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
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.
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.
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.
News Release: https://audiologist.org/resources/communications/in-the-news/item/dr-david-akbari-receives-prestigious-ada-hearing-industry-leadership-award
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
February 15, 2022
Intricon Expands Its Batam Operations
Intricon recently relocated and expanded its operations in Batam, Indonesia, where its teams conduct PCA assembly, including ultrasonic welding, soldering and visual inspection, for micromedical technology and components. More than 150 employees at Intricon Batam focus on Class I and II FDA manufacturing assembly work. According to Winson Chan, General Manager of Intricon Asia Operations, the workforce is highly skilled and very experienced: more than 80 percent of the team’s members have been with Intricon for three or more years.
Intricon has had a facility in Batam since 2011. The new production space is over 30,000 square feet and is ISO 9001 and ISO 13485 compliant. It features state-of-the-art equipment and a streamlined layout that optimizes workflow. Its design integrates Lean principles to enhance productivity and efficiency while reducing waste in production. The new space effectively manages the work environment for employees, with an energy efficient, highly responsive air conditioning system that regulates room temperature and humidity as well as a noise management system that isolates louder noises in order to take care of worker wellness and minimize disruptions.
Intricon attracts its skilled assembly team from the Batam adjacent area, which is one of the largest in the province and a core urban industrial zone. The new Intricon facility is located in a key free-trade zone that is part of the Indonesia-Singapore-Malaysia Growth Triangle, a global economic and transportation hub.
“Creating a thoughtful, modern environment for our employees to do their best work has always been key to the new facility,” said Winson. “We look forward to continuing to grow our presence in Batam and add more opportunities for fulfilling careers to more people in the community.”
Dave Liebl Promoted to Intricon Chief Commercial and Technology Officer
Intricon has named Dave Liebl as its first Chief Commercial and Technology Officer (CCO/CTO).
“The new role is essential as we enhance our commercial growth strategy. Dave’s commercial experience makes him an ideal leader for Intricon’s next phase of growth and development,” said Scott Longval, president and chief executive officer of Intricon. “In Dave’s expanded role, he is responsible for accelerating our innovation roadmap and expanding our customer relationships.”
Dave’s career includes more than 25 years of business development, engineering, and product development experience at multiple high technology and medical technology companies. Prior to joining Intricon in August 2021 as vice president of research and development, Dave served as the president of Biomerics NLE’s West Operations. Prior to his role at Biomerics, he held several roles at Heraeus Medical Components/NeoMetrics, Inc., including EVP, product and business development, president and chief technology officer, and VP of development, spanning from 2005 to 2019. His career also includes director and vice president level positions at Pearson, Datacard Group, and MedAmicus, Inc. (now part of Integer Holdings).
“Intricon has a strong foundation of core competencies and technologies, which are well positioned to meet the needs of industry trends. Further, our global manufacturing footprint enables us to meet customer cost targets,” said Dave. “I’m looking forward to pursuing opportunities in high-growth markets by advancing our technology and commercial operations to meet and exceed our customers’ expectations.”
Annalee Lutgen Named Intricon Chief Financial Officer
ANNALEE LUTGEN NAMED CHIEF FINANCIAL OFFICER
Long-time employee Annalee Lutgen has been promoted to chief financial officer (CFO) at Intricon and now oversees financial operations for the company.
“Annalee will play a critical role on the leadership team and as CFO during this new stage of accelerated growth,” said Scott Longval, Intricon president and CEO. “She knows our business and her proven financial experience in the medical device and high-tech industries is a valuable asset as we continue to expand the company.”
Annalee joined Intricon in 2010 as Corporate Controller and has since gained increasing responsibility for the accounting and finance functions of the company, most recently as the director of finance. She is a Certified Professional Accountant and holds an MBA from St. Cloud State University.
Annalee now oversees financial operations for Intricon.
“I’m excited to take the position of CFO during this transformational period of the company,” she said. “IntriCon has a solid track record and great potential for growth. As a team, we’re committed to further growing the company.”
Clinical Trial Results
June 15, 2022
Intricon Sentibo technology is first psychoacoustic-based hearing aid with audio that can be self-fit by its user, setting new standards for the hearing aid industry
ARDEN HILLS, Minn. (June 15, 2022) – Intricon, a micromedical technology company that makes interventional, implantable, and body-worn medical devices, has announced the results of a clinical trial studying its new Sentibo self-fitting hearing aid technology. The study compared the sound quality, fitting process, and overall benefits of hearing aids that were self-programmed using the Sentibo mobile app to hearing aids programmed by a hearing care professional. The study concluded users were, on average, more satisfied with the self-fitting hearing aid. Intricon commissioned the study to prove satisfaction, quality, and safety of its proprietary self-fitting technology, in time for the FDA decision that will allow hearing aids to be sold over the counter (OTC).
The Sentibo self-fit method, which uses a proprietary psychoacoustic audibility model, is the first to not rely on the National Acoustic Laboratory (NAL-NL2) prescriptive fitting method. Audio is self-fit by the wearer.
“We commissioned the study to make sure people will have an equal if not better experience with over-the-counter hearing aids than traditional prescription hearing aids. At the same time, we wanted to evolve the industry and its traditional fitting standards that have existed for years,” said Scott Longval, CEO of Intricon. “We view OTC hearing aids as an opportunity for the industry to take a major step forward, and we want to be a leader in taking it into the future.”
Intricon studied the NAL-NL2 audibility model, common in the industry since 2011, to identify opportunities for new advancements, such as using a psychoacoustic audibility model during self-fitting for people with varying fidelity expectations to identify their unique needs, with a wider dynamic range of sound. Because psychoacoustic audibility focuses on the user’s perception of sound, it helps everyone hear at a level that is optimized for their unique perception to not miss certain sounds, regardless of their hearing sensitivity.
“Sounds have never been combined in this way before,” explains Longval. “Sentibo is truly precedent-setting in all aspects of the hearing aid customer experience.”
Longval adds that Intricon’s goal in developing technology for OTC hearing aids is to improve access and affordability for the 38 million people in the U.S. with mild to moderate hearing loss. Intricon provides components and technology for hearing aids that are professionally fit and self-fit, such as the commercially marketed Lumen 155 hearing aid used in the study.
“For 45 years, Intricon advancements have been focused on expanding the hearing aid market and giving people more options,” said Longval.
About Intricon Corporation
Intricon is a Joint Development Manufacturer that integrates micromedical components and assemblies to advance technology across a range of medical device platforms for global customers. Intricon approaches each engagement with an all-in commitment, working with customers every step of the way, from the earliest idea stages to ongoing production, in order to advance program performance and deliver results. With a focus on key device platforms, Intricon helps advance clinical outcomes by always looking ahead with proactive support and resources through integration of its core competencies. Intricon has facilities in the United States, Asia, and Europe.
Micromedical tolerance stack-up: Insight into the inner workings of high-density microelectronic medical devices
June 22, 2022
Intricon’s Manufacturing Engineering Manager Darren Gilmer provides Medical Design and Outsourcing readers with an article on the importance of tolerance stack-up in micromedical components for medical devices.
At a time when the future of micro miniature medical devices seems unlimited, one fundamental reality remains firmly in place — the sizes and shapes of human anatomy. From blood vessels to ear canals, respiratory passages to neural pathways, the physical dimensions of the body available for life-saving and life-enhancing medical therapies exist within a minimum and maximum range. For medical devices, the general rule for reaching deeper into the tiniest areas of the body is “the smaller, the better.”
The article outlines key considerations when a thousands of an inch in design can make a significant impact in accelerating a product’s time to market.
Read Article here: https://bit.ly/3OheGrr.
Learn more about Intricon’s expertise in microelectronics here.
Note: The illustration shown above is an example only. Project specifications will vary. Illustration copyright of Intricon.
Intricon Featured on Medical Alley Podcast
Founder Mark Gorder and CEO Scott Longval join Medical Alley for a discussion on Intricon’s history and future
Intricon founder Mark Gorder and president and CEO Scott Longval joined Frank Jaskulki, vice president of intelligence at Medical Alley, for a podcasted discussion on Intricon’s 45-year legacy in the micromedical industry and the future of the company.
Medical Alley is The Global Epicenter of Health Innovation and Care®, a place that healthcare leaders call home. The Medical Alley Association is a community of these leaders, who represent the world’s highest concentration of top innovation and healthcare companies. Minnesota, where Intricon is based, is at the heart of Medical Alley. The Medical Alley region is home to the nation’s largest private health insurer and more than 1,000 med device and healthcare companies, employing millions of people worldwide. Medical Alley has history, as the birthplace of implantable medical technology, collaborative care delivery, and innovative health plan models. The Smithsonian has recognized six “Great Places of Invention” in the U.S., including only one for healthcare: Medical Alley.
Intricon is a key part of both the history and the future of this ecosystem. The company designs, develops, manufactures, and even packages microminiature components for companies worldwide. It is a pioneer in micromedical med devices.
Hear more about the Intricon story by listening to the Medical Alley podcast here.