Medical Device Development

Defining and Planning the Product from idea to Market

I’m passionate about Medical Device development because of it’s unique combination to the noble cause in creating something that can change and save lives, as well as the engineering elegance in building something to high quality and good practice standards.

Developing a medical device is basically developing a device, with an additional effort aimed for satisfying particular regulatory needs. There are certain steps in the development of a medical device to be aware of, and these span from the idea stage all the way to the sales and support stages.

In this article I will put emphasis on the two major aspects that are must, before you start developing a medical device: Regulatory requirements, and Market considerations.

Intended Use and Classification

The first step of your medical device definition starts by its medical Intended Use; such as, is it intended for therapy, treatment, or diagnosis for example.

This usage leads to classification categories depending on the risk of harm to the users. Surgical and life supporting devices being the highest classified.

I encounter many brilliant well meaning innovators who, unfortunately, miss on the importance of this step at early stages of the product development, and wait until they have an advanced prototype or even a full product ready for submission, before they start thinking about classification.

I will elaborate on how this impacts planning shortly in this article.

Another aspect to classification is that it’s not necessarily relevant to the whole device. One device could have many parts and each may have its own classification; for example a system with two parts, say a smart watch collecting and transmitting data, to a cloud engine to analyse the data, could probably mean two different classifications for these two parts.

Standards and directives

A medical device requires a regulatory approval to sell it in a specific region. Usually this is per country (TGA for Australia, FDA for the US, PMDA for Japan, etc.)

Regulators rely on directives that explain the regulatory process, backed by process-oriented standards of quality. For example, the European ISO-13485 for medical companies and the ISO-14971 for establishing risk management process.

If your medical device includes software, the IEC-62304 is dedicated standard for the process of developing medical device software. In the last decade the notion of ‘software’ has been expanded to virtually include any piece of code controlling a programable unit (including embedded software, firmware, or even configuration of a HW module”.

In addition to process related standards, there are detailed quality and performance standards, such as the ISO 60601 risk for medical electric equipment or ISO 10993 for biocompatible materials that contact the human body; or RoHS directive related to using environmentally hazardous materials such as Lead and Mercury.

Then there are detailed and explicit standards to test specific categories of devices. Such as Dental, Respiratory, CT machine, Masks, etc.

In addition to all these, there are certain guidelines relevant to the certification of devices (not necessarily medical), such as Safety of electric devices, or using batteries, or emitted radiation when charging a device, etc.

This is certainly not a comprehensive list, and many countries have similar requirements, but the point is to know what is needed for your device. Understanding the standards relevant to your device, allows for a more robust development process; also it allows seeking relevant suppliers that follow these standards. Planning your activities accordingly can become a make or break factor to your success.

My advice is always to complete the mapping of relevant standards to your device before you start! Understand the complexity and what is required upfront. This could help you estimate the funds you need better; or have the realistic timelines to market; or even define your MVP in a way to avoid some standards if you can, at least as you start!

Regulatory Submission

Approving a medical device follows a submission process to a regulatory body in the relevant country of sale. Understanding and planning for a balance between the needs of the technical development plan and the regulatory strategy, is crucial to achieve a reasonable time-to-market. The key point to understand is, you cannot sell, and sometimes cannot promote, your product without the regulatory submission process.

The common factor to medical device regulation, is the request for compliance based on three key things: create a quality system, follow it, and have evidence that you followed it. The effort will depend on the device’s classification. This is where proper quality procedures that follow the standards could tremendously help adding value to the development process to avoid redundant efforts or missing out. Especially that blindly applying rigout could become a very expensive tick-the-box bureaucratic exercise. In one extreme case coaching a medical device development team, I found their development processes were costing 30-40% of the development budget!

Market and Post-MArket considerations

Innovators today understand the importance of product-market fit solutions, and the importance to adapt the plan to users’ needs. In Medical Device development this is even more crucial. Marketing and Sales strategy as well as maintenance needs, so called “post-market” considerations, have direct impact on the definition of the product and should be defined as early as possible, and could become a severe risk to the overall success of the product.

I've seen more than often development teams take the easier route focusing on the technical aspects with minimal information and understanding of the product, to rush (hurriedly, rather than speedily) into a development phase assuming progress is in hand.

This inevitably leads to more and more changes as the non-technical teams catch-up and learn more, be it  marketing, customer service, purchasing, sales, etc. Whereas, mapping the information from these teams as early as possible, can provide the broader picture to put efforts and budgets in the right direction at suitable stages of the development, as part of a measured plan and not as a mitigations to problems.

Here are some Use Case related questions you need to clarify, and I hope you see the importance of clarifying those before you start development:

• Will the device be used in a hospital or clinic environment? Is it then operated by a patient, or a professional surgeon, physician, nurse or under their supervision?

• Is this a home device, bought over the counter by the patient directly?

• Is device is prepared and controlled in the clinic or hospital, and borrowed by the patient for the period of the test.

These in turn will lead to further usability aspects to take into account, such as:

• Consider which parts of the devices are consumable single-use, leading to impact on costs and ROI, disinfection considerations, and even waste management directives.

• Aspects of maintenance to the device, who will do it, and where.

• Environment of use, for example should it be wearable which might require special design or even made reasonably fashionable!

Another connection between classification and intended use with market considerations, is that of reimbursement. These have direct impact on costs for example, both of the product and each procedure using it. You start exploring other sets of questions, such as:

• Is imbursement relevant? by public or private health insurance?

• What intended use will make it possible as the device competes with other existing medical procedures?

The more elaborate these questions, their investigations, and the insights learned from them, the better defined the product, and the less unfortunate surprises you might find. The more you uncover and know at early stages of the product development the better you could prioritize and manage risks and tradeoffs in your planning.

To summarise, early planning and preparations for a medical device taking into consideration both pre-market and post-market stages, are crucial to avoid years of delay, wasted efforts and exaggerated budgets.