Navigating medical device development data from beginning to end

A medical device travels a long path before it’s put into use, from the initial design to final regulatory approval. While different people are involved at every stage, it’s important to maintain communication through clear, comprehensive data throughout each process. Manufacturing falls in the middle of the production chain, so medical device manufacturers must look backward and forward to ensure they’re creating a product meeting strict regulatory requirements – before physical production even starts.

Better product data for better clinical trials

“It’s crucial medtech leaders really understand their manufacturing process and have a well-defined approach leading into the study so they’re making material that’s representative not only of what is going to be submitted in an IDE [investigational device exemption] but then potentially subsequently submitted in a premarket approval, 510(k), whatever requirement it may be across the globe,” says Paul Swift, head of Regulatory and Clinical Affairs, Americas, at ZEISS Medical Technology during Veeva MedTech Summit. “The more changes in process you have throughout that time, the more data you need to be able to support your subsequent submission. It just makes things more challenging. So, if they do a good job of pinning down their suppliers well in advance, that really helps.”

ZEISS Medical Technology’s largest business unit is ophthalmology, followed by microsurgery, which encompasses dental; neurological; ear, nose, and throat (ENT); spinal; and radiotherapy specializations. Swift is responsible for all regulatory and clinical activity across these sectors, covering a large geographical region. Needless to say, he works with a lot of data and information.

The challenge is to manage all that data – and the many people who handle it – while making things as easy as possible for the clinical study participants.

“The last thing you want is for a participant to be frustrated by your study process,” he continues. “That can impact your data, and that subject can very easily become lost to follow up if they get too frustrated. Making it easy at all levels when we’re capturing and transmitting data is probably one of the biggest challenges we face.”

Swift listens to study coordinators, clinicians, and patients to understand their needs throughout the study and ensures every study includes a diverse representation of subjects. Ultimately, data collected through clinical trials should fully represent the population using the medical device – this goes a long way toward building trust and makes the most sense scientifically.

“One well-designed clinical trial, designed to account for large variances in population – especially when you think on a global basis – is a lot more effective than executing two or three smaller scale studies,” he points out.

Regulatory awareness

Manufacturers can impact the clinical trial process by, as Swift mentioned earlier, having a clear objective from the beginning and coordinating with designers, engineers, material suppliers – everyone involved with the initial stages of development – to ensure that objective is achieved as smoothly as possible. At the same time, they should be in contact with the regulatory professionals to clarify that objective and make sure everyone’s on the same page.

Like any important endeavor, the medical device development process will have setbacks and obstructions along the way. Manufacturers are well aware of the need to quickly adapt to changing technology and medical advances, but regulatory professionals must be even more tuned into what’s new. Regulations shift quickly and differ between regions, so a regulatory intelligence professional must be prepared for constant learning and pivoting.

It’s a job with a broader range of responsibilities than many people expect, says Darren Thain, director of Global Regulatory Policy and Intelligence at Smith+Nephew – even for a position with the word ‘global’ in it.

“It’s not just looking at standards and legislation but also looking at competitive market intelligence and other competitor information,” he explains. “I need to keep up to date with what’s going on, what’s changing, and how others are responding to the regulatory environment.”

Meeting these challenges requires a proactive, rather than reactive, approach – while still maintaining the flexibility allowing for quick changes.

“It’s no good finding out, when you’re ready to launch in the market, that you haven’t taken into account a change in the regulation you weren’t aware of,” Thain says. “That can range from a labeling change to a whole redesign. You need to build that into the regulatory strategy affecting the commercial launch plan on the proactive side. There’s no point in starting to develop a product or design a device that’s going to run into additional regulatory hurdles, or things that haven’t been considered in the future.”

The importance of communication

Sterile data may seem the opposite of human experience, but they impact each other closely on the path to developing safe, effective medical devices – so it’s up to everyone at every stage of device development to ensure the data supports the patient. Communication and networking are key. Thain points to trade organizations as excellent resources for people at different parts of the development continuum to connect and share information. Pay attention to what regulatory professionals say through these networking opportunities, he emphasizes, because they share a lot of valuable information affecting the design and manufacturing side of medical device development.

Thain has bad news for anyone who’s frustrated with the complexity of the regulatory landscape – things aren’t going to get any simpler. New regulations are continuously being developed for things that, while they’re not medical devices themselves, directly impact them. The most obvious example is artificial intelligence (AI), but others include environmental regulations related to design and sterilization methods, the batteries powering many medical devices, and other interconnected factors many people that don’t work in regulatory may not even think of.

“The regulations aren’t getting easier to understand,” Thain says. “So, we’ve got to empower our regulatory people. We’ve got to train them up.”

Tunnel vision is generally detrimental to any profession, but in manufacturing – especially of highly regulated products such as medical devices – it can cause a great deal of damage in terms of wasted time, lost revenue, and potential safety risks. Even the simplest medical device requires careful thought, planning, flexibility, and communication at – and across – every level.

ZEISS Medical Technology
https://www.zeiss.com/ meditec/en/home.html

Veeva MedTech
https://www.veeva.com/medtech/

Clare Scott is managing editor for GIE Media’s Manufacturing Group of publications. She can be reached at CScott@gie.net.