The 6 Biggest Obstacles for High-Tech and Medical Device Manufacturers and Their Solutions

Modern HTM manufacturers involved in computing and telecommunication, as well medical device OEMs, are confronted with different and dynamic issues. However such ideas as Industry 4. 0, cloud-based IT and DT, to high-tech and medical devices manufacturers, it is not enough just to decide that one has to follow the most modern technology by investing in end-to-end, stable, and efficient software solutions that provide leverage. 

Currently, managing our company with global offices and having over 17 years of experience in the manufacturing and rental industries, at STAEDEAN, we are not strangers to the changes in industry and market as well as the growth of customer requirements. We assist enterprises to model their business through industry-specific solutions integrated into Dynamics 365 Finance and Supply Chain Management. 

This article will tell how the realm of high-tech equipment and medical devices looks today, what are the major issues of the industry, and how our software helps to solve them. 

What does the present day picture of high-tech equipment and the manufacture of medical devices appear as? 

Medical device OEM landscape 

The medical device manufacturing industry or medical device original equipment manufacturers (OEMs) deal with one of the most fundamental and vital sectors in the society, which include the health and lives of people. The medical device manufacturing industry wants to supply everything that can be sold or rented within the healthcare setting including X-ray machines, ECG, oxygen concentrators, hypodermic needles, syringes, and defibrillators. 

This sector has over the recent years and especially due to the COVID-19 market greatly change and while some of the medical OEMs are experiencing increased demand for their products, there are others who are observing their market share decrease. In order to protect their market share and gain competitive advantage, medical device manufacturers are currently looking forward to incorporating Industry 4. 0 and the company bring forward new technological solutions to overcome challenges of the new market.

Small profit margins, restricted visibility across assets, inapt ability to optimise utilisation, and operating performance – few struggles medical device companies experience that can be very expensive to address if poorly done. In fact, KPMG observes that medical device manufacturers risk a profit loss of 21 percent, being non-adaptive to digital change. 

The high-tech equipment manufacturing industry environment 

High-tech equipment manufacturers include those who involve in manufacturing, selling, renting or retail of semiconductors, PCs, network equipment and related assets. 

The role of various digital transformation activities and remote work setup which has seen a boost after the pandemicINES has faster growth in the industry. However, manufacturing businesses that are not considering innovative technology and integrating recurring revenue sources in their business with ideas such as Equipment as a Service may find themselves obsolete. 

As the trends are only painting a more complex picture, today’s high-tech companies cannot afford to adopt outdated technologies for their business. As time goes on, it may present difficulties for corporations that are using high technology equipment in their operations to deal with their data and address issues to do with process automation, environment and related regulations, costs, visibility of the supply chain, product traceability, and improved cooperation. 

Wondering about ERP essentials, what high-tech equipment and medical device companies should seek? View this Checklist. 

There are many similarities between the high-tech equipment industry and the medical device manufacturing industry and it is seen that they share many of the generic problems. Here are some of those challenges with how the STAEDEAN Rental Management, sitting in Dynamics 365 F&SCM can help adopters solve them: 

Which are the past issues problematic to the high tech and medical device manufacturing companies and how can STAEDEAN Rental Management for Dynamics 365 address them?

Challenge 1: Most of the time, there is little or no visibility on the supply chain and in product tracking. 

Supply chain management is critical especially for manufacturing industries, as sometimes technicalities of compliance may not be easily observed only to realize a company has lost a lot of money and its reputation is at stake. 

Any question concerning damage, defects, or recall can become a nightmare if there is no way of managing your inventory from start to end. 

Solution: You can sequentially number your devices with serialization feature in STAEDEAN Rental Management and monitor your all equipment from purchase, production, rental, sales, to a successful customer order with a final invoice. 

Also, consider the possibility of the PLM-ERP connection that links the engineering and manufacturing departments and helps manage your products’ lifecycles. 

Challenge 2: Managing the clients when most of the work is done online

The post-partum period signifies the growth in remote working operations, therefore, high tech as well as medical OEMs have to go for selling, renting as well as getting their products directly to end users from a distance. However, inability to take care of all your clients maybe detrimental in that there could be dissatisfied customers. 

Solution: Utilize a single CRM solution, for instance, STAEDEAN Rental Management for D365 Sales that is compatible with STAEDEAN Rental Management. You can ensure all lead-to-cash processes as a single system, create fast and accurate quotes, and cross- and upsell according to customers’ behavior. 

Another way that the employer may incorporate such an idea as the ‘remote work’ setting is offering your field employees the necessary information through a mobile application that is the STAEDEAN Rental Mobile Operations. 

Also, with an awareness of all your products on offer, you can indeed engage your end customers through the customer portal solution like the STAEDEAN Rental Customer Portal. This solution enables your customers to book equipment(s) for use, monitor them and or make changes independently.

Challenge No 3: Which have resulted to P3 development is IP theft and counterfeit products. 

Anti-competition business practices that are experienced by high-tech and medical device manufacturers are the instances of theft of IPs or counterfeiting. Among various kinds of crimes the most frequent one is the violation of the data protection and stealing of identity in high-tech industry most products in the market are manufactured using low standards of quality and the original product they claim is a fake. 

Besides, medical product counterfeits including substandard and falsified counterfeits can put a medical device OEM legally at risk and negatively affect their business. 

Solution: Improve each product in your manufacturing unit through bar code identification, serialization or batch tracking. Our scanning solution, STAEDEAN Rental Logistics Scanning, offers possibility to scan each item separately and obtain information on the serial number of each order. Finally, it supports on-site rental depots with prospects of check out within the location and one can manage both serialized as well as non-serialized equipment. 

Also, you can schedule any issues that may appear in your production line with equipment maintenance information using STAEDEAN Rental Management that provides history, insights, forecast time for maintenance. 

Challenge No 4:  To establish regulatory compliance into the company. 

The regulation of medical device OEMs is hugely so by country, they have stiff regulation. Any medical device; whether new or refurbished, must receive clearance from FDA, GMP, and ISO before its is put into the market. 

Protean manufacturers also have to additionally respond to the environmental legislation, export control, jurisdiction lists of exclusion or inclusion, and reporting that is provided from the standard bodies like GDPR, EU, HIPAA and others. 

Solution: Using STAEDEAN Rental Management, it is possible to place documents for medical devices and other high-tech products and configure a quality control for each of the pieces of equipment or the produced items. It provides excellent project management tools with subcontracting and integrated planning so it will assist in documenting and managing multifold business processes and enable compliance to various regulations.

You can even to a greater extent, adopt a master data management to put in place data governance, thereby enabling the control and organization of data quality, accuracy, consistency among others. 

Challenge No. 5: Unplanned downtime and the best use of asset time 

Some of the issues that the high-tech & medical device OEMs are encountering include the optimization of machine use and minimizing of non-scheduled machine down time. High production costs viewed especially in production of high-end equipment, medical devices and high margin pressures drastically deplete the business when it is hit by more than intended downtimes. 

Solution: Optimize the use of available assets by having a holistic view of the entire supply chain through STAEDEAN Rental Management and monitor real time availability to have an overview of all the upcoming reservations in one place while organizing all the rental process beginning with the bookings and ending with the returns to make the best out of products. 

Lastly, we have an analytics add-on solution known as STAEDEAN Analytics for Rental, whereby you can get more information about the utilization rate, the frequency of bookings, and more specific KPIs by having more elaborate reports and IoT sensors for your best-performing products and equipment. 

Challenge No. 6: Competition and pricing strategies as well as the distribution systems are complicated. 

Producers should strive to meet the emerging needs of consumers in addition to coping with diverse income models that include service-based charging, conventional leasing services, usage-based tariffs, and so on. It must be sustained through a combination of this tiered pricing, real special volume pricing agreements with distributed or the end users and rebated or discounted prices. 

It was actually possible to have several distributors of a single product and these could have different prices depending on the region. Having a Global Customer base would also involve multi-currency and multi-location policies to be taken care and addressed efficiently. 

Solution: In STAEDEAN Analytics for Rental, you are able to enter and carry out different complex projects or contracts and using the consolidated invoicing in such a way that it can help you to get the payments that are paid over a long period of time. It is capable of handling operations such as multi-currency and multi-country operations, complex production, and distribution, as well as, multiple cost and revenue generation making the pricing and invoicing process to be easily accomplished.

If you have distributed ERP systems you may integrate your operations and rental-specific business data from your local ERPs to the parent ERP and obtain a consolidated statement of all your financials. 

It’s time to move to the next level of your high-tech and medical device manufacturing digital evolution. 

If you are willing to go for the modern technology with the Microsoft Dynamics 365 ERP and thinking to take the end-to-end software solution then it is high time for you to go for STAEDEAN Analytics for Rental. 

You could explore more about the STAEDEAN Analytics for Rental solution by checking out this factsheet which shares information on:You could explore more about the STAEDEAN Analytics for Rental solution by checking out this factsheet which shares information on: 

  •  The following is the list of the kind of features and benefit that the solution offers. 
  •  Industries in which this solution is helpful 
  •  That is the relevance of each of the optional add-on solution features. 
  •  About STAEDEAN Analytics for Rental & how it can assist your organization

References:

  1. American College of Emergency Physicians
  2. Gallagher Healthcare
  3. Medtronic plc
  4. Becton, Dickinson and Company
  5. Boston Scientific Corporation
  6. BladGo – Portable Bladder Scanning Device

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