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Summary: Challenges such as staff shortages, rising costs and increasing competition can be tackled effectively with digital options. New healing methods, miniaturization, eHealth and homecare are shaping the MedTech sector. At the same time, more and more rules and regulations are increasing the scope of the sector. Digital trends, opportunities, obstacles - we take a look behind the scenes and find out how digitalization is impacting the medical device industry.
The medical technology industry is a key component of the healthcare sector and is in a state of flux. The past few years have brought about some significant changes. For companies, this represents both a challenge and an opportunity.
The legal framework for companies in the medical device industry is becoming increasingly strict and complex. The prime example is the Medical Device Regulation (MDR), which has been binding since 2021. This is a challenge for small and medium-sized enterprises (SMEs) in particular, as meeting the strict and numerous requirements ties up numerous resources that are often not readily available. The requirements contained therein aim to manufacture and provide medical devices with maximum patient safety. Digital options and software systems continue to support this, but must also meet the strict requirements. Requirements such as auditability and the traceability of batches, audit-proof archiving and Unique Device Identification (UDI) also concern companies in the medical device industry.
Digitalization means acceleration. This is a good thing, but it can also become a challenge for some areas of medical devices. The speed of innovation and product cycles is increasing all the time - at the same time, regulatory requirements are slowing things down. The result: competitive pressure is increasing noticeably. In addition, more and more start-ups and new companies are flooding the market and challenging established players.
The issue is more topical than ever: the shortage of skilled workers. Companies in almost all sectors are desperately looking for personnel support. This is particularly problematic in industries that deal with health - such as medical devices. Employers are increasingly faced with the task of attracting new employees in order to cope with existing and additional tasks at an appropriate pace. Another challenge: staff turnover. New colleagues must first be trained. This is very time-consuming and processes are sometimes not consistently trained. This can lead to gaps in knowledge, user errors and a lowering of quality standards.
Cost savings are also the order of the day in the healthcare system. In order to make optimum use of economies of scale and link potential with each other, companies are joining forces and forming communities. Additional companies from the emerging markets are also focusing on the topic of cost optimization. The pressure to work efficiently is paramount - this can be a Herculean task for SMEs with limited resources. In addition, the speed at which innovations are brought to market is increasing rapidly. The pressure to keep up with the pace is enormous. But to avoid being left behind, companies need to step on the gas. Digitization? Definitely helpful! But to be able to use it, it must first be implemented. A time factor that ties up additional resources in hectic everyday life.
Better healthcare, access to water and food and better ways of combating diseases mean that people are living longer on average. In human terms, this is an absolute gain and good news. For the healthcare system and medical devices, it is also a situation that requires new impetus.
The center of life is increasingly shifting to the city. The demand for living space as well as retail and medical care is migrating from the countryside. However, this is not right for everyone. Many want to stay outside the hustle and bustle of the city - and are feeling the pinch. Medical care is particularly precarious in villages outside larger cities.
Many companies are turning to digitalization and replacing manual processes. This saves time, reduces effort and lowers the susceptibility to errors. To achieve all this, they rely on software. But beware, only the right solution will create sustainable success. Anyone interested in enterprise resource planning, for example, should make sure that it includes precisely those functions that are relevant to the medical technology sector. However, products from the medical technology sector are also being enhanced by digital components. For many companies, this is a big step towards the future. But beware, in order to gain a foothold in the digital world in the long term, a digitalization strategy is necessary. And this is lacking in many companies - like the willingness to work paperless. Familiar processes and a lack of trust in the auditability of digital solutions mean that some companies still tend to rely on traditional manual processing.
Most companies in the medical device sector are small and medium-sized enterprises (SMEs). Rising prices and increasing expenditure are particularly challenging for them, as they have to invest a large proportion of their financial resources in research and development. They are also feeling the effects of additional competition from new manufacturers. Always breathing down their necks: the high development costs. These are all obstacles when it comes to establishing digital technologies.
Everything that has to do with medical data is subject to very strict guidelines. After all, this is extremely sensitive data that should not fall into the wrong hands under any circumstances. With the use of digital tools, the issue is becoming even more explosive: companies are obliged to introduce modern and particularly secure standards when it comes to processing data via interfaces. Practices and hospitals must reliably meet all data protection requirements. As far as security is concerned, this is not only important but also a good thing. However, it makes the use of digital medical devices more difficult.
Digitalization makes many things easier. But it also causes concern. Will the surgical robot really be able to successfully support the surgeon? Does the AI evaluate the collected data correctly and draw the right conclusions? Is sensitive health information really stored securely? People are concerned about questions like these. The be-all and end-all is education to allay concerns and highlight opportunities. Until this is achieved, skepticism will remain an obstacle to the digitalization of the medical technology sector.
Essential for companies in the medical technology sector: supply chain management to be able to track where a product is at any time, how long it will take to reach the patient and how reliably a replacement will be on site in the event of a complaint. Not so easy with so many processes and products.
It is clear that the mountain of challenges is high. In order to tackle and successfully master them, many companies in the medical device industry are turning to digitalization. This results in numerous potentials.
Digital measures improve examination options and increase precision, making diagnoses easier and more reliable.
Automated and digitally recorded health data makes it easier to create treatment plans more simply and accurately and to monitor them continuously.
Because digital tools reduce time and effort, medical care is not only better and faster, but above all more affordable.
The combination of information and medical devices increases the effectiveness of medical care. It also increases efficiency for manufacturers.
Digital communication channels, also known as e-health channels, connect both doctors with each other and doctors with their patients. This facilitates communication and enables more targeted treatment.
Finding the right employees is not that easy. There is often a shortage of specialists. Options such as digital consultations compensate for this shortage, as less effort is required and more time is available for a larger number of patients.
The costs of many hardware components and on-site services are skyrocketing. Digital tools offer the opportunity to reduce these costs so that even small companies can survive on the market in the long term.
Digital medical devices and their future prospects have many facets. Some of them are:
Artificial intelligence (AI) holds great potential for digital medical devices. Machines capable of learning are designed to make it easier to make diagnoses and detect diseases and treatments at an early stage. They support doctors in the evaluation of ultrasound and CT scans, for example, and facilitate the medical monitoring of patients. By recording medical data automatically, treatment plans achieve improved results thanks to artificial intelligence. AI also makes it possible to record, process and evaluate large volumes of data - so-called big data.
Electronic health, or e-health for short, shifts medical contacts that previously took place in person to an electronic level. The best and most common example is electronic consultations, where the doctor assesses the patient's state of health via webcam. Portable ultrasound devices make it possible to take images in the ambulance and send them to the clinic. But online appointment calendars are also becoming increasingly popular. E-health brings many benefits: Diagnostics are not only easier, but also faster, advice is personalized and therapies are more optimized and with better time management.
These are primarily implanted sensors, wearables and special apps that automatically record health data when worn. These tools fall into the category of mobile health, or mHealth for short, i.e. health tools that can be used regardless of location. A great opportunity, for example, for pacemakers, blood sugar monitoring or blood pressure monitoring. All these tools make patients' everyday lives safer - and easier. This is because mHealth also makes it possible to communicate digitally with the doctor treating them.
Robots are already being used in the operating theater. They support surgeons, especially when extremely high precision is required. Hospitals and surgeries not only use software to connect their own devices with each other, but also connect third-party devices via interfaces.
Digitally recording and processing medical patient data makes it possible to customize medical devices. It is already possible today to print prostheses and joints using 3D printing in order to prepare for operations, for example. But that's not all: there are also plans to print transplant organs in the future.
Digitalization, with all its facets, has already firmly arrived in the medical technology sector and is becoming increasingly established.
Whereas in the past, an ultrasound device was associated with high one-off costs and had to be located at a fixed location, mobile, app-based devices can now be rented for a monthly flat rate and can be used on the move.
Another prominent example is early aneurysm detection. GPs measure pulse curves via hands and feet. An algorithm takes over the evaluation and predicts the probability of an aortic aneurysm.
The digital transformation in medical device industry also offers great potential for cancer therapies. Well-trained data models for AI are already being used precisely in the early detection of tumors, sometimes exceeding the capabilities of the human eye. Based on CT images and laboratory values, algorithms assess tumor size, tissue structure and composition. Another algorithm calculates the patient's probable survival time and uses this to indicate how successful a therapy will be.
People who are dependent on a cochlear implant can also expect immense progress. Using CT scans that show the size of the cochlea, an algorithm evaluates the patient's hearing profile. The combination of data results in a recommendation for the manufacture of the implant.
Digital technologies are already finding their way into other industries and offer a wide range of potential applications for optimizing the processes that prevail there. For example, the same tools are used in the digital transformation in food industry, but the potential and application scenarios are completely different.
A variety of opportunities is therefore faced with a variety of obstacles. What can be done? How do companies manage to master the balancing act and realize the potential of digitalization for themselves? Quite simply: with the right partner who has the necessary expertise and the right ERP software, especially for the medical devices industry. It's a good thing that industry-specific ERP 365 exists.
The world is changing. This is also noticeable in the medical technology sector. Companies are being driven by issues such as the legal framework, digitalization, competition, a shortage of skilled workers and urbanization. Each individual area offers great opportunities - and is also riddled with obstacles. The trick is to turn challenges into opportunities and exploit the potential that arises. Accurate diagnoses, improved medical care, bridging staff shortages and lower costs are additional opportunities that await companies.
But how can these be achieved? Software is a proven and future-proof option. In most cases, it is an ERP system with the option of building up an entire universe of applications, interfaces and apps in the Microsoft 365 spectrum, with which medical device companies can position themselves securely for the future. But there are challenges lurking here too, because the solution is only really helpful if it includes all the important functions. The secret is the right industry solution paired with a software partner who has the necessary expertise.
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