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Meeting Highlights:
- Hologic’s Priorities in 2025: Focus on women’s health portfolio (market leader in breast and cervical cancer) and molecular testing (HIV) / Outcome for 2D & 3D digital mammography clinical study, promising future for investment in breast health / Adapting to the changing healthcare landscape in Germany.
- Germany’s Evolving Healthcare Landscape: Hospital reform that will impact healthcare activities and reimbursement, Hybrid DRGs moving forward, reform for pharmacies to conduct infectious diseases testing with rapid assays that will affect quality and business model = environment of uncertainty but with future opportunities.
- Hologic Advancing Women’s Health: Global Women’s Health Index provides data on the unmet needs for women to attract investment, shape policies, and prevention / Women's Health Forum in Berlin.
- Innovation & Digital Transformation: The role of AI in health to make data-driven decisions faster.
- Hologic’s Commitment to Education & Training: Guiding medical professionals in the use of innovative technologies whilst guaranteeing the best patient experience.
- Raising Awareness: The importance of prioritizing women’s health disparities in clinical development and diagnostics.
- Hologic’s Holistic Approach: Addressing women’s health in a holistic approach to create valuable socioeconomic impact.
EF: Could you give us an overview of the current priorities on your agenda and what we can expect from Hologic in Germany in 2025?
WP: In 2025, our primary focus will remain on Women's Health, which makes up 80% of our business. We also have a molecular diagnostics segment contributing to HIV patient testing and the transplant panel. These efforts aim to broaden our assay menu on the existing platforms to increase consolidation and efficiency, but Women’s health remains our core activity. We see a mix of optimism and challenges ahead, particularly with changes in the German healthcare market. The government has initiated a hospital reform to reduce hospital beds and shift some interventions to day clinics or simpler procedures to keep the system sustainable. However, with the government transition and policy uncertainties, how 2025 will unfold regarding reimbursement levels and hospital operations needs to be clarified. Hospitals are expected to be categorized into tiers A, B, C, and D, but details are still being finalized.
For Hologic, which specializes in breast health, the landscape is evolving. Germany's organized screening programs and designated breast centers play a key role, but questions remain about how these centers will link to local hospitals for chemotherapy and follow-up care to provide fast and accurate patient treatment. These changes are under discussion, and we'll need to adapt as the situation develops. Looking at other countries, we see successful examples of centralized breast centers connected to local hospitals, ensuring accessible care. This model could guide future developments in Germany.
Meanwhile, new approaches like hybrid DRGs are slowly gaining traction, which we're closely monitoring as part of this evolving environment. Hybrid DRGs are used to group hospital interventions, combining traditional inpatient care with outpatient or day clinic procedures. For example, a patient might spend part of the day under supervision but go home afterwards. This system creates a single reimbursement rate by averaging costs, even though specialized interventions like ours are more expensive. This could result in a choice where the best patient treatment is not always favored compared to the financial profits.
In Germany, implementing reimbursement regulations like hybrid DRGs can be slow, but some changes happen rapidly, sometimes within three months. This fast pace has challenged us, even with our dedicated market access teams, as it's harder to predict changes. Still, these shifts create opportunities. For instance, hybrid DRGs could allow us to enter markets we previously couldn't, such as polyps or myoma removal, where our devices are costly. Balancing these uncertainties is challenging, especially for leaders who prefer clear predictions, but it also brings growth potential. We are actively engaged in the laboratory environment in Germany, where we see challenges not just in reimbursement but also in the financial stability of labs and the timing of testing. A recent reform allowed pharmacies to conduct rapid infectious disease testing, such as for COVID-19. While this approach works well during a crisis, the quality of these tests is generally lower. This reform is currently on hold, but if it continues to include tests like flu or COVID routinely, it could lower testing quality and force us to adapt our business model. We're closely monitoring how this model evolves, especially with pharmacies gaining access to reimbursed assays and the potential consequences for us.
On a more positive note, we’re following the TOSYMA trial in breast health, the world’s largest study comparing 2D and 3D digital mammography. Alongside extended age screening, we expect 3D tomosynthesis to gain wider adoption due to its advanced technology. We are well-positioned with strong 3D imaging technology and AI-powered software that supports efficient image acquisition and interpretation. By 2025, the study’s final results should be published, requiring the German government to make key decisions on integrating 3D mammography into screening programs. This will impact investments in mammography systems, as hospitals will need devices capable of both 2D and 3D imaging to ensure they are future-ready when 3D becomes part of the reimbursed screening algorithm.
EF: Could you give us an example or elaborate on how you are pushing the Women’s Health Agenda in Germany beyond the physical portfolio?
WP: We attend events such as Gesundheitsstadt Berlin and the Economic Environment for Women's Health, where we aim to contribute meaningfully. We focus on defining key points to present to political parties about Women's Health. This urgency stems from the earlier-than-expected elections, initially planned for next October. A common challenge is that many politicians see Germany's healthcare system as one of the best globally and question the need for further changes. However, our German Global Women's Health Index highlights areas that need attention, especially in organized screening and prevention. While accessibility, poverty, and life security for women in Germany are less of a concern overall, some populations still face significant issues.
One major gap lies in prevention efforts, where participation rates still need to be higher. Programs like cervical and breast cancer screenings, where we are market leaders, require much more focus and a long-term vision. Insurance companies often assess benefits over a three-year portfolio, which complicates showing the long-term value of screenings that prevent cancer over 10-20 years. We aim to address these issues by encouraging better communication and responsibility for inviting women to screenings. This aligns with our goal of improving Women's Health outcomes. Through the activities we organize with Forum Frauengesundheit, we plan to continue this work, likely hosting two events in 2025. Our primary objective remains to ensure Women’s Health stays on the political agenda. At Hologic, we have clear ideas on what needs improvement, and we aim to provide policymakers and parliament members with actionable insights to make meaningful changes.
EF: How are you using AI and technology to enhance your operations and bring treatments to patients faster, internally, and patient-facing?
WP: Ensuring compliance with patient safety and respecting the responsibilities of doctors, radiologists, and gynecologists is essential. We need to align their practices with the logic of our proposals. AI is designed to assist in faster decision-making, enabling radiologists or cytologists to focus on specific areas rather than scanning entire images. While this starts with computer learning teaching systems to identify abnormalities, it’s not true AI. For example, 2D mammography has used such technology for 15 years, but it’s limited to pattern recognition rather than advanced decision-making.
The future of AI in healthcare, particularly in Germany, faces challenges. There is a growing strain on the healthcare workforce globally, and Germany’s system will likely demand solutions sooner than others to maintain the current quality and access levels. AI could help by identifying negative cases, allowing healthcare workers to focus on higher-risk patients, such as those with dense breast tissue or lifestyle-related risks. However, this evolution depends on legislative changes. Legislation must clarify acceptable sensitivity and detection rates for AI systems, acknowledging that no AI is 100% accurate and mistakes will occur. For example, using AI to clear 60% of mammograms as negative would still involve some errors, similar to current practices. The key is ensuring these risks are minimal, comparable, or slightly better than today's standards. However, legislative delays are expected because the topic intersects with sensitive areas like patient outcomes and doctor compensation. If AI reduces the volume of slides a doctor reviews, it could impact their income. Striking a balance between AI investments, maintaining doctors’ roles, and ensuring fair compensation is critical, just as we balance our position in the medical device market. While workforce pressures might accelerate AI adoption, proper legislation is crucial to guide its implementation and address these challenges effectively.
EF: Is there any initiative Hologic is working with to address this medical education and training in women’s health?
WP: From a data and reading perspective, radiologists are doing well with mammography interpretation. Our focus now is on improving the experience for women during mammography, ensuring they feel comfortable. A growing trend is using real-life data, where AI integrated into mammography systems can immediately flag high-risk cases. For example, suppose a patient’s scan shows a potential issue. In that case, the radiologist can prioritize it, allowing the patient to stay for further diagnostics, such as a biopsy, instead of going home uncertain. This approach helps patients get quicker clarity, whether it’s cancer, something benign, or something requiring further investigation. In Germany, the process currently needs to be revised. Screening images are often reviewed one or more days late by radiologists. However, with “AI” technicians, MTAs in Germany could immediately assess breast density and decide whether a 2D or 3D mammogram is more appropriate. If AI identifies a high-risk case, the patient can immediately proceed to additional diagnostics on the same visit.
Regulations require biopsy and pathology results within a couple of weeks to one and a half months. We aim to shorten this period so that high-risk patients can be identified quickly and prioritized for further care. This improves the system's efficiency and enhances the overall experience of patients by addressing their concerns faster. Mammogram discomfort often comes from technicians applying too much compression. The machine only needs enough pressure to keep the breast stable for the image, but sometimes, MTAs press harder than necessary, causing pain. So, we are focusing on training MTAs. We also offer support plates and paddles in various shapes and sizes to suit different breast types: large, small, or very small, ensuring compression is even but not painful. This training is something we emphasize heavily.
On the data side, Germany faces significant challenges. Unlike other countries, population health data is not centralized. Insurance companies keep data to themselves, and cancer registries report at a state level, creating a fragmented system. If I were in politics, I'd emphasize the immense potential of Germany's data, which offers unmatched insights to 80 million people. Real-life screening results could be analyzed within two years, compared to smaller countries like Belgium or the Netherlands, which may take a decade. Unfortunately, this isn't happening. Germany needs to leverage its data to evaluate the impact of changes or learn from them efficiently. Germany has the potential to lead healthcare system improvements. For instance, the NHS excels in using data to drive decisions, investing in more expensive technology if it saves time and improves outcomes. Germany, the largest European country, should aim to match that efficiency level, using its data to analyze performance quickly and make real-time improvements.
EF: If you had to address the World Health Summit from a women's health perspective, what would your message be?
WP: I recently attended the Women's Health session at the World Health Summit, organized by the Berlin Economic Forum, where policymakers, journalists, and other stakeholders discussed this important issue. The key message was clear: even in Western societies, leaders cannot treat women's health as an accomplished fact. Significant delays still exist in approving simple interventions that could improve women's lives, especially when compared to the faster approval processes for treatments like prostate cancer.
Although healthcare legislation promotes equality, the reality often needs to be revised. Historically, pharmaceutical studies focused on healthy, 30-year-old white men because they were considered uncomplicated subjects. Women were largely excluded due to the additional costs and challenges posed by pregnancy, menstrual cycles, and other physiological differences. However, this sidelined women in clinical studies for years. Regulations now require that clinical trials include the populations they aim to treat, which has improved understanding and support for women's health. But there's still a long way to go. Legislators need to recognize that men and women have different healthcare needs and ensure that policies reflect those differences, not by pitting genders against each other but by acknowledging and addressing the unique challenges women face.
Society has evolved, and the role of women has changed significantly. Today, women work as much as men, contributing equally to their families' economic well-being. Women deserve the same access to health resources because their health directly impacts their ability to work, thrive, and live long, fulfilling lives. With many expected to work into their mid-60s or beyond, ensuring women's health isn't just a social responsibility; it's an economic necessity. Women's health must be central to decision-making, reflecting their growing societal role and value.
EF: What would be your message to your team internally as to how to continue driving this very important work you are doing regarding healthcare for women’s health in Germany, the DACH region, and globally?
WP: This message has been consistent for a long time: we're dedicated to ensuring women have access to the right healthcare at the right moment. Our team is incredibly passionate about this mission, which shows in our work. Currently, a significant proportion of our workforce is women, a great strength and a key driver for our focus on innovation. This balance gives us a strong foundation to drive innovation and reinforce our commitment to women's health. We aim to remain market leaders in the DACH region by providing women access to top-tier technology. The debate often comes down to cost. For example, there’s a €20,000–€25,000 price difference between a high-quality mammography system and a cheaper alternative. While the savings might amount to just €0.15 per woman screened, the risk of missing cancers with lower-quality systems is unacceptable. These discussions fuel our team’s drive and pride. Our culture is centered on advancing women’s health and owning that space, guided by ethical principles and a global perspective on women’s health.
When I started in the medical device industry, there was skepticism about companies prioritizing profit over value. But at Hologic, and even in my prior roles, the focus has always been clear: delivering value to society. We ask how we can improve lives and ensure people live healthier for longer. This approach is evident in our Global Women’s Health Index and how we combine expertise in scientific research, market access, and healthcare organization. We take a holistic approach to women's health, understanding the entire journey from screening to treatment. This expertise allows us to address the challenges radiologists, gynecologists, and policymakers face. We see the big picture and can offer solutions to radiologists and gynecologists who often struggle to communicate the value they bring to the healthcare system. We are invited to discussions to share insights, analyze data, and recommend strategies. We drive impactful changes in women's healthcare beyond just selling devices. We know how to make a real impact and are committed to leading the way.
