Kaleidoscope Innovation an Infosys company
Kaleidoscope Innovation an Infosys company

Matt Berning

Jyuthika Sen joins Kaleidoscope as a Human Factors Engineer

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Jyuthika Sen joins Kaleidoscope as a Human Factors Engineer

Jyuthika Sen
Human Factors Engineer
Cincinnati Ohio

Jyuthika Sen joins Kaleidoscope as a Human Factors Engineer based out of our Cincinnati Ohio headquarters. Jyuthika is experienced in evaluating design issues and errors that that may occur during use to optimize design, usability, safety, effectiveness, and customer appeal of a medical device or combination product. She has worked to become an expert in therapeutic areas such as Parkinson’s, Diabetes Care Management, Rheumatology, Nephrology and Hemophilia.

Overview:
Master’s in Biomedical Innovation and Development (MBID)
Bachelor of Technology (B.Tech) in Biomedical Engineering

Areas of Specialty:
Phases of development for combination products and medical devices from unmet needs finding, concept generation, through validation
Leading cross-functional teams to conduct projects which include usability testing protocol creation, study moderation, data analysis, and FDA submissions
Creating FDA compliant documents for client’s Design History Files
Conducting risk management activities and maintaining risk documents for client’s Design History Files
Performing heuristic evaluation of medical devices and combination products using a human-centric design approach

About Kaleidoscope Innovation
Kaleidoscope Innovation is a full-service product development firm innovating across medical, consumer and industrial markets. For over 30 years 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, Medical Affairs, Industrial Design & User Experience, Engineering, Visualization and Software Development.

Gaining Meaningful Experiences through Real World Exposure

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Gaining Meaningful Experiences through Real World Exposure

As every new semester approaches, we are excited and eager for the new round of Co-Ops to join the Kaleidoscope organization.  Attracting some of the brightest minds from Universities all over the globe; Kaleidoscope welcomes Designers, Engineers, Human Factor Engineers, Researchers and Sales and Marketing professionals to our headquarters in Cincinnati Ohio. Through our robust and collaborative program, Kaleidoscope Co-Ops are able to strengthen and grow their professional and personal skill-sets prior to graduation through real world applications and scenarios. The impact is felt immediately through their hard work, determination, unique perspective and overall drive to support Kaleidoscope’s Mission to “Improve the Human Experience through Meaningful Innovation”. Having the exposure to several dynamic and challenging programs during their rotation, they have the opportunity to solve problems within many of the different stages of the development process. Allowing them to wear many different hats and be creative in their solutions.   

We have been really impressed with the Co-Ops that have come through our program over the years. They are confident, diligent, socially skilled and talented problem solvers. If you have interest in joining Kaleidoscope, please stay connected through our Website, LinkedIn channel and Careers Page.  

When deciding on your next rotation, we have sound advice from Kaleidoscope’s Co-Op Leaders as well as former Co-Ops: 

    • Seek guidance from not only academic advisors, but also industry professionals. 
    • Pursue what you want with confidence.  
    • Don’t be afraid to not know the answer, but be ready to go find it.  
    • Don’t miss out on the meaningful professional and personal bonds you can build in the workplace. 
    • Your enthusiasm and drive are some of your biggest assets. 
    • Don’t hesitate. 

Authors

Matt Suits

Matt Suits
Business Development Manager
msuits@kascope.com

Pulkit Verma
Senior Design Engineer & Filmmaker

Kaleidoscope Innovation Takes Measures to Help Protect Employees and the Community While Moving Business Forward for Clients

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Kaleidoscope Innovation Takes Measures to Help Protect Employees and the Community While Moving Business Forward for Clients

Statement from Kaleidoscope CMO & VP of Medical Affairs Elliott Fegelman, MD:  

Last updated 05/04/2020

Kaleidoscope Innovation cares deeply about the well-being of our employees, clients and the wider community.

As the situation regarding COVID-19 evolves, Kaleidoscope is adapting our policies in a way that continues to help safeguard our team and others as our top priority. We are continuing to utilize remote technologies that allow our employees to work from home. For those who choose to come into the office, we have implemented safety requirements that integrate state recommendations and best practices. A few of these requirements for employees who opt to come into the office include taking their temperature upon entering the building, maintaining a social distance of at least 6 feet, wearing face masks and restricting the number of individuals allowed in our conference rooms at a given time. Kaleidoscope is also continuing to keep our team apprised of updates related to COVID-19.

We also care very strongly about serving our partners, and want to provide assurance that as an essential business we are fully operational and still moving business forward for our clients. We are continuing to leverage various remote technologies to support the delivery of our end-to-end product development services.

We understand the pressures our clients are facing and want to reassure them that we are committed to making sure we keep them informed and that their projects stay on track.

Kaleidoscope is constantly evaluating the situation and will continue to update this information as needed.

Elliott Fegelman, MD
CMO & VP of Medical Affairs

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

Elliott Fegelman, MD Kaleidoscope Innovation

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
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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