Flexible instruments for minimally invasive treatment - what OEMs need to know

Alison Benson: Foreign. Hello, and welcome to this episode of the podcast Advancing the future of Medtech with Alema. My name is Alison Benson and I'm one of the editors here at Global Data. In this episode, we will be unpacking flexible instruments and exploring their growing importance in minimally invasive therapy. That market, which enables doctors to access internal organs through small incisions rather than open surgery, is showing exciting expansion. By 2033, Global Data anticipates the minimally invasive devices market to reach $3.1 billion. And that would represent an estimated 50% growth from today's levels. But what are they exactly? And how can a global high tech engineering group like the Swedish company Alema help their OEM partners lead in this area? Joining me today is Tom Schmidt, Global Product Manager for flexible instruments at Alema. Welcome, Tom. And let's get going. So, Tom, let's start with when we talk about flexible instruments in the medical device sector, uh, what are they and how important are they?

Tom Schmidt: So flexible instruments are, as their name says, instruments to be used in medical applications mainly in the or, but also sometimes in offices. It's worth it to distinguish between flexible and rigid instruments since they target completely different areas of applications. Rigid instruments can be used when there is enough space, or sometimes you need a handle, while flexible instruments come into place when it gets more and more into mini, mainly invasive surgery where space is limited and you want to navigate to, um, narrow anatomies of the humans or patient's body. So in general, flexible instruments are precision engineered devices. They're tools and components designed to bend, to twist, to navigate complex anatomies, as I've mentioned, um, while still having the possibility to delivering control, strength and also repeatable precision. So sometimes it requires movement be to be performed plenty of times, um, which is able to be done by flexible instruments as well as rigid, of course. But flexible instruments, uh, pay a lot of attention to that to not just slip away. For example, you see them across minimally invasive procedures where clinicians need to cut, to grasp, to capture. Also a lot of retrieval can be seen there. Or more and more interesting, uh, is to suture through natural pathways, um, where the body does not have to be hurt, you do not need incisions. Or if, um, there is not a natural opening to the body, you apply only a very small incision. They mainly let physicians to reach target deep in the human body while the trauma to the patient is minimized, um, as well as to the surrounding tissue. So you are unable to really target only on what you want to target and want to Treat in general, uh, we can say that these procedures start with a, ah, diagnostic endoscopy for example, decades ago and they evolve over the years. The gallbladder for example, is a perfect example, um, where we use flexible endoscopes to get into the gastrointestinal area of the human body and perform interventions such as the angioplasty here or the ercp for example. Today it gets even more relevant, uh, to work with or to be able to work with flexible instruments since, uh, robotic assisted surgery is accelerating there. The flexible instruments are being pushed further into the more complex and highly specialized procedures where even tighter tolerances are demanded and more advanced materials which are more reliable, which work perfectly together with the robotics and the surgeon. So they build a perfect team.

Alison Benson: Interesting. So actually my next question was going to be what are the main therapy areas today that can be treated through minimally invasive treatment? Because you mentioned that these flexible instruments, they're becoming more significant over the years and I wonder which therapy areas that they were being used mainly for in emerging areas too.

Tom Schmidt: Yeah, so we can say that today minimally invasive carespans, um, major therapy areas like the GI topic I was talking about and urology procedures such the ERCP or kidney stone retrieval for example. But alongside with cardiovascular interventions like uh, clot retrieval or pulse field ablation, including endovascular therapies. Of course, what we see more and more is also a growth in neurovascular therapies, especially talking about the clot retrievals when it comes to stroke treatment or stroke avoidance for example, and fast moving innovation in cardiology, especially the electrophysiology and ablation. So we are able to say, or what we can say is that H field ablation for example has been a catalyst because it's opening new discussions about where um, energy based catheter delivered therapies can go next. And early clinical work in this field is exploring nanosecond PFA for indications such as benign thyroid nodules and certain solid tumors. What is also an additional emerging area is the duodenal mucosal resurfacing. And this is um, something really interesting which will gain a lot of traction over the next coming years. Being or hearing about the popularity of These diabetes type 2 drugs such as uh, Wegovy or okay, while these drugs you have to take for years or maybe also during your whole life, the duodenum mucosal surfacing enables the patient to get to a treatment, uh, of the duodenum or the surface of the duodenum and aiming to reset the Metabolic function and improve the glycanic control in diabetes type 2, since this is the area where our insulin level is regulated based on the uh, glucosa, uh, identified by the cells in the duodenum. Currently this treatment is not clinically available yet, but it is still undergoing clinical studies. However, the medical community expects and is very excited about it because of how widespread diabetes type 2 became around the world and the issues related to that and what diabetes type 2 can cause in the end as well. In general we can say that the demand for mini mali invasive treatments will continue to grow. Of course, uh, we always want to have less trauma to the human's body. It's also most of the times more efficient in the or. So we are um, cost saving for the or, for the hospitals, for the physicians as well. But also it is more secure for the patient. You have way less open incisions to the human body with a risk of uh, afterwards inflammation. And the patient's outcomes in the end are usually better, they recover faster. And this makes the whole healthcare system more, I don't like the word profitable, but let's say more efficient and more reliable in total. Again so it's a win win. But the procedures will get more complex of course, means that there needs uh, to be more training for the applicants, but also a higher focus on the technology and the material innovation that is being used to create the necessary instruments.

Alison Benson: So fascinating trend. What does this mean for the manufacturing of the instruments involved?

Tom Schmidt: One general thing we can say is that the smaller the instruments get, of course, the smaller the tolerances get and the higher uh, reliability on process, on people, but also on the development already itself is necessary. So minimally invasive interventions raise the bar on the performance, the consistency and the scalability. Instruments for example, like guide wires, baskets, raspers, durable components in general must keep uh, delivering torque, the kick, the kink resistance, especially when it gets more and more into the neurovascular applications. But also a highly precise movement and most of the times in very narrow pathways without damaging in tissues. This puts an intense demand on the materials, the surface quality, the dimensional tolerances. As I have mentioned, when it comes to materials, um, this is when you, you as a OEM want to really want to rely on someone who has the experience, on someone who has the right people and someone who is also able to own the processes and not thus have to rely on plenty of sub suppliers as well. Because then you can make sure that everything that is being manufactured, developed ends up well and streamlined in these flexible instrument technology. So this is why it's widely used in devices that most collapse and deploy reliability like stents for example clot removal tools, well frames, neurovascular snares also for example. Then talking about Nitino related to Alema and its 25 years expertise in Nitino manufacturing and development. It's getting more complex since 19o requires tightly controlled heat treatments to set the memory shape effect and optimize the fatigue life. But also making sure that we keep our super elasticity and the biocompatibility of course. So you have to be really aware of what your material consists of. Especially when it comes to 1910 where small deviations in the composition can cause a ah, big difference in the required treatment. But in general the direction of travel is really toward even smarter designs including more steerable mechanisms, sensor integrations as well into the components directly. So there will be guide wires with sensing technology, there will be baskets with sensing technology. And this all can capture parameters such as blood flow, pressure on temperature and make the procedures even more efficient, more secure for the patient. And uh, in the end the doctor itself also or the whole or stuff knows what is going on at the point of treatment.

Alison Benson: Interesting times. So final question. Uh, how can a layman support the market uh, as OEMs face supply chain pressure and the pricing need to reduce lead times.

Tom Schmidt: The support Alema can provide relates also to the to the question prior answered. It is really the vertically integrated value chain we have. So we start really from the scratch of manufacturing. When we talk about 19o we take the wire and process this for example up to the entirely sterile, packaged finished good. So we can be considered as a one stop partner where you get everything. And also talking about doing something from the scratch in manufacturing also means doing something from the scratch in research and development where speed to market is nowadays a competitive advantage and supply chain slows down progresses. Here we talk about custom components where you as an OEM for example have to involve multiple suppliers, long lead times, repeated regulatory qualifications and this all has fit together. That's where the vertical integration of Alema and the early collaboration make a measurable difference. So you avoid lead times that are not necessary, you avoid waiting times where of one supplier. This all is being captured by Alema and the team here. As I've mentioned, Alema acts as a one stop partner across wire based components as assembly. And talking about wire is also uh, circling back to the integration of smart materials into the flexible instruments. We cover precision wire drawing, forming, laser cutting, um, shape setting, 19 oh processing 90 no in general like center is grinding stranding, we cut to length. We have huge capabilities in polymer coating and in the end fewer hands off means fewer delays, tighter process control. You do not have to consider plenty of suppliers for your RQA requirements. Um, the supplier management in general gets easier and the quality framework is way way leaner I would say and an early alignment on material selection, the tolerances, the formats also improves manufactureability and the scalability. So while Alema's nitro expertise and strengthened through the recent strategic acquisitions like endosmart a few years ago but endocs only past year, um we are able to support reliable high performance components while helping customers to shorten the development cycles and stabilize supply. And now concluding this all with getting to us at a very early stage of development, we can make sure that we cooperate together in finding the perfect solution and avoid unnecessary curves that are being taken or pathways that are not efficient.

Alison Benson: Thank you very much Tom.

Tom Schmidt: Thank you Ellison. It's been a pleasure to explain a little bit about flexible instruments and also how Alema can support you as a partner and what the benefits are.

Alison Benson: It sounds like interesting times ahead for our listeners. If you would like to find out more about flexible instruments and collaboration opportunities with Alema, do Visit their website www.alema.com Medical and download Alema's white papers available there. Looking forward to next time.