Author Archives: Matthew Theobald

Which option would you choose?

You’re running late, you’re hungry and won’t have another chance to pick up something to eat before your journey.

There’s a busy food retailer nearby, and you go in to find something to tide you over, scanning the sandwiches, wraps and salads. A couple of the products on offer look safe to eat, but there’s no labelling on the shelf or the wrapper about allergens.

You are faced with three options;

  • Buy the product that looks like it would be safe to eat,
  • Leave the shop and search for something else, or
  • Join the queue for the counter and when you finally get there, ask for the allergens information folder, to search through for the information you need.

Which option would you pick?

For those with food allergies, It is hard enough finding safe foods to eat when you’re out and about. How challenging it must be, especially if you’re not confident in public, to have to ask at the counter for information on allergens. You’re then probably confronted with a folder full of hard to find, hard to read information.

When you’ve plenty of time to sift through the information, it’s a large emotional burden. When you’re pressed for time, how much harder must it be to take those steps.

For many in the UK, the unfolding story from the family of Natasha Ednan-Laperouse this week was heartbreaking. The paucity of legal requirements for food labelling was hammered home by the experience of Natasha’s Grandmother, who went into her local branch of the national chain in question, and asked for allergen information for the same sandwich her Granddaughter had eaten. She recounted the stress and difficulties experienced in asking for and then struggling to understand allergen information from within a folder.

As of this Wednesday, the company at the centre of the storm have agreed to steps that ought, one might be forgiven for thinking, have been in place for years – placing food allergen information on freshly made products. The company were complying with the law on food labelling. However, that law includes a loophole permitting establishments that prepare food freshly on the premises to simply have a folder available on request with allergen information. It is even permissible to impart the information verbally to the customer.

It shouldn’t take the death of a person for change to happen, but so often it does. In light of the Coroner’s findings in this family’s case, a review of current Food Labelling legislation has been promised by the UK Government.

You only have to look at the history of medicines regulation to see that many pieces of legislation were put in place as a result of human tragedy. Thankfully, there are now regulatory requirements for labelling and Instructions for Use on all medical devices and drug / device combination products

Even so, when developing a new product we must be mindful of what else the user or patient may have to contend with whilst using our device. Ask yourself, is it reasonable and practical to use the materials we provide with the product. If the answer is “no”, how else might the product be designed to reduce uncertainty over its use, how could information be better provided, to be more readily accessible to the user?

Considerations for Usability studies for medical devices with complex user groups

Medical devices, and combination products, are typically targeted at therapeutic areas with large patient populations, so recruitment is fairly straightforward. Usability studies recruit participants from groups of representative users, commonly from;

  • Healthy, able bodied adults,
  • People with Type II Diabetes,
  • People with Rheumatoid Arthritis,
  • Non-specialist Healthcare Professionals.

Key aspects of the study design must be tailored to the representative users and adequate to deliver a sound piece of development;

  • Participant informed consent,
  • Study design ethics,
  • Participant data protection and anonymisation,
  • IRB or Ethics committee review, where required.

And of course, design the study to provide the maximum feasible insight into the device design, Use Errors, and risk mitigations, gathering data that can be directly related to design inputs and envisaged design outputs, all whilst ensuring the cognitive burden upon participants is appropriate.

Developing a medical device for a challenging user group

There are additional challenges when you’re developing a medical device for an unusual or complex group of users.  The picture is further complicated when you’re developing a medical device that is intended for use by several, disparate, user groups.

Specific additional requirements arise for study design, when the user groups include;

  • Minors (i.e. people under the legal age of majority), either as a discrete and separate user group or as a sub-group,
  • Vulnerable adults,
  • Disease groups with extremely low incidence, or
  • Specific specialisms of healthcare.

When you’re considering designing a Usability study for a device for these user groups, consider how you’ll address;

  • Recruitment of the participant and their parent/guardian,
  • Identifying a study centre (or centres) located where there is a sufficiently large pool to recruit from. Achieving adequate participant numbers often results in conducting your study across multiple centres,
  • Working with a recruitment partner that can adapt to the unique challenges these groups present,
  • Consent and involvement of someone with parental responsibility in the study,
  • Design of study documentation to ensure both the carer and participant are able to give informed consent based upon information that is understandable to them,
  • Identifying study facilities that are suitable for the particular needs of your participants (e.g. venue and study room access).

For low incidence disease groups, evaluate the number of participants you’d want for a study against the numbers of people, in the chosen country, who are likely to fit the anticipated inclusion criteria.  This will guide your thinking about how many people are needed/can participate in your Usability study, forming part of your rationale for the study design.  You may even decide to hold the study in another country than originally envisaged, to get sufficient participants involved.

Evaluating external support

Often, development teams look for external support to Usability study design, execution or reporting.  If your project is in that situation, it would be sensible to include some or all of the considerations we’ve mentioned, in your discussions with potential suppliers, particularly for complex study requirements.

Answers to these questions will help you select the optimum support package to ensure you get the most out of the study.

Benefit from our experience

We have undertaken a number of studies that involved challenging user groups like those described above, both in the UK and North America.

As a result, we have developed strong relationships with expert recruiters and study facilities across the UK, East Coast USA, Midwest USA, Canada. These organisations understand the specific requirements and constraints, to support successful formative and validation studies for our clients.

Perhaps your development project involves an unusual or challenging user group demographic? Get in touch today for support in delivering a Usability programme and studies that meet your requirements from the start.

9 changes to FDA goalposts for medical devices

A potential silver lining for medical device developers and manufacturers exists in the FDAs response to 2016 “21st Century Cures Act”, with publication of a draft Guidance document outlining the agencies planned changes to the medical device approvals process and their oversight activities.

The 22 page document makes for heavy reading, so we’ve highlighted some of the key points that you should be aware of as you manufacture or develop medical devices for the US market.  Many of the changes will have a positive impact upon your preparations for marketing authorisation submissions; 510(k), PMA, De Novo, IDE, etc.

 

1. 510(k) exemptions

FDA periodically reviews premarket and post-market activities to identify Class I and Class II devices that no longer require a 510(k) submission.  The list of exemptions is regularly updated, so it is worth checking before setting your regulatory strategy for a new medical device.

2. Enforcement discretion

Additionally, enforcement discretion is being exercised for certain products, to focus oversight on medical devices that could pose a higher risk to patients.  Information can be found for specific product codes by searching the FDA product classification database for submission type: “Enforcement Discretion”.

3. Changes to part 820

As we recently reported, FDA plans to replace parts of 21 CFR 820 (Quality System Regulation) with requirements of ISO 13485:2016, harmonising with other key regulators around the globe.  This will remove a significant barrier to entry for manufacturers, particularly the smaller organsiations.

4. Aligning expectations with other regulatory authorities

FDA expects to be in a position to leverage data and regulatory decisions from other regulatory authorities, by aligning requirements other regulators’ requirements.  The focus will be on reviewing scientific data, rather than the methods used to generate it. The agency plan includes recognition of additional international standards, to facilitate the move.

5. A “bottom-up” approach to request for information

FDA will request from manufacturers the minimum information needed to address questions or issues. The agency will consider a “bottom-up” approach to data requests, so in some cases descriptive information (such as dimensional analysis or materials comparisons) may be all that is needed. If that proves insufficient, it may be that some non-clinical performance testing data is required.  Animal or biocompatibility data or ultimately data from clinical investigation may be requested if none of the earlier data sources provide adequate data to address the question or issue at hand.

6. Manufacturer submissions

Manufacturers will be expected to submit materials that are “least burdensome” to review/assess.  Your documentation needs to be concise, well organised and clear.  Including rationales for responses to agency questions will go a long way towards expediting review and promote open communication with the FDA.

7. Use of post-market surveillance data

Consider where post-market surveillance data can be utilised, instead of gathering new data from pre-market investigations.

8. Alternatives to Clinical Investigation

Alternative sources of clinical data, such as;

  • Peer reviewed literature,
  • Data generated outside of the US,
  • Real-world evidence and,
  • Well documented case histories,

may be used, where it is appropriate to help assessment of device safety and effectiveness.

9. “families” of medical devices

Bundling of submission documents to cover multiple devices, or indications, within a single submission, may be an appropriate route for agency review, where scientific and regulatory issues for the devices / indications can reasonably be dealt with in the same review.

Related Information

As you’ve read this far, it’s fairly safe to assume that the topic of regulations and quality management interests you.  You can search and read other articles in this topic here: http://threecircles.eu/category/quality/

FDA Quality System Regulation and ISO 13485

A ray of sunshine has appeared for medical device developers seeking to market their devices in the US as well as other territories.

Often, manufacturers wrestle with ensuring that their development process, activities and documentation aligns with both ISO 13485 and the Quality System Regulation (21 CFR 820).

US FDA has announced plans to harmonise the requirements contained in 21 CFR 820 with the content of ISO 13485:2016.  There is planned to be a fundamental revision to part 820, that will “supplant the existing requirements” with the content of the revised 13485 standard.  The agency intends the changes to reduce the compliance and record keeping burdens on manufacturers.

For the canny development organisation, little will actually change, as they will have planned their activities to achieve compliance with both the US and other territories requirements at the same time.  FDAs intentions will make their lives a little easier, removing the need for  translations between, for example document names, from the standard and part 820 terminologies.

For people embarking upon development with an eye on the US market for the first time, there’s likely to be one less hurdle to surmount once FDA’s intentions bear fruit.

Ultimately, the plans are good news for manufacturers who develop and market products for the EU, Japan, Canada, Australia (and the US), as all have regulatory requirements aligned with a single Quality Management Standard – leading to a reduction in compliance requirements for manufacturer Quality Management systems.

You may be thinking about seeking reassurance that your medical device development plans adequately address the regulatory requirements of the US and ISO 13485:2016 aligned regulations.  Get in touch with our team today.