Here’s how the UK will regulate medical devices after Brexit

Image from Jonathan Chng on Unsplash

The United Kingdom issued an outline of how it intends to regulate medical devices beginning in 2021 after Brexit.

From Jan. 1, 2021, the responsibilities for the UK medical devices market that are currently governed by the European Union (EU) will be taken over by the Medicines and Healthcare products Regulatory Agency (MHRA), the guidance said.

Changes to how medical devices reach the market in the UK will be implemented over time, although CE Mark approval will continue to be used and recognized until June 30, 2023, as will certificates issued by European Economic Area (EEA)-based notified bodies.

After Jan. 1, 2021, all medical devices and in vitro diagnostic medical devices placed on the UK market must be registered with the MHRA, although a grace period for registering includes:

Four months for Class IIIs and Class IIb implantables, and all activ…
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Medbio acquires Polymer Conversions

Medtech contract manufacturer Medbio (Grand Rapids, Mich.) announced today that it has acquired Orchard Park, N.Y.–based Polymer Conversions.

The financial terms of the deal were not disclosed.

Polymer Conversions is a full-service medical device contract manufacturer that specializes in complex thermoplastic injection molding and value-add assembly. Its offerings complement Medbio, which specializes in cleanroom injection molding of plastic components for the medical and biotechnology industries.

“I’m looking forward to partnering with the PCI team to expand Medbio’s manufacturing capabilities, while reaching new customers and end markets,” Medbio CEO Chris Williams said in a news release.

Medbio is a portfolio company of Graham Partners, a private investment firm with a specialty in industrial technology and advanced manufacturing companies.

 

 

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Closed Fluid Delivery Systems: Unmet Needs in the Hospital and Home Care Environment

by Steve Bello, Business Development Director, Halkey-Roberts Corporation, St. Petersburg, FL.

Fig. 1 – Fluid delivery bag with integrated female valve.

The home healthcare market is growing rapidly and is forecasted to continue to grow at a CAGR of eight to nine percent over the next five years. There are several factors driving this growth including an aging population, increases in chronic diseases, increasing healthcare costs, and patient preference to receive care in a familiar setting. The delivery of fluids to and from the patient in applications such as infusion, drainage, and dialysis are increasingly being done at home. The need to make these procedures safe and easy for the home care setting can be a challenge with respect to infection control and exposure to hazardous fluids (drugs and bodily fluids). The introduction of easy to use closed fluid delivery systems will help to reduce and eliminate…

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Benefits of Fiber Optics in Medical Devices

by Steven Lassen, Senior Customer Application Engineer, LEMO USA

Fiber optics is being used as a backbone to many networking systems, which means that it is infiltrating many previously wire-only industries. Fiber optics superior capabilities in transmitting a wide range of communications signals is being recognized by medical device manufacturers and integrated into sensors, imaging and minimally invasive surgical systems.

What Makes Fiber Optics Better?

Data rates are continually growing faster for robotics and medical devices so fiber optics provides a better choice in networking. The basic difference between a wire system and a fiber optic system is that fiber optics sends data, in the form of light pulses, down the fiber cable instead of using electronic pulses through copper wires. Fiber optics is fast, has much larger capacity and provides faster data rates per size than standard copper wire. Fiber cables are thinner,  more flexible, typically str…

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Hiring the right freelance consultant

Medtech manufacturers have access to a large talent pool of PhDs, post docs and others whom they can approach when needed to streamline the journey from product idea to market.

Ramya Sriram, Kolabtree

(Image courtesy of Science in HD on Unsplash)

Medical device manufacturers may not always have all the skills to successfully bring a device to market in-house. In these circumstances, manufacturers with smaller internal teams can look for these skills elsewhere. For example, an increasing number of working professionals, including medical consultants in a range of fields, now choose to work remotely or as freelancers to have more flexibility.

Why hire a consultant?

Freelance scientists and researchers can support medtech manufacturers in a variety of ways, such as developing a device’s design, troubleshooting problems or preparing documentation for the regulatory approval process. This help is …

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Does plasma therapy work against COVID-19? NIH panel says data lacking

[Photo by Fusion Medical Animation on Unsplash]

More than a week after the FDA granted an emergency use authorization (EUA) for the use of convalescent plasma against COVID-19, an NIH advisory panel is saying that there is insufficient data to recommend either for or against the treatment.

The National Institutes of Health’s COVID-19 Treatment Guidelines Panel said in a statement released today: “There are currently no data from well-controlled, adequately powered, randomized clinical trials that demonstrate the efficacy and safety of convalescent plasma for the treatment of COVID-19.”

FDA commissioner Stephen Hahn already apologized on Twitter last week after heavy criticism for his statement that convalescent plasma donated by former coronavirus patients could reduce COVID-19 deaths by 35% — criticism that he acknowledged was justified. The FDA has taken heat over its decisionmaking a…

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Smith & Nephew is using vibrating bracelets to encourage social distancing

(Image courtesy of Tharsus)

Smith & Nephew (NYSE:SNN) having its employees wear devices made by Tharsus to help with social distancing as they return to the office.

A report in The Telegraph outlines how the London-based medtech company is providing vibrating bracelets from Blythe, England-based Tharsus to keep the six-foot (two-meter) distance widely recommended for preventing the spread of COVID-19.

Smith & Nephew held a three-week trial for Tharsus’ Bump system, which provides a “gentle, non-intimidating” vibration if two employees get too close, according to the report. The system was put to use in Smith & Nephew’s laboratories, warehouses and on its manufacturing floor.

One additional function for the Bump system includes collecting data to allow companies to monitor behavior and identify potential hotspots where social distancing may prove difficult. H…

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Smith & Nephew is using vibrating bracelets to encourage social distancing

(Image courtesy of Tharsus)

Smith & Nephew (NYSE:SNN) having its employees wear devices made by Tharsus to help with social distancing as they return to the office.

A report in The Telegraph outlines how the London-based medtech company is providing vibrating bracelets from Blythe, England-based Tharsus to keep the six-foot (two-meter) distance widely recommended for preventing the spread of COVID-19.

Smith & Nephew held a three-week trial for Tharsus’ Bump system, which provides a “gentle, non-intimidating” vibration if two employees get too close, according to the report. The system was put to use in Smith & Nephew’s laboratories, warehouses and on its manufacturing floor.

One additional function for the Bump system includes collecting data to allow companies to monitor behavior and identify potential hotspots where social distancing may prove difficult. H…

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Look outside your company for IP opportunities during unprecedented times

COVID-19 has caused many companies to hunker down, protect the status quo and embrace a conservative mindset. But some are taking this time to seek out intellectual property (IP) opportunities, and they are doing so in new ways and in new places.

David D. Headrick, McAndrews, Held & Malloy, Ltd.

(Image courtesy of Rohan Makhecha on Unsplash)

It is said that 80% of the information in patents is never published anywhere else. Despite this treasure trove of knowledge, many companies do not systematically examine patents others are pursing. Patent mapping — sometimes called landscaping — allows one to use search terms, patent classes and a database to see what patents others are pursing in a given field.

Years ago, this effort would entail excruciating, costly manual work. But today’s cloud-based software makes collecting and visualizing such information easier. For a given field, one can dete…

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Can you add connectivity to medical devices already in the field?

(Image courtesy of Joshua Sortino on Unsplash)

You can add internet connectivity to older devices if you identify the right combination of business goals, customer needs and technology solutions.

Piotr Sokolowski, S3 Connected Health

Many medtech companies require their devices to be connected to the internet. Connectivity can be added to the thousands of pre-existing devices in the field. Here are some guidelines to help you succeed.

Identify your business needs

You’ll need to identify a genuine business reason to justify the effort required from R&D, regulatory, operations and other functions. For internal stakeholders to back your project, explain how collecting data on the device will benefit the company. Offering tangible gains for particular departments is crucial for success here.

Examples of areas that can achieve tangible improvements from device data include:

Preventi…
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How to navigate regulations for in vitro diagnostics

Working through the regulatory requirements for IVD devices in your target markets can mean a successful launch into an industry segment poised for great growth in the coming years.

Claudia Sirch, Intertek

(Image courtesy of the National Cancer Institute)

In-vitro diagnostic (IVD) devices help detect diseases using samples from the human body, such as blood draws or mucus swabs. Examining these specimens provides essential information to identify, cure, treat or prevent illness. As populations age and pandemics such as COVID-19, SARS, and other infectious diseases sweep the globe, the IVD market is expected to grow, resulting in an increased demand for early and simplified diagnosis and rapid-test products.

IVD regulatory requirements

Global regulatory requirements for IVD products vary and often differ from requirements for other medical devices. In the U.S., Canada and Europe, requirements d…

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When to switch materials

Breaking the hold on single-source suppliers creates a less costly and more sustainable material supply chain for medical device manufacturers.

Lars Gerding, Freudenberg Medical

(Image courtesy of Freudenberg Medical)

Many medical device manufacturers are relatively “cemented into” using one material provider. Oftentimes, they are not aware of the full scope of materials available on the market that might fill an application.

In the prototype or early-launch stages of a product, the focus is not concentrated on the cost of every material used in a device. But as volumes increase, price becomes an issue and suddenly an OEM may find it is being held captive by a single-source supplier. This may be the time to switch from a specialty material to a standard material.

Other reasons driving the need for material substitution might be changes in the regulatory environment, such as a ban on cer…

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