A Medtech Challenge - Phase Out or Redesign Devices

Author : Dunstan Power, Director of ByteSnap Design

21 April 2024

Worth approximately £26 billion (according to the International Trade Administration), the UK medtech industry is a profitable one for those involved, which tend to largely be SMEs scattered around the country.

However, companies in the sector have to navigate a particular set of challenges when it comes to manufacturing their products. These include obsolescence, stringent regulations and limited engineering resources.

There are exacting requirements for anyone developing equipment for the healthcare industry. One of the most significant hurdles is attaining compliance with the regulatory standards that are in place to ensure all equipment is safe for use. Dealing with complex regulatory frameworks, obtaining necessary approvals and maintaining compliance throughout the development process can be both hugely time-consuming and financially demanding too.

The clinical validation of equipment will, of course, be vitally important in the development of such items. They will need to undergo extensive trials to prove their efficacy and safety, which means collaboration with healthcare professionals, the obtaining patient consent and the conducting of thorough testing, which is likely to be resource intensive.

Technological advances in both healthcare and general technology require continuous innovation. Companies must stay updated with the latest developments and decide how to go about integrating cutting-edge technologies while ensuring compatibility with existing healthcare systems.

Interoperability is a common challenge, given that medical equipment often needs to seamlessly interact with other devices and systems within the healthcare ecosystem. Achieving interoperability becomes particularly challenging due to diverse standards and protocols, along with the presence of legacy systems.

The risk of obsolescence
While consumer products have casual, inbuilt obsolescence, encouraging users to re-purchase another updated model, when medical devices become obsolete, it can often be for arbitrary reasons. Obsolescence may be caused by a chip no longer being produced, or outdated firmware that suddenly presents a security vulnerability.

Medtech devices facing obsolescence may still be in demand by users, and prove perfectly usable and profitable. It is therefore in the interests of consumers, respective healthcare providers and manufacturers to extend the shelf life of these products for as long as viable. However, when they become obsolete, it is not a simple case of manufacturing a new, similar product. A medical product company will often be left with very little time and a limited workforce via which to conduct a redesign.

The financial aspect
Developing a new product from scratch could have associated costs reaching up to £20 million and may take 4 to 5 years to make it to market. The new medical technology would need to be tested and certified, and it would have to pass regulatory scrutiny. Medical companies, particularly the UK’s SMEs, often don’t have the time or resources to shelve a still functioning product and pause profits while investing into a new team and a new compliant product. 

Although government regulations for medical devices will be put in place between 2024 and 2025 to make certain that the UK remains attractive for medical technology innovators to operate in, they will also add a further layer of complexity. The resources involved in developing a new medical product, added to the impact of discarding units in need of an upgrade, mean that repurposing existing products and tackling obsolescence is economically and environmentally preferable to developing a whole new product. How medtech firms proceed will depend upon what is required to refresh their products. For instance, minor firmware updates might not require recertification, but more significant modifications often do.

Avoiding potential skill gaps
Once a medtech equipment producer decides to tackle the obsolescence of an existing product in order to renew it, they must take into account their development team and whether they have the requisite skills to deliver the project within time and on budget. Dedicating an in-house R&D team for a single particular product comes at a cost. Furthermore, retraining staff to fill in any skills deficiencies takes additional time and investment - when both are of the essence. 

Let’s examine common skills issues. Perhaps the new medtech device requires extra hardware and software expertise. It may need a new FPGA for the embedded electronics. Alternatively, it might call for the replacement of no longer available off-the-shelf integrated circuits. Medical products facing obsolescence can be based on very outdated software, such as previous versions of Windows CE from 2 decades ago. Software like this will present security issues. While this is a problem in itself, it is compounded by the fact that there’s a global shortage of Windows CE engineers with sufficient proficiency. Engineers with niche knowledge often require an accurate memory recall of how to update the software, given that these kind of specialist capabilities are no longer taught and rarely come with instruction manuals.

Other skills may include understanding how to program software specifically for a Linux-based hospital environment, modernising it without affecting the hardware, or finding replacement hardware components that are compatible with the software in question. An experienced team can deploy effective solutions where the modifications are so minor that recertification of the renewed device may not be necessary. In addition to expert knowledge of legacy operating systems, key skills to look for (whether hiring for an in-house team or engaging with a consultancy offering software services) may include:
  •  Porting from old to new operating systems.
  •  Removing bugs. 
  •  Implementing security updates. 

If your in-house team does not have the necessary skills, outsourcing the R&D to an experienced external team can be a savvy and cost-effective move.

Outsourcing the repurposing of a device to a knowledgeable consultancy can result in substantial time and monetary savings. The right team could bring a renewed medical device to market within 3/4 months. Whether it is replacing constituent components that are no longer sold, updating firmware, or modifying a combination of hardware and software, a busy consultancy will come across similar issues regularly and be able to attend to them proficiently. 

Design standards (like IEC 62304, ISO 13485, ISO 14971 and IEC 60601) are essential for developing compliant solutions. An experienced partner can provide guidance on refining quality management systems and change control procedures. They will make sure that the defining, design, implementation and testing of software-based enhancements are all coherently linked. Despite having the right knowledge, the external partner does not necessarily have to possess the same certifications to work on the product. When modernising the product, they can instead work alongside core in-house team members that are certified. However, an external team should be proficient in rapid innovation and compliance risk reduction.

Use case example 
ByteSnap is regularly involved in extending the lifespan of medical products. A recent example was with regard to a healthcare firm’s remote tracking device for medical oxygenators. The 2G device faced obsolescence, due to security issues plus limited coverage. The ByteSnap team developed a solution that would instead run over Bluetooth, which could connect to hub systems in hospitals that were situated in places with coverage issues. Bluetooth deployment meant that the Linux software needed to be updated to ensure connectivity with the more modern platform. In this way, a legacy, still-in-demand product was refreshed without the need for complete redevelopment to be undertaken.

UK medtech companies face numerous challenges when it comes to extending their products’ lifespans - whether it is regulatory compliance, limited time or lack of funds to start from scratch. In many cases, companies are outsourcing to expert partner teams, so as to overcome the gaps they have in terms of skills and legacy knowledge, or a lack of understanding of certain compliance elements. This means that their revamped technology will make it to market on schedule and within budget.

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