Boyd Biomedical Design Stories

John Bonham-Carter on the state of quality and regulatory affairs for cell and gene therapy manufacturing

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FeaturedJim Biggins and Dr Gary Ansel, Access Vascular

Jim Biggins, Founder and CEO of Access Vascular, and Dr Gary Ansel, System Medical Chief of the Vascular Program at Ohio Health, sit down to discuss Access Vascular's approach to innovation and advanced manufacturing in vascular care.

Episodes

Episode 1: Brian Johnson, MassMEDIC

Matthew sits down with Brian Johnson, President of MassMEDIC, to discuss Brian's background in media, entrepreneurship, and why now is such a vibrant time to be in the Med Tech and Life Sciences industries in Massachusetts

Episode 2: Robert Coughlin & Travis McCready, JLL

Robert Coughlin and Travis McCready discuss the Life Sciences ecosystem in Massachusetts. Hosted by Matthew Boyd and Brian Johnson.

Episode 3: Governor Deval Patrick

Matt and Brian are joined by Governor Deval Patrick where they discuss healthcare and the life sciences ecosystem here in Massachusetts.

Episode 4: Kenn Turner, MLSC & Kendalle Burlin O'Connell, MassBio

Kenn Turner, CEO and President of Massachusetts Life Sciences Center, and Kendalle Burlin O'Connell, President and COO of MassBio, discuss healthcare and the life sciences ecosystem in Massachusetts.

Episode 5: Leon Amariglio & Shawn Riley, Lexington Medical

In this episode, CEO and Founder, Leon Amariglio, takes us on a tour of Lexington Medical's new facility where humans and robots co-work alongside one another; discusses why he saw an opportunity in taking on two of the largest OEMs in a sector many others saw as stagnant; and the value proposition of manufacturing in Massachusetts.

Episode 6: Michael Chiu and John Bonham-Carter, Erbi Biosystems

In this episode of Boyd Biomedical Design Stories, Dr. Michael Chu and John Bonham-Carter discuss Erbi Biosystem’s approach to innovation, advanced manufacturing, and building a growing workforce.

Episode 7: Jim Biggins and Dr. Gary Ansel, Access Vascular

Jim Biggins, Founder and CEO of Access Vascular, and Dr. Gary Ansel, System Medical Chief of the Vascular Program at Ohio Health, sit down to discuss Access Vascular's approach to innovation and advanced manufacturing in vascular care.

On Point - Advanced Manufacturing

Jim Biggins on the benefits of proximity of R&D and manufacturing

There is tremendous value to be gained from the learnings of manufacturing materials and devices in-house, but it is very difficult to quantify. It is extremely expensive and it is not an obvious choice when you are a start-up. Access Vascular brought more in-house than initially anticipated and that is a function of witnessing the disruption to other businesses from not being vertically integrated.

Jim Biggins on whether having a domestic manufacturing footprint matters to hospitals

Two things have dramatically changed due to the pandemic: hospitals are asking if the manufacturing is done in the United States; and hospitals are asking for guaranteed, uninterrupted, supply as part of the value proposition.

John Bonham Carter on what cell and gene therapy means to advanced manufacturing

The Cell and Gene Therapy market is the pinnacle of personalized medicine. We are just beginning. There are less than a dozen cell and gene therapies in the market today which serve a very small number of patients. All of these therapies require manufacturing that is personalized. That means closer to the patient, highly intensified, and efficient. The process requires a very small footprint and needs to be distributed so it is close to the patient. We don't need to protect manufacturing or even reshore manufacturing...we need to completely reimagine what manufacturing is.

Michael Chiu on building a patient-centric manufacturing ecosystem

Large centralized facilities making individual, personalized, therapies won't scale. If we are going to get beyond a few thousand doses per year we need to automate manufacturing platforms that are the scale of a small desktop machine. We have to think about building a manufacturing ecosystem that is patient-centric.

Leon Amariglio on how vertical integration in manufacturing improves quality and innovation

Vertical integration into manufacturing provides Lexington Medical with two advantages. They can control quality and maintain the highest quality control standards in the industry. They have the ability to take iterations from the operating room into manufacturing and deliver them back to the market rapidly – within weeks.

Leon Amariglio on making the long-term strategic investment to manufacture domestically

Supply chain stability and resilience were not top of mind prior to the pandemic. Many had given up on the value of domestic manufacturing altogether. But Lexington Medical had made a long-term strategic decision to manufacture domestically before the pandemic. For Lexington, the decision to manufacture in Massachusetts was a no-brainer from a talent point of view. To become a legitimate player in the market Lexington knew it would need to be able to produce the best surgical stapler in the world in high volume. The only way to do that was to become vertically integrated by investing in manufacturing infrastructure and capabilities.

Brian Johnson on changing the narrative on advanced manufacturing

If you are 30 years old you have not had a single year of your life where manufacturing meant a thing to you. The old narrative about manufacturing is that it's dark, dirty, and dangerous. You were told it is a dead end job. We have to change this narrative. Vocational High Schools and Community Colleges need to help sell the value of manufacturing. If we aren't intentional about taking these next steps on advanced manufacturing we will repeat the same mistakes we have in the past decades.

Kendalle Burlin O'Connell on the case for standardizing curriculum

Are we asking Vocational Schools and Community Colleges to guess at what their curriculum needs to be to address industry needs? What can we do as an industry to help ensure they are teaching the skills companies want to hire for. We need to have a standardized curriculum in these schools - this is what made North Carolina competitive with Massachusetts in Life Sciences. We need to position ourselves to be really successful at commercializing the new novel products that we are discovering in labs.

Leon Amariglio on smart manufacturing and robotics

We have invested in smart manufacturing and robotics. We not only design and build our own products we design and build our own machines and robots to make those products. Our investments in automation provide us with scale and quality control. If we do this correctly, we will need more robots and more people.

Matthew Boyd on the opportunity to lead in manufacturing-led innovation

Nationally we have a system of "pipeline innovation" which is early stage research pushed through the phases of commercialization. Other countries, our competitors, like China, Germany, and Japan, are much more focused on "manufacturing-led innovation". Now, we have an opportunity to combine our leadership in "pipeline innovation" with new investments in "manufacturing-led innovation" and that could be very powerful.

On Point - Healthcare

Dr. Gary Ansel on the implications of COVID-19 on vascular access

There is an underlying smoldering of chronic care that will raise it's head in the next 7-10 years. That means more hospitalizations or some additional facilities to provide care. Most of these settings will need vascular access devices and today's rates of complications will worsen this situation.

Dr. Gary Ansel on the patient experience and cost when vascular access goes wrong

80% of patients have a vascular access device put in them when they visit the hospital. 30% end up with complications. Patient experiences go from positive to negative, and the cost implications are huge; new patients are prevented from necessary visits, and re-admission impact hospital scorecards and reimbursement rates.

Dr. Gary Ansel on whether leading hospitals are adopting innovative new technologies

Dr. Ansel offers insight as to whether hospitals most focused on patient outcomes tend to be early evaluators of new technologies. The vast majority of community-based hospitals are focused on the status quo and maintaining margins. These smaller organizations tend to be more siloed and less comprehensive with their analysis. Entrepreneurs need to be efficient in their presentation of their benefits and cost analysis.

Governor Deval Patrick offers his perspective on trust in public health institutions

If a therapy isn't presented to a patient from a trusted source it's credibility will be challenged. Trusted sources vary from community to community. We need community leaders to educate patients and care givers with more accessible language and education channels in order to increase trust and participation.

Jim Biggins offers insight on the impact of value analysis on the adoption of innovation

Jim Biggins discusses whether value analysis is good or bad for innovation; how entrepreneurs build a narrative and data that can successfully get through analysis committees; and if the supply chain is incentivized to keep innovation out of healthcare.

Leon Amariglio on the transition from large hospitals to distributed care settings

The pandemic accelerated our transition from large hospitals to distributed care settings, like ambulatory surgery centers, where the cost of care and the quality of care are better for patients and the healthcare system at large. The pandemic accelerated this transition in the United States but this is very much a global phenomenon as the rest of the world is watching and learning.

Governor Deval Patrick weighs in on lessons learned from the pandemic

Governor Deval Patrick weighs in. Are we going to remember what we learned from the pandemic? Are we going to understand the disparities in health? The impact on health from the social, racial, and economic disparities in our communities? Distributed, localized care is often higher quality and less expensive and it presents industry with an opportunity to innovate.

Jim Biggins on why innovation in healthcare is so difficult

Jim Biggins explains how incentives in healthcare are not aligned toward innovation. Entrenched interests do not have the motivation to disrupt the status quo or take risk. Jim offers his entrepreneurial experience of gaining access to care settings to shadow nurses and clinicians and search for unmet needs.

Governor Deval Patrick speaks to healthcare reform in Massachusetts and its broad coalition of support

Governor Deval Patrick speaks to healthcare reform in Massachusetts and his comments that healthcare reform is an expression of shared values and a belief that health is a public good. Massachusetts had a broad coalition of healthcare leaders, practitioners, workers, businesspeople, legislators, and patient advocates who came together to invent our reform and also stuck together to refine it.

On Point - Innovation & Startups

Jim Biggins on innovating in a market that is inherently disincentivized to change workflows

Inherently, innovation is focused on disruption and changing patterns of behavior. In healthcare you have to fit innovation into an existing framework of what clinicians are already doing. Access to observe procedures is invaluable when it comes to new design and innovation. It is imperative that you do not disrupt clinical workflows with new innovations - which is very difficult. And if you do, the disruption of the workflow has to be matched by the benefit of the innovation. You can not have big change and a small impact.

Michael Chiu on the challenge of attracting investors to a process technology or manufacturing platform

It's easy to find investors for exciting new therapies. It's not as easy to find investors who fund the picks and axes to dig the gold. Dr. Michael Chiu discusses how Erbi Biosystems first found success in intensified process development for antibodies and then leveraged that success to move into the cell therapy market. A lower-risk approach with extremely high potential.

Leon Amariglio on how sustained incremental innovation can beat out incumbents who are only incentivized by large innovation leaps

It is easy to assume that in a large category with two dominant players there isn't an opportunity for innovation. Leon Amariglio explains that the hurdle, from a purely economic point of view, is that innovation has to be big enough and valuable enough for a large multinational to pursue it. This opens opportunities for incremental innovation. If it is sustained over a long period of time this velocity of innovation can quickly become disruptive.

Leon Amariglio on his playbook for a long-term investor strategy

As an entrepreneur, aligning oneself with investors is critically important. Leon Amariglio's playbook for a long-term investor strategy is to develop a shareholder base that understands a 15-20 year investment horizon and believes in what can be accomplished. Lexington Medical was founded in 2013 but didn’t earn revenue until 2018. They focus on doing right by the customer, doing right by the product, and building a manufacturing infrastructure. These are the building blocks of their long-term strategy.

Shawn Riley on the innovation feedback loop at Lexington Medical

Shawn Riley discusses Lexington Medical's tight collaboration with physicians. Lexington's team gathers feedback from observing, listening, and learning. These ideas have to make it into engineering, manufacturing, and then back into the field. The tighter the feedback loop the bigger the advantage. This is how Lexington Medical is building organizational customer centricity.

Leon Amariglio on his process to pick a winning market strategy for Lexington Medical

Leon Amariglio discusses his process to pick a winning market strategy for Lexington Medical and bring innovation to a market that has been dominated by incumbents for 45 years. He is building a long term commitment to customer centricity and incremental innovation in a high volume category.

Brian Johnson on his founding vision for MassDevice and the story behind it's launch

Brian Johnson shares his founding vision for MassDevice and his desire to show the human stories behind the health technology industry through high quality journalism. MassDevice is one of the most comprehensive histories of the medical device industry and equivalent to a 50,000 page book. It changed the landscape in the industry by educating and providing access to entrepreneurs from outside the industry.

Governor Deval Patrick on innovation and building a tolerance for failure at the public policy level

Governor Deval Patrick discusses his decision to make a long term billion dollar investment in the Life Sciences Industry in Massachusetts. We have to get to a place where we are permitting at the public policy level, just as we do in the private sector, a willingness to try new things. One of the things about innovation is that you have to also raise your tolerance for failure and politics punishes failure. Leadership has to talk consistently about where we are going for public support.

Brian Johnson on how start-ups and entrepreneurs are the lifeblood of the Life Sciences Industry

Brian Johnson shares his passion for startups and entrepreneurs who are the lifeblood of the Life Sciences Industry. He embraces their their courage, naivete, and the audacity of thinking they can change world. Brian highlights the MassMEDIC Ignite accelerator program he runs and how it will impact the next generation of Life Sciences founders.

On Point - Life Sciences Industry

John Bonham Carter on the growth trajectory in the cell and gene therapy market

Cell & gene therapy is at the beginning of its growth trajectory - there is tremendous growth in new technologies entering the market. But every new modality that comes along in biotech will require new tools and will add new layers of complexity. Manufacturing and process development lag behind new therapies as they are racing into the market. These inefficient processes need investment in process development. Erbi Biosystems is providing a toolkit for personalized therapies to do proper process development, early on, which can then be transferred into commercial production. That's how you deliver personalized medicine to masses of markets.

Dr. Michael Chiu on addressing the non-availability of starter material to conduct process development

Cell and Gene therapy needs well-structured, well-understood processes, so we can confidently make therapies that are not only for late-stage patients. We need to make therapies that are preventative and curative for the masses. A critical issue to overcome is the non-availability of "starting material" to run process development experiments with. How do you run process development experiments to define a manufacturing process without raw materials? The non-availability of starter material to do process development limits our ability to develop high-performing processes. We have to conduct process development at dose scale.

John Bonham-Carter on the state of quality and regulatory affairs for cell and gene therapy manufacturing

John Bonham-Carter from Erbi Biosystems elaborates on the state of quality and regulatory affairs in cell and gene therapy manufacturing. We need to get to a place where there is no drama in the manufacturing of cell therapies. Our quality and regulatory understanding currently allows us to treat late-stage patients with personalized therapies. But that's not the goal. The goal is to industrialize cell therapies so we are predictive, preventative, and curative.

Dr. Michael Chiu on single points of failure in the Life Sciences supply chain

Dr. Michael Chiu discusses single points of failure in the Life Sciences supply chain. These failure points are a critical issue in the Life Sciences industry and building a broader supply chain is going to be increasingly forced upon the industry. Companies can only do so much to manage the supply chain - be proactive, focus on core competencies, and build your internal technical skills. In the long term, all manufacturing will need to be more regionalized. The "arbitrage" era of globalization we've been living in for decades is not globalization. Globalization occurs when we move towards parity in labor and goods globally. This will require more regionalized manufacturing.

Kendalle Burlin O'Connell on the 'secret sauce' in Massachusetts' Life Science ecosystem

Kendalle Burlin O'Connell discusses the 'secret sauce' in Massachusetts' Life Science ecosystem. Key partnerships between government, academia, and industry are critical to the success of this ecosystem. Growing our workforce has become the top priority as a result of the pandemic.

Travis McCready on enabling technologies accelerating growth in the Life Sciences Industry

Travis McCready discusses how enabling technologies have helped accelerate growth in the Life Sciences Industry. When you look back over 40 years of history in the Life Sciences Industry the one common theme is that acceleration occurred because of enabling technologies. As more enabling technologies came online the industry disrupted itself and adapted new ways of developing drugs, devices, therapies, and diagnostics. The Commonwealth has been at the center of creating those enabling technologies. We need to be intentional about the next set of enabling technologies that allow us to be more efficient at design, development, and manufacturing. The convergence of enabling technologies is at an inflection point now.

Kenn Turner on the strategic vision for the Massachusetts Life Sciences Center

Kenn Turner outlines the strategic vision for the Massachusetts Life Sciences Center. The center is going to focus on innovation, biomanufacturing, and regionalization. Those three pillars will be underpinned with workforce development and DE&I. We need to convince our workforce partners to manufacture in Massachusetts outside of the greater Boston and Cambridge area.

Brian Johnson on the excitement of medical technologies that keep patients alive

Brian Johnson discusses the excitement of medical technology and why it is the coolest technology in the world. Biotechnology may have captured our imagination because we are all focused on "the cure" but cures take a long time. Medical technology keeps us alive. We are creating solutions to problems that have plagued human kind forever. Together medical technologies and biotechnology therapies are arm and arm finding solutions for human problems. This is the best time to be part of the Life Sciences Industry.

Bob Coughlin on inventing therapies that change the course of disease, and in some cases, cure disease

Bob Coughlin discusses therapies that change the course of disease and in some cases cure disease. We are in the second inning of a nine inning scientific game right now. We've gone from the golden age to the platinum age of science. We are not just inventing therapies that treat the symptoms of disease, these are therapies that change the course of disease using cell and gene therapy and in some cases cure diseases. America's technology highway left Massachusetts and now you could argue it is America's Life Sciences highway.

Governor Deval Patrick on making a durable commitment to the Life Sciences industry

Governor Deval Patrick discusses the genisis of his 2008 Life Sciences Initiative. Government has gotten out of the habit of thinking long term but in the Life Sciences industry you have to think in longer terms. The idea of Massachusetts making a commitment to the Life Sciences industry that was durable, and enduring, was supported. The Life Sciences initiative funded a scientific panel that would review ideas and give small grants - that was a place where there was previously a market gap. Massachusetts gave a grant to a company called Moderna. In hindsight, Governor Patrick wishes Massachusetts had taken equity in that one.

Brian Johnson on entering the golden age of the Life Sciences industry and what it means to the Massachusetts' economy

Brian Johnson discusses Massachusetts entering the golden age of the Life Sciences industry and what it means to the economy. There is eleven million square feet of lab space being developed in the greater Boston area and five to ten thousand new jobs needed in the next five years alone. Those jobs pay an average salary of about one hundred and fifty thousand dollars a year. That is paradigm shifting for the region.

Governor Deval Patrick on cultivating and growing our life sciences ecosystem

It could be gone like that. There are things we need to do to cultivate and grow our Life Sciences ecosystem. The manufacturing of the inventions that come out of Kendall Square still disproportionately goes elsewhere. We need to manufacture the inventions we discover - and we can practically expand beyond the Boston area - but we have to be intentional about our strategy.

Travis McCready on the growth trajectory of the Life Sciences industry

Travis McCready discusses the growth trajectory of the Life Sciences industry today. Currently there is 9 million square feet of unmet demand for lab space in greater Boston alone. A typical high year historically is between 2.3 - 3.2 million square feet. The amount of money coming into the industry today is extraordinary. We didn't expect this and we were not ready for it from a physical infrastructure standpoint and workforce standpoint.

Bob Coughlin on changing the drug discovery model in Life Sciences during the 2008 recession

Bob Coughlin discusses changing the drug discovery model in Life Sciences during the 2008 recession. We used the Life Science Initiative to continue to create new companies and we used that to recruit big pharma companies to come to Massachusetts and do business development deals. We changed the model to external innovation. We were able to do that because we have a native Life Sciences ecosystem that has startups, scale ups, experts in commercialization, government support, and mentors.

Brian Johnson and Matthew Boyd announce collaboration on biomedical video series

We are living in a period that we may talk about in 100 years and we could be sitting in the epicenter of where we will change the limits of human possibility. During this video series we hope to dig into the stories that matter in this industry at this time.

On Point - Workforce, Education, and DE&I

Dr. Michael Chiu on the workforce challenges for start-ups when they begin to grow

Dr. Michael Chiu discusses the workforce challenges for start-ups when they start to grow and scale their team. How do you transition the company from a scrappy start-up with innovative solutions to a scaling organization that is focused on strong execution? By hiring cross-functional leaders and deep technical experts who can execute.

Governor Deval Patrick on how to meet the workforce needs of the Life Sciences industry

Governor Deval Patrick discusses the workforce needs of the Life Sciences industry today. The skillset for many of the jobs in the Life Sciences Industry is the same skillset that needs to be cultivated for lots of other jobs too. That is not going to happen by accident, or by training alone, some of it has to be exposure. But it needs focus.

Kenn Turner on the gaps in the Masschusetts' Life Sciences ecosystem and the workforce we need to fill them

Kenn Turner discusses the gaps in the Masschusetts' Life Sciences ecosystem and the workforce we need to fill them. We are on top by any metric you can think of. But we have uneven success - we have gaps in workforce, manufacturing capabilities, and capacity. If we can drive more manufacturing we can bring more people into the industry and they don't have to have advanced degrees. So we are now in the business of jobs.

Kendalle Burlin O'Connell on women in the Life Sciences workforce

Kendalle Burlin O'Connell discusses women in the Life Sciences workforce. Venture funding for venture backed start ups, women at the executive level, women at the board level - we need to do better on gender equity. Men and women enter the Life Sciences Industry at the same rate, but we see significant drop off at the mid-career level and more significantly at the c-suite level. Most of my Board Members don't know I have kids. I don't talk about my kids. I'm usually the only women in the room. Some men don't make eye contact with me. We need pathways and sponsors and it has to be intentional.

Kenn Turner on building a coalition to address workforce challenges in Life Sciences

Kenn Turner discusses his efforts to build a coalition to address workforce challenges in Life Sciences. Workforce needs collaboration between industry, government, and academia. We need to bring smart people together, give them the problem to solve, provide them with resources, and ask them to work the problem.

Governor Deval Patrick on the relationship between inclusivity and our growing workforce needs

Governor Deval Patrick discusses the relationship between inclusivity and our growing workforce needs in the Life Sciences Industry. There is no question that the Life Sciences Industry needs to be more inclusive before it can be more diverse. People need to be exposed to the Life Sciences Industry in order to know what it is. The industry is one of the most international, and the nature of it is to solve problems that improve humankind, that is pretty inspiring stuff.

Travis McCready on how we can make the Life Sciences Industry more accessible

Travis McCready discusses how we can make the Life Sciences Industry more accessible. The desire to cure isn't a reflection of gender or ethnicity. It is a reflection of personal purpose - disease states that exist in ones own family. Tap that by providing 'onramps and runways' that allow people access to the industry from our own underserved neighborhoods.

Governor Deval Patrick on how the Life Sciences Industry can be more intentional about accessing and hiring from under-represented populations

Governor Deval Patrick discusses how the Life Sciences Industry can be more intentional about accessing and hiring from under-represented populations. Companies need to be intentional about finding ways to expose people to the industry and life up those successes as examples.

Audio Podcast

Jim Biggins and Dr Gary Ansel, Access Vascular

Jim Biggins, Founder and CEO of Access Vascular, and Dr Gary Ansel, System Medical Chief of the Vascular Program at Ohio Health, sit down to discuss Access Vascular's approach to innovation and advanced manufacturing in vascular care.

Michael Chiu and John Bonham-Carter, Erbi Biosystems

In this episode of Boyd Biomedical Design Stories, Dr. Michael Chu and John Bonham-Carter discuss Erbi Biosystem’s approach to innovation, advanced manufacturing, and building a growing workforce.

Leon Amariglio & Shawn Riley, Lexington Medical

Matt and Brian are joined by Leon Amariglio and Shawn Riley from Lexington Medical. They discuss Lexington Medical’s approach to innovation, advanced manufacturing, and building a growing workforce.

Kenn Turner & Kendalle Burlin O'Connell

Kenn Turner, CEO and President of Massachusetts Life Sciences Center, and Kendalle Burlin O'Connell, President and COO of MassBio, discuss healthcare and the life sciences ecosystem here in Massachusetts.

Governor Deval Patrick

Matt and Brian are joined by Governor Deval Patrick where they discuss healthcare and the life sciences ecosystem here in Massachusetts.

Robert Coughlin & Travis McCready

Robert Coughlin and Travis McCready discuss the Life Sciences ecosystem in Massachusetts. Hosted by Matthew Boyd and Brian Johnson.

Brian Johnson

Matthew sits down with Brian Johnson, President of MassMEDIC, to discuss Brian's background in media, entrepreneurship, and why now is such a vibrant time to be in the Med Tech and Life Sciences industries in Massachusetts