In these days of heightened public awareness of healthcare issues and an increasingly litigious society, who in their right mind would risk marketing an unsafe or poorly performing product? Nobody, of course; nobody would risk their reputation, let alone the financial security of their business, on a bad product.
Regulators, industry and patients all want the same thing: safe and effective healthcare technologies. Regulatory affairs is the mechanism to ensure that we all get what we want – medical technologies that are safe and effective by the time they get to market, yet reach the market as rapidly as possible.
So let us once and for all dispel this myth about regulatory affairs being a negative profession. Regulatory affairs is not about saying "no", but about saying "yes" – when the time is right. This means that regulatory affairs is both a core activity and controlling feature of the process to speed medical technologies to their potential users.
WHAT IS YOUR PRODUCT?
The first step to developing any new product is to understand exactly what it is. Ask this question and watch the enthusiastic inventor produce his cherished prototype. Then we frequently start the verbal struggle – "but what is it? What does it do? What is it for?"
The harsh truth is that the physical item is only part of the whole product. It is the words around the physical item that make the item into a product: the intended use, the intended patient population, the method of use, the environment of use (home, hospital), the claims, the contraindications and of course the marketing materials are what turns this lump of material into a medical device.
Frequently organisations get so obsessed with developing the physical item that they forget to develop the words. It is these words that determine the regulatory approvability of the product, the testing (laboratory and clinical) requirements. The future lies in integrated development: developing the physical item, intended patient population, method of use and marketing materials concurrently. Only by understanding the complete product at every stage in its development can we set a realistic strategy for development.
It is this holistic development that enables healthcare technology developers to start having meaningful discussions with regulators at an early stage, agreeing a protocol for bringing the product to market; hence removing roadblocks and taking regulatory issues off the development critical path. No one likes surprises in business and good early-stage communications are the keys.
It is important to use your regulatory professional to liaise with the regulators. One poorly chosen word from an enthusiastic product developer or marketer can add a whole new level of regulatory complexity because it raises issues in the regulator’s mind – and once such demons are raised, they prove very difficult to slay.
CLASSIFICATION AND REGULATION
Establishing an early agreement with the regulators on how the product will be regulated and the correct classification of the product are key to setting a regulatory strategy and protocol for bringing the product to a particular market. Again, it is the words – particularly about the intended use and claims – that count.
The nature of both healthcare and medical technologies is changing. Products are frequently used by a different group of care providers or in a different setting from those originally intended by the manufacturer. It is essential for manufacturers to keep abreast of these changes when developing a new product to understand the inherent risks associated with their developing design and the consequent regulatory issues.
Medical Technologies are increasingly complex and defy the old characterisation into biologics, devices and drugs. Frequently products are regulated differently in different jurisdictions: for example, there is a product that is regulated as a drug in Canada, a device in the USA and an active implantable device in the EU. Establishing how a product will be regulated early is the key to a successful international strategy – seeking approval at different times in different markets, based not just on sales potential, but ease of regulatory approval and the ability to use data generated from sales in one country in lieu of an expensive clinical trial in another.
In this environment, it is frequently regulatory possibilities and clinical practice that drive market entry strategies. Clinical data is frequently generated in an intercontinental manner, each piece building on the last and requiring only a small confirmatory trial (to cover population demographics such as ethnicity) to generate the submission information for a new market.
This approach, although time- and cost-efficient, has a potential pitfall: you are building a ‘house of cards’ that is only as strong as the weakest card. If this card folds the whole house will crumble, so applying the highest ethical and administrative standards to all trial work becomes a key activity.
At a time when many devices are being developed by venture-funded or spin-out companies, the ability to get an early launch in one market can be significant in generating cash to fund the further trials, regulatory submissions and introductions to other markets.
Similarly, launching an early product with limited indications and claims can be an important source of cash generation for further development. Together these ideas suggest a step-wise approach, which can dramatically reduce the negative cash-flow implications of product development.
The same technology (or new product) take-up profile is generally followed in every country. 5% are early adopters, 10% are followers and then comes the bigger hurdle of entering the mainstream, convincing the conservative and inherently sceptical bulk of the medical profession. Different markets will be at different phases, so in the development of multiple markets, a holistic strategy has to include consideration of funds generated from one market to support development of the next.
REGULATORY AFFAIRS AS PROJECT MANAGEMENT TOOL
If we accept the argument at the beginning of this article, that regulatory affairs is about the "the power to say 'yes' – when the time is right", then it is a corollary that regulatory affairs is a natural coordinating function and hence can be used a project management tool. In a holistic business plan, regulatory affairs is much more than a service activity; it is at the heart of the system both monitoring and driving progress to the predetermined goals.
Global thinking and project management are all very well, but the key resource of any business is its people. A holistic business plan is still doomed if people to not buy into it, and in particular of they do not appreciate how their role will change as the plan develops. In the beginning the plan is about development and design trying to achieve a functional product; then the emphasis switches to the product’s use and gaining regulatory clearance; and finally it is about the ability to manufacture, market and supply the product.
In the global strategy, because markets are being developed at different rates, different management team members will need to take the lead in different markets at different times. The key to implementing such a plan is to get a group of people who genuinely welcome and embrace this change and work for the good of the team and project, rather than for personal aggrandisement.
Planning is the key to any successful project, so integration of risk management and design controls at the earliest possible stage will pay dividends in the long run. It is always easy to see key milestones in retrospect, such as "when design starts", but difficult to pinpoint them at the time, let alone in the pre-project planning.
Many businesses fear a loss of agility through early introduction of a structured design process; this only occurs because the process is wrong for the business. At the earliest stage, the right process will generate a more structured, organised and analytical approach without any loss of creative ability or speed of response. To achieve this, the process needs to be designed around the people, business and product – trying to graft in or transplant a process from another organisation or, worse still, a general case standard inevitably leads to the feared loss of agility.
USING THE BUSINESS’S EXISTING PROCESSES
In this world where a company has to show compliance to multiple quality systems, the temptation to start designing a company quality management system from one or more standards has never been stronger. This may seem like the easiest way to meet all the various requirements, but in truth it remains a fast track to crippling a business.
It remains the case that companies and regulators still want the same thing: safe and effective devices – so if a quality management system meets the company’s needs, then it should also be broadly in line with all the various regulatory and quality system requirements and only require minor adjustments. The most important point is that a system written around the business’s existing processes will be easy for the employees to use and hence demonstrate better compliance in any audit or inspection.
The ability of an organisation to embrace change is the key to developing new products in fast-evolving regulated markets such as medical technologies. A holistic business plan that embraces technical, financial, marketing, clinical and regulatory considerations across diverse global markets is the critical tool in turning a great idea into a new healthcare reality.
This article is adapted from a presentation entitled ‘Speeding Medical Technology Advances to Market Regulatory Affairs: The Power to say Yes!’ by Neil R Armstrong to the Frost & Sullivan Medical Technologies Europe Forum 2005.