Medical Device Manufacturing


  • Failure Analysis 101

    A one percent failure rate should be unacceptable in any industry, especially healthcare. More aggressive and smarter testing will, in essence, cut that current failure rate in half. 

  • Lights, Camera, Validation! — Preparing For FDA Prime Time

    In the “validation/manufacturing transfer” stage, we move beyond lab-queen prototypes, small sample sizes, and controlled bench testing to prove that the product will fully satisfy user needs under actual or simulated operating conditions. This is the dress rehearsal for commercialization.

  • To Test Is Human, But Verification Is Divine

    This article is the third in a series exploring some of the important relationships involved in each phase of medical device development. Here, we'll look at key relationships during the verification phase.

  • Making A Hard Choice To Thrive

    If everything has been going so well, why did iuvo BioScience divest the sterilization portion of its business? In a word – focus.

More Perspectives On Medical Device Manufacturing


  • Introduction To Liquid Crystal Polymers

    Liquid polymer crystals are important in day to day use, especially in medical device fields and applications. This article introduces liquid crystal polymers and discusses their origin, structures, behaviors, and uses in thermoplastics and fibers with potentially broad applications.

The Growth Of Biocompatible Silicone In Implantable Medical Devices

The use of silicone rubber in medical implant devices continues to grow exponentially in many types of applications. This article offers a brief overview of the history of biocompatible silicone, new testing and standards, and the issues regarding biocompatibility and patient safety.

Barcoding Standards And The Search For A UDI “Easy Button”

As the FDA’s next deadline for the unique device identification (UDI) of Class II devices draws closer, medical device manufacturing companies are looking to further their UDI implementation, whether they are well on their way to success or they haven’t even started. Barcoding, or identifying products via GS1 regulatory standards, is essential for companies wishing to be up to date on UDI implementation. Unfortunately, companies may be delaying UDI implementation because they view the new regulations as something an organization can address quickly. This is not the case. This article discusses the importance of viewing UDI implementation as process that encompasses the entire company rather than just as a “quick fix.”  

How To Select A Pump For Surgical Ablation Applications

Radio frequency (RF) ablation uses RF energy to ablate or destroy unwanted tissues. When delivered via a catheter, it offers a minimally invasive treatment for a wide variety of conditions, including atrial fibrillation (AF). These systems typically include a peristaltic pump to provide cooling or temperature control, and this pump must be able to produce and control the high pressures (up to 130 psi) required in this application.

An Introduction To Manufacturing Execution Systems For The Medical Device Industry

Manufacturing Execution System (MES) solutions have the potential to generate efficiencies, improve productivity, and simplify compliance within the medical device manufacturing industry. Used to manage production activities, this class of software typically provides the ability to schedule activity, deliver instructions to operators, synchronize manual activities with automated processes, and integrate with manufacturing computer systems to enable quality control, deviation management and effective enterprise resource planning (ERP), equipment management, and the documenting of floor activities for monitoring and reporting purposes.

More White Papers & Case Studies


Medical Device Contract Manufacturing Medical Device Contract Manufacturing

Contract manufacturing for single-use medical devices is how Phase 2 got their start. They provide ultrasonic cleaning, injection molding, solvent and UV bonding, soldering, annealing, and more manufacturing services to both startup single-use medical device companies and larger-sized OEMs.

Medical Device Assembly, Kitting and Packaging Services Medical Device Assembly, Kitting and Packaging Services

SMC provides manufacturing and assembly services for full devices or subassemblies for finished devices. Our global facilities offer ISO 13485 systems for assembly as well as kitting and packaging services. SMC’s assembly services range from skilled human touch to fully automated assembly and testing equipment. Whether your program requires simple table-top fixtures or fully automated cells, our in-house automation team will assess your program and work with you to build a cost effective solution to meet your stringent requirements.

Plastic Injection Molding Plastic Injection Molding

PTI’s plastic injection molding services include prototype, short-run, high-volume, and multi-cavity molding for a wide variety of applications. These monitored and controlled processes are completed in-house and contribute to providing competitive advantages in cost, quality, and lead times.

Cleanroom Injection Molding for Disposable Medical Devices Cleanroom Injection Molding for Disposable Medical Devices

Phase 2 Medical’s Rochester, NH location was recently outfitted with 2,500 sq. ft. ISO Class 8 (100,000) cleanroom facility with an injection molding press. This was done in an effort to integrate quality plastic components in their customers’ disposable medical devices.

More Products & Services


Medical device manufacturing includes all aspects of the fabrication of a medical device, from designing a manufacturing process to scale-up to ongoing process improvements. It also includes the sterilization and packaging of a device for shipment.

Throughout the manufacturing process, medical device makers strive to be faster and more efficient, but they also wish to be responsible corporate citizens. Thus, manufacturing demands constant insight into renewable resources, sustainable materials, equipment that is more energy efficient, and methods to reduce waste creation. Solutions to these issues can come in the form of improved processes, technological advances in machines or equipment components, or safer/more reliable materials. The same principles apply to the packaging process.

Many companies call these ideals “lean” manufacturing, which is considered an industry best practice: eliminating any activity, process, or material that does not add value for which a customer will pay.

Still, while speed and cost-savings are vital to successful manufacturing, quality control is of the utmost importance — particularly as medical device market demands shift toward a more value-driven landscape. Packaging validation, proving to the FDA that a product is sterile when it ships, is the final step.

Many medical device manufacturers excel in the ideation, concept, and prototyping phases of product development and outsource the production of components or entire devices to contract manufacturers. This is as true of established original equipment manufacturers (OEMs) as it is for mid-sized companies and startups. Contract manufacturers vary in size and expertise, as well — some comprise small, precise operations specializing in particular materials or components, while others are massive cleanroom facilities equipped for large-scale production.


  • Obamacare Replacement Will Permanently Remove Medical Device Tax

    Republican leaders in the U.S. House of Representatives have unveiled proposed legislation to repeal and replace the Affordable Care Act, which, among several tax cuts, will eliminate permanently the 2.3 percent excise tax on medical devices and products.

  • India To Split Med Device Industry From Pharma, Revisit Free Trade Agreements

    Moves under consideration include separation of medtech from its pharmaceutical industry, increased government funding for the medtech industry, and the renegotiation of existing free trade agreements (FTAs) with other countries. The device industry also is asking the government to recognize local regulatory certifications, in addition to the currently accepted FDA approval from the U.S.

  • Wearable THz Scanning Device For Inspection Of Medical Equipment, Human Body

    Scientists at Tokyo Institute of Technology have developed a portable and wearable terahertz scanning device made using arrays of carbon nanotubes, for applications including non-invasive inspection of equipment such as syringes, and imaging of cancer cells, blood clots, and teeth. The findings are published in Nature Photonics, November 2016.

  • Thinfilm Launches Medical Device Communication Platform

    Norwegian printed electronics maker Thinfilm has partnered with an unidentified Fortune 500 pharmaceutical firm to build a near-field communication (NFC) platform for medical devices to help patients adhere to treatment regimens and connect with healthcare providers.

  • 3D-Printed Camera Small Enough To Be Injected Through a Syringe

    German scientists have produced a camera, using additive manufacturing with a femtosecond laser printer, capable of building free-form optics. Researchers claim that technology opens possibilities for micro- or nano-optical devices, such as endoscopes and mini-robots with autonomous vision, and paves the way for a “paradigm shift” in medical imaging that could be injected into the body through a syringe.

  • Cancer Moonshot Initiative To Speed Cancer Research, Treatment

    United States Vice President Joe Biden led the National Cancer Moonshot Summit in Washington, D.C. to call on patients, families, advocacy groups, researchers, scientists, physicians, organizations, and companies to work together in accelerating the diagnosis, treatment, and research toward cures for cancer.

  • 3D-Printing Method Uses Multiple Materials At Once, Expands Personalized Medicine Options

    Researchers from Dresden have introduced additive manufacturing (AM) technology that can work with multiple materials at the same time, giving greater design flexibility to the 3D printing process. Their technique — which can work with any combination of plastic, glass, ceramics, or metal — would allow for the quicker production of more complex and personalized bone implants, dentures, or surgical tools.

  • imec, Holst Centre Unveil Time-Based ECG Readout Chip For Wearable Applications

    Nanoelectronics research center imec and Holst Centre, an open-innovation initiative set-up by imec and TNO, today presented a 0.6V ECG readout chip in 40nm technology based on time-domain circuit techniques. The chip maintains consistent beat detection capabilities, even under movement (~40mVpp), paving the way to a low cost, low power multi-sensor Systems-on-Chip (SoCs) solution for wearable medical applications.

More News