Medical device industrial design

Optimal performance and safety in use are fundamental requirements in the field of medical device industrial design.

• Health care workers – whether doctors or nurses – must be able to carry out their work in the maximum possible safety.
• Patients must be able to have the tranquility of entrusting their health to ‘friendly’ technologies, to medical instruments that inspire trust and communicate a sense of reliability and safety starting from design.
• They must be able to work safe from errors that could compromise the effectiveness of a therapy.
• A medical device must be characterized by the presence of intuitive interfaces and control systems.
• Technologies able to provide valid help in completing tasks that directly concern the health of patients.
• In this historical period we are witnessing the development of increasingly intelligent products, equipped with advanced technologies that allow them to communicate with the surrounding environment and interpret user requests quickly and effectively.

• Designers thus have tools that simplify and secure high-risk healthcare services. The quality of the design and attention to detail are the means to arrive at medical instruments that doctors and patients can trust unconditionally.

The regulatory standards of medical devices

Medical devices are classified by law according to their function and potential risk for the patient.

Devices must meet specific requirements, quality standards that make them easy and safe to use.

These standards represent a concrete transposition, they are subject to constant revision. As far as European countries are concerned, it is the well-known CE mark that allows the launch of medical products on the market. The certification is done by the so-called ‘notified bodies’ (including the Italian ISS – National Institute of Health).

Dispositivi medicali DEHP-free

In order to obtain greater resistance and flexibility, many manufacturers use PVC by associating it with ethylhexyl phthalate, also known as DEHP.

However, it is now known that the exposure of patients to PVC and DEHP causes various undesirable effects on their health; among them:

• squilibri ormonali;
• interruption of reproductive and developmental processes;
• onset of allergies in children;
• increased chances of malignant tumors;
• scleroderma, or hardening of the connective tissues.

It is increasingly common among medical manufacturers to create and market DEHP- Free.

L’approccio al medical device design

A medical device is compliant with regulations when the design process includes accurate design controls. Planning, checking specifications and requirements, identifying potential risks and correcting problems. In other words, design controls include:

– careful assessment of user needs.

– design and development planning;

– input e output di progetto.

– project verification, by conducting product tests in real or simulated conditions of use;

– design validation, performed to provide objective evidence of compliance of product specifications with user needs and intended use;

– eventuali revisioni.

This approach allows us to have a vision of the product life cycle.

We help medical companies, equipping them with the internal systems needed to support innovation through correct design.

The advent of the Internet of Things (IOT) has radically changed the landscape of medical devices. Patient involvement must necessarily be taken into account in the design of effective and modern medical equipment. The arrival of digital healthcare responds to the objective of guaranteeing more efficient, safe and clinically effective results for doctors and patients.

We take care of our customers and their projects

As a design agency we design medical device taking into account the way the electronics are integrated.

Design For Assembly is essential for positioning electronic components (sensors, batteries, boards, LEDs, displays, etc.). Manufacturing tolerances affect assembly and depend on factors such as materials used, part design, manufacturing technologies adopted. We design medical devices in compliance with the principles of Design For Manufacturing (DfM), for an optimized production process.

Design for manufacturing

For DfM we mean the finalized design to production. A careful design that considers the quantity of pieces to be produced, the material used, the complexity of the surfaces, the tolerances. The environmental conditions in which the medical device will be used are also considered.

Il medical device design secondo PQ

User centric design

At PQ we adopt an approach that starts from the customer’s needs.

We design the style and usability of the medical device, balancing the needs of operators and the reference market. Through tools such as focus groups, surveys, interviews and usability studies, we involve users in every phase of the design.

Partners of our customers

At PQ we are committed to selecting the best materials and production processes, as well as supporting product certification.

Unity is strength

Ours is a lean reality, but with the mentality and ambition of a top design firm. Years of shared projects have forged that solid partnership network that enriches and makes our work more efficient.

Thanks to a team of experts in product design and industrialization, we are able to design complex medical devices.

Design to Cost vs Design to Value

Through a Design to Cost (DTC) approach, the relationship between product value and sustained production costs is optimized. We combine the most exquisitely creative skills with those of industrial production and industrialization experts. The precious collaboration with the partners of our group allows us to intervene on electronics, production, software, and so on. We design medical devices in compliance with cost and time to market constraints.

Long experience in the field of medical device industrial design

We have been operating in the medical design sector for over twenty years. Our many projects are appreciated by professionals and users: equipment, analysis tools, furnishings and so on. The various international awards we have won certify our commitment in the field of medical design.

Contact us today to learn more.