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Josh Blackmore recently joined M Holland Co., a leading distributor of thermoplastic resin, as its global healthcare manager to help expand the company's participation in the medical device industry. He provides insight on the importance of plastics and how this material plays an important role in helping to drive medical device-makers innovate.

 

 

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Plastic is so common that it may often be overlooked as an important driver of innovation in the history of medical technology, but it is not overlooked by companies trying to develop new devices or make existing devices easier to use, safer, or more cost-effective.

 

 

To respond to the medical device-makers' need for technical expertise on plastic, suppliers of this material are looking to expand more into the medtech field and help device-makers with product development solve problems related to, for example, infection control or durability.

 

 

One company investing in this opportunity is M Holland Co. Based in Northbrook, Ill., M Holland is the largest privately held international distributor of plastic resin – the main component of all plastics – selling more than 1.4 billion pounds of resin annually to more than 4,000 customers across different industries.

 

 

Recently, the company formed a business-development group to coordinate sales and sourcing strategy to specific markets, and in August, M Holland hired Josh Blackmore as its global healthcare manager. Blackmore previously had the same title at RTP Co. for more than 11 years, where he helped develop the company's medical sales team. He has also worked for Magline, GE and Dow Chemical Co.

 

 

Blackmore talked to Medtech Insight about trends he sees in the market from his vantage point working for a materials-provider.

 

 

Medtech Insight: How would you describe M Holland's business and its relationship to medical devices?

 

Josh Blackmore: M Holland is a premier resin distribution company. M Holland doesn’t actually make the resin. … We bring it in in a railcar or a tanker truck, or a big truck, and we break it down into smaller package sizes so we can sell either bulk or in smaller packages.

 

 

Over the years, since the late '40s, it’s grown up to serve many industries like automotive or industrial, consumer, wire and cable, appliances, and building construction.

 

 

Over the years, it was discovered that the medical business was growing and was consistent, [and] what we have done since I’ve been here is put together a complete team with medical experts – people with a lot of experience in helping to develop new medical devices – placing them strategically around the country [and] supporting that with regionally based technical medical champions. These are technical engineers who are very good with medical regulations and medical plastics that are based in each of our eight regions of the United States.

 

 

So, in relatively short order, we’ve really fielded one of the most comprehensive, experienced medical teams in the industry. We’re not yet the biggest segment within the company, but we’re going to try and fix that as the years go by.

 

 

Understanding which materials to use can reduce the gestation time of a new product by half, M. Holland's Josh Blackmore says.

 

 

Q: In the process of a medtech company trying to develop a prototype into a working product, where do you fit in?

 

 

Blackmore: I’ll give you an example. Say you’ve got a couple inventors who get together … and they want to create a product that would help take pictures of the inside of the body, but really don’t know how to do that, [but] they've got the guy who understands camera technology and the other guy who understands ergonomics in the body. What often lacks in a developmental team is the material science [expertise]. What kind of material can survive in the stomach? What kind of material is good for taking pictures through?

 

 

Where we really fit – our best possible fit – is at the very beginning, at the mashup between the design and manufacturing and material selection… [Understanding which materials to use] could reduce the gestation time by half – by having the right people there at the very beginning. If we do get brought in later when they run into problems … they may have to go back to the materials stage. We could potentially get into any part of that chain of development, but the best place is obviously in the beginning.

 

 

Q: Where to you see the most demand for your services? What kind of help are companies looking for and what are they asking you to do? And what does that say about the business or where you see the technology going?

 

 

Blackmore: We cover medical devices, which includes surgical tools, medical electronics – which are diagnostics and monitoring – and we do in vitro diagnostics. We do packaging, [in which] we serve a wide variety of segments.

 

 

Diagnostics, for example … plastics play a huge role. In some cases, these tests require electromagnetic shielding, which plastics do very well. Sometimes they’re required to filter out certain wavelengths of light which would disrupt the test procedure or the test reading, and plastics are a great job in filtering. … And both hydrophilic and hydrophobic materials are used for in vitro diagnostics, to the point that new testing is starting to be done on a wide variety of polymers to characterize them. What we would do as a materials supplier is help get a designer into something that would be extremely, say, hydrophobic but super clean, or wouldn’t be giving off anything into the testing mechanism in terms of leachables, or things like that. … Or we have to get that big machine they use in the lab into a small space or a handheld space. That whole phenomena of miniaturization favors plastics, as well.

 

 

Q: Are the most important developments in medical plastics usually related to the plastics themselves or in the applications, such as 3D-printing or other manufacturing processes?

 

 

Blackmore: It’s in the plastics themselves. There are many resins that we would call a "barefoot resin." Most often, medtech people are going to want something more than a barefoot resin, and it’s these additives – whether it’s for color just to identify something or maybe it’s a filter, or maybe it’s a laser-marking additive – are the way to build-up [the resin] for specific applications.

 

 

And you’ll see every single resin supplier is looking at their [polymers and asking]: "What else needs to happen? What [additives] can that polymer accept? What does it do very well?" Some polymers accept a lot of glass. Some don’t accept very much. Some will accept gamma stabilization, and some, not so much, et cetera.

 

 

For example, in medical or pharmaceutical packaging, where there are new regulations for unique identification markers. (Also see "US FDA Extends UDI Deadlines For Low-Risk Devices" - Medtech Insight, 16 Jan, 2018.) There are things you can put into a barefoot resin that absorb certain wavelengths of light energy, which allow a high-contrast, dark, permanently etched-in mark to be incorporated in the plastic. This would be versus a sticker or pad-printing on ink, which could be rubbed or scraped off. A laser-marked piece of plastic would be permanent.

 

 

Q: Are there any developments in materials that are important to developing implantable technologies to make them smaller and easier to implant, or less invasive?

 

 

Blackmore: At the M Holland Co., we will not work on any medical devices that are permanently implanted into the body.

 

 

One of the reasons behind that is that anything that goes into the body [requires] a very particular chain of custody. The resin-maker will have taken that exact batch of resin through a certain extensive battery of tests. They will have separated it and segregated it, and it will be more along the lines of the Brink’s truck that brings money to your ATM, where everybody knows what batch it is, and there are all kinds of signage and ownership transfer along the way and a complete understanding of the liability that would go along with that.

 

 

The people who want to play in that arena understand that there are not a lot of pounds of plastic that would actually go into a human, and I think that [those] volume tend to drive the price up, because there’s not much of it. There’s a lot of testing, chain of custody, care, et cetera. All the things that go into it that drive the price up because of how important it is to do all the right extra testing and the processing, and the cleanliness, et cetera. It tends to weed out those people who just want to sell volume, but don't want to sell higher-priced materials. So now you end up with a small subset of the plastics business – the people who might sell acetyl or polyethylene are probably your leading suppliers of implants.

 

 

Q: What kind of companies are most interested in what you do in these high volumes?

 

 

Blackmore: In the medical industry, I have found that medical companies want to do business with others who are dedicated to the medical industry. If they come and buy a plastic from M Holland and we drop that plastic, or it changes or it gets discontinued, or we change our mind, this is hugely disruptive to a medical OEM [original equipment manufacturer]. If they have to change a material, they have to go through the whole requalification process and resubmit that through the US FDA. This is a nonvalue-added expense that’s time-consuming and expensive.

 

 

The No. 1 reason people are coming to M Holland is because we’ve been in the business for decades, and almost all of the resins we have now … are the global market leaders for resin in that space.

 

 

We have done a really good job with aligning ourselves with suppliers of plastics which are … famous in the industry because they’ve been doing it for so long. That would be who would want to come to us. And the people that do that are people that are doing pharmaceutical packaging, surgical-tool packaging, surgical-tool creation, drug delivery device-like injection pens, diagnostics, and companies like that.

 

 

Q: We have seen the interest in drug-delivery devices steadily grow because it is a way to differentiate the drug that may have generic competition and it may improve outcomes with that drug. (Also see "Nanorobots, Digital Tracking, Dose Printing: Innovative Drug Delivery Systems Will Make Precise Drug Dosing A Reality" - Medtech Insight, 18 Dec, 2017.) Are you seeing a lot of interest in that particular area?

 

 

Blackmore: Drug-delivery devices in the health-care industry are going to have above-average growth for the foreseeable future for many of the reasons you’ve touched on.

 

 

If you look at the new drugs that are coming on patent, these are often biologic drugs … and for getting something in the body that’s based on a biologic, there’s only a couple ways. One would be an inhaler, which is also a drug-delivery device; and another way could be a pump or an injection pen. And some of these therapies are critical and being driven by an aging population, so that these are an above-average trend.

 

 

Injection devices are becoming automated – you hit the button, and a spring force will take over, and it will eject the drug fraction through the needle into the body and stop when it’s all done. Some of them have elastomeric grips, so a person, whose grip strength isn’t so great, can [handle it].

 

 

There are injection pens for single specific drugs that are reaching over 400 million units a year. This attracts great attention from the molders, because only the biggest and best, and the most automated or the most global can participate in [this competition], because 400 million of anything is a lot of volume.

 

 

Or, for example, a device with a dosing dial is a perfect opportunity for laser-marking, and maybe it will have a window that needs to be clear so you can see through to the dial. We have great technology using polycarbonate to thicken it up so that it magnifies the number and makes it easier for people to see. We’ve got elastomeric grips to hang onto. Then all the internal mechanisms have to be strong to withstand the constant stress load of a spring, and they have to be safe so the needle shield has to automatically cover the needle. … All these things are facilitated by plastics.

 

 

Q: When you’re talking to a company that’s making this device, would you be saying "Hey, did you know that the plastic could do this or do that?" Or is that something they already know and they’re just telling you what they want?

 

 

Blackmore: Around 80% of all the plastic medical device-makers have less than a hundred employees. It’s a fragmented market. [Other than] the companies of size that have some staff of engineers who study plastics, the vast majority of medical device companies don’t have those type of people on board.

 

 

[We are] – by coming in and putting on "lunch-and-learns" or webinars, and things like that – establishing our leadership and knowledge about plastics for these OEMs that simply don’t have access or the bandwidth to know about all these different plastics.

 

 

If I were a medical device-maker, one of the first calls I would make would be to a credible, dedicated raw materials supplier. Whether it was metal or plastic or any other raw material, that’s the quickest way you can get an idea from concept out to something that’s actually manufacturable.

 

 

Q: Payers are creating economic incentives for hospitals to crack down on the number of hospital-acquired infections and just basically making sterile things more sterile. (Also see "Battling Infection: Hospitals Seek High-Tech Solutions" - In Vivo, 29 Jan, 2014.) Are you seeing that impact the plastics business?

 

 

Blackmore: MRSA (methicillin-resistant staphylococcus aureus) is its own line-item in a hospital these days, and it’s one of the few line-items that cuts across all the departments. From food preparation in the kitchen, to maintenance and cleanliness, to hospital rooms, and diagnostics and monitoring, it cuts across the entire hospital … and if you look at what the WHO [World Health Organization] directives are on MRSA, they’re focused in on hard-surface disinfection.

 

 

What’s a hard surface? It’s a switch plate on the wall of the room. It’s the walls. It’s the splashboard on the floor. It’s the floor. And it’s also the hospital bed arms, the medical electronics used to monitor heartrate and blood pressure, and all the other monitoring. The directives coming out of WHO are saying that [hospitals] have to use really harsh chemicals, like glutaraldehyde or certain alcohols, and some of these disinfectants can dissolve some plastic over a week, so medical electronics have been failing.

 

 

The medical industry in the last, say, three years has responded by taking these plastics – which are dimensionally accurate for making beautiful housing and making them super-tough enough that you can drop them and they won’t break – and blending in, or alloying in, new materials to make them more chemically resistant. For example, taking polycarbonate and alloying PBP or polybutylene terephthalate, or PET, Polyethylene terephthalate, which has huge improvement over chemical resistance.

 

 

The whole plastics industry is now responding to the way people are disinfecting. … It hasn’t been fully implemented, but it’s a hot trend for anybody making a medical electronic, a switch plate, or anything that’s going to get disinfected to start using these newer kinds of alloys.

 

 

Q: Is there anything else you want to emphasize about how plastics technology is impacting the medical device sector?

 

 

Blackmore: The plastics industry is mostly a raw materials industry, and many of these resin-makers are mature and refined and sophisticated, and they know exactly what helps them grow. But with medical devices, a lot of times it starts off really small. Over time, some of these resin-makers have pulled back sales and development resources from the marketplace, creating this vacuum that they used to fill with knowledge about new plastics. But having pulled back, they’re starting to rely on this new segment called distribution.

 

 

That’s what we do. We are distributing products for someone else. And what we have done is create these new business-development organizations. The one I lead is for health care for the medical device business … and we’re putting in resources that will help medical device OEMs be able to understand plastics better, be more cost-effective at selecting them, and help them reduce their timeline to develop.

 

 

The phenomenon I’m describing is that the distribution segment of the industry is shifting from resin-producer to resin-distribution, to being able to provide companies access to cutting-edge or novel products that are coming into the plastics industry that potentially solve problems like disinfection.

 

 

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From the editors of Clinica

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