Integer Holdings Profile
Integer Holdings Corporation (Integer) operates as a medical device outsource (‘MDO’) manufacturing company worldwide.
The company is serving the cardiac rhythm management, neuromodulation, orthopedics, vascular, advanced surgical and portable medical markets. The company provides high-quality medical technologies that enhance the lives of patients worldwide. In addition to medical technologies, the company develops batteries for high-end niche applications in energy, military, and environmental markets. The company’s brands include Greatbatch Medical, Lake Region Medical and Electrochem. The company’s primary customers include large, multi-national original equipment manufacturers (‘OEMs’) and their affiliated subsidiaries.
Segments
The company organizes its business into two reportable segments, Medical and Non-Medical; and derives the company’s revenues from four principal product lines.
Medical segment
The Medical segment includes the Cardio & Vascular, Cardiac Rhythm Management & Neuromodulation and Advanced Surgical, Orthopedics & Portable Medical product lines.
Cardio & Vascular
The Cardio & Vascular product line leverages a global footprint to produce a full range of components, subassemblies, and finished devices used in interventional cardiology, structural heart, heart failure, peripheral vascular, neurovascular, interventional oncology, electrophysiology, vascular access, infusion therapy, hemodialysis, urology, and gastroenterology procedures.
The following are the principal products and services offered by the company’s Cardio & Vascular product line:
Interventional Cardiology. The company’s interventional cardiology portfolio is focused primarily on the design, development and manufacture of catheter and wire-based technologies intended to diagnose and treat cardiac disease. Key products and capabilities span a full suite of devices, including coronary stents, balloon catheters, atherectomy devices, imaging and sensing devices, chronic total occlusion solutions, percutaneous transluminal coronary angioplasty and access guidewires, introducer sheaths, and vascular closure devices. Core areas of technical expertise include laser-cut hypotubes, catheter shafts (extrusion, filmcast, and reflow), integrated hub assemblies, pad printing, tip shaping, polytetrafluoroethylene (PTFE) coating, complex machining, and sensor integration.
Structural Heart and Heart Failure. Structural heart and heart failure products include those used by cardiologists, echocardiographers, cardiac surgeons, and heart failure specialists to treat diseases or defects of the heart, such as valvular diseases and congenital defects. Integer provides components, subassemblies, and finished devices to these markets leveraging a wide range of technologies and capabilities. These include laser-cut and machined components, complex braided meshes, guidewires, introducer sheaths, steerable sheaths and delivery catheters, and implants used in transcatheter aortic valve replacement, balloon aortic valvuloplasty, transcatheter mitral valve repair and replacement, atrial and defect closure, left ventricular assist, and shunt procedures.
Peripheral Vascular, Neurovascular, and Interventional Oncology. The company’s peripheral vascular, neurovascular, and interventional oncology portfolio is primarily focused on the design, development and manufacture of devices used during the treatment of peripheral artery disease, transcatheter embolization and occlusion, aortic aneurysm repair, and neurovascular stroke treatment. The company’s broad portfolio of devices, capabilities and technology platforms provides the company’s customers with high quality solutions ranging from device components to complex assemblies to finished devices such as regulatory approved guidewires and introducers.
Integer’s broad technology and capability portfolio within the peripheral vascular markets enables the company to address the full spectrum of devices needed in the diagnoses and treatment of peripheral vascular disease. In the peripheral artery disease markets, the company’s technologies are focused on the manufacture and development of interventional guidewires, support catheters, introducers and guiding sheaths, balloon catheters, self-expanding stents and stent grafts, as well as embolic protection devices. The company’s neurovascular technology portfolio encompasses micro guidewires, micro and access catheters, aspiration catheters, stent retrievers, embolization coils, as well as flow diverters. In the interventional oncology market, the company offers customers guidewires and microcatheters designed to enable the effective delivery of embolic agents.
Electrophysiology. Electrophysiology products include devices used by electrophysiologists and interventional cardiologists for the treatment of cardiac arrythmias, such as atrial fibrillation. Integer primarily produces devices used for the treatment of atrial fibrillation, the most prevalent cardiac arrythmia. These devices include sheaths and needles for transseptal access, diagnostic and mapping catheters to record and map the arrythmia sources, and ablation catheters to create lesions for blocking the arrythmia signals. Integer has the technical capabilities and expertise to provide the full spectrum of products from components to finished devices. Typical components include polyimide tubing, electrode rings, platinum tips and fine wires. Sub-assemblies include electrode ring and wire assemblies, steerable handle assemblies, and spline and basket assemblies. Finished devices include steerable transseptal sheaths, diagnostic catheters and ablation catheters.
Vascular Access, Infusion Therapy and Hemodialysis. The company’s solutions in these markets are focused on vessel access, treatment and device placement for medication and fluid delivery in patients with severe conditions requiring repeated vessel access. The company designs and manufactures a wide range of vascular access guidewires, stylets, catheters, valved / non-valved peelable and micro introducers. The company’s portfolio of market-ready vascular access guidewires and introducers kits enables a range of venous and arterial access applications, including transradial access. Additionally, the company supports customers with custom introducer sheaths and kit solutions leveraging the company’s deep expertise in thin-wall sheath design, hydrophilic coatings and guidewire manufacturing (including poly-jacketed, mandrel, and nitinol core guidewire constructions).
Non-vascular Markets: Within the Cardio & Vascular product line, the company also manages non-vascular markets for which the company has expertise and offers a broad range of products, technologies and capabilities. Those markets include:
Urology. The company’s main focus is in endourology for which the company develops and manufactures finished devices and components for access and interventional devices, such as guidewires, ureteral access sheaths, dilation devices, retrieval devices, ureteral stents, biopsy forceps, and endoscopes.
Gastroenterology. The company’s comprehensive range of technologies and capabilities enable the company to support its customers’ needs with a broad variety of products, such as guidewires, dilatation devices, retrieval devices, snares, wire-formed and polymer stents, stent delivery systems, RF ablation devices, and endoscopes.
Cardiac Rhythm Management & Neuromodulation
The Cardiac Rhythm Management & Neuromodulation product line offers design, development and manufacturing capabilities for components, sub-assemblies, assemblies, and finished medical device systems. The company supports a variety of clinical markets, with an emphasis on the following markets:
Cardiac Rhythm Management. The cardiac rhythm management (‘CRM’) market comprises implanted medical devices (‘IMDs’), implanted leads, procedure accessories, as well as external devices that monitor and treat heart rhythm disorders and heart disease. Examples of CRM products include implantable pacemakers, implantable cardioverter defibrillators (‘ICDs’), insertable cardiac monitors (‘ICMs’), implantable cardiac pacing and defibrillation leads, and heart failure therapies, such as ventricular assist devices and cardiac resynchronization devices (‘CRT-P’ and ‘CRT-D’). An IMD system generally includes an implantable pulse generator (‘IPG’) and one or more stimulation leads. An IPG is a small battery powered device implanted under the skin in the chest that can sense and produce electrical pulses through specialized wires called leads. These leads sense electrical heart signals and carry them back to the IPG which in turn delivers electrical pulses back through the lead to the heart to deliver therapy.
The company’s portfolio of technologies and products include components, sub-assemblies, and assemblies for active IPGs, implanted sensing and stimulation leads, accessories, or external instruments. The company’s investments in research and development have created leadership positions in battery, capacitor, and feedthrough technology, including filtered feedthroughs. The company is also a supplier of medical stamped components, and shallow and deep draw casings and assemblies.
Beyond the IPG, Integer’s CRM product line provides lead development and manufacturing solutions, including expertise in low-polarization specialty-coated electrodes and components, and lead and device accessories, such as stylets, guidewires, introducers, and lead adapters. Integer also offers fully designed and manufactured epicardial pacing leads.
Neuromodulation. Similar to the CRM market, the neuromodulation (‘Neuro’) market comprises IPGs, implanted leads, procedure accessories, and external devices, such as battery chargers, trial stimulators and patient controllers. Examples of Neuro products include implantable spinal cord stimulators for chronic pain, sacral nerve stimulators for incontinence, deep brain stimulators for movement disorders and other IMDs to treat psychiatric disorders, sleep disorders and hearing loss. The Neuro market also includes several new emerging applications, such as implanted bioelectronic devices aimed at treating chronic diseases.
Within the Neuro market, the company offers IMD component technologies that have been developed to meet the needs of the company’s customers including the company’s Xcellion line of lithium-ion rechargeable batteries, QMR and CFx non-rechargeable batteries, feedthroughs, device enclosures, machined components and lead components and sub-assemblies. Additionally, Integer helps OEMs and other emerging companies with the development and manufacture of complete neuromodulation IMD solutions, including custom IPGs, programmer systems, battery chargers, patient controllers, fully finished lead systems and accessories from initial development through commercial quantities.
Advanced Surgical, Orthopedics & Portable Medical
The Advanced Surgical, Orthopedics & Portable Medical (‘AS&O’) product line offers a broad range of products and services across the many businesses it serves. During 2018, the company sold its advanced surgical and orthopedics product line but continue to manufacture advanced surgical and orthopedic products under a supply agreement with the buyer.
The following are the principal products and services offered by the company’s AS&O product line:
Minimally Invasive & General Surgery. The company’s minimally invasive and general surgery products are primarily arthroscopic, laparoscopic, and general surgery devices and components used for minimally invasive procedures in the joint, abdominal, gastroesophageal reflux disease (‘GERD’), ophthalmology, oncology, and general surgery spaces. The company’s products include, harmonic scalpels, shaver blades, burr shavers, radio frequency probes, biopsy probes, trocars, electrocautery components, wound dressings, GERD treatment components, and phacoemulsification needles.
Orthopedic. The company’s orthopedic products include instruments used in hip, knee, and spine surgeries. The company’s products primarily consist of reamers and chisels.
Portable Medical. The company is a leading provider of advanced batteries and power solutions for global OEMs. The company specializes in the design and manufacture of Li-ion battery packs and chargers. Through the combination of the company’s research and development expertise, manufacturing excellence and leading customer partnerships, the company advances the way healthcare is powered. The company’s offerings include customized rechargeable batteries and chargers to power medical devices across multiple clinical markets, including patient monitoring, ventilators, portable defibrillators, portable ultrasound and X-Ray machines. The company collaborates with its customers on product development opportunities incorporating the company’s power solutions into Class I, II or III medical devices.
During the fourth quarter of 2021, the company initiated plans to exit its portable medical market to enhance profitability and reallocate manufacturing capacity to support growth. Since that time, the company has been working closely with impacted customers to support the transition of these products to other suppliers. Due to quality and regulatory requirements, the company expected it would take three to four years to complete this transition. The company expects Portable Medical sales to wind down with the final sales and market exit occurring in 2025.
Non-Medical segment
The Non-Medical segment comprises the Electrochem product line.
The company’s power solutions enable the success and advancement of the company’s customers’ critical non-medical applications. The company provides custom energy storage cells and battery packs for use in extreme environments where failure is not an option.
The following are the principal products and services offered by the company’s Non-Medical product line:
Electrochem. Electrochem provides customized battery power and power management systems to markets where safety, reliability, quality and durability are critical. The company designs and manufactures customized primary (non-rechargeable) battery solutions, which are used in multiple industries, including the energy, military and environmental markets, among others.
Electrochem’s primary lithium power solutions, which include high, moderate and low-rate non-rechargeable cell constructions, are utilized in extreme conditions and are built to withstand robust temperature extremes. The cells can be optimized for targeted environmental demands, including high shock and vibration, extended run times, and specific discharge or pulse requirements. Electrochem’s control of the active cell component and the electrolytes enables customized products that are optimized for specific applications. In addition, Electrochem’s product design capabilities include protective circuitry, glass-to-metal hermetic seals, fuses and diodes to help ensure safe, durable and reliable power as devices using the company’s battery solutions are often subjected to harsh conditions. The company’s primary batteries are used in remote and demanding environments, including down hole drilling tools, pipeline inspection, military defense-based devices, and a broad range of remotely deployed and oceanographic devices.
Electrochem also manufactures complementary technologies in the form of real time battery monitoring, and an alternate power technology in the form of high temperature super capacitors.
Acquisitions
Effective as of October 1, 2023, the company acquired substantially all of the assets and assumed certain liabilities of InNeuroCo, Inc. (‘InNeuroCo’), a privately-held company based in Florida. A recognized leader in neurovascular catheter innovation with strong development and manufacturing capabilities, InNeuroCo’s expertise and highly differentiated neurovascular catheter innovation complements the company’s existing capabilities and market focus, while further increasing the company’s ability to provide enhanced solutions to the company’s customers in the neurovascular catheter space.
Customers
The company’s products are designed to provide reliable, long-lasting solutions that meet the evolving requirements and needs of the company’s customers.
The company’s Medical customers include large multi-national medical device OEMs and their subsidiaries. During 2023, three of the company’s Medical segment customers, Abbott Laboratories, Boston Scientific and Medtronic were each in excess of 10% of total sales and collectively accounted for 45% of the company’s total sales.
The company’s Non-Medical customers include large multi-national OEMs and their subsidiaries serving the energy, military and environmental services markets.
Sales and Marketing
With limited exceptions, the company sells its products directly to its customers, including large, multi-national OEMs and their affiliated subsidiaries. In 2023, approximately 56% of the company’s products sold were shipped to locations in the United States (‘U.S.’). Sales within and outside the U.S. are primarily to customers whose corporate offices are located and headquartered in the U.S.
Although the majority of the company’s customers contract with the company to develop custom components and assemblies to fit their product specifications, the company also provides system and device solutions ready for market distribution by OEMs. The company has established close working relationships between its internal program managers and the company’s customers. The company markets its products and technologies at industry meetings and trade shows domestically and internationally.
For system and device solutions, the company partners with its customers’ research, marketing, and clinical groups to jointly develop technology platforms in alignment with their product roadmaps and therapy needs.
Strategy
One facet of the company’s growth strategy is to acquire additional technology or manufacturing capability to expand the company’s product offering in the company’s key existing growth markets.
The company’s strategy aligns with enhancing the company’s portfolio from both organic and inorganic means to partner more broadly with the company’s customers to support their growth.
Patents and Proprietary Technology
As of December 31, 2023, the company owned 496 U.S. and foreign patents, and have license right to another 133 patents.
Manufacturing, Regulatory and Quality Assurance
The company’s manufacturing and engineering services include design, testing, component manufacture, and device manufacture. The company also provides regulatory and clinical services, including product registration, clinical evaluations, and post-market surveillance in accordance with the regulatory requirements of the U.S. and European Union (‘EU’), as well as other geographies. The company has integrated its proprietary technologies in its own products and those of the company’s customers. The company’s flexible, high productivity manufacturing capabilities span sites across the U.S., Mexico, Uruguay, Ireland, Malaysia, and the Dominican Republic.
Along with ISO 13485, the facilities producing finished medical devices are subject to oversight by national regulations and the various national regulatory bodies where the company does business, including the U.S. Food and Drug Administration (‘FDA’), to assure the conformance of devices and components in the international markets where they are sold. For these facilities, the company maintains FDA registration and compliance with all applicable domestic and international regulations.
Government Regulation
Integer develops, manufactures, markets and sells products in multiple countries throughout the world and is therefore subject to regulation by numerous agencies and legislative bodies, including the FDA, European Medicines Agency, Health Product Regulatory Agency, Health Canada, Therapeutics Goods Administration, and other comparable foreign counterparts.
In the U.S., these regulations are enacted by the Federal Food, Drug and Cosmetic Act and its subsequent amendments, and the regulations issued or proposed thereunder.
The FDA’s Quality System Regulation sets forth quality requirements for the company’s sites that includes product design and manufacturing processes, requires the maintenance of certain records, and provides for on-site inspection of the company’s facilities and periodic review by the FDA.
The company is subject to Securities and Exchange Commission (‘SEC’) rules adopted pursuant to the Dodd-Frank Wall Street Reform and Consumer Protection Act concerning ‘conflict minerals’ (generally tin, tantalum, tungsten and gold) and similar rules adopted by the EU.
The company is also subject to disclosure requirements regarding abusive labor practices in portions of the company’s supply chain under the California Transparency in Supply Chains Act and the UK Modern Slavery Act.
The company’s sales and marketing practices are subject to regulation by the U.S. Department of Health and Human Services pursuant to federal anti-kickback laws, and are also subject to similar state laws.
Research, Development and Engineering
The company’s research, development and engineering expenses were $63.8 million for 2023.
History
The company, a Delaware corporation, was founded in 1970. It was incorporated in 1997. The company was formerly known as Greatbatch, Inc. and changed its name to Integer Holdings Corporation in 2016.
