Manufacturing commercial medical devices and apparatus
Ximedica is a medical device product realisation firm with a year history of delivering innovative devices across diverse product categories, including endoscopic devices, laparoscopic devices, emergency care systems, infusion and drug delivery systems, ultrasound and medical imaging devices, oral appliances, remote patient monitoring, in-home diagnostics, dental products and more. Ximedica delivers the services that medical device companies need to bring their product from the initial ideation stage, through product design and development up to product validation and launch, all while complying with FDA regulations and conforming to the relevant ISO standards required for medical device quality systems. GCMI opened its doors in April and to date has worked with over 50 different startups, clinician innovators, university tech transfer offices and academic researchers to design, engineer, prototype, and facilitate commercialization of a broad range of innovative medical devices. The independent, c 3 non-profit organization has a robust and ever-growing network of experts, including intellectual property, regulatory, quality systems and investors, to help bring ideas from concept to market.VIDEO ON THE TOPIC: Production Process Overview - Medical Device Manufacturing
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- Medical device design
- SO, YOU WANT TO BE A Successful Med tECH Device DevelopER?
- How 70 Percent of the Largest Medical Device Manufacturers Got Started in Mexico
- Medical Equipment Distributors In Qatar
- Top Countries to Drive Medical Device Manufacturing
- Medical Equipment Manufacturing
- medical devices mashining
- Medical Technology Spotlight
- Medical laboratory equipment price list
Medical device design
If you want to be a medical device developer you need a great idea for a product, as well as the ability to build it.
But if you want to be a successful medical device developer, you're going to need to do considerably more than that. Medical device development is one of the most heavily regulated sectors in the world.
The consequences and penalties for making mistakes and releasing unsafe or poorly designed devices can be serious. But the rewards for success are considerable:. The distinction and boundaries between software, apps and medical devices are blurring, opening up new opportunities but presenting new complexities for developers.
In McKinsey found that sales opportunities in high-growth med tech segments were shrinking as it became more challenging to innovate and global competition continued to tighten. They concluded that successful products in this category were those that:. Given the heightened stakes and the pressure in the sector to deliver more complex products faster and to a higher quality than ever before, this guide focuses on helping developers avoid the biggest and most common mistake in medical device development — the failure to plan effectively.
A plan is essential because designing and developing a medical device will take longer than you think, there will be set-backs and challenges you cannot possibly predict.
Your plan and the Quality System or mechanism that you create to deliver it, will be the means by which you make a product that is safe and capable of meeting all the user and regulatory demands that are made of it. This section of our website is designed to help you prepare for these requirements. These distinctions are important, because they are going to impact on the lead time and the rigour of the certification processes you will have to undertake before your product can launch.
In the EU market these legislations will dictate and define the processes you will need to go through to secure your CE marking, the only method by which you will be legally allowed to market your product in that territory. The US has similar classifications of device with different regulatory requirements associated with them. These are all set out here by their regulatory body - the FDA.
The European Medical Devices Regulation defines a medical device as:. Apps or devices that monitor fitness, health or general wellbeing, are NOT usually considered to be medical devices, nor are those that simply digitise information that would normally be printed or completed by hand, such as patient diaries for recording blood pressure.
However, many other apps and pieces of stand-alone software are classified as medical devices and will be subject to the same compliance requirements. The MHRA has published an interactive guide to help you determine the exact classification of your device. However, it is still a new area of medical device regulation, so it may be worth reaching out to the MHRA directly or even a Notified Body for their opinion. A Medical Device can only be CE marked and placed for sale on the EU market when it meets all of the applicable regulatory requirements.
The assessment route depends on the classification of the device and may require your Quality Management System to be audited by one of the Notified Bodies which are licensed and approved in the UK by the MHRA. When it comes to compliance, the burden of proof is higher or lower depending on the classification of the device and the degree of risk that its use could present to the patient or user.
The risk of harm represented by the device will also determine whether you can self certify the device or if its conformity needs to be certified by an external body. So, you know what classification your product falls into and what you need to do to meet the regulatory requirements to place it on the market.
But have you asked your potential customers and users if they actually need it or would buy it? Of course, the cost of getting it wrong in medical device development can be far higher than for other products due to the exacting demands of the tech expertise required and the regulatory hurdles you will need to clear to get to market. When drug giant Pfizer started working on delivering insulin via an inhaler they went in all guns blazing.
They thought there was huge customer demand for a non-painful alternative to injections among diabetics and believed that the technology could be developed to deliver it. The Exubera product was eventually launched in , to much fanfare. But the product did not live up to the hype.
For a start, the company had found it impossible to deliver a complete, required insulin dose within a single inhalation. To make matters worse customers responded badly to the appearance of the device which was regarded as unwieldy and difficult to use. This should be a lesson to all developers to do detailed research about what their customers really want before they start developing, and to regularly review those requirements throughout the development lifecyle.
The ideal starting point to validate your idea is to investigate your chosen user group these might include patients suffering from a specific disease or condition or clinicians of a specific medical specialty. Ultimately, this will become part of the User Requirement Specification against which you will design a device to solve their problem.
Regardless of whether the concept for your medical device design has come to you fully formed, you will still need to test the waters of the market to see if it is going to solve a problem or not. You need to keep in mind that even if it does solve the problem, does it solve the problem in a way that customers will be happy with?
The Summary Technical Documentation STED or Medical Device File that you will need to produce as part of your compliance documentation must contain evidence that user needs have been collected at the beginning of a project and then validated against the finished product at the end.
Not only is this a compliance requirement it is also a common sense requirement that will save you money and keep you focused on customer needs throughout your design process.
After all, the more successful and efficient a product is at meeting user needs, the greater the demand for it should be and the more commercially successful your company will become. This may result in tweaks or a major redesign to make your product what the market wants and needs. Download your guide to understanding how best to apply risk-based thinking to quality processes. In this eBook, we break down risk assessment techniques and consider their applicability to quality management.
A QMS formally documents processes, procedures, and responsibilities for achieving quality policies and objectives. It should be always and easily accessible to stakeholders and auditors for guidance, review and implementation.
A QMS should govern and record every element of your device planning, design and development in line with the needs of your end user and the demands of the regulator.
This in turn, may prove a huge hurdle in winning confidence and funding from investors, obtaining ISO , gaining a CE marking, and successfully launching your product on the market. You know what kind of device you want to build. You have a vision of the product and a commercial proposition that has been validated by your research.
When can you start developing? This measured approach is the means by which you can mitigate the risk of failure or the possibility of making dangerous errors. It requires that you put together a plan for the safe delivery of your end product. It requires that you define and observe a set of systematic processes and procedures that will allow you to manage, review, and document every step of that plan and its delivery.
It should define the objectives and parameters of each stage of a project and help you deliver against them. Of course, particular elements within your plan will inevitably fail and fall apart, change and reshape themselves as you go along. An unexpected test result or failure of a prototype component may send you back to the drawing board. They can result in a radical reshaping of your designs. But the central tenants of your plan will still remain in place; the order in which phases are tackled and the requirements that need to be met before each phase can progress.
As a formal, approved document the plan can be used to guide both project execution and project control. The plan should set out your assumptions and the important decisions you have made prior to commencing the build. It will form the basis of a shared understanding amongst project stakeholders, since it will contain within it the approved scope of the project, including a basic schedule and timeline for completion.
It may be used as a measure of the time commitment required by investors and your ability to correctly judge the amount of work involved. If the plan looks amateur and wildly optimistic it may put potential backers off. If it proves unrealistic in practice and you end up meeting none of its targets, it may cause backers to refuse further funding and your entire team to lose confidence in your ability to deliver.
Now you need to describe and define a set of processes and standard operating procedures SOPs by which you can deliver your plan.
This set of process and procedures is your Quality Management System and it is pivotal to the successful delivery of any medical device. Nearly all Medical Device regulations require that you are able to prove you have a compliant and operational QMS in place to martial your business processes and deliver products of a consistent quality to your end user:.
And as the diagram below shows, almost the entire product development lifecycle of a medical device needs to be governed and controlled by the kind of QMS it specifies:. The design of a functional, effective and fully auditable QMS is no easy task. Among other things it defines the way risk is reduced and potential non-conformance mitigated within every function of your organisation.
It outlines an approach to your work that will prioritise the delivery of an end product that is safe, effective and performs as intended. For this reason, ISO focuses heavily on the way your QMS will implement design controls, creating a phased process that verifies and validates that your design outputs match requirements at any stage of the development process.
Starting development work before you have correctly understood your obligations under both the regulations and ISO - and before you have put in place at least the procedures for device development, risk management and document control - can have serious consequences for your timeline and your sanity.
The idea of a developer coming up with a brilliant concept, then slaving away in their workshop to bring it to life, before showing it to investors, winning funding and selling their device for millions is at odds with the reality. In fact, one of the worst-case scenarios for an investor or quality consultant is being presented with a fully formed prototype by a developer but no documentary evidence about how they have got the product to that stage.
Given the lengthy timelines involved in getting from initial idea to applying for a CE marking, having to go back and reconstruct any of the key stages of a project, could elongate the whole process unacceptably for an investor.
As the diagram below makes clear, you will need EVERY step of your process recorded and documented appropriately. Documenting those processes retrospectively may prove to be difficult or impossible. Although it can be a complex task, creating a plan and designing a QMS should, therefore, be your top priority. In the end, your QMS, which has defined, tracked and logged every part of your design and development process, will also be the tool by which you draw out and compile your Medical Device File also known as a Technical File, Design Dossier or STED file.
These are the documents that are essential to be audited by your Notified Body to secure your CE marking and finally get your product to market. The QMS, then, is critical to creating a smooth running, properly organised and documented design and build process that delivers a product that meets customer needs and is safe to use.
And it should do this by managing the risk of technical and commercial failure in a highly proactive way. By guarding against the risk of failure of the design and build processes, a QMS should ultimately help guard against customer harm or dissatisfaction, and, therefore, the commercial failure of the product itself. The purpose of risk management practices are to minimise the risk either to the achievement of the objectives of the med tech project or to the reliability of the developed device and safety of the users.
In any medical device development project a Risk Management Plan needs to be prepared. This plan lays out the approach to identifying, tracking and resolving each risk to a device, associated with its design, production, storage and usage. And the elements of the plan should be implemented and evident according to the procedures of the QMS. Risk is a hot topic in ISO Helpfully, the regulation draws our attention to areas of particular importance here, including design and development, training and purchasing i.
These are areas where there is particular danger posed by non-conformance e. The responsibility for assessing the compliance of your suppliers against the relevant regulations might seem an onerous one, but it is entirely consistent with the risk-based approach. And you will need to have a process in place to assess whether their QMS and, therefore, any product or service they are supplying to you is compliant.
But this risk-based approach, with its focus on outcomes and reducing risk of customer harm or dissatisfaction can also be an opportunity. It should mean you are continually reviewing processes and focused on improving the consistency and quality of your end product before anything goes wrong.
This is an opportunity for innovation as you strive to make your processes as efficient, innovative and error free as possible:. Clause 7.
SO, YOU WANT TO BE A Successful Med tECH Device DevelopER?
Create a Board. Skip to content Indonesia Country Commercial Guide. Open Articles. This sector presents strong opportunities for U.
The sector continues to rely heavily on imports, USD 7 billion in Germany accounts for approximately 50 percent of the imports, while the United States has approximately 25 — 30 percent of the market share. Most of the well-known U. Spanish manufacturers are compensating for the drop in domestic activity by stepping up their international activities.
How 70 Percent of the Largest Medical Device Manufacturers Got Started in Mexico
If you purchase a report that is updated in the next 60 days , we will send you the new edition and data extract FREE! The briefing provides a short overview of countries that are expected to lead medical equipment manufacturing growth over Files are delivered directly into your account within a few minutes of purchase. Gain competitive intelligence about market leaders. Track key industry trends, opportunities and threats. Inform your marketing, brand, strategy and market development, sales and supply functions. Ireland will continue to have among the fastest growing medical and surgical equipment industries, as global players choose the country for their manufacturing base. German medical device manufacturers are being somewhat slowed down by modest export growth to Western Europe as the main trade destinations are expected to continue cost containment measures in their healthcare spending. Israel is becoming one of the fastest-growing medical device production hubs in the world.
Medical Equipment Distributors In Qatar
Create a Board. Skip to content Colombia Country Commercial Guide. Open Articles. Overview The Colombian medical devices market relies overwhelmingly on imports, which made up about 82 percent of the market in , despite strong domestic production focused mainly on consumables. Since the implementation of the U.
Home Research Industries. The medical equipment and device manufacturing industry often referred to as the medtech industry or medical devices industry designs and manufactures a wide range of medical products that diagnose, monitor, and treat diseases and conditions that affect humans. These products range from inexpensive tools, such as tongue depressors, to complex, multimillion-dollar systems, such as magnetic resonance imaging systems.
Top Countries to Drive Medical Device Manufacturing
Medical Equipment Distributors In Qatar. Stryker does not offer medical advice, and we recommend healthcare personnel always undergo training prior to using any product on a patient. One example is the support surface fabric from Dartex, used in hospital best to prevent pressure injuries. We are a well established, financially stable company with an ISO quality certification to our credit, currently one of the biggest companies dealing with medical supplies in Oman.
Medical Equipment Manufacturing
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medical devices mashining
We develop and manufacture technologically-advanced medical equipment and devices for modern healthcare practices. These Intellectual Property assets along with the custom fabricated capital equipment required to fabricate and validate the systems were acquired by Medived. Contact verified Medical Equipment Manufacturers, Medical Equipment suppliers, Medical Equipment exporters wholesalers, producers, retailers and traders in India.
Medical Technology Spotlight
The medical device manufacturing industry produces equipment designed to diagnose and treat patients within global healthcare systems. Medical devices range from simple tongue depressors and bandages, to complex programmable pacemakers and sophisticated imaging systems. Major product categories include surgical implants and instruments, medical supplies, electro-medical equipment, in-vitro diagnostic equipment and reagents, irradiation apparatuses, and dental goods.
Registration Of Medical Devices. Indonesia medical device registration is a relatively fast and inexpensive process particularly considering the size of the country. Medical Devices categories. Medical device registration committee: Competent members of the committee make assessment for medical devices in an unbiased — internationally - harmonized. Part 1: Pre-Market Control.
Medical laboratory equipment price list
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