Medical Device Design & Development

INDUSTRY PERSPECTIVES

Beyond Connectivity: Where Digital Technologies Create Real Value In Drug Delivery

Where can digital technologies can solve real problems for patients, healthcare providers, and industry, while avoiding unnecessary complexity? Here's where the strongest value propositions currently sit.

You Can't CAPA What You Can't Classify

An LLM or agentic error can occur with no component broken in any way the QMS recognizes. Classifying it takes two fields: the error type and the error origination point.

Who Exactly Owns Quality?

We’ve all heard the rhetorical question, “Who owns quality?” And we all reply with the answer they expect to hear: “We all do!” This mindset needs to be fully integrated into the minds and systems of a company.

The Career Path Through QA Produces Better Medtech Engineering Leaders

Engineers with direct exposure to failure outcomes are more likely to build risk mitigation in from the start, not bolt it on later. When they're tapped for leadership positions, this makes them better leaders.

More Industry Perspectives

WHITE PAPERS & CASE STUDIES

  • online document verification, file management, data storage-GettyImages-2265259381
    The PMCF Decision Guide

    Proposed EU reforms may remove standalone PMCF reporting, yet the duty to proactively collect clinical data remains. Method selection, notified body defense, and data-capture cost determine what comes next.

Your Quality Team Is Already Using AI To Draft Compliance Documents

Quality teams already use general-purpose AI for deviations and submission drafts without validation. Regulators expect governance, and the gap is an undocumented process step, not unreliable output.

Why Passing Audits No Longer Predicts Scale

Clean audit results confirm past compliance but say little about future performance. As products, markets, and regulations multiply, readiness depends on whether evidence stays connected.

Why Audit Success No Longer Predicts Clinical-Stage Performance

Passing inspections no longer signals that a growth-stage biotech can sustain clinical-stage complexity. The gap between audit readiness and operational readiness opens quietly.

5 Hidden Risks In Manual Life Science GRC Systems

Spreadsheets and siloed quality systems conceal five compounding exposures, from single-person knowledge dependencies to scalability limits, that tend to surface only when an inspector finds them.

More White Papers & Case Studies

DESIGN COMPONENTS & SERVICES

Class A Solid State Amplifier: 150W1000
Class A Solid State Amplifier: 150W1000

AR’s 150W1000 is a class A solid state amplifier that provides 1500 watts of output power from 80 to 1000 MHz. It has superior gain flatness, an exceptional noise figure, and better efficiency and harmonics than competitive products.

ADMP801 Hearing Aid Omnidirectional MEMS Microphone

The ADMP801 is a high quality, ultralow power, analog output, bottom-ported, omnidirectional MEMS microphone, designed specifically for hearing aid applications.

SMCLtd_SupplyChainMng
Medical Device Supply Chain Management (Metals, Electronics)

At SMC Ltd. we understand your desire to have a single point of contact for your full medical device. With SMC’s demonstrated strength in IQ/OQ/PQ validation, our network of established and qualified suppliers, and our experience in custom manufacturing, we have the comprehensive resources in place to manage your program from conceptual design to final distribution.

drug delivery
TheraPEA™ Biodegradable Polyester Amide Platform

DSM Biomedical is a global leader in biomedical materials science with experience in creating advanced drug delivery technologies. Their proprietary bioresorbable polymers provide the foundation that enables biopharmaceutical companies to formulate implantable drug delivery systems for specific applications. This technology assists in the creation of platforms for medication delivery to precise target areas in the body, with controlled release from several days to multiple months.

Light Capacity Rodless Miniature Linear Positioners: LCR Series

This series of linear positioners is ideal for medical device OEMs looking to automate light payloads. They’re ideal for applications involving sample preparation, liquid handling, microtiter automation, and elevators and storage/retrieval axis.  

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
More Components & Services

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.

LATEST HEADLINES

More News