Have you ever grilled your regulatory personnel: ”What does it cost?” or “How long it’ll take?”.
Regulatory personnel, how often are you milked for the answers?
I think the answer from both is “Often”.
The questions are common in health tech companies. The industry is highly regulated. It takes time and money to play the regulation game. That’s why companies and investors are interested in how fast they can get the regulations under their belt (sales can begin), and how much money they’ll need to spend doing it.
Completely understandable. And human.
But. The way health tech regulations and regulatory management are judged above all and especially through the cost and delays they bring, is one-sided.
There’re more layers in regulatory management than what meets the eye. It can bring significant value, benefit and advantage to the company.
Make your business smarter.
Let’s dive into the 5 ways.
* * * Please note – this is English version of the blog post Terveysteknologian regulaatiohallinta: 5 tapaa miten se tekee liiketoiminnastasi fiksumpaa
1. Regulatory management helps you save and earn
Regulatory management performed by regulatory personnel is one key factor that a health tech company can use to keep costs in control and maximise market earnings.
With regulatory management, you can find out what costs the company has to bear from conformity assessments, marketing approvals/clearances and registrations in different market areas. Regulatory professional can take care of, or instruct, mandatory marketing approval/clearances, registrations and certification procedures right the first time, which will show right away as cost savings.
When your health tech medical device is on the market, regulatory personnel needs to renew the device’s marketing approval, registration or certification at regular intervals. The more proficient regulatory expert, the more affordable this process will be for you and device sales can continue uninterrupted.
Incidents may occur to the user or patient with the device, or the user may want to give feedback, perhaps complain. Those aren’t the end of the world as such. But what is a bigger issue and can become costly, is if the incidents and feedback are not handled efficiently and systematically, as regulations oblige. A harmless looking thing can grow into a nightmare that causes noticeable image harm. Now that’s expensive to fix.
Regulatory management saves time, money and nerves.
2. Regulatory management improves strategic business
When a health tech company wants to sell its medical devices to different countries, they are going to run into each country’s laws and regulations. If you’re unfamiliar with them or don’t know how to work according to them, the running into will become a concrete collision which will prevent sales from starting.
If the medical device’s risk class hasn’t been defined at the beginning of product development or it has been defined wrong, it can mean marketing approval/clearance or registration process to be put on hold. Product development needs then to conduct more verification and/or validation to be able to finish the marketing approval/clearance or registration process.
Because health tech industry is complex and includes more risks than many other industries, companies need a regulatory strategy. It’s used to get an understanding of the target market requirements, the right regulatory approval/clearance path and schedule of regulatory approvals. To avoid costly mistakes.
Health tech manufacturers who anticipate potential regulatory challenges earliest possible during product development can bring their devices to the market the fastest and most efficiently. Risks are identified and mitigated in good time. Expensive corrections don’t need to be made near the finish line. Even investors appreciate the efficiency of commercialisation and predictability of costs.
Business makes strides with regulatory management.
3. Regulatory management increases transparency
Health tech regulations demand more and more transparency. For example, EU MDR requires public visibility of manufacturers’ devices on the market and their recalled devices, economic operators, post-market surveillance, etc.
It means A LOT of information (read: documents). And they are not coming from one person. Actually it calls for the input and cooperation of several professionals and expert areas at one manufacturer.
Because regulatory management is critical for the success of a health tech company, companies should capitalise on the pressure it brings to increase transparency. After all, transparency is generally considered a competitive factor in the business world. The company transparency required in regulatory management will benefit the company itself.
The less borders, silos and communication blocks a company has, the more efficient its operations are. The more comprehensive external requirements (such as regulations) are understood companywide, the better results the company gets. Faster. More cost-efficiently. It shows to investors and partners too.
Regulatory management boosts business transparency.
4. Regulatory management sharpens decision-making
For a company to make wise decisions and avoid costly fumblings (costs are often used in the same context with regulations), it needs information.
For instance, information on the changing regulatory requirements. They are always appearing from some direction: directives become regulations; guidances are updated; standards are revised. They can directly impact product development, labelling, testing, technical documentation. Just to name a few.
In regulatory management, people are constantly absorbing information on changes and putting it into use in the company with trainings and guidances. Keeping everyone aware of what needs to be done next. Creating a dynamic navigation for the company to help it avoid expensive rocks.
A company has a good foundation to make wise decisions when it has regulatory intelligence. The competence of regulatory personnel is the key. For example, where time and money should be spent in each product development phase makes a difference to the company and its investors. Each party is expecting return of investment. Regulatory intelligence helps to make wise decisions.
Regulatory management makes company decision-making stronger.
5. Regulatory management secures public relations
Health tech devices are difficult to bring to the market without partners. Notified Body, certification organisation and authorities in different countries are examples of typical regulatory actors. Working with them, the manufacturer can bring its device to the market and keep it there.
Regulatory actors can however be very demanding, ask really detailed verification of devices and require several documents from the manufacturer as a condition for giving green light. Manufacturer needs to be able to respond to them – and usually quickly. Regulatory management personnel can.
Regulatory management knows the right contacts, their way of working, communication channels, relevant documents, even wordings that meet the criteria. These are used to build and maintain confidential relationships with regulatory actors on behalf of the company. And – once again – help the company save time, money and resources in bringing the device to the market and keeping it there.
Regulatory management is a strategic partner to company’s top management. Regulatory management keeps up company’s good standing in the regulatory actors’ eyes, and if needed, knows how to get it back on its feet. It can play a pivotal role in getting the device to the market and keeping it there. For that reason too, companies need regulatory management to succeed.
Regulatory management takes care of critical regulatory relationships for the company.
To conclude, regulatory management brings smart value, benefit and advantage to a health tech company. It helps save time and money, and strengthen device earnings on the market. Regulatory management makes company’s strategic operations more effective, while promoting business transparency. It also supports company’s decision-making and protects crucial regulatory actor relationships.
Health tech companies should definitely take advantage of regulatory management in key decisions, because the best foundation is then laid to the success of business and innovation in a highly regulated environment.
Let’s talk more about how to keep you on the path in regulatory jungle: