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The Rise of At-Home Diagnostic Tests: Convenience, Affordability, and Digital Health Integration

May 23, 2023

Healthcare has always been an industry characterized by constant evolution and innovation. In recent years, one of the most significant shifts we’ve witnessed is the move toward patient-centric care that is accessible, personalized, and convenient. A key driving force behind this transformation is the advent of at-home diagnostic tests.

At-home diagnostic tests, quite literally, bring healthcare into the comfort and safety of our homes. Enabled by technological advancements and fueled by changing consumer expectations, these tests have begun to reshape the traditional healthcare landscape significantly. Their rising popularity is a testament to their ability to meet the evolving needs of today’s healthcare consumer – someone who demands not just quality care but also convenience, affordability, and control over their health.

The Growing Necessity for At-Home Diagnostic Tests


As healthcare landscapes continue to evolve, the demand for at-home diagnostic tests is reaching unprecedented heights. This upsurge is driven by a variety of factors.

Changing Patient Expectations: Modern healthcare consumers are informed and proactive. They demand convenience, autonomy, and personalized care. At-home diagnostic tests cater to these expectations by allowing individuals to monitor their health conditions at their convenience, without leaving their homes.

Pandemic-driven Need: The COVID-19 pandemic has underscored the importance of at-home diagnostic testing. With lockdowns and social distancing measures in place, many people have found it challenging to visit healthcare facilities for routine tests. At-home diagnostic tests have served as a vital tool in such scenarios, enabling individuals to test for various conditions, including COVID-19, from the safety of their homes.

Expanding Access to Healthcare: At-home diagnostic tests can be particularly beneficial for people living in remote areas or those with mobility issues. By eliminating the need for travel, these tests make healthcare services more accessible for these individuals.

For example, an individual living in a remote area might have to travel several miles to the nearest healthcare center for a simple cholesterol test. With an at-home diagnostic test, they can conduct the test themselves and receive accurate results without leaving their home.

Preventive Care and Early Detection: At-home diagnostic tests can play a crucial role in preventive healthcare. Regular self-monitoring can lead to early detection of potential health issues, enabling timely medical intervention. 

For instance, at-home tests for blood glucose levels, cholesterol, or blood pressure can help individuals keep track of these vital parameters and spot any abnormalities early. Similarly, at-home cancer screening tests can enable early detection, increasing the chances of successful treatment.

Cost Savings: In many cases, at-home diagnostic tests can be more cost-effective than their counterparts conducted in healthcare facilities. By reducing the need for in-person consultations and the associated costs, these tests can make healthcare more affordable for many individuals. These savings can accumulate over time, especially for individuals who require regular testing for chronic conditions.

These factors highlight the growing necessity for at-home diagnostic tests in the current healthcare environment. By offering a convenient, affordable, and effective way to monitor health and detect diseases early, these tests are set to become an integral part of modern healthcare delivery.

Key Features of At-Home Diagnostic Tests

At-home diagnostic tests are designed to be user-friendly and easily accessible to individuals without medical training. Clear instructions, simplicity of use, and rapid results are hallmark features of these diagnostic tools. 

Ease of Use: At-home diagnostic tests typically include everything needed for the test, from the testing instrument to the detailed instruction manual. Users can perform the tests at their convenience, eliminating the need to schedule and travel for a lab appointment. 

Quick Results: Many at-home diagnostic tests provide results within minutes. This rapid turnaround time allows for immediate action if needed and can significantly reduce anxiety associated with waiting for test results.

The onboard chemistry of these tests is a marvel of modern science. They leverage technologies from various fields, including biochemistry, immunology, and microfluidics, to analyze biological samples such as blood, urine, or saliva. This onboard chemistry allows for the miniaturization of lab equipment, enabling complex tests to be performed right at home.

For example, some at-home diagnostic tests use lateral flow assays (similar to home pregnancy tests), which utilize capillary action to move a sample along a test strip. When the sample encounters specific reagents on the strip, a visible indicator appears if the target condition or substance is present. This relatively simple technology allows for quick, easy-to-interpret results.

The Intersection of At-Home Diagnostics and Digital Health

At-home diagnostic tests and digital health platforms are two rapidly growing areas of healthcare that are increasingly intersecting. This convergence is driving a new era of patient empowerment, data utilization, and personalized care.

Integration with Digital Platforms: Many at-home diagnostic tests now come with digital components, such as smartphone apps, that can record and track results over time. This data can be invaluable for monitoring health trends, sharing information with healthcare providers, and personalizing treatment plans.

Enhancing Patient Engagement: The integration of digital health platforms and at-home diagnostic tests provides users with an active role in managing their health. This active engagement can improve adherence to treatment plans, enhance understanding of personal health, and ultimately lead to better health outcomes.

Facilitating Remote Consultations: The combination of digital health platforms and at-home diagnostic tests can also facilitate telehealth consultations. Healthcare providers can review test results remotely, provide feedback, and adjust treatment plans without requiring an in-person visit.

A New Way to Deliver Excellent Care

The rise of at-home diagnostic tests is a clear indication of the shifting paradigms in healthcare. Their convenience, affordability, and the seamless integration with digital health platforms are reshaping the patient experience, improving access to healthcare, and empowering individuals to take charge of their health.

As advancements in technology continue, we can expect these tests to become even more accessible, accurate, and varied in their capabilities. The future of healthcare is here, and it’s in our homes. Embracing at-home diagnostic tests and digital health is the way forward to a more patient-centered and proactive approach to healthcare.

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The Impact of Deep Learning on Medical Technology

April 13, 2023
Interested in learning more about our capabilities in machine learning in medical technology?
Download our white paper about identifying and counting blood cells with deep-learning models.

As artificial intelligence (AI) continues to play an increasing role in nearly every sector, medicine is no exception. Techniques such as deep learning (DL) are pushing the horizons of possibility when it comes to diagnostics and imaging by enabling faster and more efficient predictions, pattern-matching, and modeling of the human body. 

From providing accurate medical imaging to recognizing cancerous cells, AI models can detect and diagnose illnesses. AI has the potential to revolutionize healthcare by enabling quicker diagnosis, reducing costs, recommending treatments, and improving accuracy, all of which equip doctors and physicians with the best possible analysis when making vital decisions on how to help patients. 

This article surveys the growing impact of deep learning models on medical imaging and diagnostics, identifying the trajectory of these advancements looking forward as well as laying out the core benefits and limitations to DL models.

What is “Deep Learning”?

Deep learning models are an AI technique inspired by the human brain that emphasizes multiple layers of prediction and revision. By mimicking the way human neurons signal each other and adapt to new information, these models are able to “learn” by layering these artificial neural networks on top of each other to create increasingly efficient predictions and patterns.

DL technology can and has had a major impact on the field of healthcare by expediting the process of medical image analysis. Instead of manual examination, DL models can process exponentially more medical images; these models can detect anomalies based on deviations from standard human physiology and provide an accurate diagnosis. With the help of deep learning, healthcare professionals no longer need to carry out manual segmentation or laborious classification tasks—this process, and many others, can be done automatically.

Current Medical Deep Learning Advancements

 

Image recognition and pattern analysis

Healthcare professionals increasingly use deep learning models in medical imaging to assist with tasks such as recognizing tumors, detecting abnormalities, and recommending treatments. For example, providers can train deep learning algorithms to recognize patterns in MRI scans that indicate a certain type of tumor or diagnose conditions such as Alzheimer’s disease.

Improved accuracy and imaging speed

Deep learning models can also improve the accuracy and speed of medical imaging. For instance, a deep learning system can detect abnormalities in images that healthcare providers might otherwise miss. In addition, deep learning models can also allow for faster analysis of medical images since they are able to interpret large amounts of data quickly.

Diagnostic Applications

Finally, providers are also using deep learning models in diagnostic applications. For instance, deep learning algorithms can be trained to diagnose various diseases and disorders based on patient data such as blood tests or X-rays. In addition, deep learning models can recommend treatments for specific conditions and monitor the progress of a patient’s condition over time.
Deep learning models play an increasingly important role in the field of healthcare. With its ability to quickly analyze large amounts of data and make accurate diagnoses, deep learning can help healthcare providers provide more efficient and effective care for their patients.

Challenges and Limitations

While deep learning algorithms can provide accurate results, they do have some drawbacks. The following are two major limitations of deep learning models in medical imaging and diagnostics.

Lack of diversity in data sets used for training models

One challenge with deep learning models is that the data sets providers use to train them are often not diverse enough to accurately represent all demographics. This challenge can lead to inaccurate results, as the model may be unable to recognize certain features or patterns that would be visible in a more diverse set of data. This form of “algorithmic bias” requires deeper investments in research and development in order to ensure more equitable and accurate predictions. 

Need for interpretability and transparency in deep learning models

Another limitation of deep learning models is that they are often difficult to interpret. Like peering into a human brain, these kinds of artificial neural networks are exceedingly complex and how they come to the conclusions they do is often just as opaque. 

This can make it difficult for healthcare providers to understand the decisions made by a model, as well as how it determined the results. It is important for providers to be able to interpret deep learning models in order to ensure that they are making accurate decisions, which is another major area for AI research and innovation. 

What Comes Next for Deep Learning Models in Medicine

The potential for deep learning models in medicine is vast and ever-growing. Researchers are currently exploring ways to use deep learning models to analyze medical records, identify patterns in genomic data, and even develop personalized treatments based on a patient’s characteristics. 

With the right tools and data, deep learning can revolutionize healthcare by providing patients more accurate and personalized care.

Advancements in data collection and analysis

In addition to deep learning, there has also been progressing in data collection and analysis tools that can help healthcare providers make more informed decisions. Artificial Intelligence and Machine Learning can organize and analyze large amounts of patient data to provide insights that providers can use to improve care. In addition, advances in robotics and automation make it easier for healthcare providers to automate processes and streamline care.

Integration with electronic health records

Another area in which DL models can improve healthcare operations is the integration of electronic health records (EHRs) with deep learning models. By connecting EHRs to deep learning models, providers can access additional insights that can help them better understand their patient’s conditions and make more informed decisions about their care. This integration could lead to more accurate diagnoses and improved patient outcomes.

Collaborations between AI and medical professionals

There are also initiatives to bring AI and medical professionals together. These collaborations between the two fields could lead to more efficient healthcare systems and better patient outcomes. For example, researchers at Stanford University have developed an AI-assisted surgical robot that can provide a surgeon with additional insight for performing minimally invasive surgeries. This type of collaboration will revolutionize the way healthcare is delivered in the coming years.

Conclusion

The drive to integrate AI with medical technology has already picked up steam as this preliminary assessment has shown. As a result, the potential for improving care is enormous.  By analyzing data sets, developing personalized treatments, and integrating with electronic health records, deep learning models have the potential to revolutionize how healthcare is delivered globally. In addition, collaborations between AI and medical professionals can help lead to more efficient healthcare systems and better patient outcomes with less costs all around. 

If you’re interested in learning more about how AI impacts the healthcare industry, Gener8 is a great place to start bringing AI into your medical device applications. 

It’s now easier than ever before for physicians, researchers, and healthcare professionals to access innovative technology that will further their practice or research goals.

Reach out today to learn more about how Gener8 can help you take advantage of the latest advancements in AI technology.

Read our white paper:

“From Microscopes to Machine Learning: Identifying and Counting Blood Cells with Deep-Learning Models”

This paper presents a new technique for identifying and counting different blood cell types in the human body using computers. It proposes a stain-free method that utilizes supervised machine learning algorithms, rather than traditional staining techniques. Three deep neural networks – U-net, Segmentation Transformer, and YOLO – were trained to accurately identify the five major white blood cell types, their nuclei, and red blood cells. The technology has the potential to greatly benefit medical disciplines like hematology, pathology, and oncology by improving accuracy and efficiency in diagnosis and treatment.

Download White Paper Here:

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Applications of Point of Care Diagnostic Devices

April 10, 2023

Applications of POC Diagnostic Devices

Point of care (POC) diagnostic devices produce results outside of laboratory settings by collecting and analyzing specimens at the time of the patient’s visit to the doctor’s office or outpatient treatment location. Patients can sometimes use point-of-care diagnostic devices at home, as with pregnancy or blood glucose tests. Technology advancements have expanded the applications of point-of-care diagnostic devices to provide a broader range of tests.

Point-of-care testing devices can be as simple as a thermometer or the basic pulse/oximeter that so many people purchased when news came out that extreme but “silent” low blood oxygen levels could indicate COVID-19. Other POC devices gather blood, saliva, urine, stool, and skin cells. They then expose the sample to a medium intended to detect the presence of certain types of cells or chemical markers. The medium is like a strip infused with a substance or chemical that will react with the sample and show a visible result (like the colors that emerge in a home pregnancy test kit) that indicates the presence or absence of the disease or condition the test is performed to detect.

Some typical applications of point-of-care diagnostic devices include:

  • Cholesterol testing
  • Blood glucose level testing
  • Alcohol or drug tests
  • Analysis of electrolytes and enzymes present or absent in the sample
  • Tests for signs of infection
  • Fecal matter tests for markers of colon cancer
  • Blood markers for certain cardiac conditions
  • Levels of blood gases that might cause medical concern

Some of the newest point-of-care (POC) diagnostic devices come in the form of wearables that use electrochemical sensors to detect the presence of, for example, blood alcohol levels.

Benefits of Point of Care Devices

Testing with POC devices is convenient. The devices are small and portable. They provide fast results. POC devices protect the integrity of samples, and some even deliver results via internet connectivity integrated into the device. In the development phase, many in vitro diagnostics companies for a new product team up with a diagnostics and life sciences device design company to ensure that new devices will work as intended.

Factors That Affect Design

The main concern of POC diagnostic device design is that the device will provide an accurate result while ensuring the integrity of the specimen sample. Depending on the application of the point-of-care diagnostic device and the type of specimen tested, the materials the device is made of, and the kind of plastic or metals used in the device, may be critical to its testing accuracy. Simplicity, convenience, and comfort are important factors as well, as these affect the user experience and, thus, the willingness to undergo testing or use the test at home according to instructions or as prescribed.

Considerations for designing diagnostic device mechanisms may include packaging, how users can safely dispose of the device, and how the device communicates results to avoid ambiguity. Follow-up care depends on accurate results, so the quality of the design process and reputation for accuracy should be a significant consideration when selecting a point-of-care diagnostic device.

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How Does a Lateral Flow Immunoassay Work?

April 5, 2023

Lateral flow immunoassays—also known as lateral flow tests, lateral flow immunochromatographic assays, rapid tests, and strip tests—are a straightforward and accessible diagnostic technique. Lateral flow immunoassays offer fast results for a wide range of diagnostic applications, from home testing to laboratory use,

The most common example of lateral flow tests is an over-the-counter pregnancy test. However, scientists and medical professionals also use these tests to identify diseases (such as Ebola or COVID-19), detect toxins in food and environmental fields, and analyze specific target molecules and gene expression.

Lateral flow immunoassays have a significant impact on numerous scientific and medical fields. How does a lateral flow immunoassay work, though? Learn the answer and everything else you need to know about lateral flow tests with this guide.

An Introduction To the Lateral Flow Immunoassay

A lateral flow immunoassay is a simple diagnostic device that confirms the presence or absence of a specific analyte. That target component might be a pathogen or other biomarker in human or animal samples. Alternatively, the lateral flow test might target contaminants such as chemicals or toxins in water or food.

The simple function of a lateral flow immunoassay grants it the versatility to serve a wide range of applications. Moreover, lateral flow tests are relatively easy and affordable, making them an accessible solution for researchers, doctors, clinics, and more.

How Lateral Flow Tests Work

A lateral flow test is simple: the sample flows along the device, meeting conjugated labels and antibodies that bind to the target analyte if it’s present. These binding reagents will continue along the device to the test lines, which bind to the test line to show a positive result. If the target analyte is not present, no binding occurs. The test lines remain blank to show a negative impact.

A few key components work together to ensure the sample moves swiftly through the device and delivers an accurate result.

Sample Pad

Lateral flow immunoassays can work with various samples, including urine, blood, sweat, and other fluids. The sample pad collects the sample and begins the process of the lateral flow test. The sample pad evenly distributes the model to ensure a proper and controlled flow throughout the device. The pad often includes components such as buffer salts or proteins, which help direct flow and prepare the sample to interact with the rest of the immunoassay.

Conjugate Pad

The liquid moves from the sample pad to the conjugate pad. This area stores conjugated labels and antibodies until the test begins. The pad contains a conjugate buffer that preserves the conjugate particles until the sample enters the pad. If the target analyte is present in the sample, then the conjugates will bind to it and move along with it as it flows through the conjugate pad toward the rest of the device.

Membrane

The sample then moves from the conjugate pad to a nitrocellulose membrane. This membrane contains binding reagents at the test lines. Suppose the target analyte has bonded with the conjugate particles in the conjugate pad. In that case, those particles will attach to these binding reagents and form the line that indicates a positive result. If no target analyte is present, there will be no conjugate particles to bind to the test line, creating a negative result.

The membrane also includes a control line at the end. This line contains specific detection antibodies that bind with the sample to indicate that the test was performed correctly.

Absorbent Pad

The absorbent pad sits at the end of the device and wicks moisture through the membrane, aiding in sample flow throughout the lateral flow test. As the name suggests, the absorbent pad absorbs the sample once it reaches the end of the device. This allows users to work with larger sample volumes, creating better sensitivity and accuracy for the test.

Different Types of Lateral Flow Immunoassays

Lateral flow tests come in two main formats: sandwich and competitive. These formats work similarly, but they have different ways of displaying results.

Sandwich Immunoassays

Sandwich assays—direct format immunoassays—are the more common format. These tests follow the above explanation of how a lateral flow immunoassay works. The target analyte binds to the conjugate particles in the conjugate pad, then binds again to the reagents at the target line. As a result, a colored bar at the test position indicates a positive test, and the lack of a line means a negative test.

The sandwich immunoassay gets its name from how the target analyte is sandwiched between the conjugate particles and the binding reagent. This test format works best with larger analytes that can bind to multiple antibodies. Examples of sandwich-format lateral flow tests include HIV tests and pregnancy tests.

Competitive Immunoassays

Competitive assays only work when testing smaller analytes that can’t bind to more than one antibody at a time. In this lateral flow test format, the conjugate particles and the binding reagents at the test line “compete” with each other to bind to the sample.

If the target analyte is present in the sample, it binds to the detection antibody in the conjugate pad. As a result, it cannot bind to the reagents at the test line. Therefore, the lack of a colored line indicates a positive result, while a colored line indicates a negative result.

Challenges and Requirements When Designing Lateral Flow Devices

While the process of a lateral flow test is simple, the device itself is a remarkably complex instrument. Point of lab (PoL) testing device development and manufacturing is a precise science that requires extensive knowledge of how analytes, antigens, and materials interact.

Lateral flow immunoassays require a clean, sensitive read to produce accurate results. As such, device developers must find suitable antigens or antibodies for the detection method.

Additionally, incompatible materials can cause problems and create inaccurate results. Developers must choose materials that perform the test efficiently without contaminating the samples or altering results. Developers must select every material on the particles that react with the sample to the backing card that stabilizes the test strip.

At Gener8, we pride ourselves on our extensive knowledge and attention to detail. Our experienced team and comprehensive development services will help you achieve the desired results with better flexibility and a shorter time to market.

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The Advantages of Stereolithography

April 3, 2023

Stereolithography (SLA) is a type of 3D printing technology that uses a laser to cure a liquid resin into a solid object.

Stereolithography is one of the oldest types of 3D printing. The process applies laser light to photosensitive polymers (resins) to form models or prototypes under computer controls. The process helps medical device designers and other industrial creators visualize their concepts in three dimensions and refine their ideas as a result. The advantages of stereolithography include flexibility, cost savings, and precision.

Stereolithography Is Fast

Depending on the size of the model, prototype, or part being formed and the number of layers necessary, stereolithography can be fast. The resins laid down in this way cure quickly.

Stereolithography Is Accurate

The computer-guided lasers used in the stereolithography process produce detailed models and prototypes. These help designers and manufacturers avoid costly mistakes and redesigns by allowing them to catch flaws early in the process so they can adjust accordingly.

This process can apply very thin layers of resins, resulting in models or parts with exceptionally realistic details. As an additive process, stereolithography doesn’t use molds. This saves the time and materials it would take to produce a mold.

Prototypes and models produced with stereolithography have smooth surfaces, produced without an extra finishing step.

Stereolithography Works With Different Materials

The stereolithography process has evolved to accommodate more than plastic resins. The process can now be used on ceramic powders or to join metals. The process can replace expensive and labor-intensive machining to form precision component parts.

Sustainability

Resins used in stereolithography are reusable. Prototypes that reveal design flaws can be adjusted as they are made. Materials that haven’t yet cured to hardness can be reused to produce other parts or models.

Multi-Part Assemblies Are Possible

The precision computer guidance and computer-assisted designs make it possible to produce several parts that can then be connected in a more complex assembly. This ability also makes design changes easier by breaking down complex designs into component parts that can be individually adjusted.

Texturing Is Possible

Although the smooth finish produced by stereolithography is one of its best benefits, stereolithography makes it possible to create objects with varying textures. Prototypes can be formed from different kinds of resins or layered under computer instructions to create textured areas based on how the material is layered and built.

Stereolithography provides advantages in speed, cost-effectiveness, flexibility, and precision. These advantages make stereolithography for medical device design, among many other industries, a vital process for creating models and prototypes that help refine and prove designs.

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The 3 Best Practices for Biotech Product Development and Commercialization

March 24, 2023

Top Three Best Practices for Biotech Product Development and Commercialization

With so many rapid breakthroughs and disruptive innovations, biotech is constantly evolving.  The big question is, how do innovators like you take your concept to market while avoiding pitfalls that can slow down the process and risk your early-to-market advantage?  Designing and developing a product presents many challenges involving technical feasibility, build process, budget, regulatory compliance, and manufacturability. Getting assistance from a trusted partner with experience in biotechnology and medical device product development will save you time, money, and stress. Gener8 has served that role for biotech and medical device companies, from small startups to giant corporations. Our integrated teams have over two decades of experience helping clients overcome challenges.

To help you avoid these common challenges as you approach the development of your first or next product, we are sharing three guiding principles that our design leads live by. 

Principle #1:  Define the Product Early On

Analyze and reflect on your idea from every angle to ensure it will be a viable and thriving product.  You can refine the product concept by performing market research and analysis to understand the need for this product in the market. From there, you can define who your user will be, how they intend to use your product, and their expected result. This exercise will determine the high-level product framework.  Under this framework, you can come up with clear product definitions that can be translated into product requirements and priorities. A successful customer-centric product will be prioritized based on customer needs and the performance needed for the system.

Defining your biotech or medical device product happens through brainstorming, clear market research and analysis, and the inclusion of consultants or subject matter experts (SMEs). Ensure that your SMEs have experience in designing, developing, and producing biotech and medical devices for your target market so they can properly guide and advise you throughout this process. While defining the product takes the work of many stakeholders. Clearly written and prioritized requirements will enable rapid development. It helps keep your multifaceted team on the same page, clearly communicates the goal that you are working towards, and helps engineering teams match a design solution with each product requirement needed to get to market. 

Principle #2: Designing for Reliability Early On to Avoid Costly Redesigns Downstream

Reliability questions and unexpected failures are expected during the product development phase. However, you can avoid these issues that can lead to costly redesign and product recalls by implementing a Design for Reliability conceptual framework.  This includes identifying potential causes for failure early on and applying engineering knowledge at concept to get to a design that minimizes the risk of loss and improves reliability.  Some examples may include pre-validation of your novel chemistry or assay works, risk assessment (in compliance with ISO 149711:2007), and failure mode and effects analysis (FMEA). This strategy will ensure the product will remain reliable for its intended use throughout its lifetime.  We recommend you allow plenty of time for these exercises before starting the design work.

Another important aspect of reliability engineering is to take design shortcuts, such as utilizing OEM or pre-assembled parts only after considering the impact of how well these sub-assemblies can integrate.  Identifying a partner who can provide component integration and fabrication expertise can save you time and money and de-risk downstream failures.

Principle #3: Engage in Regular Reviews with the Full Design Team

Meeting regularly with your functional teams to review progress allows you to infuse new design ideas, bring up design problems, or identify lower-cost solutions. It will ensure product requirements are met and identify any issues that could come up during the transfer to production. However, too often, different functional product development teams can get siloed and lose sight of the goal because they are overwhelmed with other company goals and projects.

Working with Gener8 will help you break down the walls between the functional teams, such as engineering, software development, and prototyping.  Our experts focus on delivering your product with your best interests in mind.  We meet regularly with you at every decision point and rapidly create an alpha prototype early on so you can immediately test the product concept and refine the product design to avoid expensive re-design.  Once we move forward with beta production, we will have de-risked any manufacturing variability for you to scale up quickly.

Moving from Development to Manufacturing

At Gener8, we aim to help you create the best possible product. We have the expertise and capability to design, prototyping, and manufacture your final products.  This in-depth knowledge can help you take the best approach to commercialize your product and avoid pitfalls that can hamper your progress.

Please look at what our industry-leading expertise can do for your product development. 

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Gener8 Chooses Costa Rica For First Manufacturing Plant Outside United States

December 1, 2022
Gener8 Costa Rica

Gener8 Chooses Costa Rica for First Manufacturing Plant Outside United States

 Gener8 LLC (“Gener8”), a portfolio company of Sverica Capital Management LP (“Sverica”), announced today that it has expanded its manufacturing footprint by launching a new facility in Costa Rica.

Gener8’s 30,000 square feet manufacturing facility is located in La Lima industrial Park in Cartago. The state-of-the-art facility will enable highly complex electromechanical instrument manufacturing in an ESD-controlled environment and ISO Class 8 cleanroom.   

“Just as Gener8 has aggressively built a complete biotech instruments design services solution comprised of hardware, software, and micro-fluidic cartridges, the Costa Rican site adds the last piece for a complete product life cycle solution – efficient, high-volume manufacturing. This is a compelling offering for our customers” said Jerry Jurkiewicz, Gener8 CEO.   
 
“We chose Costa Rica due to its wealth of technical talent, its eager and available workforce, and its geographic and time zone proximity to our US operations. I’d like to thank the Costa Rican government and CINDE for creating such a business-friendly environment and for making the process of launching a site here so seamless,” Jurkiewicz added.

Manuel Tovar, the Minister of Foreign Trade stated, “Costa Rica is a regional leader in the sophistication of manufacturing processes with a proven track record. Thanks to this, Gener8 honors us with the decision to establish its first manufacturing plant outside the United States in our country. The investment will allow 60 Costa Ricans to have quality employment in the manufacture of electromechanical instruments. We are an ideal location for smart manufacturing industries, which operate with a high level of complexity and generate a wide range of products while contributing to the revitalization of the economy”.

“The arrival of Gener8 on national soil presents us with a great opportunity to go beyond activities related to designing and manufacturing highly complex instruments and boost the research and development of new technologies for medical diagnostics and clinical laboratory equipment. This result is a reflection of the huge efforts that we have made as a country in the last several years to turn into a world leader in attracting medical device companies, occupying fifth place after powerhouses such as Germany, the United States, and France,” commented Jorge Sequeira, managing director of CINDE. 

Gener8 will employ 60 employees in the first 12 months with an aggressive growth projection in the coming years.

“The high complexity of instruments we design, and manufacture will bring exciting job opportunities for engineers and technicians with experience in mechatronics, systems integration, and software testing” said Alfred Macha, Vice-president of Costa Rica Operations, Gener8. 

About Gener8

Gener8, founded in 2002, is a leading provider of turnkey design and manufacturing services specializing in high-complexity products, primarily for medical device and diagnostics applications. Gener8 maintains state-of-the-art facilities and a world-class engineering team with more than 40 PhDs spanning a multitude of disciplines, including electrical, mechanical, software, optical, and systems engineering. For more information, please visit www.gener8.net. 

About Sverica Capital Management

Sverica Capital Management is a leading growth-oriented private equity firm that has raised over $1.1 billion across five funds. The firm acquires, invests in, and actively builds companies that are, or could become, leaders in their industries. Since its inception, Sverica has followed a “business builder” approach to investing and takes an active supporting role in its portfolio companies. Sverica devotes significant time and internal resources to help its management teams develop and execute growth strategies and proactively looks for levers to pull to accelerate growth by reinvesting back into those companies. Sverica firmly believes in building businesses collaboratively that can endure for the long term by starting with a strong foundation and bringing the right people and playbook to drive reinvestment and ultimately strong returns for our investors. For more information, please visit www.sverica.com. 

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Gener8 Celebrates 20 Years of Business and Continued Growth

September 16, 2022

Gener8 Celebrates 20 Years of Business and Continued Growth

Gener8 LLC (“Gener8”), a portfolio company of Sverica Capital Management LP (“Sverica”), celebrates the company’s 20th anniversary this month. Since its founding in September 2002, Gener8 has developed into a full product lifecycle engineering and manufacturing partner, successfully serving the biotech, life sciences, and medical device industries.

“I feel lucky and honored by the team of amazing employees and customers that have assembled to make Gener8 what it is today. I had no idea when Gener8 started in my garage that it would grow to become the leading global life sciences company that it is now”, said David Klein, founder of Gener8. “None of this would have been possible without the dedicated team who shared a vision and worked tirelessly to achieve it”.

In recent years, Gener8 has expanded its core instrument engineering capabilities through strategic acquisitions in 2019, adding microfluidics cartridge design, development, and manufacturing, and in 2021, adding full lifecycle software development capabilities. Gener8 now offers comprehensive turnkey solutions for instrument, consumable, and software design, development, and manufacturing, under one roof.

“These synergistic capabilities provide significant value to our clients by coordinating all aspects of a project, under one roof”, said Jerry Jurkiewicz, Gener8 CEO. “As an evolving company, the new Gener8 logo reflects the seamless connection we provide through each stage of the product lifecycle – from product development and launch through to manufacturing. Gener8 now offers a true end-to-end solution.”

Gener8 is continuing to expand its services by introducing a cost-competitive manufacturing site in Costa Rica in Q4 of this year. In addition, Gener8 will relocate its current company headquarters to a larger facility in San Jose. Gener8’s leadership anticipates continued growth and expansion thanks to the dedication of the entire staff to emerging technology and the trusted confidence of their clientele.

About Gener8

Gener8, founded in 2002, is a leading provider of turnkey design and manufacturing services specializing in high-complexity products, primarily for medical device and diagnostics applications. Gener8 maintains state-of-the-art facilities and a world-class engineering team with more than 40 PhDs spanning a multitude of disciplines, including electrical, mechanical, software, optical, and systems engineering. For more information, please visit www.gener8.net. 

About Sverica Capital Management

Sverica Capital Management is a leading growth-oriented private equity firm that has raised over $1.1 billion across five funds.  The firm acquires, invests in and actively builds companies that are, or could become, leaders in their industries. Since inception, Sverica has followed a “business builder” approach to investing and takes an active supporting role in its portfolio companies. Sverica devotes significant time and internal resources to help its management teams develop and execute growth strategies and proactively looks for levers to pull to accelerate growth by reinvesting back into those companies. Sverica firmly believes in building businesses collaboratively that can endure for the long term by starting with a strong foundation and bringing the right people and playbook to drive reinvestment and ultimately strong returns for our investors.  For more information, please visit www.sverica.com.

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Gener8 Welcomes Mark Chatfield as Global Vice President of Operations

February 9, 2022

Gener8 Welcomes Mark Chatfield as Global Vice President of Operations

Gener8 LLC (“Gener8”), a portfolio company of Sverica Capital Management LP (“Sverica”), welcomes Mark Chatfield as the new Global Vice President of Operations. Mark brings thirty years of experience with Thermo Fisher Scientific running operations in the fields of specialized x-rays, chromatography, and mass spectroscopy.

“We are lucky to have Mark join the Gener8 team. He brings deep experience in manufacturing complex instruments for a formidable OEM in the Life Sciences space,” said Jerry Jurkiewicz, Gener8 CEO. “He is a world-class Ops professional proficient in modern manufacturing techniques like Lean, Six Sigma, and Class A planning and scheduling. Mark will be leading our global operations transformation across our three-site manufacturing footprint.”

During his employment at Thermo Fisher Scientific, Mark studied Business Administration at San Jose State University. Despite intentions to retire upon his leaving his previous role, Mark was intrigued by the unique and challenging opportunities offered by Gener8 and the consistently changing portfolio of work put out by the company.

“I describe myself as someone who has no fear to fail and a desire to succeed. After learning about the challenging and unique opportunities Gener8 provides, I believe in the vision that is being promised. It is exactly what I need right now,” says Chatfield.

Mark looks forward to contributing to the growth and expansion of Gener8’s teams and locations worldwide. He strives to contribute to positive company culture as a part of the leadership team. Gener8 is thrilled to bring his depth of experience to their company, and to the medical and biotech industry.

About Gener8

Gener8, founded in 2002, is a leading provider of turnkey design and manufacturing services specializing in high-complexity products, primarily for medical device and diagnostics applications. Gener8 recently acquired The RND Group, adding nearly 75 SW engineers, with a focus on FDA Regulated Software capabilities. Gener8 maintains state-of-the-art facilities and a world-class engineering team with more than 40 PhDs spanning a multitude of disciplines, including electrical, mechanical, software, optical, and systems engineering. For more information, please visit www.gener8.net. 

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The Advantages of Polymerase Chain Reaction in Diagnostics

January 3, 2022

Polymerase chain reaction technology allows scientists to copy and amplify DNA samples for more accessible study quickly

The world of science and medicine never stops evolving. Every day, new technologies emerge and improve to give scientists more tools and methods to work with. Each innovation creates new and exciting potential across a wide range of fields and markets. One cutting-edge method that many industries are closely watching is the polymerase chain reaction. Polymerase chain reaction technology allows scientists to copy and amplify DNA samples for more accessible study quickly. How exactly does this technology work? What does it mean for various fields of science and medicine? Explore the technology and potential of this field with this guide on the advantages of polymerase chain reaction in diagnostics and beyond.

An Introduction to the Polymerase Chain Reaction Technique

In 1983, biochemist Kary Mullis discovered the polymerase chain reaction technique, and this accomplishment forever changed the world of DNA studies. The polymerase chain reaction method presented a faster and simpler way to study DNA, and scientists can focus on any DNA sample they want and amplify it exponentially. PCR has since become fundamental in various scientific and medical fields, including genetic testing, criminal forensics, medical research, analysis of ancient DNA, and more. Mullis even shared the Nobel Prize in Chemistry in 1993 for his discovery of the technique.

How Polymerase Chain Reaction Works

Despite its incredible usefulness and potential, the polymerase chain reaction technique is relatively simple. Scientists can perform PCR with many different types of DNA samples, and these samples come from tissues or organisms such as blood, skin, saliva, hair, or microbes. Because PCR is such a sensitive assay, scientists only need trace amounts of DNA to perform the procedure.

Within its PCR assay are the template DNA, the polymerase DNA, primers, and nucleotides. These components work together to create the PCR product. During the PCR process, the DNA’s double helix separates. The primers bind to complementary sequences of DNA, creating templates out of the two DNA strands. The DNA polymerase then uses these templates to assemble a new DNA strand out of the freestanding nucleotides. As PCR goes on, these new DNA strands become templates themselves. The replication continues, exponentially amplifying the sample.

Once the PCR product is complete, scientists must be able to visualize the DNA to analyze it. They can achieve this through techniques like staining the DNA or labeling primers and nucleotides with fluorescent dyes. Scientists might also use agarose gel electrophoresis, which separates DNA products by size and charge. These visualizing methods help scientists understand the PCR product as they study it, allowing for more precise insights.

Quantitative PCR

While polymerase chain reaction technology is instrumental in its simplest form, scientists have developed various adaptations of the technique to specialize in certain areas. One such adaptation is a quantitative polymerase chain reaction, which creates Quantitative PCR (qPCR) or Real-Time PCR. This method allows scientists to examine the amount of a given sequence within a sample. For example, qPCR will enable researchers to detect RNA viruses—like HIV—and amplify these specific sequences until there’s enough of a sample to measure and study. With this technique, scientists can study the levels of a specific condition or genetic mutation within various cell populations, which offers insight into where these conditions show up and affect the body.

Applications of Polymerase Chain Reaction

Several fields within science and medicine make use of polymerase chain reaction technology. Some scientists use this technique to clone DNA for sequencing, gene cloning, and gene manipulation. Others amplify ancient samples of DNA for further study and analysis. Forensic scientists also make use of PCR methods, often by analyzing genetic fingerprints for DNA profiling. This same technique is also helpful in parentage testing. However, one of the most promising fields that can benefit from PCR is medical diagnostics.

Polymerase Chain Reaction in Diagnostics

Polymerase chain reaction technology holds incredible potential for the field of diagnostics, and its uses continue to grow. Genetic testing and diagnosis are a massive part of this, and PCR techniques allow scientists to test parents or children for genetic diseases and their effects. Doctors can also take this further by obtaining prenatal DNA samples and testing developing embryos for diseases and conditions. This can help both doctors and parents prepare a fetus and expectant mother for any complications during pregnancy.

PCR technology also benefits the field of cancer research. Doctors can use PCR-based testing to obtain an early diagnosis of malignant diseases like leukemia and lymphomas. These tests also allow doctors to study mutations resulting from certain forms of cancer. These diagnostic improvements allow for earlier treatments, which are far more successful than treating cancer in later stages.

In addition to studying genetics, PCR technology also gives insight into infectious diseases. One extremely relevant example of this is the use of PCR-based testing against the SARS-CoV-2 viral genome. Scientists have used PCR techniques to sequence and analyze the viral genome. Meanwhile, the high sensitivity of PCR-based COVID-19 testing allows health professionals to detect the virus soon after infection. PCR tests can detect the presence of COVID-19 even before a patient starts to show symptoms. Fast and reliable testing is an invaluable part of monitoring the disease, starting treatment, and preventing the further spread of the virus.

Advantages of PCR in the Field of Diagnostics

Why is PCR technology so invaluable for diagnostics? One of the most significant advantages of polymerase chain reaction in diagnostics is its speed. Because PCR technology creates replicas, it can deliver results in a fraction of the time that culturing and other methods require.

Beyond the incredible speed of this method, PCR techniques are helpful when detecting pathogens that require a long cultivation process or struggle to grow in vitro. Even better, PCR technology requires less genetic material than other tests, making testing more accessible in these scenarios.

Limitations of PCR in the Field of Diagnostics

Despite its advantages, PCR technology also has its limitations. PCR techniques don’t work in every situation. Before testing, scientists must have information about the DNA sequence to ensure that the DNA polymerase binds appropriately to the template. Furthermore, the DNA polymerase can create mistakes like all enzymes, such as false mutations in the PCR product. Additionally, the specificity of PCR technology means that even trace amounts of contamination will amplify with the DNA, creating incorrect or misleading results.

Polymerase chain reaction technology continues to evolve as an indispensable tool in diagnostics and beyond. Here at Gener8, we work with companies to produce a breakthrough in vitro diagnostic medical devices that aid in PCR techniques and other crucial applications. Push the boundaries and bring your device design to life when you work with the highly passionate and highly qualified teams at Gener8.

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