Class 1 medtech start up and regulatory decisions

[timbro]

Hello all. 1st post. Bear with me. Ok, I am in Australia. I am a clinician and I have developed some devices that are in use in the angiography lab used by cardiologists, radiologists, vascular surgeons, anaesthetists and nurses in a private hospital where I work. I am in the patient positioning space - armboard and a drape support. We use my prototypes in procedures and we use them every day. Quite simple devices that have fixed a problem, but it is a competitive space with established players.
So I believe I have some devices that clinicians like and are easy to use.
My devices are a surgical accessory, so low volume/high cost. Class 1 non-measuring, non-sterile. I have GMDN codes. I am starting this journey in Australia which is a small market, but I am hoping to test the market here. I have IP protection in place in way of provisional patent and design registration.
I am getting some good help with a mentor who has a good network. They have put me in front of a regulatory advisor who tell me i need to find a contract manufacturer in Australia that have ISO13485. 14971 (Risk MAnagement Medical Devices) has also been suggested. I have started talking to manufacturers and they have looked at my regulatory advice and suggest that I don't need 13485. I am in Class 1 so ISO 9001 should be adequate. This is good news as 9001 will be adequate and cheaper. The TGA states as I am in Class 1 my regulatory requirements are lower than Class 2 etc. Does anyone have any thoughts on this?
Established competitors with many more devices than me have 13485. I have seen other devices much more complex than mine with 9001.
I am pre-money. I am trying to establish what the costs are going to be re regulatory, manufacturing, business costs before I pitch to potential investors.
Any thoughts are greatly appreciated, or questions if clarification needed.
Thankyou

 

[yodon]

If you're going for ISO certification, I would suggest that having 13485 would be more beneficial to you in the long run than having just 9001. It's not that big of a leap in terms of processes but puts you in better alignment with global expectations for a device company. While costs to implement a QMS might be similar between 9001 and 13485, there may be higher costs for audits and certification so I don't want to imply they're similar in all respects.

14971 is in kind of a gray area for Class I (effectively very little risk). I still typically recommend it for customers with Class I devices - it shows they've done their due diligence on risk / risk management (however little there may be).

Another standard you may want to consider is IEC 62366 (Usability Engineering). UE is getting a much closer look these days from regulatory bodies. And I feel that proper application will help you build a more user-friendly, user-adoptable device. Since your devices are already in use, you may already have good usability information, though.

 

[Ed Panek]

I have a medical device developed under an ISO 9001 QMS is much less impressive than I have a medical device developed under an ISO 13485 QMS.

Messaging is important for a start-up company. Investors will probe for weaknesses and risks so I would invest in ISO 13485 and lower the real or perceived risks of stakeholders.

 

[timbro]

Thankyou for your reply. This is all good information for me. It is all a fascinating process and a privilege to have this opportunity. Reading between the lines, and as you point out, 13485 is more beneficial in the long run. I have one shot at this and it is all dependent on investors, therefore having 13485 will lower risks for investors as Ed pointed out in his reply.
I will have a look at IEC 62366 also. Thanks again, Tim

If you're going for ISO certification, I would suggest that having 13485 would be more beneficial to you in the long run than having just 9001. It's not that big of a leap in terms of processes but puts you in better alignment with global expectations for a device company. While costs to implement a QMS might be similar between 9001 and 13485, there may be higher costs for audits and certification so I don't want to imply they're similar in all respects.

14971 is in kind of a gray area for Class I (effectively very little risk). I still typically recommend it for customers with Class I devices - it shows they've done their due diligence on risk / risk management (however little there may be).

Another standard you may want to consider is IEC 62366 (Usability Engineering). UE is getting a much closer look these days from regulatory bodies. And I feel that proper application will help you build a more user-friendly, user-adoptable device. Since your devices are already in use, you may already have good usability information, though.

 

[timbro]

I have a medical device developed under an ISO 9001 QMS is much less impressive than I have a medical device developed under an ISO 13485 QMS.

Messaging is important for a start-up company. Investors will probe for weaknesses and risks so I would invest in ISO 13485 and lower the real or perceived risks of stakeholders.

Thanks Ed, agree with you on this.