Top 5 Misconceptions Medical Device Startups Have

Medical Device Startups

All startups face similar set of challenges in the early days – fund raising, managing project timeline, establishing relationships with suppliers, engaging potential customers and the list goes on. However, for medical device startups, we know there’s another uphill task – complying with the regulation/law.

Most startups that we have met had a common misunderstanding – compliance revolves around the medical device itself. Most think that they only need to focus on developing a safe and effective medical device, seek approval from the respective health authorities and can start commercialising! They did not realise that compliance includes the setting up of a business structure within the organisation first. This structure should not only define how your team runs the daily operations, but also demonstrates how your organisation can meet the regulation/law of the countries that you intend to sell your medical device. This structure is known as a “Quality Management System (QMS)”.

 
QMS is a set of processes within the organisation to identify, measure, control and improve core activities to meet customer and regulatory requirements applicable to your organisation’s medical devices and related services.
 

Most countries have also recognised international standards that are published by committees, such as the International Organisation of Standardisation (ISO), as the fundamental requirement for compliance. For medical devices, the ISO 13485 is the widely adopted standard worldwide, while the U.S. has their own unique system known as the U.S. FDA 21 CFR Part 820.

The Misconceptions

Below are the top 5 misconceptions about the ISO 13485 that most medical device startups have:

1. My organisation owns the medical device but does not need to be certified to ISO 13485 because I’m not manufacturing my medical device.

We hear this as one of the most common statement that associates the ISO 13485 accreditation to just the organisation dealing with manufacturing.  However, the standard states:

This standard is applicable to an organisation involved in one or more stages of the life-cycle of a medical device, including design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, and design and development, or provision of associated activities (e.g.technical support).

Thus, in the situation where you have outsourced ALL your processes, the health authorities would still expect to see your organisation take ownership of your medical device and be certified to ISO 13485.
 

2. I don't need to be certified to ISO 13485 yet. I would look at it at a later stage.

It’s true that when you are at the earlier stages of product development, e.g., at the stage of defining your design specifications, you need not be certified, BUT you should start complying with some ISO 13485 requirements. Some people called it a “bootstrapped” structure – basically, setting up and adhering to a few key procedures first before setting up the rest at a later stage. This will prevent all the last minute scrambling on documentation when you need them - investor due diligence, grant application, partner collaboration, customers’ request, ISO 13485 audit/certification and many more!
 

3. I need the ISO 13485 certificate ASAP so I can to get my medical device into the market quickly.

Most companies treat the ISO 13485 certification milestone as a trophy. A trophy that allows your organisation to immediately start thinking about the next milestone - getting your medical device certified so commercialisation can begin! It is not wrong to view the overall schedule in this light, as the interest of all businesses is to start selling as early as possible. However, if you speak with any experienced consultant or use suitable QMS software, you will realise that setting up a good business structure goes beyond meeting the ISO 13485 requirements.  It's a continuous process to incorporate the best industry practices! This brings us to the next two points.
 

4. I'll leave compliance to my QA team to handle. I'll rather focus my time on developing the product.

If you dive deeper into the ISO 13485 requirements, you will realise it encompasses the requirements of the management, training (HR), purchasing, sales, customer feedback, product development, manufacturing on top of other quality related ones. So you may have to think twice about leaving this responsibility to the QA team to handle it. In fact, the management has to set the drive for it!
 

5. Compliance/documentation is a chore.

A business structure that is poorly set up, e.g., documents that does not describe how the organisation runs its daily operations or one that requires too much time and effort to maintain, will definitely become a chore for the team.  Eventually, the team will be maintaining two workflow of the same process – one that is used daily and the other one that is just used to meet compliance. This is bad, but it does not have to be if you have the right mentality from the start!

The Recommendation for you

If you are facing any of the scenarios above or have any other regulatory challenges throughout your startup journey, we would be happy to hear more about it!

In collaboration with our consulting partner MT Promedt Consulting and supported by NUS Enterprise, we have organised the following event to reach out to every one of you:
 

Regulatory Compliance Clinic
An exclusive 1-to-1 session with Dr Michael Rinck (MD of MT Promedt Consulting GmbH), Jason Lim (CEO of Stendard) and your team
Date: 6th & 7th March 2017
Time: 1 hour per team (to be allocated after sign-up)
Venue: NUS Enterprise@Blk71 (71 Ayer Rajah Crescent, #02-01, Singapore 139951)
Price: Complimentary
 

Who should sign up?

  • Medical device companies looking to achieve ISO 13485 certification or meet US FDA requirements,

  • Looking to expand into larger markets like Europe (CE Marking) and the U.S.,

  • Any medical device companies with regulatory issues and require advices from the industry experts,

  • Any potential startups looking to dive into the medical device sector.

All of you are welcomed to sign up using the form below! Each team will be allocated one hour for an in-depth discussion with our panels, so the slots are limited. Do express your interest as soon as possible to avoid any disappointment!


About Dr Michael Rinck

Dr. Michael Rinck is the founder and managing director of MT Promedt Consulting, a German consulting company specialised in regulatory affairs, quality management systems, CE marking and international product registrations for medical devices, IVDs and combination products. He is a regulatory specialist with strong scientific background in microbiology possessing a Diploma and a Ph.D. in Microbiology from Technical University Berlin and a License in Pharmacy. He has conducted research in antimicrobial coating, biomaterials and sterilisation technologies and developed and implemented these into routine manufacturing processes. As an independent consultant with over 25 years of international experience, he was responsible in several positions for R&D, quality control, manufacturing and QA/RA for major health care companies.

About Mr Jason Lim

Mr Jason Lim is the CEO and co-founder of Stendard, a cloud based software that simplifies the process for medical device companies to fulfil international regulations, such as ISO 13485 and US FDA 21 CFR, before products are approved for commercialisation. Conventionally, such work is performed manually and is very time-consuming. Stendard is the first to help small businesses achieve compliance in a fast, convenient, scalable and affordable manner.


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