Medical Device Design & Development

INDUSTRY PERSPECTIVES

Tips From A Biomedical Engineer For Medical Device Innovation And Compliance

Every new medical device feature must live within a quality management system that tracks design control, risk management, and post-market performance. Waiting until design freeze to loop in your quality and regulatory experts invites costly rework and setbacks.

Understanding The Impact Of An RMP On Patient Risks Using Relational Risk Analysis

Using relational risk analysis, let's take a closer look at risk management plans for identifying and managing adverse reactions for administering a new therapy to a patient.

AI In Medical Devices: Meeting The Regulatory Challenge Around The World, Part 1

This article explores the global regulatory landscape, examining how leading authorities in the U.S., EU, U.K., Canada, China, Brazil, Australia, and South Korea are approaching AI in medical devices. 

A Proactive 6-Point Approach To Security For Neurotech Developers

There are several key security concerns neurotech developers must address from the outset to ensure both medical and ethical compliance, as well as commercial success. 

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WHITE PAPERS & CASE STUDIES

Challenges In Developing Medical Devices From Animal-Based Biomaterials In China

Bovine collagen, valued for biocompatibility and versatility, is gaining attention for medical devices in China as regulatory barriers ease, though safety assurances remain crucial.

Design Testing Strategies To Develop A Drug-Device Combination Product

Leveraging the expertise and experience of a trusted partner can reduce risk and accelerate the time to market for drug-device combination products by creating an optimal Validation Master Plan.

2R Vials And Deep Cold Storage - Determining Mechanical & CCI Performance

Review the implications of this study on the storage of sensitive molecules that require deep-cold storage and learn how 2R Fina glass vials are poised to enhance cold storage practices.

Solving The Silicone Challenge In Pre-Fillable Syringes

Discover a technology platform that is revolutionizing the pre-fillable syringe market by solving the challenge of silicone sensitivity, ensuring stability for sensitive drugs.

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DESIGN COMPONENTS & SERVICES

Absorv® Bioabsorbable Polymers

Bioabsorbables are capable of safely existing in the body for controlled lengths of time before absorbing without causing any harm or adverse reactions. The Absorv® biomaterial platform is optimized for the development of a wide variety of medical products for preventative care and disease treatments. The ever expanding list of applications includes orthopedic, dental, surgical, stents, and tissue engineering.

Solenoid Pumps: LPL Series
Solenoid Pumps: LPL Series

The LPL series of solenoid pumps are ideal for integration into medical devices that require precise, fixed volume dispensing. They’re available in MINSTAC port, straight port, flat bottom boss, standard manifold mount, and combination manifold/soft tube port styles. These self-priming pumps have a 10 million cycle life, low power consumption (2 and 2.5 W models), a 2 Hz response time and standard 50 µL dispensing (special sizes also available).

Spanner-Head Filters

Spanner bushing filters solve those tight center-to-center hole spacing requirements. The spanner bushings are designed without the hex used on the standard bolt-in series. The spanner feedthrus are easily installed using the CMI spanner tool. Spanner bushings can be installed with center-to-center spacing down to .110” or 2.8mm when using the 2*56 threaded size. Spanners are available with capacitance up to 10,000 pF and sizes from 2*56 to 8*32.

High Performance NIR Spectrometers: AvaSpec NIRLine

The new AvaSpec NIRLine high performance spectrometers provide leading-edge performance for dispersive NIR instruments with toroid focusing mirrors and dynamic dark correction for enhanced stability.

Image Companion®
The company is a leading developer and supplier of comprehensive, easy-to-use and highly innovative software applications, capable of assisting and advancing productivity of image and data processing, computer-aided detection ("CAD"), diagnostic imaging support and image retrieval for a variety of customers and markets. The Company’s flagship product is Image Companion®, that enhances, filters, sharpens and profiles digital images or Regions of Interest (“ROI”) within digital images, as well as detects, counts, measures and searches objects for similar to selected template(s) object(s) or even template image. While equally successful in application to a variety of different types and modalities images, all processing and analysis is independent of the image sources. Enabled with non-scripting Macro Libraries capability and batch processing, this simple-to-use software facilitates computer-aided segmentation, and biomedical information retrieval automation at the same time reducing operating costs, improving analytical accuracy and easy user barrier to complete automation
Solenoid Valves: LSP Series
Solenoid Valves: LSP Series

The LSP Series consists of 2-way, manifold mounted valves with a normally closed design. The valves are equipped with features that including a working pressure of 15 psig, zero dead (unswept) volume, 30ms response time, and a full bore flow path.

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MEDICAL DEVICE DESIGN & DEVELOPMENT

Medical device design and development is the cyclical process of creating a device for a specific task or set of tasks, and then continuously reevaluating its effectiveness and improving upon it until the device reaches obsolescence. Design and development begins with ideation and the creation of a concept that, if found to be both fiscally and clinically viable, is then designed, engineered, and prototyped. This preclinical period includes bench testing — accomplished through simulated use of the product — and animal testing, along with any necessary redesign work.

Throughout the process, the proposed medical device, and the process by which it will be manufactured, is examined for flaws that may negatively impact the device’s safety, market viability, regulatory acceptance, customer satisfaction, usability, or profitability. Any shortcomings are corrected, and the improvements applied to the final design. Due to the wireless connectivity capabilities of many modern medical devices, cybersecurity and interoperability also must be incorporated into the design. Clinical testing is conducted, using human subjects, to further expose flaws and confirm product strengths. Once both the product design and the manufacturing process have been validated and approved by the U.S. Food and Drug Administration (FDA), production and commercialization of a device may begin.

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