Membrane Device Development for In Vitro Diagnostics

The surging trends of an aging global population, the prevalence of chronic diseases, and the rise in outbreaks of infectious diseases have helped to expand the growth of the in vitro diagnostics (IVD) industry in the past several years. The demand for personalization and ease of use in IVD products for consumers and the influence of information technology have helped to cultivate more innovation in the industry.

The point of care (POC) market segment, which includes medical diagnostic membranes and filtration solutions, has also benefited greatly from these developments. Yet there are challenges that come with the expansion and innovation for the IVD industry in general and for POC membrane and filtration products specifically.

Challenges in the Development of IVD Products

Many of the challenges for the IVD industry are typical for manufacturers in the medical device sector. For example, the majority of new IVD products are heavily regulated and are subject to a multi-step approval process which, in turn, may slow down or stall funding from investors. The amount of time it takes for an IVD innovator to win regulatory approval and proper funding to bring a product to market means that product development is at least 18-24 months behind technology and consumer expectations.

Other difficulties related to innovations for manufacturers of in-vitro diagnostics products are:

• The dearth of benchmark products and case studies
• Limited market intelligence
• Inadequate product specifications
• Maintaining testing accuracy and product robustness
• The retention of adequate, qualified personnel.

Also, when device makers bring a new IVD product to market, adoption, and reimbursement risks are high. Consumers may not be reimbursed by their health insurance plans for a new product, reducing the likelihood of mass adoption. And if the product's clinical utility is not proven, clinical laboratories may be reluctant to accept it.

Development Challenges for Medical Membranes

Manufacturers of POC medical diagnostic membranes and filtration solutions are confronted with most if not all of the same challenges that device makers in other segments of the IVD industry face. But another, more critical issue specific to the development of medical membranes and filtration solutions comes into play: the customization of POC solutions.

The Complex Challenge of Customization

In the IVD industry, and especially in the POC market segment, product customization is the rule rather than the exception. The challenge in customizing each device or test lies in the different and highly specific criteria it must meet. The diversity of needs in diagnostic testing for chronic and infectious diseases, the broad array of testing methods, and the assortment of design requirements for effective testing drive the customization challenge.

For example, companies that manufacture diagnostic medical membranes and filtration solutions must have strong expertise in producing a wide range of microporous membranes for applications such as lateral flow assays, blots, biosensor utilities, and gas and liquid filtration systems, among many others. Although the manufacture of such an assortment of products is challenging in itself, device makers that are agile enough to develop and manufacture a variety of membranes will be able to hold their own in the POC market segment.

Technical risk as it relates to membrane customization is also a significant challenge for manufacturers. The microfluidic systems that comprise diagnostic cartridges may not behave predictably, or assays that performed consistently in the lab may fail in another context. Sorting out the cause of the problem may mean checking to see if the assay chemistry is a good match for the material or if the on-cartridge fluid is insufficiently mixed. 

At the operational level, manufacturing and assembly for customized products may be difficult to scale. Meeting demanding quality control standards and keeping down the cost of consistently producing a diverse range of sophisticated POC products are issues that add to this challenge. Finding the appropriate raw materials without interruption in the supply chain can also be problematic for medical membrane manufacturers. 

Regardless of where the pain points emerge in the customization process, they all require time and funding to resolve. And time and money, unfortunately, are the critical variables needed in getting a POC product to market so that consumer and supplier expectations are met.

Future Challenges 

The projected growth of the IVD industry in the near term means that at least some of its current challenges, such as regulatory and funding problems, may not diminish to a noticeable degree. Obstacles in the regulatory environment, in particular, may become even more complex as agencies continue to piggyback new requirements on top of current rulings and approval processes for novel devices.

Markets in emerging countries such as China and India may prove challenging for U.S. and European IVD manufacturers due to domestic competition, diverse market demand even within a single region, and the chances of adoption of technology by healthcare providers in those countries.

And a number of diseases and conditions still do not have adequate coverage in the development of diagnostic tools, especially in the POC segment. These include rare diseases and those that are difficult to diagnose. The demand for early detection of serious diseases will also continue the pressure on device makers. Customization most likely will continue to challenge medical membrane makers, as the requirements for sensitivity and specificity for in vitro test applications for rapid disease identification become more urgent.

What's Next for Medical Membranes in IVD Applications

When planning for future products, manufacturers of medical membranes for IVD applications will need to take into account factors such as worldwide health issues, testing methods, technology, delivery methods, reimbursement requirements, and specialization. These factors, along with the trends and challenges noted previously, will keep the IVD industry dynamic in its growth process.

With that in mind, here are a few examples of IVD applications in which medical membranes are expected to play an important role in the future:

• Lab-on-a-chip (LoC). If sample preparation techniques can be developed and regulatory obstacles can be overcome, LoC technology has the potential to ultimately provide consumers with direct, relatively noninvasive, rapid diagnostic results for chronic diseases such as cancer and for infectious diseases as well.
• Evolving use of biosensors for real-time, non-invasive medical diagnostics. Two examples of this growing technology are smart contact lens sensors that can monitor physiological parameters and a wearable patch that samples sweat as effectively as blood over a period of several hours for diagnostic purposes. 
• Continued improvement in molecular diagnostics. Next-generation sequencing has great potential in becoming more accurate, and many more disease targets will be identified. LoC will be an enabling technology for high throughput sequencing.

Conclusion

Global health trends are pushing device makers both large and small in the in vitro diagnostics industry to balance considerable challenges with the tremendous potential of new technology and applications. Medical membrane and filtration solution manufacturers that work in this industry, especially in the point of care segment, must be just as dexterous: they must balance specific "no size fits all" customization challenges with continuing to meet the rising demand for novel diagnostic devices and tests that are easy to use and produce rapid, accurate results.