Tom McLean, VP, Development Engineering, R&D Innovation & Technology, West Pharmaceutical Services04.01.20
Scientific and medical progress in the pharmaceutical industry has, in recent years, accelerated at unprecedented rates—and doesn’t show any sign of slowing down. In view of these rapid changes, the medtech industry has had to become increasingly flexible in order to adapt and deliver.
The two primary industries driving healthcare innovation—pharmaceutical and medtech—are intrinsically intertwined. From clinical research to administration and drug development to packaging design, all critical elements must operate synergistically in order to succeed. Collaboration, cooperation, and communication are critical to ensuring customer needs are met, quality is upheld, and desired outcomes are supported.
There are several factors originating within the pharmaceutical industry that impact how medtech companies create, design, and manufacture drug delivery products. In turn, medtech helps open the doors to new pharmaceutical developments, offering solutions not only to make possible the packaging and delivery of important therapies, but also to optimize them.
It Starts with Patient-Centricity
One of the most significant common threads running through both the pharmaceutical and medtech industries today is an increased emphasis on patients and personalized care. While patients have always been at the heart of nearly all healthcare innovation, in recent years, the pharmaceutical and medtech industries alike have placed even greater emphasis on understanding the patient populations being served in order to better meet their needs. This has led to an increased focus on patients as the end-user, which translates into treatment options with delivery systems more intuitive, simple-to-use, and convenient, while upholding safety, efficacy, and quality.
These innovations cannot be successfully executed in a silo. Engaging customers—from pharmaceutical partners to patients—on a regular basis to discuss and understand their feedback concerning products must be a priority. This feedback is critical in helping to understand what is working and where gaps may exist. This feedback also helps inform and shape the development of drug delivery tools for patients based on actual, real-world needs.
Working directly with our pharmaceutical partners helps ensure we stay abreast of issues they may be facing and/or changes they may be implementing, so we too can adjust our strategies and focus accordingly.
Evolving Drug Type and Formulation Trends
One area of major change in the pharmaceutical industry that directly impacts how medtech operates is drug development—specifically, the various types of drugs being developed today. Treatment advancements in recent years are far-reaching, with a notably increased emphasis on combination products. This has led to the need for more patient-operated devices and delivery systems—some of which call for injectable solutions that can support, for example, larger dose volumes or formulations with higher viscosities.
Biologics and biosimilars now make up a larger portion of many pharmaceutical companies’ pipelines and portfolios across therapeutic areas. These delicate drugs can be temperamental and require unique production formats/sizes, packaging, and delivery systems. These specific requirements demand a precise level of temperature stability and orientation during transport and storage, among other nuances, in order to preserve the integrity of the product.
We are also observing potential opportunities within both the curative and chronic drug spaces. The variances between the two can impact dose volume, storage needs, delivery mechanisms, customer engagement duration, and more. All of these factors continue to influence containment and delivery technology.
Advancing Standards and Regulations
Standards and the next echelon of success continue to metamorphosize within both pharma and medtech, often in tandem. While there are several general but constant measures of success across the two industries—such as quality, safety, efficacy, and simplicity—there are also ever-changing regulations that require even greater diligence in order to remain compliant.
Pharma must constantly evolve in order to adhere to changing and stricter guidelines and standards of excellence, all while under increased scrutiny, as must medtech. This is not always easy, as U.S. and international governing bodies often issue complicated and ever-changing guidelines.
While regulatory changes pose challenges to pharma, they also offer an opportunity for medtech to become a better cross-functional partner. Medtech can play a more integral and productive role working with pharma, helping to ensure complex requirements are understood and executed accordingly.
Working Together Toward a Better Future
It is medtech’s role to work not only for, but with, those we aim to serve, from patients to pharmaceutical companies, in order to optimize the value of the products, services, and support medtech can provide.
Medtech companies must constantly assess, analyze, and anticipate the pharmaceutical industry landscape, asking pertinent questions, such as:
Asking and answering these questions on an ongoing basis paves the road to staying ahead of the curve and raising the bar for excellence. It means we can continue to meet the needs of pharmaceutical partners (and ultimately patients), ensuring our offerings meet our highest standards of quality, safety, and efficacy standards, while also driving improved outcomes.
Tom McLean has served as vice president of development engineering, R&D innovation and technology at West Pharmaceutical Services since 2016, with responsibility for the development of West delivery system products from concept through product design, verification, and validation. He has been working at West since the acquisition of Tech Group in 2005 and has held various senior leadership positions during this time in development engineering, leading product realization, program management, sampling, and business systems. McLean is a member of ISO/TC 84 (Devices for Administration of Medicinal Products & Catheters). He holds a B.S. in mechanical engineering from Purdue University.
The two primary industries driving healthcare innovation—pharmaceutical and medtech—are intrinsically intertwined. From clinical research to administration and drug development to packaging design, all critical elements must operate synergistically in order to succeed. Collaboration, cooperation, and communication are critical to ensuring customer needs are met, quality is upheld, and desired outcomes are supported.
There are several factors originating within the pharmaceutical industry that impact how medtech companies create, design, and manufacture drug delivery products. In turn, medtech helps open the doors to new pharmaceutical developments, offering solutions not only to make possible the packaging and delivery of important therapies, but also to optimize them.
It Starts with Patient-Centricity
One of the most significant common threads running through both the pharmaceutical and medtech industries today is an increased emphasis on patients and personalized care. While patients have always been at the heart of nearly all healthcare innovation, in recent years, the pharmaceutical and medtech industries alike have placed even greater emphasis on understanding the patient populations being served in order to better meet their needs. This has led to an increased focus on patients as the end-user, which translates into treatment options with delivery systems more intuitive, simple-to-use, and convenient, while upholding safety, efficacy, and quality.
These innovations cannot be successfully executed in a silo. Engaging customers—from pharmaceutical partners to patients—on a regular basis to discuss and understand their feedback concerning products must be a priority. This feedback is critical in helping to understand what is working and where gaps may exist. This feedback also helps inform and shape the development of drug delivery tools for patients based on actual, real-world needs.
Working directly with our pharmaceutical partners helps ensure we stay abreast of issues they may be facing and/or changes they may be implementing, so we too can adjust our strategies and focus accordingly.
Evolving Drug Type and Formulation Trends
One area of major change in the pharmaceutical industry that directly impacts how medtech operates is drug development—specifically, the various types of drugs being developed today. Treatment advancements in recent years are far-reaching, with a notably increased emphasis on combination products. This has led to the need for more patient-operated devices and delivery systems—some of which call for injectable solutions that can support, for example, larger dose volumes or formulations with higher viscosities.
Biologics and biosimilars now make up a larger portion of many pharmaceutical companies’ pipelines and portfolios across therapeutic areas. These delicate drugs can be temperamental and require unique production formats/sizes, packaging, and delivery systems. These specific requirements demand a precise level of temperature stability and orientation during transport and storage, among other nuances, in order to preserve the integrity of the product.
We are also observing potential opportunities within both the curative and chronic drug spaces. The variances between the two can impact dose volume, storage needs, delivery mechanisms, customer engagement duration, and more. All of these factors continue to influence containment and delivery technology.
Advancing Standards and Regulations
Standards and the next echelon of success continue to metamorphosize within both pharma and medtech, often in tandem. While there are several general but constant measures of success across the two industries—such as quality, safety, efficacy, and simplicity—there are also ever-changing regulations that require even greater diligence in order to remain compliant.
Pharma must constantly evolve in order to adhere to changing and stricter guidelines and standards of excellence, all while under increased scrutiny, as must medtech. This is not always easy, as U.S. and international governing bodies often issue complicated and ever-changing guidelines.
While regulatory changes pose challenges to pharma, they also offer an opportunity for medtech to become a better cross-functional partner. Medtech can play a more integral and productive role working with pharma, helping to ensure complex requirements are understood and executed accordingly.
Working Together Toward a Better Future
It is medtech’s role to work not only for, but with, those we aim to serve, from patients to pharmaceutical companies, in order to optimize the value of the products, services, and support medtech can provide.
Medtech companies must constantly assess, analyze, and anticipate the pharmaceutical industry landscape, asking pertinent questions, such as:
- What are recent changes in pharma and in the needs of the patient?
- What future changes can be anticipated?
- What are the current top priorities for pharma?
- What are the most critical emerging drug trends?
- What have been our most recent challenges, and how can we address them?
Asking and answering these questions on an ongoing basis paves the road to staying ahead of the curve and raising the bar for excellence. It means we can continue to meet the needs of pharmaceutical partners (and ultimately patients), ensuring our offerings meet our highest standards of quality, safety, and efficacy standards, while also driving improved outcomes.
Tom McLean has served as vice president of development engineering, R&D innovation and technology at West Pharmaceutical Services since 2016, with responsibility for the development of West delivery system products from concept through product design, verification, and validation. He has been working at West since the acquisition of Tech Group in 2005 and has held various senior leadership positions during this time in development engineering, leading product realization, program management, sampling, and business systems. McLean is a member of ISO/TC 84 (Devices for Administration of Medicinal Products & Catheters). He holds a B.S. in mechanical engineering from Purdue University.