A Team Member Perspective: My SmartDose® story

I’ve worked at West for 28 years. I lead our Venture Group, Global Labs, and Data Science Team; I’ve spent most of my career in R&D. There’s an expectation from our customers that West will lead the way in developing new products. Ones that are going to be better for patients, easier to use and more cost efficient for the health system. That expectation drives a lot of the R&D work we do.

We want to be the best. We want to be the leaders. That’s the reason West is moving beyond just being an elastomer manufacturer to a company that now delivers systems and full medical devices to patients.

The challenge of Monoclonal Antibodies

About 20 years ago Monoclonal Antibodies (mAbs) came onto the market. A new type of biologic drug composed of sugars, proteins, nucleic acids.

The complexity of these new drugs required new solutions. They did not work well with the existing syringes that used silicone oil. Silicone oil and other contaminants would aggregate the proteins and cause adverse events especially in immune compromised patients. On top of this, patients were needing to receive doses larger than 3mL. Resulting in compliance issues and patient discomfort from needing to give multiple injections –

R&D is about developing solutions to unmet needs, and that’s exactly what we did.

Daikyo Seiko Ltd. – a beautiful partnership

Well before my time in the early 1970s, West purchased 25% of Daikyo Seiko, Ltd. We had just become a public company and saw it as a way of entering the Asia Pacific market. Initially we sold some of their unique products such as Flurotec™ film and B2 coating.

In the 1990s, we started to visit some of our multinational customers together. Then, in the early 2000s, we decided we wanted to solidify our technical relationship. Daikyo Seiko were selling a Crystal Zenith® plastic syringe in the Japanese market that didn’t use silicon oil. It was a successful product, but it wasn’t sterile nor packaged in a way that could be sold in the US or Europe.

Understanding there was a growth opportunity, we formed a technical team which spent lots of time over in Japan to figure out what we needed to do to launch their product to the US and European markets. We didn’t fully understand how big the opportunity was, but we knew lots of customers were complaining.

Together, we’ve enjoyed a lot of commercial success across many different products and programs. We also developed ready-to-use vials and other containers based on Daikyo Crystal Zenith® technology, including the SmartDose® injector cartridge.

The SmartDose® story

We decided to look for a piece of technology that could potentially solve the problem of needing to give patients multiple injections.

We found a small company in Israel. They had a wearable product that had a number of patents. The great thing about it was that it could deliver amounts greater than 3mL. The beauty of a wearable device is that the patient can administer the drug themselves in the comfort of their own homes. Patients would never see a needle, perfect for those with needle phobia. That discovery became the genesis of the SmartDose® injector. 

I worked on the container side. Our challenge was to figure out how to develop a container that could hold a Monoclonal Antibody formulation, that’s easy for a patient to assemble and use outside the doctor’s office.

It was so much fun.

Israel is well known as one of the best start-up nations. They have some of the greatest entrepreneurs in the world who have wonderfully novel ideas. I was in Exton, Pennsylvania, Daikyo Seiko were in Tokyo, our Scottsdale Manufacturing and Design and Development was in Arizona and our first SmartDose® device customer, Amgen, was out in Thousand Oaks, California. It was great to work with a customer like Amgen as they really understood the unmet need and the value of the project.

All these innovative minds, knowledge and experiences coming together made it very exciting. The program took eight years to bring the SmartDose® device to the market.

At that time, I was working with the best of the best in developing products for West. Many of these relationships and friendships remain strong today.

I love seeing TV commercials in the US for the products that use the device. While they don’t show our SmartDose® device directly, I tell my family that drug is contained in our SmartDose® device. It makes me feel proud to have played a small part in helping people bring their treatment home.

The future

West has an exciting future ahead of us. The decades to come will see a lot more at home services, such as diagnostics and digital health. Home care will be better for patients because the need to go to medical centers will be reduced and it will take cost out of healthcare systems. There are many more innovations to come.

Important product and safety information and warnings available at:

https://www.westpharma.com/products/self-injection-platforms/smartdose/smartdose-3-5 and

https://www.westpharma.com/products/self-injection-platforms/smartdose/smartdose-10