensure your team is prepared to address the clinical, technical and commercial considerations inherent in developing medical product innovations. Depending on your organization’s size, the team may also need to be prepared to address organizational variables.

Building a team to address the clinical, technical, commercial and organizational considerations of product development requires a different way of looking at the individuals you choose. Rather than focusing on a person’s primary technical skill (i.e. engineering, design, marketing), identify team members who have the breadth of experiences necessary to successfully navigate the requirements in each category of thinking. From my experience, these individuals can come from various technical backgrounds.

Let’s look at the role each category plays in medical product innovation.

Clinical Considerations

In medical device development, a deep understanding of the users and clinical problem is critical to developing successful solutions. For instance, the concept development team must understand the problem, anatomy, physiology, pathology, users, use environment and so on.

Someone on the team needs to develop this multilayered understanding. This allows the team to represent patients, physicians, other healthcare professionals and key stakeholders who will benefit from the solution.

Depending on their training and backgrounds, this in-depth clinical knowledge might be a stretch for some. But with diligent observational research, relationships with consulting subject matter experts and secondary research, this knowledge can (and must) be integrated into the team. A good scientific or clinical advisory group, composed of relevant subject matter experts, can be invaluable.

Although this clinical understanding speaks specifically to medical device development, it has an equally critical corollary in any field of innovative product development. Simply foster a deep understanding of the end users and the job(s) they are trying to accomplish.

Some methods and tools that can help develop this knowledge include:

  • Ethnography and customer observation
  • Regulatory assessments
  • Procedure maps
  • Clinical stakeholder assessment

Commercial Considerations

Much like fostering an understanding of clinical considerations in your team members, integrating commercial considerations is highly important. Even if your innovation team is staffed exclusively with engineers or individuals with technical backgrounds, someone on the team needs to be ready and able to put on a business thinking hat. Ideally, this individual would come from a business or marketing background or have additional experience in these fields.

Examples of commercial considerations the team should address include:

  • Customer value proposition
  • Claims exploration
  • Competitive assessment
  • Business plan development
  •  

Innovation teams that fail to incorporate these commercial considerations in developing their solutions run the risk of creating wonderful technical solutions that the market will not embrace for any number of reasons.

  • Tools to help make sure the innovation team addresses these considerations include:
  • Concept selection criteria
  • Concept exploratory research
  • Customer segmentation and persona development
  • Financial modeling

Innovation Leadership & How to Build the Ideal Innovation Team – Part 1 of 2

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Innovation Leadership & How to Build the Ideal Innovation Team – Part 1 of 2

This is part one of a two-part series about innovation leadership and the ideal innovation team, by Kaleidoscope VP of R&D, Medical, Michael Clem DVM, MS. In this article, he examines the functional and cross-functional expertise needed to drive the best innovation resources to turn creative ideas into quality products that benefit consumers.

People often think of Thomas Edison when they think of innovation. This focus on the single inventor can sometimes give the wrong impression of how successful innovations take place. In reality, Edison surrounded himself with teams of creative individuals. It has been said that innovation is a team sport, requiring teamwork.

But how do you approach staffing your ideal team to drive innovation in your company?

Perhaps the most important aspect of innovation leadership and building the ideal innovation team is to foster cross-functionality. Really focus on getting people who serve specific functions in the team, but who also have a shared vision and shared incentives. This ideal innovation team is not just assigned to a common project, not just sitting together. The ideal innovation team is really working together and pushing boundaries to take on additional roles outside of their areas of specialization.

From a functional expertise perspective, here are the essential functions or team members:

 

Engineering

Engineers bring technical expertise in product design and development to the team. Over time, I came to broadly characterize two types of engineers as critical to successful development. Both types have their own inherent strengths and are equally valuable.

“Idea” Engineers

These are the creative “inventive engineers” who are always coming up with new ideas. These individuals are extremely important to have on the team, but often hard to keep focused. They like to move on to the next challenge or exciting problem to solve. These out-of-the-box thinkers come up with new solutions to break new ground.

“Closer” Engineers

These are the heavy lifters who are needed to follow through to make the big, creative ideas become a reality. They work out the problems, build the prototypes and run the tests. They are essential to getting to final designs that can be manufactured. This is certainly not to say that these individuals are not creative or that they do not also come up with great ideas. They just tend to excel in dotting the “i’s” and crossing the “t’s” required to advance a radical idea.

These team members capture opportunities as defined by Thomas Edison when he said, “Opportunity is missed by most people, because it shows up dressed in overalls and looks like work.”

Occasionally, someone will find an individual engineer who embodies both characteristics, but in my experience, most people excel in one direction or the other.

 

CAD Design

Fifteen years ago, it was not the norm for engineers to do their own CAD. However, the digital design world has evolved and this is no longer the case. With that said, having a dedicated CAD designer on the team can free engineers to concentrate on other tasks. Otherwise, engineers would be devoting “screen time” to refining concept design for rapid prototyping. In many instances, a seasoned CAD designer can fulfill the role of the “closer” or heavy-lifting engineer. They will build models, test and refine designs for manufacturing.

Industrial Design

Industrial Design is an extremely valuable skill to have at all stages of concept development. Industrial designers bring the Design Thinking process to life. Beginning with understanding customer needs, translating insights into concept design, and integrating human factors into usability, their work is essential. Good industrial design work isn’t possible when the designers are brought in at the end to “make it look good.” It must be incorporated from the beginning of the process.

 

Marketing / Business

Early in the process, the team needs to be thinking about the market and whether their ideas would fit in the current market environment. Marketers and business people know what sells and how to make the case for the product. In many companies, they often drive a project and should always be included in discussions and planning from the outset.

“Hard work is still wasted on features that don’t make the marketing headlines,” says GV Design Partner Jake Knapp in an article on product design and marketing. “Instead of the icing on the cake, I like to think of marketing as the sugar in the batter. You’ve got to get it in before the cake gets baked.”

Clinical

In medical device design and development, the team should include an expert with in-depth clinical understanding. This is often the end-user physician. In addition to physicians though, it is crucial that the team also consider inputs from the entire healthcare ecosystem. This includes personnel who may be involved in the purchase, such as the value-analysis committee. (Learn more about the essential role of a value analysis committee.) Also the project needs to consider those involved in the preparation or use of the final product, such as technicians and nursing staff. This clinical knowledge may come from an individual clinician or a physician advisory panel, augmented by formal usability and concept research with users.

Support Functions

In an innovation setting, there will need to be additional support functions. Some of these important roles might be contracted from the outside, depending on the size of the organization. These roles include legal advisors, HR professionals, finance professionals, IT professionals, regulatory affairs, quality and operations management professionals.

Leadership

Ideally, the team leader should come from one of the functional roles on the team, engineering, marketing or design. The team leader serves as the main point of contact with management and other entities that need to be engaged to keep the project moving forward, and they must be able to recruit.

With the team leader also playing a functional role on the team. They are more like a “Player Coach,” providing direction while making meaningful contributions to the advancement of the project. At the same time, every member of a high performance innovation team needs to be a leader in his or her own right.

Transitional Innovation Leadership

In this model, leadership may be transitional. Marketing and Industrial Design may lead the early stages of the project. For example, in the phases of understanding the customer needs, conducting market research and developing insights that shape the work. Later, leadership may transition to Engineering and Design leading during the ideation and concept development phases. At that time, Marketing then focuses on developing the business case for moving forward. With concepts in hand, leadership may transition back to Marketing for final validation research, pricing and launch planning.

Regardless of which function is taking the lead for a project phase, the best innovation comes when other functions are included throughout. This helps everyone to better understand what needs to be done from a big picture perspective. This also helps teams feel more invested in the outcome as well. Cross functional teams mean getting rid of information silos and opening communication.

Hot Teams

These ideal innovation teams can also be thought of as “hot teams.” These embody the idea of a cohesive group, working well together. Here the whole is greater than the sum of the parts.

The ideal innovation team does not need people who can only work in their specific areas of expertise, but who exhibit cross-functionality. People who don’t fear trying new roles. These individuals possess certain characteristics, such as their abilities to work together as a team. They also use their leadership skills to advance the work before them, take directives from management and embrace a fluctuating team structure.

They should also possess the tact and ability to navigate corporate processes to accomplish their team’s goals. But, be highly focused on reaching these relevant milestones in line with the end objective(s).

All things considered, ideal innovation teams need to have the right combination of skill sets, and must be willing to work collaboratively.

For those interested in learning more about how to form the ideal innovation team, I have written an e-book with input from my innovation-minded colleagues at Kaleidoscope that is free and available for download here. In the Ships and Castles Model I describe details on how to navigate front-end innovation efforts while fortifying an existing product line.

Ideal Innovation Team Sources

“Rapid Team Learning: Lessons from Team New Zealand America’s Cup Campaign,” by Kambiz Maani and Campbell Benton
Ships and Castles Model: 7 Steps for Fortifying Your Base While Navigating Front-End Navigation
GV: How to build an opinionated product: design the marketing first

About the Author: Mike Clem

Vice President of Research and Development, Medical, Mike Clem, DVM, MS, thrives at the juncture of medical technology and clinical understanding. From his training as a veterinary surgeon through more than 20 years with Johnson& Johnson, Ethicon Endo-Surgery, Ethicon and Cordis, he has developed innovative solutions to complex customer problems. He covers medical device design for Kaleidoscope.