OEMs and start-ups that seek to bring a biosensor device to the medical market must be strategic in their approach or risk delays and inflated development costs. The design phase is a critical juncture, as decisions made during this stage are often the difference between a commercially successful biosensor device and one destined for significant redesign — or one that might not be viable at all. Read on for Dave Liebl’s seven best practices for starting a design process that fosters commercial success for medical biosensors, as featured in Medical Design Briefs. https://lnkd.in/gUAvv2vB
Second Harvest Heartland
Intricon team members volunteer at Secondharvest Heartland, a food bank in Minnesota that operates across the emergency food chain to distribute healthy food. The organization partners with community resources to help neighbors in Intricon’s headquarters community of St. Paul-Minneapolis thrive. Volunteers from Intricon sort and pack food and provide other assistance to further the mission of Secondharvest and impact people living in low-income households, seniors, and others needing food assistance.
ST. PAUL, Minn. (Feb. 1, 2023) – Intricon, developer and manufacturer of medical devices
powered by smart miniaturized electronics, today announced that it has named Darren Gilmer
senior manager of a new biosensors medical device product development team in the company’s
Biosensors Center of Excellence (CoE).
Since announcing its CoE last month, Intricon has engaged in several new biosensor initiatives,
according to Dave Liebl, chief commercial and technology officer at Intricon. “This new team is
focused on helping companies with biosensor device designs get their devices to market faster,
keeping Design for Manufacturing, quality and regulatory requirements in mind every step of the
way,” said Liebl.
Gilmer was most recently senior manager of manufacturing engineering at Intricon. He has three
decades of experience growing the company’s expertise in creating sensor-driven devices that
are smaller, lighter, and more comfortable for patients. “The biosensor device market is very
complex,” said Gilmer. “There’s not yet agreement on definitions and standardizations, for
example, which makes it challenging to bring a new device to operability or convert a consumer
biosensor device for a medical application.” Gilmer and his team of engineers are focused on
helping companies overcome these challenges and capture the significant opportunities of the
rapidly growing biosensor category.
About Intricon
For four decades, Intricon has improved and extended people’s lives by developing and
manufacturing sensor-driven micromedical devices. Intricon partners with medical device
companies, providing unique microelectronic expertise — including miniature molding through
final assembly – and regulatory guidance, supply chain optimization, and scalable production,
exclusively for the medical market. Intricon brings the world’s smallest, smartest new and next
generation devices to life.
May 10, 2022
INTRICON R&D VP DAVE LIEBL SHARES ADVICE ON HOW OEMs CAN LEVERAGE OUTSOURCED PARTNERS FOR COMPLEX PRODUCTS IN CHALLENGING TIMES
Medical Products Outsourcing, a leading media authority in the med device industry, recently called on Dave Liebl, vice president of research and development at Intricon, for insight for its latest article on how outsourced partners like Intricon can meet the demanding design challenges from OEMs.
He highlights how trends will lead to less-invasive approaches for diagnostic and therapeutic procedures and non-invasive technologies to help visualize and/or transmit key health data for analysis, and how Intricon is overcoming supply chain challenges for its customers.
“Lead times for raw materials required to prototype new product concepts have definitely increased—often two- or three-fold—from pre-pandemic levels,” he notes in the article. “Thus, companies that can find a way to prototype faster in the current environment will rise to the top.”
Other trends Dave touches on in the article include:
- Product design trending toward smaller, smarter devices that combine multiple technologies
- Speeding up product design and development by outsourcing to trusted and experienced contract manufacturers
- Electronics that are used to protect the health of patients and physicians, such as electromagnetic field (EF) generators and sensor technologies as alternatives to fluoroscopy
- More frequent use of FEA as product designs become smaller and more complicated, especially for the evaluation of complex assemblies
The article, posted online and in the May issue of Medical Product Outsourcing, ends with Dave’s observation that “Joint development manufacturers (JDMs) like Intricon have systems that are nimble and are ‘external eyes’ with deep category expertise to foresee both opportunities and challenges—now and down the road—during the manufacturing stage. As more OEMs experience this, they embrace the practice of third-party development for its efficiency and are able to leverage the resources and the expertise of the joint development manufacturer, that then becomes a valued extension of their team.”
Article in MP&O May, 2022 issue: https://bit.ly/3Nnu04R
April 11, 2022
INTRICON ENGINEERS MENTOR ROBOTICS COMPETITION TEAM
Intricon medical products engineer Austin Barrett has been a mentor to the Holy Family Catholic High School Robotics Team for the past five years. Austin dedicates approximately 200 hours each year to the team during the robotics build and competition season, from January through April. Austin works with students, teaching robotics building and development, along with teamwork and communication skills. This year, Intricon senior process development engineer Julia Rusciano joined Austin as another mentor from Intricon for the team.
On April 8 and 9, 2022, the robotics team competed in the Minnesota 10,000 Lakes Regional Competition, presented by Medtronic. The team, called Pyrobotics, placed 15th out of 55 teams in the qualification rounds and went on to be the 7th seed in the quarter finals. While the team lost in the finals, its robot reached the highest level of traverse climbing in the competition.
Intricon supports Austin, Julia, and the members of the Holy Family robotics team as a team sponsor.
FIRST® Robotics Competition teams design, program, and build a robot, starting with a standard kit of parts and common set of rules, to play in themed, head-to-head challenges. Teams also build a brand, develop community partnerships for support, and work to promote STEM in their local community as part of their role in the program.
Under strict rules and limited time and resources, students are challenged to build industrial-size robots to play a difficult field game in alliance with other teams. Students at all skill levels participate — technical or non-technical. The robotics competition gives high school students and their adult mentors the opportunity to work and create together to solve a common problem.
April 20, 2022
INTRICON RANKS HIGH IN GENDER DIVERSITY
Intricon was recognized as an Honor Roll company in the 2021 Minnesota Census of Women in Corporate Leadership. The census is the results of an annual study, conducted by St. Catherine University, which tracks how public companies are diversifying their boards and executive leadership teams by adding more women.
Intricon was one of only 15 other companies in Minnesota to earn Honor Roll status, which requires adding or diversifying board members and executives to achieve a minimum of 20% of corporate directors and/or a minimum of 20% of executive officers who are women. Intricon was recognized for its pursuit of gender parity at the top levels of the company.
An Intricon team attended the presentation of the research results by the university and Twin Cities Business Monthly, which publishes the research. CEO Scott Longval accepted an honorarium at the event and was featured in the publication of the results, commenting “We knew we needed greater diversity and more women in management and leadership roles. We were more conscious about how we thought about that as we were filling roles within the organization.” In addition to filling its CHRO and interim CFO executive positions with women leaders, Scott and the board also welcomed director Heather Rider, a global human resources specialist with 30 years of experience at medical technology companies, and Kathleen Pepski, former CFO of Hawkins industrial company, as directors.
All leaders at Intricon plan to continue to cultivate a culture of diversity and inclusion as the company grows. According to Scott, “The best way to solve complex problems is to have diverse views and experiences at the table. Looking at issues from all perspectives provides greater outcomes for Intricon.”
November 14, 2022
Intricon’s Dr. David Akbari Receives Prestigious Hearing Industry Leadership Award
The Academy of Doctors of Audiology (ADA), a leading national audiology association, selected David Akbari, Au.D., senior medical science, clinical, and regulatory affairs liaison at Intricon, to receive its prestigious annual ADA Hearing Industry Leadership Award for 2022. The award recognizes an individual or organization for outstanding achievements that elevate or advance the hearing industry. Dr. Akbari was recognized at the 2022 ADA AuDacity Conference in Dallas in October.
Dr. Akbari is the first and only individual to win the award. The 2022 award is significant in that the ADA has not given an award in the past 10 years, and it does not take nominations for the award.
The ADA chose Dr. Akbari because of his vision for and significant contributions to the hearing health industry throughout his career. One of those contributions included serving as a member of the ADA Over the Counter (OTC) Hearing Aid Working Group, through which Dr. Akbari provided invaluable technical and scientific expertise to help formulate the ADA’s recommendations to the U.S. Food and Drug Administration (FDA) in response to its Proposed Rule Establishing Over the Counter Hearing Aids, many of which were adopted by the agency.
The FDA ruling on OTC hearing aids was passed and, on October 17, 2022, for the first time, adults with mild to moderate hearing loss in the U.S. were able to buy hearing aids at retailers and online, without a prescription. The development will provide greater access to hearing aids for millions of people.
Dr. Akbari is a national authority on hearing health and leader at Intricon, which has a 45-year legacy of improving people’s lives with sensor-enabled micromedical devices.
October 6, 2022
This comprehensive podcast, produced by The Hearing Journal, the premier publication for hearing health professionals, features Intricon’s senior medical science, clinical, and regulatory affairs liaison, Dr. David Akbari. Dr. Akbari discusses his predictions on the impact of the recent FDA ruling that allows hearing aids to be sold over the counter, without the need for an audiologist.
The FDA decision ends five years of commentary and speculation on how OTC hearing aids will impact on people with mild to moderate hearing loss and hearing health practitioners.
The podcast is part of a four-part series examining the game-changing transformation of the industry. In this episode, Dr. Akbari and other guests review the FDA OTC rule and:
- Defining an OTC device – how it’s different than prescriptive hearing aids
- Quality control and standards, including performance criteria – higher threshold of performance rigor to be marketed and labeled as OTC hearing aids
- Holistic care model for OTC hearing aids
- Role of the audiologist
- Benefits of OTC to audiology model
- Distribution at the state level
- Fitting hearing aids
Dr. Akbari has been very active in hearing health industry professional associations involved in setting standards for objective measurement of quality and performance of OTC hearing aids.
The podcast is available at https://journals.lww.com/thehearingjournal/pages/podcastepisodes.aspx?podcastid=4 and on Stitcher, Apple podcasts, and Spotify.
December 5, 2022
David Liebl, Intricon’s chief technology and commercial officer, was a featured expert on Medical Design Briefs magazine webcast: Developing the Ultimate Medical Sensor Technology. Biosensor devices monitor and detect changes in biological processes and convert them into a physical signal. Biosensors can be close to the body, on the body, or in the body.
As companies develop such monitoring devices that incorporate sensors, it is important for them to understand how to partner to effectively and cost-efficiently bring their devices to the medical market. On the webcast, Dave provided guidance on:
- Integrating sensors in devices
- Understanding the growing need for point-of-care biosensor devices and biosensors in a waning COVID-19 pandemic
- Working with a knowledgeable, experienced partner on quality and regulatory requirements, development, assembly, manufacturing, and packaging of wearable biosensors as medical devices
Intricon is part of a growing wearable biosensor ecosystem, providing unsurpassed expertise in miniaturized electronics for biosensor innovation through prototyping, testing, validation, product launches, and fulfillment. Intricon uses technical capabilities and regulatory acumen as a contract development manufacturer in the wearable biosensor industry for manufacturers of biosensors used in pulmonology, remote patient monitoring, audiology, orthopedics, endocrinology, and gastroenterology.
Since 1977, Intricon has been bringing bioelectronic devices to life. Over 45 years, it has grown and evolved processes and capabilities to create biosensors that are smaller, lighter, and more comfortable for patients. As a contract manufacturer exclusive to medical technology, the company partners with industry leading medical device companies from around the globe to build world-class products that make the lives of patients better.
The webcast can be viewed by visiting https://event.webcasts.com/starthere.jsp?ei=1579008&tp_key=2a980ad4bb
July 7, 2022
This Week in Hearing Webcast features Dr. David Akbari, Intricon’s Senior Medical Science, Clinical, and Regulatory Affairs Liaison
Intricon’s resident audiologist, Dr. David Akrabi, was recently interviewed by Dr. Amyn Amlani of Hearing Health and Technology Matters media for a This Week in Hearing webcast. Dr. Akbari was asked to share more about a recent study that examined the performance of Intricon’s Sentibo self-fit hearing aid audio technology to professionally fit hearing aids. The study compared sound quality, fitting process, and overall benefits of the two hearing aids, each with different fitting approaches.
Intricon commissioned the study to measure a minimum of non-inferiority of the self-fit to the pro-fit, yet findings revealed that satisfaction and experience of the self-fitting technology ranked higher than the professionally fit model.
The webcast discussion also covers how the Sentibo self-fit method uses a proprietary psychoacoustic audibility model vs. the standard National Acoustic Laboratory (NAL-NL2) prescriptive fitting method.
Drs. Akrabi and Amlani discuss the state of the hearing aid industry and the impending OTC market, which will provide more accessible and affordable quality hearing aids to millions of people with mild to moderate hearing loss. They predict that products and service delivery models will be enhanced when hearing aids become available over the counter.
Sentibo, which is already used in Germany and is currently awaiting regulatory clearance, was designed by Intricon with human factors in mind — to make complex technology as simple to use as possible.
“Meeting patients where they are and empowering them is the future of hearing health,” said Dr. Amlani.
Click here to listen to the webcast: https://anchor.fm/thisweekinhearing/episodes/071—Comparing-Self-Fit-Hearing-Aids-to-Professionally-Fit-Devices-Intricons-Clinical-Trial-e1krnj5/a-a87a8fr