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Software Solutions for the Medical Device Industry

Trends, features and challenges of an industry that demands top safety and reliability

The medical device industry is facing the greatest challenges in terms of safety and reliability among the manufacturing sectors. Our software tools are particularly suited to enable these challenges to be met successfully. In addition, our team has a long experience in the field, daily supporting many customers working in the medical device industry.

medical devices industry

What is a Medical Device?

According to European Union Medical Device Regulation, a Medical Device is any instrument, apparatus, appliance, software, implant, reagent, material, or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

  • diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
  • diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
  • investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
  • providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations,

and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.

The following products are also considered medical devices:

  • devices for the control or support of conception;
  • products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point.

Classification of Medical Devices

Classification of Medical Devices drives many pre- and post-market requirements. Due to the large variety of products, the level of control made by a third party (the “notified body”) before placing them on the market depends on the level of impact on the human body that their use might imply. The same notified body is involved post-market to ensure the ongoing safety and performance of medical devices.

Medical Devices are classified by European Union into 4 classes following a risk-based classification system:

medical device: wheelchair

Class I

Low Risk

(examples: wound care products, wheelchair, spectacles)

medical device: syring

Class IIA

Medium Risk

(examples: hearing aids, syringes for pump infusion)

medical device: anaesthesia machine

Class IIB

Medium to High Risk

(examples: anaesthesia machines, ventilators)

medical device: defibrillator

Class III

High Risk

(examples: pacemakers, defibrillators, implanted prosthetics, breast implants)

Innovation in the Medical Device Industry

Medical technology is characterized by a constant flow of innovations, which are the results of a high level of research and development within the industry, and of close co-operation with the users.

In 2021, more than 15 000 patent applications were filed with the European Patent Office (EPO) in the field of medical technology – 8.2% of the total number of applications – more than any other sector in Europe. 41% of these patent applications were filed from European countries (EU28, Norway, and Switzerland) and 59% from other countries, out of which the majority of applications were filed from the US (38%).

medical device patent applications

The top country for medical device patent applications is the United States (38% of applications), followed by Germany (9%), Japan, Netherlands, Switzerland (6% each) and France (5%) in 2021.

Digitalization in the Medical Device Industry

Medical Device manufacturers can drive profitability in today’s era of increased complexity through digitalization.

Digitization today affects every industry and creates new opportunities everywhere. It can help companies develop innovative products and bring them to market faster and with higher quality. The methods used to date are no longer sufficient. Innovation without digitization is no longer a viable option.

Medical device companies are facing crucial challenges, such as:

  • Global competition
  • Intense cost pressure
  • Continued regulatory scrutiny

Relying on paper records can lead to missed deadlines, human error and inefficient processes. Today, producers and their information work in silos. This means there are few opportunities to capture traceability and key knowledge.

To be more agile and get to market faster, medical device companies must transform their operations with the digital enterprise. The digital enterprise leverages digital data, virtual product models and a digital thread of information.

Digitization is the only way medical device companies can use new technologies and tools to overcome market challenges. Through digitization, companies can improve quality, increase accuracy, reduce contingencies, and achieve manufacturing excellence.

Digitalization in the medical device industry

Infographic

Discover why the Digital Device industry requires Digitalization, what the Global Trends are and how Digitalization is powering the Digital Device industry.

Why to choose Cadlog?

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Siemens Ecosystem

The technologies already used by best-in-class organizations and Siemens' Digital Twin-based method made accessible for any small and medium business thanks to a set of scalable solutions.

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360-Degree Digitization

You will be part of a large industrial system where many different companies cooperate to provide you with the best solutions for Digitization, whatever the field of application.

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Experts in Electronics

We have been working in Electronics for more than 30 years. We have built a portfolio of solutions and own an expertise that allow us to face any aspect related to the design and manufacturing of electronics.

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Customer at the Center

Listening to you, deeply understanding your company and requirements. Taking into consideration your budget and the goals you want to achieve. Supporting you daily to grow faster,  together.

Software for the Medical Device industry

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Xpedition Enterprise

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PADS Professional

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HyperLynx

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PCB DFM

Valor NPI – The Siemens Solution for managing PCB DFM Rules

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Simcenter FLOEFD

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Simcenter Flotherm XT

Simcenter Flotherm XT is a CAD centric electronics cooling simulation software provided by Siemens, which allows you to reduce time to market.

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Siemens Process Preparation for SMT Process Engineering

Valor Process Preparation is Siemens‘ Process Engineering solution for a fast and high-quality New Product Introduction (NPI) right the first time.

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MES Software – Siemens Opcenter Execution Electronics

Opcenter Execution Electronics is a complete MES Software solution based on direct connectivity to machines and production lines.

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