Innovative and holistic approach for medical device development

Medical and in-vitro diagnostics (IVD) devices help to save lives, diagnose and treat diseases, and offer pain relief. And because of their strength, versatility and durability, plastics have become the material of choice for such devices. But how do you keep up with all the innovation on the market? Which polymer is most suitable for a new medical device? And how do you get your device approved? The medical polymer experts at IMCD can help you navigate the entire process.

 

17 November 2023 |  5 minutes read | Share case study:  

In 2021, the medical technology market in Europe – dominated by Germany, France, the UK and Italy – reached about €150 billion, having grown by an average of 4.8% per year over the past ten years.  And in an increasingly complex environment with more sophisticated equipment every year, it continues to grow. Moreover, there are upwards of 500,000 types of medical devices on the European market, according to the EU Commission. These range from low-risk devices like stethoscopes and tongue depressors, to medium-risk devices like syringes and catheters, to high-risk devices like pacemakers and stents. Meanwhile, IVD devices include blood sample tubes, pregnancy tests and HIV status tests. In other words, the potential applications for medical and IVD devices are vast and wide ranging.

Feeding the need for innovation

The European population is an ageing one, which means innovation in the medical industry is vital. But this development isn’t new: innovations in medical device technology have been rising steeply for a few centuries already. Take the urinary catheter, for instance. The most primitive methods for draining urine from the bladder using reeds or straw go as far back as 3000 BC. In the 18th century, rubber came into use, making the treatment less painful. Then, in the 20th century, latex became the material of choice. Nowadays, catheters with complex balloons made of combinations of polymers like silicone, PVC, PEBA, PA, TPU, PET and PTFE are used, guaranteeing easy and safe treatment for patients.

IMCD’s focus has always been to help customers bring innovations to the medical technology market.  For example, IMCD worked with a producer of membranes for monitoring fluid pressure in bloodlines. With our support they developed a silicon-free solution using thermoplastic elastomers to significantly improve the gas barrier. For patients, it means more efficient treatment while being assured of comfort and safety.

As a specialty distributor of raw materials, especially medical polymers, IMCD has established a broad network of customers from all stages of device development – from initial design through market launch.

Navigating the complexities of medical device development

The development of medical devices can be a long and complex process. Stringent testing, clinical studies and rigorous documentation are all factors that need to be taken into account. High upfront investments are often needed, and the lead time from initial design to final launch can be five to seven years or more. Once launched on the market, however, a device can be used to help patients for 20 years or even longer.

Take pre-filled syringes (PFS), for example. As they are in contact with the drug inside for an extended period, long-term studies need to confirm that the medium will not attack the polymer and the polymer will not migrate into the medium. IMCD is working on a number of PFS projects, one of which is now in its eighth year.

All of this means that optimising the time to market is key to the success and profitability of a product. Quick response times to requests for regulatory documents of the polymer material or for sample material are fundamental. IMCD’s medical polymer experts have decades of experience in helping customers’ projects through the various development phases – from technical knowledge of the materials themselves through to understanding regulatory requirements and application-specific details.

Securing the process

Where innovation meets development, protecting intellectual property while sharing all the necessary information with the various parties involved in developing a medical device, is crucial. That’s where a non-disclosure agreement (NDA) comes in. An NDA can be signed by the designer, development company, original equipment manufacturer (OEM) and IMCD. But it can also involve the polymer producer, if desired. At the same time, long-term, stable, sustainable supply of raw materials is central to the success of a project: signing a quality agreement ensures that supply and specification details are properly set upfront.

Medical polymer producers usually have their own policies relating to the applications that are supported for use: for example, the amount of time that a medical device can safely be in contact with bodily fluids. These policies often contain a warning that the polymer producer reserves the right to stop supply in case of non-compliance. IMCD can also help its customers navigate these various policies.

Smoothing the way

Having developed an innovative product, attracted investment, protected the intellectual property and found the right polymer material and corresponding supplier, another step is to request approval from so-called notified bodies. A notified body is an organisation designated to assess whether a medical device fulfils the legal requirements before it can be sold on the European market. And this can be a challenging process: any change to the polymer composition can be fatal for the validity of the approvals.

While change is undesirable, it’s sometimes unavoidable. In order to reduce risk, it’s essential to have a sound notification-of-change (NOC) process in place. IMCD has NOC agreements with all its medical polymer suppliers. These agreements include details about how far in advance a change needs to be notified, and whether a final buy option can be granted.

IMCD’s medical polymer experts know how to manage this process as smoothly as possible, by providing information well in advance and by understanding the options for re-assessment and re-certification. For example, a recent change in production site by a supplier of polymers for medical extraction devices required close cooperation with customers to share the extensive data and samples required in a timely and fully transparent way.

IMCD's expertise in medical polymers from start to finish

Teamwork – working closely with all stakeholders involved in medical device development, including design companies, start-ups, academia, contract manufacturing/development organisations and OEMs – is imperative. IMCD has exclusive partnerships with market-leading producers of medical polymers, which means it can offer a broad portfolio of polymers as well as expertise in selecting the right polymer material for the specific medical application.

To get the most benefit from the partnership, it pays to involve IMCD’s medical polymer experts at the earliest stages of development. Because upfront knowledge translates into better advice later in the process. Find out more about the solutions that IMCD can offer.

Jana Zietzling

Head of Product Management Medical, Advanced Materials