Jon Speer
Founder of Greenlight Guru - Helping medical devices get to market faster with less risk
Hire resource (even if consultant) to do a thorough regulatory strategy. Hire someone to address quality system. But don't worry about building the entire QS right away. Bootstrap it, focusing on elements that are needed (e.g. design control, risk management, supplier control). Be sure the QS resource has other valuable skills too to assist with other startup needs.

Throughout development, have regulatory resource "check in" from time to time. As you approach a submission, this resource should start to look more and more like a full time regulatory employee. Same with quality.

Adolfo Menendez
Design Assurance Engineer at Mindlance
What is 'necessary' should be based on the company goals/objectives? Which regulated markets are you intending to sell the product in? As the numerous suggestions provided illustrate, a viable option to get started is to use regulatory consultants. At some point, for some markets, it may be more practical and/or cost effective to have some 'regulatory employees' to craft and/or implement a suitable quality management system (e.g. policies, procedures, processes, etc) for quality assurance in product development, manufacturing, customer service, etc. For management reviews, quality inspections and/or audits, who would be the management representative that sits with the inspector and/or auditor to review compliance if not the 'regulatory employees'; the alternative would be to have an on-site regulatory consultant(s), essentially 'regulatory employees'.
To use a sport metaphor, if you have an all-star quarterback and receivers, is it really necessary to have blockers? The answer should be yes if you want to the others to be able to succeed at doing what they do best.

Rob Packard
510(k), CE Marking & Quality System Consultant
This is a timely question. For start-up companies that are seeking CE Marking, the consultant approach could be a potential problem in the future. The proposed regulations include a requirement for a "qualified person". Using an Authorized Representative (AR) won't cut it, because the regulation states that the AR should have a person meeting the same qualifications as the company's regulatory compliance person. This requirement is Article 13 of the MDD/AIMD propoal and also Article 13 in the IVD proposal. It will be interesting to see how the various NB's enforce this and how early they start to audit for this.

Jean (Gregory) Bigoney, PhD, RAC, CQE
Regulatory Affairs / Materials Engineering
I think it is also worth talking to a regulatory consultant early in order to develop a regulatory and reimbursement strategy that is consistent with the financial goals. How you approach the FDA to obtain clearance can have a bearing on how CMS classifies your device later on.

Many start-ups focus on getting FDA clearance only and end up blindsided by reimbursement decisions that make it difficult for them to be profitable even with a technologically superior product.

Richard Del Mastro
Director Biomarker Discovery Development at Progenity, Inc.
Agree with all above. Hire a regulatory consultant when you are close to beginning the clinical trials. Get a QA person in now. That covers your QMS part. Make sure your product development team knows how to work in that QMS. Scientists are not trained to work in a regulated environment and continue to work in a research mind set. Getting on top of this from the get go is very important. You must have a R&D leader that knows how to bring that research team into the product development phase and must work closely with the QA person. If you neglect this then you will see extended timelines and costly over-runs. There are many regulatory consultants available. Interview them and make sure that you get one that your team can work with.

Perry Mykleby
Customer Activation, Engagement & Retention
Agreed. There are qualified Regulatory consultancies. One way or the other you've got to have Regulatory. But QA is also a must to put a Quality system in place. You'll need to cover ISO 13485 and 14971 in addition to the quality requirements of the FDA. One consultant may be able to handle both.

Marc Hollingworth
Proven Business Leader in Medical Devices and Healthcare
I agree with Erich. Unless the company is doing significant clinical trials there are many excellent consultants in regulatory affiars out there that can assist them short term.

Erich Coiner
Mechanical Engineer
No. But you should at least have an adviser with deep experience who can sit in on critical review meetings and fill that role.