The medical device market is expected to significantly diversify and almost double in value to $90 billion by 2025, but vendors face significant cost and packaging challenges if they are to successfully exploit these opportunities. Increasingly there is a growing range of technical, commercial and regulatory demands. As a result, the imperative to find a focused, strategic, commercially cognizant process — with specific-field experts and proven partners to cut through these shifting parameters — is more important than ever.

Whether it’s an implantable or wearable device, medical instrumentation or a life science consumable, there are issues of ever-tightening regulation across a range of jurisdictions, especially for the more invasive products. Technically the interaction of human chemistry with photonic components, as we see in some wearable devices, adds another layer of complexity that must be resolved. Implantable devices must also navigate around the rigors of balancing longevity with performance. Weighing up one against the other is often very difficult, which partly explains the complexity of the issues that must be tackled. Against such often investment-costly dynamics, anything that can improve the financial effectiveness of development and manufacturing is welcomed.

Historically, latency describes the time interval between stimulation and response, cause and effect. Contemporary use has considerably widened the terminology to include functional aspects of architecture, capital markets, bandwidth, robotics, and more. In this article, we use the term in an engineering/commercial sense and more particularly in regard to improving efficiencies in the microelectronic medical packaging process — from concept to full-scale commercial manufacturing. The most critical points of low latency manufacturing are those adopted in the initial stages of process development and prototyping. These tend to take on a life of their own and, adopted thoroughly enough, they have an exponential impact — and value — down the manufacturing process.

Low latency manufacturing is not about approaches to efficiency per se, but (i) where it takes place, (ii) people skills and alignment, and (iii) the level of customer connectivity. In the biophotonics and medical device ecosystem, additional pressure comes not only from rapidly growing markets and application diversification but from swift technological advancement and ever downward pressures on costs. Added to which are the complexities of device approval and certification across a range of jurisdictions. This is true of wearable devices but especially true for implantable medical devices. One must consider that implantable devices are directly dealing with people’s lives, as these devices are not easily replaced or removed. Chip packaging assembly and manufacturing need to be able to deliver a highly repeatable, accurate process.

Medical technologies have been at the forefront of research and development and subsequent commercialization across many ultra-high-tech sectors over the past decade, quickly becoming more advanced and discreet, more portable, less invasive, and often more intricate in construction and packaging. This reflects high levels of research and investment, advancing science, and their merging to create more sophisticated therapy and diagnostic technologies. Thus, in the past several decades, the industry has moved from cardiac rhythm management products — the pacemaker — to devices that can be used to treat sleep disorders, pain management, certain forms of dementia and related illnesses, epilepsy, bladder control, gastrointestinal disorders, some autoimmune diseases and a range of neurological and psychological disorders. The number of medical devices with computer chips has exploded.

In turn, these advances have melded with a rising urgency of need. Western countries now face aging demographics — some of them acute — requiring improved therapies, monitoring, and chronic disease management. On the other hand, developing economies with very large populations are reaching a stage of maturity where both aspiration and affordability are leading to huge increases in demands upon healthcare. Added to these are epidemics that arise unpredictably but in this ever more traveled world require swift identification and medical response. In all three cases, the drive is toward portable, wearable, or invasive or implantable devices for diagnosis, prevention or treatment. Figure 1 shows a range of current such devices.

This article presents advanced development protocols drawn from over 40 years of experience that allow Palomar’s innovation centers and assembly services and their customers to successfully navigate through the factors surrounding medical device packaging. Detailed below is the company’s strategy to allow fully formed research to move optimally from the first stages of development and prototyping to manufacturing and commercialization.

Efficiency born through experience is critical in the concept-to-trial-and-error stage, thereafter finding important applications moving from technical success to packaging, to full-scale commercialization. At each step, adopted pragmatics are deliberately placed against core commercial demands ranging from the cost premium on innovation to skill shortages to the impact of ever more aggressive competition. In summary, the sustainable medical device market requires a packaging manufacturing culture that is acutely green and lean, optimized, agile, and efficient. This is the essence of low latency manufacturing.

Applying Best-Practice Low Latency Manufacturing

A best practice low latency approach begins with a three-fold foundation:

  1. An established time framework. This tightens up a series of crucial technical parameters. It may seem obvious, but as a principle, it is more poorly executed than not.
  2. Involve the entire team in the project. Bringing together motion control, tooling, software, hardware experts, and others, with non-engineer commercial oversight and other experts as necessary, means all the core competencies are together in the same room for strategy and implementation simultaneously embedding a high-level of commercial cognizance.
  3. Optimize the equipment/software for the task at hand.

In practical terms, these are then combined to produce the metrics by which the efficiency of low latency manufacturing protocols is judged:

  1. High yields secured through the efficient use of time, materials, and personnel.
  2. Optimum return on investment secured through high net throughput.
  3. Minimize labor training, maximize labor efficiency, and minimize the impact of labor turnover, all for ease/security of manufacturing.

The shortcomings in each project are fed back into the team for immediate changes and always documented for future improvements. These practices can be formally separated into the four pillars of low latency manufacturing:

  1. Continuous collaborative learning.
  2. Proof of concept and strategic implementation of critical design elements.
  3. Prototype development.
  4. Product and process maturation.
Fig. 2 - The four pillars of low latency manufacturing.

As Figure 2 illustrates, once put into practice, these conceptual pillars quickly dissipate into a wider and iterative dynamic entity. An order needs to be followed but when the technical activity starts, the wider principles of lean and green and commercial cognizance direct the whole.

Low latency medical device packaging starts out with expert-to-expert engagement following a structured but fluid two-way learning process. As implied, predetermined parameters have been set to ensure relevance and timeliness. This allows for a sharp focus on consumer context and the subsequent and critical elements of the technical and commercial needs behind the desired medical device to be swiftly implemented. Best practice means that the team is able to quickly cut through a number of alternatives based on experience to meet customer’s actual needs.

Fig. 3 - Small-scale medical device overview.

From here a more technical and focused collaboration begins by exploring the nuances of the specific assembly and packaging against fundamentals of cost, function, and a range of critical issues, many of them unique to medical device requirements such as power and longevity. Thereafter, potential material selections are weighed against the backdrop of, for example, bio-interaction, where such devices are invasive in some way. Oftentimes process complexity is such that it is necessary to share stages of fabrication and testing with external experts. The highest level of collaboration is clearly required based on tight logistics.

For example, in some cases, devices are partly fabricated by one company but subsequently sent away to a third-party specialist for the next process. They are then returned for the final stage of packaging. Critical for reasons of qualitative monitoring, each discreet component is serialized for traceability. Exceptionally tight logistics are required embracing both efficiencies, qualitative control, testing, and verification.

It is not only time and money but technical efficiency that requires a process utilizing sufficient — but not fully functional design test pieces — to advance the packaging process. This permits many variations and independent testing.

Getting up to speed in the prototype process can be one of the most critical times for learning but in the case of medical devices, a prototype can serve as an effective way to test certain characteristics, such as biocompatibility without having to build up the entire device, which could be costly. The value of generic cost-effective tooling to undertake small volume builds, varying materials, parameters, and processes within tightly defined and pre-verified limits is self-evident. Pre-verification is also important in securing accurate metrics, and in turn, minimizing cost and use of time. An extraordinary amount can be learned in the first 10–100 units and having a green and lean philosophy enables making quick revisions across a large range of areas. The whole process yields vital data that vendors often fail to share with their customers. Once in a while this leads to the entire redraft of the project or even abandoning it altogether. Yet even a “failure” in the commercial value can vindicate a low latency process.

Transitioning Toward Full-Scale Low Latency Manufacturing Production

Most of the time, however, a successful process is identified and mapped out with movement toward full-scale commercial production. Often that means transferring low latency manufacturing processes to the customer’s production facilities. When low latency practices are robustly developed using the four pillars of manufacturing, this secures a mature production process from day one. Immediate benefits include yield, optimum automation, proven and sustainable hardware options, proven and sustainable software options, proven metrics, and often a swift root cause analysis. In short, low latency manufacturing reduces the most complex processes into their simplest solution form at whatever point and however many parts of the process that are applied.

Looking ahead, m2m (machine to machine communication) deep learning, XR, and AI are all going to have an extraordinary impact both on medical device advances and low latency aspects of their manufacturing. Critical elements from concept to packaging design to process will increasingly incorporate these elements, and most especially diagnostics of issues that arise on the way together with suggested solutions.

Notwithstanding, human insight, experience, intuition, commercial cognizance, and the synergies between skill sets and competence will always be at the heart of the design and manufacturing process.

This article was written by Anthony O’Sullivan, BSc, MPhil, PhD, Strategic Market Analyst for Palomar Technologies, Carlsbad, CA. For more information, visit here .


Medical Manufacturing and Machining Magazine

This article first appeared in the September, 2020 issue of Medical Manufacturing and Machining Magazine.

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